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NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]
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FDA opens review of CAR-T safety after identifying 19 cases of post-treatment blood cancer
endpts.com
I said this years ago in this thread that Cart-T, a new class of cancer treatment, the most fashioned and most chased after in the Wall Street is very dangerous. Now FDA finally wakes up.
DCVax (murcidencel) is the future of cancer treatment !
FDA opens review of CAR-T safety after identifying 19 cases of post-treatment blood cancer
The FDA is reviewing the safety of CAR-T therapies after reports of patients who developed blood cancers following treatment with the products, an inquiry that’s almost certain to raise questions ...
endpts.com
I said this years ago in this thread that Cart-T, a new class of cancer treatment, the most fashioned and most chased after in the Wall Street is very dangerous. Now FDA finally wakes up.
DCVax (murcidencel) is the future of cancer treatment !
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For those of you who believe "Third time's a Charm," now is the opportunity of buying or adding shares.
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The short have covered more than 9.1 million shares while price has continually depreciated. How can the short do it? Manipulation. I have locked additional shares to roast these bastards when the time comes.
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MAA submission next week? btw a refresh of the trial data while we are waiting.
medicine.net
Phase 3 clinical trial: Brain cancer vaccine shows promising results - Medicine.net
byKing's College LondonOverall Survival for Patients With Recurrent Glioblastoma Kaplan-Meier plot comparing overall survival for patients with recurrent glioblastoma treated with autologous
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A huge milestone -- MAA finally submitted.
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Or
www.prnewswire.com
Northwest Biotherapeutics Announces That A Marketing Authorization Application Has Been Submitted To The UK MHRA For DCVax®-L For Glioblastoma
/PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor...
www.prnewswire.com
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Back from holidays and recover from flu thanks to crowded airplanes. It's the first one I got for years even not in the Covid Pandemic! Nothing to see except depressed price. After MAA submission, manipulators would have an easy job to do what they want to since we are in the darkness waiting for the decision by UK MHRA on the MAA. Below are two pieces posted from fellow longs:
The first piece courtesy of starric (note the page 3 and 4):
The second one courtesy of sentiment_stocks regarding the lawsuit against the 7 market makers:
I finally had a chance to read through the 85 page Report and Recommendation written by US Magistrate Judge Gary Stein. If I had to sum it up in one sentence, I’d say it was about 68 pages of love for the Plaintiff (Northwest) and about 17 pages of what is needed to repair it to make the dismissal an entire R&R statement of love.
I doubt that everyone has had a chance to read through the document, or even have access to it, but I would recommend that interested shareholders do so if they’re able. You can download the R&R at Pacer.
I took notes as I read through the R&R, for my own purposes, but also to provide them here to you, in the event that you are interested. A great deal of what I’ve noted below is taken directly from the document (I tried to remember to quote those sections); while some of this are just my own impressions of how the document reads.
Notes as follows:
The US Magistrate is recommending that the MTD be granted for Northwest’s failure to plead “loss causation” and that Northwest be given leave to re-plead. This is not a decision on the MTD, but rather a Report and Recommendation.
OTC Link Data:
Court does not consider this material on the MTD (page 20)
Defendants contend that the Plaintiffs “cherry picked” data that was favorable to it. Court believes the Defendants argument would stretch the “integral-to-the-complaint” doctrine beyond its proper bounds and so the argument is rejected. (Page 21)
Me: It’s interesting because the defendant states that the OTC Link Data disproves the Plaintiff’s allegations, whereas the Plaintiff claims that data from OTC Link proves their case. If neither claim can be proven at this time … which presumably Discovery would help to determine … then this argument seems to merit moving on to discovery to support or not support the interpretation of this data.
Defendant asks the Court to consider and analyze the OTC Link data to establish the truth of their assertions, which is NOT the province of the Court on an MTD. (Page 26)
And then the Court notes that the Defendants proceed to cite cases that do not even support their position (that the Court should establish this truth). (Page 26 and 27)
1. Adequacy of First Amended Complaint (FAC) Allegations
Court finds the Defendants arguments against the FAC’s allegations and standards governing a MTD claiming the Defendants were engaged in a manipulative act… unconvincing. ( page 35); and that the Defendants “mischaracterize(s)” the FAC” (page 36).
Defendants use a straw man type of argument to claim that the FAC fails to claim that Baiting Orders were placed and cancelled by the same client, and that this is fatal to the Plaintiff claiming a manipulative act. Yet the judge points out that the Plaintiff never made such a pleading in the FAC (hence a strawman argument) and that instead it may have been executed by the Defendants for their own accounts or for client accounts. So because Northwest never even stated that the Defendants were following their clients’ instructions, the Defendants version of the facts cannot be resolved on a MTD; nor is it is relevant to the Plaintiff’s theory of the case as the case instead focuses on the Defendants’ control over the high-speed trading algorithm and their responsibility to monitor such algorithms. (Page 40)
Regarding the Defendants’ argument that 95% of all placed orders are canceled in the market… that still does “nothing to explain the frequent pattern of spoofing alleged in the Complaint.”
Re: “Parking” allegations, the Court cannot consider the Defendants’ trading data on this MTD, and whether the Plaintiff can ultimately prove the Defendants parked their buys and sells behind others in front of them must await a summary judgement or trial.
In the Eighth argument, the Defendants argue that the FAC failed to allege the number of so-called Baiting Orders in each time frame of the time of each order, and often fails to allege the price and volume of each order. Yet the judge points out that the FAC indeed does includes 16 “Example Episodes” offering all of the details that the Defendants claim the Plaintiffs did not do. The Court finds these 16 allegations are more than sufficient at the pleading stage. (Page 44)
Regarding the Defendants claim that the FAC is insufficient because it alleges that the Defendants placed and then cancelled these orders within one or two minutes rather than “milliseconds” that they (the Defendants) suggest is required for spoofing… the judge states that the Defendants are mischaracterizing the allegations in the FAC. Instead, the FAC clearly states, that the Baiting Orders were w/in “one to two minutes, and at times seconds and even milliseconds.” And in the 16 Example Episodes contained in the the FAC, the Plaintiff alleges that the Defendants began cancelling the buys or sells either in milliseconds, or in less than five seconds after the Executing Purchase were made.
2. Effect on the Market for NWBO
The judge finds that the defendants’ argument that the Plaintiff insufficiently pled that the Defendants’ activity depressed the price of its shares as “unpersuasive.”
Court disagrees with Defendants’ assertion that Plaintiff’s price decline formula always generates a negative number. He does however note that the Plaintiff’s formula may be biased toward generating a negative number. (Page 48)
But the judge suggests that the Plaintiff’s price decline formula is best left to the expert analysis and should not be resolved by the Court at the MTD stage.
The judge also notes that the FAC changed the time of the best bid and offer (as they were originally presented in the original Complaint.) (Page 50)
Yet despite this change (and it’s not clear to the Court why this change was made), the Court still maintains that the Plaintiff’s allegations support the inference that the spoofing drove down the stock price during the Spoofing Episodes and therefore had an effect on the market for NWBO stock. (Page 52)
Scienter
Regarding Scienter, the Court finds that a “scheme to take advantage of depressed prices” suffices to plead scienter under a motive and opportunity theory.
Defendants claim that a total of just $94k is the total “discount” the Defendants would have made from the thousands of Spoofing Episodes in Exhibit 1 (over a 5 year period). And while its “difficult to prove intent to deceive if Defendants did not make any money off their alleged spoofing”, the court finds their argument “unpersuasive at this stage of the litigation”. The Court also notes that while “profits from a single episode may be minuscule, spoofers can generate substantial returns by repeating the scheme thousands of times across the same and different issuers’ securities.”
To that point, the Court also states that the Defendants’ metrics “understate the potential profitability of the alleged spoofing in several ways. First, while Northwest only lists 7.4mm shares in their Exhibit 1, their case “alleges that Defendants placed Executing Purchases for ‘a total of 19,300,908 shares’ below the prevailing best offer.” The Court then goes on to state that, “at its height, the alleged schemes were generating gains at a substantially higher rate than Defendants’ calculation of less than $3,000 per year per Defendant”. (Page 57)
Next, the Court doubles down on the issue of the MMs working on behalf of their clients and how that takes away any motive on the part of the Defendants, stating that while they may have traded on behalf of their clients, the FAC also alleges that they designed and operated the algorithms that spoofed Northwest’s stock. (Page 59)
The Court finds in their filing that the Plaintiff’s have adequately alleged the Defendants had an economic motive to engage in the alleged spoofing. The Court also points out the Defendants also had the opportunity as market makers and sophisticated trading firms to do so. (Page 59)
The “Court also concludes that the circumstantial evidence of a conscious spoofing scheme, when viewed holistically and together with the allegations of motive and opportunity, established the requisite strong inference of an intent to manipulate the market - one that is cogent and at least as compelling as the inference that Defendants were simply engaged in legitimate trading activity.” (Page 64)
The Court also provides in footnote 28 that the “financial literature suggests another reason why Defendants did not need to coordinate a spoofing scheme: their algorithmic trading programs can do it for them. A recent study found that algorithms can ‘learn to coordinate their spoofing when they learn together,’ even without human intervention. This is known as “algorithmic collusion.” (Page 64 - PacerMonitor Document View - 1:22-cv-10185 - Northwest Biotherapeutics, Inc v. Canaccord Genuity LLC et al, Docket Item 137)
Loss Causation
It’s on the issue of Loss Causation that the MTD is recommended, unless the Plaintiff repleads the case. The Defendants argue that the Plaintiff allegations fail to plead loss causation under either of the two theories presented (from Gamma Traders).
Temporal Proximity
Northwest argues that it traded so close in time to Defendants’ spoofing as to permit the court to “infer as a matter of common sense that the market prices were artificial” when traded. An issue for the Court is that when the alleged Spoofing Episodes occurred and ended, the closing price from which the NWBO sale price was “purported “formulaically derived.”
The Court states that nowhere does the Plaintiff explain what it means when it says that the “sale price was formulaically derived from the closing price.” And in the absence of an explanation in the FAC, it is impossible to tell what is meant. (Page 67)
The Court then notes that pleading that one or more Spoofing Episodes took place on a day whose closing price factored into the determination of NWBO’s sale of its shares does not, by itself, establish loss causation with respect to that sale. (Page 68)
And while the Plaintiff’s counsel provided further color in the oral argument, the figures are nowhere in the FAC, nor is their origin explained. The Court reviewed the Exhibit 1 further and found that an alleged Spoofing Episode on Feb 25, 2021 involving an Executing Purchase at 3:58:35 - 85 seconds before the 4:00 pm market close. This spoofing episode is associated in the Plaintiff’s loss causation chart with NWBO stock sales aggregating 302k shares on March 2, 2021. Therefore, the Court assumes the accuracy of the counsel’s representations… for now. (Page 69)
The Court then assumes that if the formulaic connection of the 30 instance in the Plaintiff’s chart to the pricing dates and the sales price all occurred within an hour of the market’s close is properly pled, then the Plaintiff’s claims are sufficient to please loss causation under the temporal proximity theory outlined in Gamma Traders. (Page 70)
The Court indicates that the Plaintiff has alleged enough facts to support a common-sense inference that NWBO’s stock price remained artificially depressed at the close of trading on the Pricing Dates in question. However, (and this is the important part) to complete the circle of causation, the Plaintiff must plead in an amended complaint “a sufficient explanation as to how the various stock sale prices were ‘formulaically derived’ from the closing prices on the days when Spoofing Episodes took place.” (Page 71)
Finally, “the Court finds that NWBO has sufficiently alleged loss causation based on the temporal proximity between the spoofing and stock sales in the case of the 30 asterisked transactions in the chart in Paragraph 289, provided it submit an amended complaint adequately explaining how the sales prices were “formulaically derived” from the relevant closing prices”.
The Court goes on to state that while Harrington’s case did show a drop in price over the relevant period of time (from $28.03 to $3.13), NWBO price actually increased during the relevant period (from $0.26 to $0.70). The Court finds, then that at most, the Plaintiff’s “allegations suggest a theoretical possibility of a long-term price impact from spoofing.”
The Court thinks that while the "Plaintiff’s allegations suggest a theoretical possibility of a long-term price impact from spoofing”, that “is not enough. Plaintiff must allege sufficient facts to ‘nudge their claims across the line from conceivable to plausible.” (Page 79)
Market Efficiency
While the Court thinks that NWBO (the Plaintiff) could have done a better job of pleading market efficiency, the Court notes that “it has pled enough to satisfy its burden under Rule 8. NWBO’s failure to specifically allege coverage by securities analysts “is not fatal at the pleading stage.” (Page 83). The Court also notes that determining whether a market is efficient “normally should not be decided on a motion to dismiss. (Page 84)
Conclusion
While the Court is recommending that the MTD be granted, IF the Plaintiff were to amend the complaint to cure the deficiencies in the FAC (which Northwest is doing), IT WOULD NOT BE FUTILE.
Please note: All words capped are my emphasis.
And that’s it! Hope that helps.
The first piece courtesy of starric (note the page 3 and 4):
The second one courtesy of sentiment_stocks regarding the lawsuit against the 7 market makers:
I finally had a chance to read through the 85 page Report and Recommendation written by US Magistrate Judge Gary Stein. If I had to sum it up in one sentence, I’d say it was about 68 pages of love for the Plaintiff (Northwest) and about 17 pages of what is needed to repair it to make the dismissal an entire R&R statement of love.
I doubt that everyone has had a chance to read through the document, or even have access to it, but I would recommend that interested shareholders do so if they’re able. You can download the R&R at Pacer.
I took notes as I read through the R&R, for my own purposes, but also to provide them here to you, in the event that you are interested. A great deal of what I’ve noted below is taken directly from the document (I tried to remember to quote those sections); while some of this are just my own impressions of how the document reads.
Notes as follows:
The US Magistrate is recommending that the MTD be granted for Northwest’s failure to plead “loss causation” and that Northwest be given leave to re-plead. This is not a decision on the MTD, but rather a Report and Recommendation.
OTC Link Data:
Court does not consider this material on the MTD (page 20)
Defendants contend that the Plaintiffs “cherry picked” data that was favorable to it. Court believes the Defendants argument would stretch the “integral-to-the-complaint” doctrine beyond its proper bounds and so the argument is rejected. (Page 21)
Me: It’s interesting because the defendant states that the OTC Link Data disproves the Plaintiff’s allegations, whereas the Plaintiff claims that data from OTC Link proves their case. If neither claim can be proven at this time … which presumably Discovery would help to determine … then this argument seems to merit moving on to discovery to support or not support the interpretation of this data.
Defendant asks the Court to consider and analyze the OTC Link data to establish the truth of their assertions, which is NOT the province of the Court on an MTD. (Page 26)
And then the Court notes that the Defendants proceed to cite cases that do not even support their position (that the Court should establish this truth). (Page 26 and 27)
1. Adequacy of First Amended Complaint (FAC) Allegations
Court finds the Defendants arguments against the FAC’s allegations and standards governing a MTD claiming the Defendants were engaged in a manipulative act… unconvincing. ( page 35); and that the Defendants “mischaracterize(s)” the FAC” (page 36).
Defendants use a straw man type of argument to claim that the FAC fails to claim that Baiting Orders were placed and cancelled by the same client, and that this is fatal to the Plaintiff claiming a manipulative act. Yet the judge points out that the Plaintiff never made such a pleading in the FAC (hence a strawman argument) and that instead it may have been executed by the Defendants for their own accounts or for client accounts. So because Northwest never even stated that the Defendants were following their clients’ instructions, the Defendants version of the facts cannot be resolved on a MTD; nor is it is relevant to the Plaintiff’s theory of the case as the case instead focuses on the Defendants’ control over the high-speed trading algorithm and their responsibility to monitor such algorithms. (Page 40)
Regarding the Defendants’ argument that 95% of all placed orders are canceled in the market… that still does “nothing to explain the frequent pattern of spoofing alleged in the Complaint.”
Re: “Parking” allegations, the Court cannot consider the Defendants’ trading data on this MTD, and whether the Plaintiff can ultimately prove the Defendants parked their buys and sells behind others in front of them must await a summary judgement or trial.
In the Eighth argument, the Defendants argue that the FAC failed to allege the number of so-called Baiting Orders in each time frame of the time of each order, and often fails to allege the price and volume of each order. Yet the judge points out that the FAC indeed does includes 16 “Example Episodes” offering all of the details that the Defendants claim the Plaintiffs did not do. The Court finds these 16 allegations are more than sufficient at the pleading stage. (Page 44)
Regarding the Defendants claim that the FAC is insufficient because it alleges that the Defendants placed and then cancelled these orders within one or two minutes rather than “milliseconds” that they (the Defendants) suggest is required for spoofing… the judge states that the Defendants are mischaracterizing the allegations in the FAC. Instead, the FAC clearly states, that the Baiting Orders were w/in “one to two minutes, and at times seconds and even milliseconds.” And in the 16 Example Episodes contained in the the FAC, the Plaintiff alleges that the Defendants began cancelling the buys or sells either in milliseconds, or in less than five seconds after the Executing Purchase were made.
2. Effect on the Market for NWBO
The judge finds that the defendants’ argument that the Plaintiff insufficiently pled that the Defendants’ activity depressed the price of its shares as “unpersuasive.”
Court disagrees with Defendants’ assertion that Plaintiff’s price decline formula always generates a negative number. He does however note that the Plaintiff’s formula may be biased toward generating a negative number. (Page 48)
But the judge suggests that the Plaintiff’s price decline formula is best left to the expert analysis and should not be resolved by the Court at the MTD stage.
The judge also notes that the FAC changed the time of the best bid and offer (as they were originally presented in the original Complaint.) (Page 50)
Yet despite this change (and it’s not clear to the Court why this change was made), the Court still maintains that the Plaintiff’s allegations support the inference that the spoofing drove down the stock price during the Spoofing Episodes and therefore had an effect on the market for NWBO stock. (Page 52)
Scienter
Regarding Scienter, the Court finds that a “scheme to take advantage of depressed prices” suffices to plead scienter under a motive and opportunity theory.
Defendants claim that a total of just $94k is the total “discount” the Defendants would have made from the thousands of Spoofing Episodes in Exhibit 1 (over a 5 year period). And while its “difficult to prove intent to deceive if Defendants did not make any money off their alleged spoofing”, the court finds their argument “unpersuasive at this stage of the litigation”. The Court also notes that while “profits from a single episode may be minuscule, spoofers can generate substantial returns by repeating the scheme thousands of times across the same and different issuers’ securities.”
To that point, the Court also states that the Defendants’ metrics “understate the potential profitability of the alleged spoofing in several ways. First, while Northwest only lists 7.4mm shares in their Exhibit 1, their case “alleges that Defendants placed Executing Purchases for ‘a total of 19,300,908 shares’ below the prevailing best offer.” The Court then goes on to state that, “at its height, the alleged schemes were generating gains at a substantially higher rate than Defendants’ calculation of less than $3,000 per year per Defendant”. (Page 57)
Next, the Court doubles down on the issue of the MMs working on behalf of their clients and how that takes away any motive on the part of the Defendants, stating that while they may have traded on behalf of their clients, the FAC also alleges that they designed and operated the algorithms that spoofed Northwest’s stock. (Page 59)
The Court finds in their filing that the Plaintiff’s have adequately alleged the Defendants had an economic motive to engage in the alleged spoofing. The Court also points out the Defendants also had the opportunity as market makers and sophisticated trading firms to do so. (Page 59)
The “Court also concludes that the circumstantial evidence of a conscious spoofing scheme, when viewed holistically and together with the allegations of motive and opportunity, established the requisite strong inference of an intent to manipulate the market - one that is cogent and at least as compelling as the inference that Defendants were simply engaged in legitimate trading activity.” (Page 64)
The Court also provides in footnote 28 that the “financial literature suggests another reason why Defendants did not need to coordinate a spoofing scheme: their algorithmic trading programs can do it for them. A recent study found that algorithms can ‘learn to coordinate their spoofing when they learn together,’ even without human intervention. This is known as “algorithmic collusion.” (Page 64 - PacerMonitor Document View - 1:22-cv-10185 - Northwest Biotherapeutics, Inc v. Canaccord Genuity LLC et al, Docket Item 137)
Loss Causation
It’s on the issue of Loss Causation that the MTD is recommended, unless the Plaintiff repleads the case. The Defendants argue that the Plaintiff allegations fail to plead loss causation under either of the two theories presented (from Gamma Traders).
Temporal Proximity
Northwest argues that it traded so close in time to Defendants’ spoofing as to permit the court to “infer as a matter of common sense that the market prices were artificial” when traded. An issue for the Court is that when the alleged Spoofing Episodes occurred and ended, the closing price from which the NWBO sale price was “purported “formulaically derived.”
The Court states that nowhere does the Plaintiff explain what it means when it says that the “sale price was formulaically derived from the closing price.” And in the absence of an explanation in the FAC, it is impossible to tell what is meant. (Page 67)
The Court then notes that pleading that one or more Spoofing Episodes took place on a day whose closing price factored into the determination of NWBO’s sale of its shares does not, by itself, establish loss causation with respect to that sale. (Page 68)
And while the Plaintiff’s counsel provided further color in the oral argument, the figures are nowhere in the FAC, nor is their origin explained. The Court reviewed the Exhibit 1 further and found that an alleged Spoofing Episode on Feb 25, 2021 involving an Executing Purchase at 3:58:35 - 85 seconds before the 4:00 pm market close. This spoofing episode is associated in the Plaintiff’s loss causation chart with NWBO stock sales aggregating 302k shares on March 2, 2021. Therefore, the Court assumes the accuracy of the counsel’s representations… for now. (Page 69)
The Court then assumes that if the formulaic connection of the 30 instance in the Plaintiff’s chart to the pricing dates and the sales price all occurred within an hour of the market’s close is properly pled, then the Plaintiff’s claims are sufficient to please loss causation under the temporal proximity theory outlined in Gamma Traders. (Page 70)
The Court indicates that the Plaintiff has alleged enough facts to support a common-sense inference that NWBO’s stock price remained artificially depressed at the close of trading on the Pricing Dates in question. However, (and this is the important part) to complete the circle of causation, the Plaintiff must plead in an amended complaint “a sufficient explanation as to how the various stock sale prices were ‘formulaically derived’ from the closing prices on the days when Spoofing Episodes took place.” (Page 71)
Finally, “the Court finds that NWBO has sufficiently alleged loss causation based on the temporal proximity between the spoofing and stock sales in the case of the 30 asterisked transactions in the chart in Paragraph 289, provided it submit an amended complaint adequately explaining how the sales prices were “formulaically derived” from the relevant closing prices”.
The Court goes on to state that while Harrington’s case did show a drop in price over the relevant period of time (from $28.03 to $3.13), NWBO price actually increased during the relevant period (from $0.26 to $0.70). The Court finds, then that at most, the Plaintiff’s “allegations suggest a theoretical possibility of a long-term price impact from spoofing.”
The Court thinks that while the "Plaintiff’s allegations suggest a theoretical possibility of a long-term price impact from spoofing”, that “is not enough. Plaintiff must allege sufficient facts to ‘nudge their claims across the line from conceivable to plausible.” (Page 79)
Market Efficiency
While the Court thinks that NWBO (the Plaintiff) could have done a better job of pleading market efficiency, the Court notes that “it has pled enough to satisfy its burden under Rule 8. NWBO’s failure to specifically allege coverage by securities analysts “is not fatal at the pleading stage.” (Page 83). The Court also notes that determining whether a market is efficient “normally should not be decided on a motion to dismiss. (Page 84)
Conclusion
While the Court is recommending that the MTD be granted, IF the Plaintiff were to amend the complaint to cure the deficiencies in the FAC (which Northwest is doing), IT WOULD NOT BE FUTILE.
Please note: All words capped are my emphasis.
And that’s it! Hope that helps.
GlobeCitizen
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As we know DCVax_L trial results has been published in JAMA Oncology with conclusions that the results are "statistically significant and clinically meaningful." Since then, the positive results have been broadly acknowledged and excitingly welcome in academics and patients advocacy groups. Since New Year 2024, first it is The Lancet, now it is the Nature, both highly prestigious medical publications.
Dendritic cell therapy for neurospoagioma: Immunomodulation mediated by tumor vaccine - Cell Death Discovery
Then when one looks at the share price it's obviously at odds with what the "reality is". So if one believes the market efficiency theory, now it presents a huge deficiency for the market to catch up thanks to market makers manipulation.
To successfully invest in stock market is to find a stock with such a huge deficiency to invest, which is easy to say but difficult to practice. At least it requires patience, toughness and endurance which will ultimately overcome manipulators deeds.
Cheers!
Dendritic cell therapy for neurospoagioma: Immunomodulation mediated by tumor vaccine - Cell Death Discovery
Then when one looks at the share price it's obviously at odds with what the "reality is". So if one believes the market efficiency theory, now it presents a huge deficiency for the market to catch up thanks to market makers manipulation.
To successfully invest in stock market is to find a stock with such a huge deficiency to invest, which is easy to say but difficult to practice. At least it requires patience, toughness and endurance which will ultimately overcome manipulators deeds.
Cheers!
GlobeCitizen
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Expert Financial Analysis and Reporting
Highly Probable UK Approval of DCVax-L in 1H, 2024 Would Be a Crowning Achievement for Northwest Biotherapeutics
POSTED by LARRY SMITH on JAN 10, 2024 • (0)
Membership Subscriptions
Key Points:
On December 21, 2023, NWBO announced that it had submitted its MAA seeking regulatory approval for DCVax-L in the UK.
The Company requested that MHRA review DCVax-L using the accelerated pathway and, in this report, I go over the reasons why I think the MHRA will do so. (The section in this report titled “Under the UK’s Early Access to Medicines Program, MHRA Review Could Be Swift” explains my thinking in detail.)
Under the accelerated pathway, the MHRA commits to reviewing the application in 150 business days or less. This indicates a decision on approval at the latest could come by mid-July, 2024. I think it could be meaningfully sooner.
I believe that the MHRA will not make any public statement on whether DCVax-L is being reviewed under the accelerated pathway nor will it make any comments during the review period. This is not how regulatory agencies work.
My conclusion about accelerated approval for DCVax-L is supported by the agency’s actions with the rapid approval of Pfizer’s COVID vaccine Comirnaty. Initial data was submitted to MHRA on October 1, 2020 and conditional approval was granted on December 2, 2020. Pfizer only issued one press release on the review process and this was on December 2, 2020, the day on which Comirnaty was approved.
The next we will hear from MHRA, in my judgment, is that DCVax-L has been approved or not. I rate the probability of approval at 95%.
Acronyms Used in This Report
This glossary of acronyms may help in reading this report.
CDMO Contract Development and Manufacturing Organization companies provide biopharma companies with comprehensive services ranging from drug development through manufacture. Northwest uses the UK firm Advent BioServices as a CDMO.
EMA The European Medicines Agency (EMA) is the European Union equivalent to the FDA.
GBM Glioblastoma Multiforme is the most aggressive and deadly type of brain cancer, ndGBM is newly diagnosed GBM and rGBM is recurrent. These are the two indications initially being sought by Northwest Biotherapeutics for DCVax-L
GMP Good Manufacturing Practice is a system required by regulatory agencies for ensuring that drugs are consistently manufactured according to carefully defined quality standards. Guidelines address issues such as process validation, quality assurance assays, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification and others.
MAA Marketing Authorization Application is the document that must be submitted to the MHRA (and other European regulatory agencies) by companies seeking approval for a drug. The MIA is an integral part of this submission. Approval of the MAA allows commercialization. This is the counterpart to the BLA in the US.
MHRA Medicines and Healthcare products Regulatory Agency is the United Kingdom regulatory counterpart to FDA. The two agencies have a close, collegial working relationship. Approval of DCVax-L by MHRA would carry great weight in the FDA’s decision making.
MIA Manufacturer's Importation Authorization is required by the MHRA before a company can manufacture, import or export drugs. To qualify, a manufacturer needs to demonstrate to MHRA that it complies with good manufacturing practices (GMP) and can pass regular GMP inspections of its manufacturing site.
PIP Pediatric Investigation Plan Under applicable UK law, a new medicine that is developed for adult patients must also be tested for potential application to pediatric patients before it can gain approval in the adult population. Approval in the adult population can be granted before such trials are started at the discretion of the MHRA.
SOC Standard of Care is the currently accepted treatment regimen for a disease. In the case of GBM, this is surgical resection followed by radiation and then the chemotherapy drug temozolomide following.
SAP Statistical Analysis Plan describes how the quantitative or qualitative data collected in a trial will be statistically handled.
Catalyst For This Report
Northwest Biotherapeutics issued a press release on December 21, 2023 announcing that it had filed its MAA seeking approval in the UK for DCVax-L in adult patients with either newly diagnosed or recurrent glioblastoma. The submission of the MAA is a critical step. Approval would validate that NWBO’s dendritic cell vaccine technology is a major advance in the treatment of not only GBM but potentially all solid tumors. This could propel NWBO to being one of the most exciting stories in biotechnology over coming years and decades, possibly the most exciting.
Investment Overview
In this report, I don’t discuss a specific price target. It is intuitively obvious that MHRA approval of DCVax-L for GBM would have an extremely positive impact on the stock, possibly increasing the stock price to multiples of the current price. And yet, this is only the beginning of the investment story. The mode of action for dendritic cell vaccines of which DCVax-L is the first, holds the promise for meaningful effectiveness in all resectable solid tumors. Hence the potential pipeline for DCVax-L beyond GBM is staggering. Management has indicated that NWBO plans to pursue clinical development of DCVax-L or other types of dendritic cell vaccines in potentially all types of resectable solid tumors-ovarian, lung prostate, breast, et. al. This is an immense addressable market.
New indications will be addressed not only by dendritic cell vaccines as a single agent as is common in cancer therapy, but also in combination with other oncology drugs. As one very promising example of the potential for combinations, an unpublished phase 2 trial has been performed in 24 GBM patients at UCLA in which DCVax-L was combined with Merck’s checkpoint inhibitor Keytruda and polycytidylic acid (poly IC). Kaplan Meiers statistical analysis projected that 50% of patients would survive eight years. This is remarkable when viewed against a five year survival for SOC of 5%. The phase 3 trial of DCVax-L plus SOC showed five year survival of 13% which itself was remarkable as compared to SOC. It seems probable that Merck will be looking to do more extensive combination trials with Keytruda involving DCVax-L and poly IC.
These promising/ spectacular results could also induce some of the other manufacturers of check point inhibitors to undertake combination trials with DCVax-L. Regeneron, Roche and Bristol-Myers Squibb all come to mind but there are others. Combinations with many other types of oncology drugs are also probable. Let me re-emphasize that the mechanism of action of dendritic cell vaccines means that they potentially could be effective in all resectable solid tumors. So, there are a vast number of potential cancer targets and combinations with other drugs to be pursued.
UK Approval Would Transform Northwest Biotherapeutics into A Premier Commercial Stage Biotech
Approval in the UK is a critical starting point for the global clinical development and commercialization of DCVax-L and future products based on the dendritic cell vaccine technology. A validation accorded by UK regulatory approval would have very positive consequences.
The EMA and FDA both have great respect for the MHRA that should lead to a positive perspective and would likely expedite their regulatory reviews. Moreover, there is an urgent need for improved therapy in GBM as no new drug has been shown to meaningfully extend survival in ndGBM since temozolomide in 2005 and for rGBM since the mid-1990s with the Gliadel wafer. UK approval would likely result in considerable pressure on EMA and FDA from advocacy groups for expedited review.
Canada has a very close working relationship with the UK which could lead to approval not long after the UK.
The commercial approval of the Sawston GMP cell manufacturing facility affords the capability of GBM patients anywhere in the world to send their resected tumor tissue and autologous cells to Sawston to have their personalized vaccine manufactured and then shipped back. Administration of the vaccine is a simple intradermal injection that can be administered in an out-patient setting. So even before approval in a given country, patients anywhere in the world potentially would be able to access DCVax-L on a compassionate use basis.
NWBO disclosed in its recent 10-Q that it was in discussions for collaborations for clinical trials in which DCVax-L would be combined with other therapies. UK approval would greatly accelerate these discussions.
The wolfpack’s criminal conspiracy to manipulate the stock price of NWBO with a purported goal of driving NWBO into bankruptcy would be thwarted.
Numerous ways to access capital on favorable terms through collaborations and non-dilutive types of financings would be opened up.
This would likely engender widespread investor enthusiasm and extensive Wall Street analyst coverage.
History will look back at Linda Powers’ decision to focus the limited resources of NWBO to first gain regulatory approval in the UK as a brilliant decision.
Critical Components of the MAA
The MAA filing comprises a staggering amount of information and there are many requirements to satisfy. However, I believe that the three most critical requirements that NWBO must meet in order for DCVax-L to obtain MHRA registration have been met. This is what gives me such great confidence that the MHRA will move quickly to approve DCVax-L. These are:
Conducting a clinical trial that demonstrates efficacy as defined in a statistical analysis plan (SAP) approved by the MHRA. This box is checked as ten days after the SAP was filed, the MHRA published on its website that it had accepted the SAP. This means that the MHRA review will be based on evaluating the primary endpoint of mOS in ndGBM and the secondary endpoint of mOS in rGBM using matched contemporaneous external controls (independently selected by outside experts). Phase 3 results as reported in a peer reviewed article in JAMA Oncology showed that these endpoints were reached with extremely impressive p values. The p-value for mOS in ndGBM was <0.002 and the p-value in rGBM was <0.001.
Approval from MHRA for commercial manufacturing of DCVax-L at the Sawston facility was obtained on March 20, 2023 following a three year process of preparations. This is a prerequisite for filing an MAA. Manufacturing issues pose a major challenge for emerging biotechnology companies and very frequently can be the cause of significant delays in approval. One year ago, I was more worried about a problem with manufacturing arising that could delay approval than I was with whether the MHRA would view favorably the clinical trial data. Not now.
MHRA approval of clinical trial plans for pediatric trials in GBM was issued on August 16, 2022. This is also a prerequisite for filing an MAA. The PIP uses the same criteria as that for the adult GBM trials. The primary endpoint is mOS in ndGBM and the secondary endpoint is mOS in rGBM using matched contemporaneous external controls.
Under the UK’s Early Access to Medicines Program, MHRA Review Could Be Swift
The submission of the MAA was a material event for Northwest that under securities laws required public disclosure. This means that in order to issue the press release, the Company had to receive confirmation from the MHRA that the MAA had been received. Northwest also requested that DCVax-L be reviewed under the MHRA’s rapid 150-day review pathway, which the agency has established for new, breakthrough medicines that address serious unmet medical needs.
I do not expect MHRA or NWBO to make any public statements about the pathway to a final decision or the details of the MAA review process now underway. Giving updates is just not how regulatory review works. The review period will involve many broad ranging interrogations and discussions between the MHRA, NWBO and the company’s various contractors and consultants. The very nature of the process involves highly confidential material of the agency, NWBO and myriad consultants, vendors, manufacturers and trial sites. All exchanges will be highly confidential. In my opinion, the next news we will hear from the Company and the MHRA is the final outcome of the whole process which will be a decision to approve DCVax-L or refuse to approve it. As previously stated, I rate the probability of approval as 95%.
I believe that MHRA will review DCVax-L under the rapid 150-day review pathway. Let me start with some background. In April 2014, the MHRA launched a new initiative called the Early Access to Medicines Program. The intent was to offer severely ill patients with life-threatening and seriously debilitating conditions the lifeline of providing access to ground-breaking new medicines much earlier than they would be the case with traditional review procedures.
Following an assessment of early clinical data, MHRA can designate a new drug as a Promising Innovative Medicine (PIM). This signals to a company that its development plan is on the right track and that its product could be a candidate for the Early Access to Medicines Scheme, when further development work has been conducted. This early boost to a drug’s potential is expected to be beneficial to companies, especially small and medium-sized enterprises, who can struggle to attract capital from investors during drug development. This is a key component of the strategy to make the UK a major center of biotech innovation by expediting approval of breakthrough drugs. It is extremely impressive that DCVax-L was the first drug out of all of biopharma to be awarded the (PIM) designation.
The MHRA will not make a public statement as to whether DCVax-L will be reviewed under the rapid 150 day pathway. However, there are several strong indications that it will use this pathway:
The designation of DCVax-L as a Promising Innovative Medicine is obviously critical. Because this was the first such drug to be so designated, I would expect that MHRA has been closely following and is up to date on its clinical development.
The SAP for the phase 3 trial stated that the primary end point was mOS in ndGBM, the secondary endpoint was mOS in rGBM and used contemporaneous external controls. Only ten days after submitting the SAP, MHRA announced on its website, that it was accepted. This indicates that the MHRA is comfortable with the design of the trial and its SAP.
The MHRA approved the Sawston plant for commercial production of DCVax-L which is a prerequisite for product approval. This involved extensive interaction with the agency. Very importantly, this was only the third facility in the UK approved for commercial cell therapy manufacturing.
The MHRA granted a license for the import and export of living cells and tissue for Sawston. Tumor tissue and autologous cells necessary for the manufacturing of DCVax-L can be imported from anywhere in the world, processed into the final product and exported back to the point of origin. This means that Sawston can be used to provide product for worldwide commercialization.
Before an MAA can be approved for use in adults, a company must submit and receive approval for a plan for pediatric studies. NWBO submitted its proposed PIP to the MHRA in February 2022 and received approval on August 16, 2022. This prompt response is encouraging.
A compassionate use or Specials program in the UK has been led by Dr. Keyoumers Ashkan, the lead European investigator for the phase 3 trial of DCVax-L. He is a top neuro-surgeon at King's College Hospital, the premier teaching hospital in the UK and Dr. Ashkan is one of the most respected neurosurgeons in the UK. This compassionate use program conducted at Kings College affords important data on real life experience. Based on his clinical experience, Dr. Ashkan believes that DCVax-L is a major therapeutic advance in the treatment of glioblastoma and should become part of standard of care. Such a strong endorsement from such a highly respected physician with extensive hands on experience could carry weight with MHRA. It seems highly probable that MHRA has closely followed this Specials program.
The MHRA has shown that it can move swiftly to approve drugs under the Early Access scheme. The Pfizer covid vaccine was approved on December 1, 2020. This was 60 days after the first efficacy data was submitted to MHRA.
Brief Review of the Extremely Positive Phase 3 Trial Results for DCVax-L
I previously commented on the results of the phase 3 trial of DCVax-L, but I will briefly repeat and then elaborate on the results. The primary endpoint specified in the SAP was mOS in ndGBM that was achieved with p<0.002; the secondary endpoint under the SAP was mOS in rGBM that was achieved with a p<0.001.
Perhaps more important, there was a powerful survival tail in ndGBM which showed 13.0% of patients alive at five years versus 5.7% for SOC. This is every bit as impressive as survival tails for the checkpoint inhibitors in recurrent non-small cell lung cancer and recurrent melanoma, aggressive cancers which are roughly equivalent to glioblastoma in terms of expected patient survival. Note that it was the demonstration of the survival tail that was key to Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo becoming multi-billion dollar drugs.
The survival tail for DCVax-L in rGBM showed that at 30 months after tumor recurrence, 11.1% of GBM patients were alive versus 5.1% in the control arm. No drug has demonstrated a survival benefit in rGBM since the Gliadel wafer which was developed in the mid-1990s.
Very importantly, DCVax-L has an extremely favorable side effect profile as almost all side effects are minor. Virtually all other cancer therapies have dangerous, life threatening side effects. This enormously increases the benefit to risk ratio for DCVax-L in both an absolute and relative sense. It is also dosed with simple intradermal injections which can be administered in an outpatient setting, i.e. a physician’s office. Many other oncology drugs require lengthy intravenous infusions which are not always available in an outpatient setting.
Having read this, you may ask why I don’t assign 100% probability of approval? Well, nothing in life carries 100% certainty.
More Detail on the Pediatric Investigation Plan (PIP)
Under applicable UK law, a new medicine that is developed for adult patients must also be tested for potential application to pediatric patients before it can gain approval in the adult population. NWBO was required to develop an overall plan to evaluate the safety and efficacy in pediatric patients. The PIP had to include all aspects required for approval, such as the patient population, eligibility criteria, stage of disease, treatment regimen, trial design and endpoints.
NWBO announced on August 16, 2022 received approval from the MHRA for the PIP This was based on two proposed clinical trials: one for ndGBM patients and one for rGBM patients. In each of the two pediatric trials, 24 patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult GBM patients. As in the adult clinical trials, the primary endpoint for each trial will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The matched external controls will be identified using the same methodology as was used to pre-specify the matched external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
The final regulatory approval of the PIP must be obtained before a sponsor may submit an MAA for approval to commercialize a new medicine for adult patients. The approval may include a deferral allowing the pediatric clinical trials to actually be carried out after the MAA has been submitted, but the PIP approval itself must have been received before an MAA can be filed and go through compliance check.
Ordinarily, a PIP must go through a series of stages of regulatory review and comment to reach a final approval, a process that can typically take more than a year. In the case of NWBO, the company worked with expert consultants for months to develop a PIP which was submitted to the MHRA in February 2022. Approval was granted six months later on August 16, 2022. The speedy approval is encouraging and hopefully presages the speed with which MHRA will review the MAA.
The Critical Importance of Approval for Commercial Manufacturing of DCVax-L at Sawston UK GMP Facility
NWBO announced on March 20, 2023 that Advent BioServices (its UK CDMO), had been approved for an MIA license issued by MHRA for commercial manufacturing of DCVax-L and other cell therapy products at the GMP facility in Sawston, U.K. This license was the culmination of more than three years work, including development of the facility, the teams of specialized personnel, the Standard Operating Procedures (SOPs) and systems, well over 1,650 regulatory documents, and a successful operating history under the initial manufacturing licenses previously obtained to produce cell therapies in the Sawston facility for clinical trials and compassionate use. All of this work was carried out by Advent BioServices under contract with NWBO.
This MIA is one of the first licenses for commercial manufacturing of cell therapy products in the U.K. To the best of NWBO’s knowledge, there are only two other such licenses, one of which was just granted. Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (autologous cells) may also be imported into the U.K. for production or release of cell therapy products under the facility’s licenses. This allows GBM patients anywhere in the world to send their resected tumor tissue to Sawston to have their personalized vaccine manufactured and then shipped back. So even before approval in a given country, patients with adequate financial resources might be able to access DCVax-L on a compassionate use basis.
Why Dendritic Cell Vaccines Like DCVax-L Promise to be A Major Advance in Solid Cancer Therapy
The company’s press release of December 21, 2023 eloquently explains the reasoning that leads me to conclude that dendritic cell vaccines represent a novel, paradigm shifting approach to treating in not just GBM but all resectable solid tumors. I quote from the press release:
“One of the key factors making GBM so difficult to treat is that it is an extremely heterogeneous tumor. Accumulating evidence suggests that intratumor heterogeneity likely is the key to understanding treatment failure in GBM (Sottoriva, PNAS, 2013). Another key challenge is that as GBM develops, it induces an immunosuppressive microenvironment which compounds the difficulty of mounting an effective immune response against the tumor - especially within the central nervous system, which is an immune privileged space behind the blood brain barrier.
DCVax-L is designed to address both of these key challenges. As the Company previously reported, proteomic studies have demonstrated that a single tumor lysate sample contained tens of thousands of different peptides and, out of this pool, the dendritic cells selected, processed and presented over 600 different peptides (tumor targets) to T cells. T cell studies (TCR sequencing and T cell clonal expansion assays) analyzing the breadth and strength of T cell response following DCVax-L treatment have found extensive responses, including clonal expansion of up to 800 T cell clones at month 4 and up to 1200 T cell clones at month 8 in the samples studied. Each T cell clone focuses on a particular and distinct target. In individuals not being treated with the vaccine, only 2 – 20 new T cells clones are seen between month 4 and month 8.
The results of these proteomic, T cell and other studies provide support for what the Company believes to be the mechanism of action of DCVax-L: i.e., mobilizing a broad spectrum and strong de novo T cell response that addresses the extensive heterogeneity of GBM and overcomes the immunosuppressive microenvironment around the tumor.
The Company believes that this mechanism of action will be applicable for most types of solid tumors. Solid tumors comprise approximately 90% of all cancers, and a key difficulty that other treatment approaches have encountered with solid tumors is their heterogeneity.
The Company has already had positive results with DCVax-L in some compassionate use cases with other diverse solid tumors. The Company looks forward to building on its experience with DCVax-L in GBM and the compassionate use cases to address a wide range of other operable solid tumors.
The Company also had positive results in its Phase 1 trial of DCVax-Direct, in which more than a dozen diverse types of inoperable solid tumors were treated. DCVax-Direct involves essentially the same mechanism of action as DCVax-L, except that the tumor target proteins are taken up by the dendritic cells in situ in the tumor following intra-tumoral injection, rather than from tumor lysate from a surgically resected tumor tissue sample. The Company looks forward to resuming its clinical development of DCVax-Direct for a wide range of inoperable solid tumors.” (Note that the underlining for emphasis is mine.)
Epilogue
It has been a very long journey since the trial of DCVax-L began in 2007. This is an extraordinary story and I believe that it could well be the basis of a fascinating book and subsequent movie. Management has faced incredible challenges that have required courage, resolve and brilliant decision making that has gotten DCVax-L to the brink of approval in the UK. To casual or even seasoned investors, sixteen years seems an eternity although not unprecedented for a paradigm changing drug like DCVax-L. Consider CAR-T (another cell based therapy) which has revolutionized the treatment of hematological tumors. The first treatment of humans with CAR-T began in the mid-90s. The first trial in hematological cancers was conducted by the famous Carl June in 2012 and approval of the first CAR-T drug Kymriah, occurred in August 2017, which was 22 years after the first treatment.
The profound hurdles involved in the clinical development of DCVax-L were tragically exacerbated by short selling and other forms of attack that have been ongoing for over a decade. Unfortunately, this type of attack by incredibly greedy, manipulative short sellers on small companies (especially biotechs) is all too common. Short sellers have exacted a huge, tragic and outrageous financial impact on NWBO and shareholders. At least ten years ago, they began an attack on NWBO in which some of the participants openly stated that their goal was to bankrupt NWBO. I believe that this stock manipulation by a group of market makers and hedge funds using spoofing and other methods such as illegal naked shorting has been coincident with vicious social media fomenting. One short seller bragged that he and his co-short sellers would make the company and its management so toxic that no one would go near it. This has starved the company of cash and forced it to finance on highly unfavorable terms leading to significant share dilution. The filing of the MAA is a major step in eliminating manipulation of the stock by this “Wall Street manipulative short selling cancer” that plagues our financial markets.
In November of 2022, Northwest filed a suit alleging that Citadel and six other market makers conspired though spoofing to manipulate the price of NWBO over a multiple year period. Citadel has filed a motion to dismiss this suit and the Magistrate Judge is in the late stages of considering this. I believe that it will be denied and that NWBO’s legal counsel will be allowed to go forward with discovery. If so, Citadel and the six other accused market makers will be open to depositions of key personnel and subpoenas of trading records. This, in my opinion, will provide a clear roadmap of what I believe to be one of the largest criminal enterprises on earth. It is highly possible that some or all of these market makers will want to quickly settle. This will be the subject of a report on which I am now working.
Highly Probable UK Approval of DCVax-L in 1H, 2024 Would Be a Crowning Achievement for Northwest Biotherapeutics
POSTED by LARRY SMITH on JAN 10, 2024 • (0)
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Key Points:
On December 21, 2023, NWBO announced that it had submitted its MAA seeking regulatory approval for DCVax-L in the UK.
The Company requested that MHRA review DCVax-L using the accelerated pathway and, in this report, I go over the reasons why I think the MHRA will do so. (The section in this report titled “Under the UK’s Early Access to Medicines Program, MHRA Review Could Be Swift” explains my thinking in detail.)
Under the accelerated pathway, the MHRA commits to reviewing the application in 150 business days or less. This indicates a decision on approval at the latest could come by mid-July, 2024. I think it could be meaningfully sooner.
I believe that the MHRA will not make any public statement on whether DCVax-L is being reviewed under the accelerated pathway nor will it make any comments during the review period. This is not how regulatory agencies work.
My conclusion about accelerated approval for DCVax-L is supported by the agency’s actions with the rapid approval of Pfizer’s COVID vaccine Comirnaty. Initial data was submitted to MHRA on October 1, 2020 and conditional approval was granted on December 2, 2020. Pfizer only issued one press release on the review process and this was on December 2, 2020, the day on which Comirnaty was approved.
The next we will hear from MHRA, in my judgment, is that DCVax-L has been approved or not. I rate the probability of approval at 95%.
Acronyms Used in This Report
This glossary of acronyms may help in reading this report.
CDMO Contract Development and Manufacturing Organization companies provide biopharma companies with comprehensive services ranging from drug development through manufacture. Northwest uses the UK firm Advent BioServices as a CDMO.
EMA The European Medicines Agency (EMA) is the European Union equivalent to the FDA.
GBM Glioblastoma Multiforme is the most aggressive and deadly type of brain cancer, ndGBM is newly diagnosed GBM and rGBM is recurrent. These are the two indications initially being sought by Northwest Biotherapeutics for DCVax-L
GMP Good Manufacturing Practice is a system required by regulatory agencies for ensuring that drugs are consistently manufactured according to carefully defined quality standards. Guidelines address issues such as process validation, quality assurance assays, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification and others.
MAA Marketing Authorization Application is the document that must be submitted to the MHRA (and other European regulatory agencies) by companies seeking approval for a drug. The MIA is an integral part of this submission. Approval of the MAA allows commercialization. This is the counterpart to the BLA in the US.
MHRA Medicines and Healthcare products Regulatory Agency is the United Kingdom regulatory counterpart to FDA. The two agencies have a close, collegial working relationship. Approval of DCVax-L by MHRA would carry great weight in the FDA’s decision making.
MIA Manufacturer's Importation Authorization is required by the MHRA before a company can manufacture, import or export drugs. To qualify, a manufacturer needs to demonstrate to MHRA that it complies with good manufacturing practices (GMP) and can pass regular GMP inspections of its manufacturing site.
PIP Pediatric Investigation Plan Under applicable UK law, a new medicine that is developed for adult patients must also be tested for potential application to pediatric patients before it can gain approval in the adult population. Approval in the adult population can be granted before such trials are started at the discretion of the MHRA.
SOC Standard of Care is the currently accepted treatment regimen for a disease. In the case of GBM, this is surgical resection followed by radiation and then the chemotherapy drug temozolomide following.
SAP Statistical Analysis Plan describes how the quantitative or qualitative data collected in a trial will be statistically handled.
Catalyst For This Report
Northwest Biotherapeutics issued a press release on December 21, 2023 announcing that it had filed its MAA seeking approval in the UK for DCVax-L in adult patients with either newly diagnosed or recurrent glioblastoma. The submission of the MAA is a critical step. Approval would validate that NWBO’s dendritic cell vaccine technology is a major advance in the treatment of not only GBM but potentially all solid tumors. This could propel NWBO to being one of the most exciting stories in biotechnology over coming years and decades, possibly the most exciting.
Investment Overview
In this report, I don’t discuss a specific price target. It is intuitively obvious that MHRA approval of DCVax-L for GBM would have an extremely positive impact on the stock, possibly increasing the stock price to multiples of the current price. And yet, this is only the beginning of the investment story. The mode of action for dendritic cell vaccines of which DCVax-L is the first, holds the promise for meaningful effectiveness in all resectable solid tumors. Hence the potential pipeline for DCVax-L beyond GBM is staggering. Management has indicated that NWBO plans to pursue clinical development of DCVax-L or other types of dendritic cell vaccines in potentially all types of resectable solid tumors-ovarian, lung prostate, breast, et. al. This is an immense addressable market.
New indications will be addressed not only by dendritic cell vaccines as a single agent as is common in cancer therapy, but also in combination with other oncology drugs. As one very promising example of the potential for combinations, an unpublished phase 2 trial has been performed in 24 GBM patients at UCLA in which DCVax-L was combined with Merck’s checkpoint inhibitor Keytruda and polycytidylic acid (poly IC). Kaplan Meiers statistical analysis projected that 50% of patients would survive eight years. This is remarkable when viewed against a five year survival for SOC of 5%. The phase 3 trial of DCVax-L plus SOC showed five year survival of 13% which itself was remarkable as compared to SOC. It seems probable that Merck will be looking to do more extensive combination trials with Keytruda involving DCVax-L and poly IC.
These promising/ spectacular results could also induce some of the other manufacturers of check point inhibitors to undertake combination trials with DCVax-L. Regeneron, Roche and Bristol-Myers Squibb all come to mind but there are others. Combinations with many other types of oncology drugs are also probable. Let me re-emphasize that the mechanism of action of dendritic cell vaccines means that they potentially could be effective in all resectable solid tumors. So, there are a vast number of potential cancer targets and combinations with other drugs to be pursued.
UK Approval Would Transform Northwest Biotherapeutics into A Premier Commercial Stage Biotech
Approval in the UK is a critical starting point for the global clinical development and commercialization of DCVax-L and future products based on the dendritic cell vaccine technology. A validation accorded by UK regulatory approval would have very positive consequences.
The EMA and FDA both have great respect for the MHRA that should lead to a positive perspective and would likely expedite their regulatory reviews. Moreover, there is an urgent need for improved therapy in GBM as no new drug has been shown to meaningfully extend survival in ndGBM since temozolomide in 2005 and for rGBM since the mid-1990s with the Gliadel wafer. UK approval would likely result in considerable pressure on EMA and FDA from advocacy groups for expedited review.
Canada has a very close working relationship with the UK which could lead to approval not long after the UK.
The commercial approval of the Sawston GMP cell manufacturing facility affords the capability of GBM patients anywhere in the world to send their resected tumor tissue and autologous cells to Sawston to have their personalized vaccine manufactured and then shipped back. Administration of the vaccine is a simple intradermal injection that can be administered in an out-patient setting. So even before approval in a given country, patients anywhere in the world potentially would be able to access DCVax-L on a compassionate use basis.
NWBO disclosed in its recent 10-Q that it was in discussions for collaborations for clinical trials in which DCVax-L would be combined with other therapies. UK approval would greatly accelerate these discussions.
The wolfpack’s criminal conspiracy to manipulate the stock price of NWBO with a purported goal of driving NWBO into bankruptcy would be thwarted.
Numerous ways to access capital on favorable terms through collaborations and non-dilutive types of financings would be opened up.
This would likely engender widespread investor enthusiasm and extensive Wall Street analyst coverage.
History will look back at Linda Powers’ decision to focus the limited resources of NWBO to first gain regulatory approval in the UK as a brilliant decision.
Critical Components of the MAA
The MAA filing comprises a staggering amount of information and there are many requirements to satisfy. However, I believe that the three most critical requirements that NWBO must meet in order for DCVax-L to obtain MHRA registration have been met. This is what gives me such great confidence that the MHRA will move quickly to approve DCVax-L. These are:
Conducting a clinical trial that demonstrates efficacy as defined in a statistical analysis plan (SAP) approved by the MHRA. This box is checked as ten days after the SAP was filed, the MHRA published on its website that it had accepted the SAP. This means that the MHRA review will be based on evaluating the primary endpoint of mOS in ndGBM and the secondary endpoint of mOS in rGBM using matched contemporaneous external controls (independently selected by outside experts). Phase 3 results as reported in a peer reviewed article in JAMA Oncology showed that these endpoints were reached with extremely impressive p values. The p-value for mOS in ndGBM was <0.002 and the p-value in rGBM was <0.001.
Approval from MHRA for commercial manufacturing of DCVax-L at the Sawston facility was obtained on March 20, 2023 following a three year process of preparations. This is a prerequisite for filing an MAA. Manufacturing issues pose a major challenge for emerging biotechnology companies and very frequently can be the cause of significant delays in approval. One year ago, I was more worried about a problem with manufacturing arising that could delay approval than I was with whether the MHRA would view favorably the clinical trial data. Not now.
MHRA approval of clinical trial plans for pediatric trials in GBM was issued on August 16, 2022. This is also a prerequisite for filing an MAA. The PIP uses the same criteria as that for the adult GBM trials. The primary endpoint is mOS in ndGBM and the secondary endpoint is mOS in rGBM using matched contemporaneous external controls.
Under the UK’s Early Access to Medicines Program, MHRA Review Could Be Swift
The submission of the MAA was a material event for Northwest that under securities laws required public disclosure. This means that in order to issue the press release, the Company had to receive confirmation from the MHRA that the MAA had been received. Northwest also requested that DCVax-L be reviewed under the MHRA’s rapid 150-day review pathway, which the agency has established for new, breakthrough medicines that address serious unmet medical needs.
I do not expect MHRA or NWBO to make any public statements about the pathway to a final decision or the details of the MAA review process now underway. Giving updates is just not how regulatory review works. The review period will involve many broad ranging interrogations and discussions between the MHRA, NWBO and the company’s various contractors and consultants. The very nature of the process involves highly confidential material of the agency, NWBO and myriad consultants, vendors, manufacturers and trial sites. All exchanges will be highly confidential. In my opinion, the next news we will hear from the Company and the MHRA is the final outcome of the whole process which will be a decision to approve DCVax-L or refuse to approve it. As previously stated, I rate the probability of approval as 95%.
I believe that MHRA will review DCVax-L under the rapid 150-day review pathway. Let me start with some background. In April 2014, the MHRA launched a new initiative called the Early Access to Medicines Program. The intent was to offer severely ill patients with life-threatening and seriously debilitating conditions the lifeline of providing access to ground-breaking new medicines much earlier than they would be the case with traditional review procedures.
Following an assessment of early clinical data, MHRA can designate a new drug as a Promising Innovative Medicine (PIM). This signals to a company that its development plan is on the right track and that its product could be a candidate for the Early Access to Medicines Scheme, when further development work has been conducted. This early boost to a drug’s potential is expected to be beneficial to companies, especially small and medium-sized enterprises, who can struggle to attract capital from investors during drug development. This is a key component of the strategy to make the UK a major center of biotech innovation by expediting approval of breakthrough drugs. It is extremely impressive that DCVax-L was the first drug out of all of biopharma to be awarded the (PIM) designation.
The MHRA will not make a public statement as to whether DCVax-L will be reviewed under the rapid 150 day pathway. However, there are several strong indications that it will use this pathway:
The designation of DCVax-L as a Promising Innovative Medicine is obviously critical. Because this was the first such drug to be so designated, I would expect that MHRA has been closely following and is up to date on its clinical development.
The SAP for the phase 3 trial stated that the primary end point was mOS in ndGBM, the secondary endpoint was mOS in rGBM and used contemporaneous external controls. Only ten days after submitting the SAP, MHRA announced on its website, that it was accepted. This indicates that the MHRA is comfortable with the design of the trial and its SAP.
The MHRA approved the Sawston plant for commercial production of DCVax-L which is a prerequisite for product approval. This involved extensive interaction with the agency. Very importantly, this was only the third facility in the UK approved for commercial cell therapy manufacturing.
The MHRA granted a license for the import and export of living cells and tissue for Sawston. Tumor tissue and autologous cells necessary for the manufacturing of DCVax-L can be imported from anywhere in the world, processed into the final product and exported back to the point of origin. This means that Sawston can be used to provide product for worldwide commercialization.
Before an MAA can be approved for use in adults, a company must submit and receive approval for a plan for pediatric studies. NWBO submitted its proposed PIP to the MHRA in February 2022 and received approval on August 16, 2022. This prompt response is encouraging.
A compassionate use or Specials program in the UK has been led by Dr. Keyoumers Ashkan, the lead European investigator for the phase 3 trial of DCVax-L. He is a top neuro-surgeon at King's College Hospital, the premier teaching hospital in the UK and Dr. Ashkan is one of the most respected neurosurgeons in the UK. This compassionate use program conducted at Kings College affords important data on real life experience. Based on his clinical experience, Dr. Ashkan believes that DCVax-L is a major therapeutic advance in the treatment of glioblastoma and should become part of standard of care. Such a strong endorsement from such a highly respected physician with extensive hands on experience could carry weight with MHRA. It seems highly probable that MHRA has closely followed this Specials program.
The MHRA has shown that it can move swiftly to approve drugs under the Early Access scheme. The Pfizer covid vaccine was approved on December 1, 2020. This was 60 days after the first efficacy data was submitted to MHRA.
Brief Review of the Extremely Positive Phase 3 Trial Results for DCVax-L
I previously commented on the results of the phase 3 trial of DCVax-L, but I will briefly repeat and then elaborate on the results. The primary endpoint specified in the SAP was mOS in ndGBM that was achieved with p<0.002; the secondary endpoint under the SAP was mOS in rGBM that was achieved with a p<0.001.
Perhaps more important, there was a powerful survival tail in ndGBM which showed 13.0% of patients alive at five years versus 5.7% for SOC. This is every bit as impressive as survival tails for the checkpoint inhibitors in recurrent non-small cell lung cancer and recurrent melanoma, aggressive cancers which are roughly equivalent to glioblastoma in terms of expected patient survival. Note that it was the demonstration of the survival tail that was key to Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo becoming multi-billion dollar drugs.
The survival tail for DCVax-L in rGBM showed that at 30 months after tumor recurrence, 11.1% of GBM patients were alive versus 5.1% in the control arm. No drug has demonstrated a survival benefit in rGBM since the Gliadel wafer which was developed in the mid-1990s.
Very importantly, DCVax-L has an extremely favorable side effect profile as almost all side effects are minor. Virtually all other cancer therapies have dangerous, life threatening side effects. This enormously increases the benefit to risk ratio for DCVax-L in both an absolute and relative sense. It is also dosed with simple intradermal injections which can be administered in an outpatient setting, i.e. a physician’s office. Many other oncology drugs require lengthy intravenous infusions which are not always available in an outpatient setting.
Having read this, you may ask why I don’t assign 100% probability of approval? Well, nothing in life carries 100% certainty.
More Detail on the Pediatric Investigation Plan (PIP)
Under applicable UK law, a new medicine that is developed for adult patients must also be tested for potential application to pediatric patients before it can gain approval in the adult population. NWBO was required to develop an overall plan to evaluate the safety and efficacy in pediatric patients. The PIP had to include all aspects required for approval, such as the patient population, eligibility criteria, stage of disease, treatment regimen, trial design and endpoints.
NWBO announced on August 16, 2022 received approval from the MHRA for the PIP This was based on two proposed clinical trials: one for ndGBM patients and one for rGBM patients. In each of the two pediatric trials, 24 patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult GBM patients. As in the adult clinical trials, the primary endpoint for each trial will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The matched external controls will be identified using the same methodology as was used to pre-specify the matched external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
The final regulatory approval of the PIP must be obtained before a sponsor may submit an MAA for approval to commercialize a new medicine for adult patients. The approval may include a deferral allowing the pediatric clinical trials to actually be carried out after the MAA has been submitted, but the PIP approval itself must have been received before an MAA can be filed and go through compliance check.
Ordinarily, a PIP must go through a series of stages of regulatory review and comment to reach a final approval, a process that can typically take more than a year. In the case of NWBO, the company worked with expert consultants for months to develop a PIP which was submitted to the MHRA in February 2022. Approval was granted six months later on August 16, 2022. The speedy approval is encouraging and hopefully presages the speed with which MHRA will review the MAA.
The Critical Importance of Approval for Commercial Manufacturing of DCVax-L at Sawston UK GMP Facility
NWBO announced on March 20, 2023 that Advent BioServices (its UK CDMO), had been approved for an MIA license issued by MHRA for commercial manufacturing of DCVax-L and other cell therapy products at the GMP facility in Sawston, U.K. This license was the culmination of more than three years work, including development of the facility, the teams of specialized personnel, the Standard Operating Procedures (SOPs) and systems, well over 1,650 regulatory documents, and a successful operating history under the initial manufacturing licenses previously obtained to produce cell therapies in the Sawston facility for clinical trials and compassionate use. All of this work was carried out by Advent BioServices under contract with NWBO.
This MIA is one of the first licenses for commercial manufacturing of cell therapy products in the U.K. To the best of NWBO’s knowledge, there are only two other such licenses, one of which was just granted. Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (autologous cells) may also be imported into the U.K. for production or release of cell therapy products under the facility’s licenses. This allows GBM patients anywhere in the world to send their resected tumor tissue to Sawston to have their personalized vaccine manufactured and then shipped back. So even before approval in a given country, patients with adequate financial resources might be able to access DCVax-L on a compassionate use basis.
Why Dendritic Cell Vaccines Like DCVax-L Promise to be A Major Advance in Solid Cancer Therapy
The company’s press release of December 21, 2023 eloquently explains the reasoning that leads me to conclude that dendritic cell vaccines represent a novel, paradigm shifting approach to treating in not just GBM but all resectable solid tumors. I quote from the press release:
“One of the key factors making GBM so difficult to treat is that it is an extremely heterogeneous tumor. Accumulating evidence suggests that intratumor heterogeneity likely is the key to understanding treatment failure in GBM (Sottoriva, PNAS, 2013). Another key challenge is that as GBM develops, it induces an immunosuppressive microenvironment which compounds the difficulty of mounting an effective immune response against the tumor - especially within the central nervous system, which is an immune privileged space behind the blood brain barrier.
DCVax-L is designed to address both of these key challenges. As the Company previously reported, proteomic studies have demonstrated that a single tumor lysate sample contained tens of thousands of different peptides and, out of this pool, the dendritic cells selected, processed and presented over 600 different peptides (tumor targets) to T cells. T cell studies (TCR sequencing and T cell clonal expansion assays) analyzing the breadth and strength of T cell response following DCVax-L treatment have found extensive responses, including clonal expansion of up to 800 T cell clones at month 4 and up to 1200 T cell clones at month 8 in the samples studied. Each T cell clone focuses on a particular and distinct target. In individuals not being treated with the vaccine, only 2 – 20 new T cells clones are seen between month 4 and month 8.
The results of these proteomic, T cell and other studies provide support for what the Company believes to be the mechanism of action of DCVax-L: i.e., mobilizing a broad spectrum and strong de novo T cell response that addresses the extensive heterogeneity of GBM and overcomes the immunosuppressive microenvironment around the tumor.
The Company believes that this mechanism of action will be applicable for most types of solid tumors. Solid tumors comprise approximately 90% of all cancers, and a key difficulty that other treatment approaches have encountered with solid tumors is their heterogeneity.
The Company has already had positive results with DCVax-L in some compassionate use cases with other diverse solid tumors. The Company looks forward to building on its experience with DCVax-L in GBM and the compassionate use cases to address a wide range of other operable solid tumors.
The Company also had positive results in its Phase 1 trial of DCVax-Direct, in which more than a dozen diverse types of inoperable solid tumors were treated. DCVax-Direct involves essentially the same mechanism of action as DCVax-L, except that the tumor target proteins are taken up by the dendritic cells in situ in the tumor following intra-tumoral injection, rather than from tumor lysate from a surgically resected tumor tissue sample. The Company looks forward to resuming its clinical development of DCVax-Direct for a wide range of inoperable solid tumors.” (Note that the underlining for emphasis is mine.)
Epilogue
It has been a very long journey since the trial of DCVax-L began in 2007. This is an extraordinary story and I believe that it could well be the basis of a fascinating book and subsequent movie. Management has faced incredible challenges that have required courage, resolve and brilliant decision making that has gotten DCVax-L to the brink of approval in the UK. To casual or even seasoned investors, sixteen years seems an eternity although not unprecedented for a paradigm changing drug like DCVax-L. Consider CAR-T (another cell based therapy) which has revolutionized the treatment of hematological tumors. The first treatment of humans with CAR-T began in the mid-90s. The first trial in hematological cancers was conducted by the famous Carl June in 2012 and approval of the first CAR-T drug Kymriah, occurred in August 2017, which was 22 years after the first treatment.
The profound hurdles involved in the clinical development of DCVax-L were tragically exacerbated by short selling and other forms of attack that have been ongoing for over a decade. Unfortunately, this type of attack by incredibly greedy, manipulative short sellers on small companies (especially biotechs) is all too common. Short sellers have exacted a huge, tragic and outrageous financial impact on NWBO and shareholders. At least ten years ago, they began an attack on NWBO in which some of the participants openly stated that their goal was to bankrupt NWBO. I believe that this stock manipulation by a group of market makers and hedge funds using spoofing and other methods such as illegal naked shorting has been coincident with vicious social media fomenting. One short seller bragged that he and his co-short sellers would make the company and its management so toxic that no one would go near it. This has starved the company of cash and forced it to finance on highly unfavorable terms leading to significant share dilution. The filing of the MAA is a major step in eliminating manipulation of the stock by this “Wall Street manipulative short selling cancer” that plagues our financial markets.
In November of 2022, Northwest filed a suit alleging that Citadel and six other market makers conspired though spoofing to manipulate the price of NWBO over a multiple year period. Citadel has filed a motion to dismiss this suit and the Magistrate Judge is in the late stages of considering this. I believe that it will be denied and that NWBO’s legal counsel will be allowed to go forward with discovery. If so, Citadel and the six other accused market makers will be open to depositions of key personnel and subpoenas of trading records. This, in my opinion, will provide a clear roadmap of what I believe to be one of the largest criminal enterprises on earth. It is highly possible that some or all of these market makers will want to quickly settle. This will be the subject of a report on which I am now working.
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SUMMARY & THOUGHTS: Plaintiff's Limited Objection to Magistrate Judge Stein's Report and Recommendation Regarding the Element of Loss Causation
$NWBO BACKGROUND On December 29th, 2023 Magistrate Judge Stein issued his Report and Recommendation (R&R) on Defendant’s Motion to Dismiss NWBO’s First Amended Complaint. “…the Court respectfully recommends that Defendants’ motion be GRANTED due to Plaintiff’s failure to adequately plead loss causation, and that Plaintiff be given leave to replead.” [1] On January 12, 2024 the Defendants filed their objections to the R&R. As expected, they objected to nearly the entire R&R: “Defendants specifically object to the R&R’s findings and recommendations concerning each element of Plaintiff Northwest Biotherapeutics, Inc.’s (“NWBO”) market manipulation claim (including the recommendation to allow amendment of the deficiently pled loss causation element), and the R&R’s findings and recommendations concerning the public OTC Link data provided by Defendants.” [2] On January 12, 2024 the Plaintiff, $NWBO, filed their limited objections as to the element of loss causation. [3] I’ll discuss NWBO's Limited Objections in this post. BURDEN "...Plaintiff respectfully asserts that the Complaint already adequately meets Rule 8’s “not [] heavy” burden necessary to plead loss causation. DoubleLine Cap. LP v. Construtora Norberto Odebrecht, S.A., 413 F. Supp. 3d 187, 212 (S.D.N.Y. Sept. 23, 2019)(Woods, J.) (citing Loreley Fin. (Jersey) No. 3 Ltd. v. Wells Fargo Sec., LLC, 797 F.3d 160, 187(2d Cir. 2015)). STANDARD Judge Stein, the Defendants and $NWBO all point to the Court in Gamma Traders for the standard to sufficiently plead loss causation. To sufficiently plead loss causation, you need to show one of the following:
“...that a plaintiff traded “so close in time to Defendants’ spoofing” as to permit the court to “infer as a matter of common sense that the market prices were artificial” when plaintiff traded (the “temporal proximity” theory)” (emphasis added) or
“...a factual basis indicating that the effects of the spoof lasted for a protracted period so as to “justify an inference that the market price was still artificial” when plaintiff traded (the “long-term price impact” theory).” (emphasis added) NWBO claims they sufficiently plead loss causation under BOTH theories. Theory
- Temporal Proximity “…49 million shares were sold at prices “formulaically derived from the closing price on dates where Spoofing Episodes occurred” – i.e. in temporal proximity to Defendants’ spoofing…” Arguments in Support of Theory
- Temporal Proximity $NWBO provided details as to the “(1) transaction date; (2) number of shares sold; (3) sale price; (4) pricing date; (5) number of spoofing episodes during that day; and (6) the average return to Spoofing Episodes for each of those 49 million shares.” The R&R stated that “Plaintiff must complete the circle of causation by pleading in an amended complaint a sufficient explanation as to how the various stock sale prices were ‘formulaically derived’ from the closing prices on the days when Spoofing Episodes took place.” NWBO countered by stating “The R&R’s recommendation in this respect is incorrect in two ways – this level of specificity is not required by Rule 8, and in any event, the Complaint provides it.” Where does the Complaint provide this formulaic connection? “Paragraph 289 of the Complaint alleges that “of Plaintiff’s 283 million shares of stock sold during the Relevant Period, more than 49 million shares were sold by Plaintiff where the sale price was formulaically derived from the closing price on dates where Spoofing Episodes occurred, such that a decline in the price on that day caused a decline in the price at which Plaintiff sold shares of NWBO stock.”” NWBO provided an example in the First Amended Complaint where they sold 1.9 million shares equal to the closing price on December 10, 2021 and on that day 5 episodes of spoofing occurred in the last hour of trading. As to this sale, NWBO stated, “This necessarily “complete(s) the circle of causation” (R&R p. 71) under any analysis and satisfies the pleading standard for loss causation.” NWBO questioned the Court’s bright line rule of only giving relevance to sales of stock based on closing prices where spoofing incidents occurred within one hour of closing. $NWBO stated, “the Second Circuit in Gamma Traders assumed that such “same-day, post-spoof” sales could be sufficiently close enough in time to have been negatively impacted by Defendants’ spoofing, and recognized, “the effects of spoofing pose questions of fact.” 41 F.4th at 80. Determining the length of time Defendants’ spoofing impacted the market price for NWBO will necessarily be the subject of hotly contested expert testimony and, as such, is inappropriate for determination at the motion to dismiss stage.” NWBO went on to state, “Furthermore, there is no economic justification, and certainly not before expert testimony, for a bright-line threshold of 60 minutes.” Theory
- Long Term Price Impact “…the remainder of the 283 million shares were also sold at “artificially depressed” prices (¶ 288) because Defendants’ spoofing had “both a temporary and long-term adverse effect” on the price of NWBO’s stock.” Arguments in Support of Theory
- Long Term Price Impact The First Amended Complaint relies on Nobel Prize-winning economist Dr. Milgrom for the proposition that “manipulative trades can lead to permanent price impact”. The R&R could not find Dr. Milgrom’s Report and thus did not consider it in their analysis. To this point, $NWBO stated, “attached as Exhibit A is the ECF-stamped full Milgrom report, which is available on PACER as ECF No. 557-7, Exhibit 7 to Declaration of Marc L. Greenwald in Support of Motion to Certify Class and Appointment of Class Counsel (filed Jan. 26, 2018).” The R&R suggested that the Milgrom Report did not concern spoofing and thus was not applicable. NWBO noted that the Milgrom report “discusses the extensive economic literature establishing that the price impact of any form of trade-based manipulation (like spoofing) is not likely to fully reverse.” The R&R assumed that the unwinding of a spoof would eliminate the permanent price impact, but Milgrom’s Report contradicted this point: “There is, however, no symmetry in the manipulative trade and its unwinding. A manipulative trader who wants, for example, to raise a price will buy in a way that maximizes the price impact. However, when unwinding the trade, that same trader will seek to minimize the price impact to avoid losses. Therefore, the upward effect can be expected to exceed the downward effect from unwinding—and that difference may represent a permanent effect.” (emphasis added) “The R&R also concluded that the Complaint alleges a “reversion of the stock price in a brief period of time,” which “undermines Plaintiff’s speculative hypothesis that the spoofing had a long-term or persistent price impact.” (R&R p. 76.) However, the Complaint does not allege a complete reversion of the negative price impact of Defendants’ spoofing, but instead alleges that any reversion was only partial and, therefore, that the long-term impact of Defendants’ spoofing was to depress the price of NWBO shares.” “The Complaint’s allegations of long-term price impact are considerably more detailed and persuasive than those that were held to sufficiently allege loss causation in other spoofing cases, including most recently in Harrington.” NWBO Alleges the R&R Made Three Errors 1. “…while the R&R correctly found that the Complaint adequately pled that NWBO’s sales in transactions for which the sale price was derived from a closing price on days in which Defendants spoofed within one hour of market close satisfied the temporal proximity theory under Gamma Traders (R&R at 70), it incorrectly concluded that the Complaint did not sufficiently explain the formula for how those sales prices were determined by closing prices. This conclusion is incorrect in two ways – Rule 8 does not require this level of detail, and in any event, the Complaint provides just that.” 2. “…the R&R concluded that the Complaint failed to adequately allege temporal proximity under Gamma Traders for sales that occurred at prices derived from the closing price on the same day, but more than one hour after, Defendants spoofed. This conclusion is also incorrect in two ways – Gamma Traders does not restrict temporal proximity to one hour, and the Complaint contains factual allegations sufficient to support price impact for sales that occurred after, but on the same day as, Defendants’ spoofing.” 3. “…the R&R incorrectly concluded that the Complaint failed to adequately allege a longtermprice impact under the second theory identified in Gamma Traders…The R&R appears to base its conclusion on an incomplete understanding of the Complaint’s allegations and inability to locate certain academic literature cited and quoted in the Complaint, which provides ample support for the plausible inference that Defendants’ spoofing negatively impacted the market price of NWBO over the Relevant Period – all that is required under Rule 8 at the motion to dismiss stage.” THOUGHTS Great work by Posner and team in skillfully pointing out the shortcomings of Magistrate Stein's R&R. I've been nothing but positive towards BOTH Magistrate Judges till this point. They've done some great work, but in these sort of complicated cases it's easy to overlook certain aspects. After reading NWBO's Limited Objections, I believe the R&R made significant errors in at least two respects. First, even under the Magistrate Stein's exacting standard for loss causation it's difficult to imagine how a sale of stock on Sunday, December 12, 2021 (a non-trading day) based on the closing stock price on Friday December 10th, when there were 5 episodes of spoofing within one hour of market close, doesn't "complete the circle of causation". The Court asks for a formulaic connection between the spoofing and NWBO's stock sales. There is no clearer connection than what is alleged for these 1.9 million shares. The sale of these 1.9 million shares on December 12th would satisfy any pleading standard for loss causation. The second mistake is when the Court failed to consider Dr. Milgrom's Report. Not only did the Court fail to consider the Milgrom Report but then it opined as to what was in said report without reading it. I searched for the report and was able to find it at Docket #557, Exhibit 7. See Image 1. I read the report. The R&R stated the report was not relevant to spoofing. Yet, after reading the report, it speaks generally to ANY form of trade based manipulation, such as spoofing. Milgrom's Report forms the basis of loss causation for the vast majority of the 283 million shares sold at manipulated prices. To not even read the report and then to incorrectly opine as to the contents of said report is an error that hopefully Judge Woods corrects in his ruling. NEXT UP Responses to each side's objections are due by January 26, 2024. After that Judge Wood's makes the final ruling on Defendant's MTD. Typically, the R&R is adopted in full. I'm not sure that will be the case here. [1] Docket #137 https://courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/
[2] Docket #141 https://courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/ [3] Docket #142 https://courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/
[2] Docket #141 https://courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/ [3] Docket #142 https://courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/
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The American System - Profits Over Life; A Tiny Biotech's Battle to Bring a Cancer Vaccine to Market
By: Hoffmann6383
There is a small and obscure biotechnology company attempting to bring a personalized vaccine to long suffering Glioblastoma (“GBM”) patients. GBM is the most aggressive and deadly form of brain cancer. This company, Northwest Biotherapeutics, Inc (“NWBO”), completed a phase III trial using a personalized autologous tumor lysate-loaded dendritic cell vaccine, called DCVax-L, that showed a clinically meaningful and statistically significant improvement in survival of GBM patients[1] and are now attempting to bring this treatment to market. On the other side, market makers and hedge funds (the “Wolf Pack”) are doing everything in their power to keep this vaccine from getting to the market in an effort to protect their own pocketbook.
NWBO started their DCVax-L Phase III trial in 2006 (the “Trial”).[2] The Trial took about 2 decades to complete.[3] It cost hundreds of millions of dollars.[4] The complexity of the blood-brain barrier in addition to the cost and time required to conduct a Phase 3 study has made progress in the treatment of GBM a rare occurrence. Newly diagnosed glioblastoma (“nGBM”) patients haven’t seen an improvement in standard of care (SOC) since 2005.[5] Recurrent glioblastoma (“rGBM”) patients have no SOC.[6] A diagnosis of GBM is near certain death.[7]
There are 14,490 Americans that are expected to receive a GBM diagnosis in 2023 and more than 10,000 that will die.[8] None of this mattered to the Wolf Pack. The Wolf Pack made a bet against NWBO and they are doing their best to protect that bet, i.e. naked, unreported and/or underreported short positions. To this end, the Wolf Pack has extensively and illegally manipulated NWBO’s share price and they have engaged in an enormous distortion campaign on social media despite real life consequences to NWBO, NWBO shareholders and most importantly, cancer patients. In this article, I’ll (1) introduce you to NWBO, (2) walk you through the lawsuit alleging illegal share price manipulation, (3) give a first-hand perspective of the social media distortion campaign and finally, (4) give some closing thoughts.
(1) Who is Northwest Biotherapeutics, Inc.?
Northwest Biotherapeutics, Inc. is a clinical stage biotechnology company focused on the development of personalized cancer vaccines to treat a broad range of solid tumor cancers.[9] NWBO’s lead treatment is DCVax-L, and the company has completed a Phase III nonrandomized controlled trial of 331 patients with GBM, a deadly brain cancer.[10] Five-year survival for nGBM is less than 5%.[11] The SOC for nGBM consists of surgical resection of the tumor, radiation therapy, and concomitant and adjuvant chemotherapy with temozolomide.[12] Nearly 100% of the tumors recur. There is no SOC for rGBM.[13] Since 2005 there have been hundreds of clinical trials in nGBM and rGBM. Prior to the results being shown for the DCVax-L trial, survival benefit has only been shown in one phase 3 trial in nGBM and no phase 3 trials in rGBM have shown a survival benefit.[14] That is until NWBO’s autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) demonstrated a survival benefit in nGBM and rGBM patients.[15]
A JAMA Oncology paper published on November 17, 2022 showed that adding DCVax-L to SOC showed a clinically meaningful and statistically significant improvement in mOS with both nGBM and rGBM when compared with matched, contemporaneous external controls.[16] On March 20, 2023 NWBO announced they received one of the first Medicines and Healthcare products Regulatory Agency (“MHRA”) licenses in the UK for commercial manufacturing of cell therapy products that allows for global delivery of their cell therapy products.[17] In an interview published July 14, 2023, Les Goldman, Senior Vice President of NWBO, stated that the company will be applying for approval in 4 places with the MHRA in the United Kingdom being the first.[18] On August 9th NWBO filed their 10-Q for the second quarter of 2023 and stated that the company is in “active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments.”[19] On December 21st, 2023, NWBO filed their Marketing Authorization Application ("MAA") with the UK's MHRA for nGBM and rGBM. [20] Upon submitting their MAA, Linda Powers, CEO of NWBO, stated,
DCVax-L is currently being used in two ongoing combination trials. One UCLA trial involves DCVax-L combined with poly-ICLC.[21] This is for nGBM and rGBM and unpublished data is showing approximately 50% overall survival at 100 months.[22] Another trial involves DCVax-L, poly-ICLC and Keytruda.[23] This trial is for rGBM and unpublished data is showing approximately 60-65% survival at 800 days (Figure 1).[24].
Figure 1 - Keytruda/Poly-ICLC/DCVax-L Combination Trial in rGBM
On June 3, 2023 NWBO presented at the Industry Expert Theater at ASCO. You can see this presentation and much more information on NWBO here: Home - Northwest Biotherapeutics
(2) Illegal Share Price Manipulation – The Spoofing Lawsuit
Spoofing is a form of disruptive algorithmic trading activity to manipulate the markets.[25] Spoofers place bids or offers on stocks with the intent to cancel before the orders are filled.[26] Spoofing may cause prices to change because the market interprets the one-sided pressure in the limit order book as a shift in the balance of the number of investors who wish to purchase or sell the asset, which causes prices to increase (more buyers than sellers) or prices to decline (more sellers than buyers).[27]
On April 10, 2023, NWBO filed an Amended Complaint in the U.S. District Court for the Southern District of New York alleging that market makers Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Susquehanna International Group LLP, Virtu Americas LLC (collectively “Defendants”) deliberately engaged in repeated manipulative spoofing of NWBO’s stock from December 5, 2017 – August 1, 2022 (Figure 2).[28] NWBO states that Defendants engaged in 2,849 spoofing incidents occurring on 395 of 1,171 trading days, or nearly 34% of the trading days, in the relevant period.[29] NWBO sold over 283 million shares at manipulated prices, 49 million of which were sold at the closing price on dates where spoofing episodes occurred.[30] NWBO claims that the market manipulation directly impacted the price of NWBO’s shares sold into the market, causing NWBO significant losses as the stock was sold at artificially depressed prices.[31].
May 10th, 2022 was the single most egregious day of illegal share price manipulation on record according to the Complaint.[32] There were a total of 100 spoofing episodes between Defendants totaling 2,883,387 shares of fictitious baiting orders (Figure 3).[33] On that day the market learned NWBO met both its primary and secondary endpoints with statistical significance, displayed an excellent safety profile and showed meaningful increases in long-term tails of the survival curves for both nGBM and rGBM.[34] Despite the excellent trial results, the share price declined from $1.73 to $0.3862, a 52 week low.[35] This was a 78% decline of the share price on a day with nothing but positive news related to NWBO.[36].
Figure 3 - May 10, 2022 Spoofing Episodes
A large portion of the spoofing incidents on May 10, 2022 occurred prior to the DCVax-L data being presented publicly, for the first time, at 11:10 EST.[37] For example, 13 of 29 spoofing incidents by Citadel Securities, LLC (“Citadel”) occurred prior to the data being presented publicly.[38] Citadel executed 24 of their 29 spoofing incidents on May 10th prior to the presentation being completed. Essentially, Citadel wanted the market to think the trial results were a failure before the market even digested said results. It wasn’t just Citadel that wanted to portray the DCVax-L trial as a failure. It was all of the Defendants. We also had the head of a hedge fund live tweeting that the trial had failed.[39] There was a reporter claiming the trial had failed.[40] This reporter, Adam Feuerstein, is cited in Defendants’ Joint Memorandum of Law in Support of Motion to Dismiss Amended Complaint for the proposition that NWBO suffered a crisis.[41] The Defendants claim it was a “crisis” when the positive DCVax-L Phase III data was presented.[42] When Citizens for Responsibility and Ethics in Washington executive director, Melanie Sloan, asked the SEC to investigate NWBO’s stock for market manipulation she paid particular attention to Adam Feuerstein, whose relentless blog posts have not only been filled with exaggeration, mischaracterization and half-truths, but curiously have also coincided with spikes in short trading.[43]
The Defendants described their actions as “bedrock market-making activity” and if they are unable to continue with this activity it could potentially upend “the entire U.S. equity market system”.[44] Essentially, spoofing is part of Defendants’ business model and if anyone tells them to stop, they are going to bring down the entire market.
On the other hand, NWBO claims in their Court filings that the vast amount of illegal spoofing incidents is being done to cover naked short positions:
Despite Defendants’ claims, spoofing is illegal, period. Spoofing is not a “bedrock market-making activity”. This is an activity that lands you in jail.[46]
Spoofing, much like naked shorting, is an illegal tactic used to destroy companies and cause their shareholders to lose a significant amount of their investments.[47] Oftentimes spoofing and naked shorting go hand in hand.
One doesn’t illegally manipulate NWBO’s stock price thousands of times in a vacuum. There is likely a significant naked, unreported and/or underreported short position that is being protected by the Wolf Pack.
(3) Firsthand View of an Extensive Social Media Distortion Campaign
What’s one way to protect a significant naked, unreported or underreported short position in a company whose stock is largely held by retail? An unrelenting misinformation campaign. Enter an online stock message board like InvestorsHub (“IHub”) with thousands of different investment forums. IHub has approximately 8,800 message boards for US listed companies, 12,984 boards for the US OTC, 2,131 for Canadian companies and 917 message boards for
other markets.[48] In total IHub has approximately 24,832 message boards.[49] Out of these nearly 25k message boards, NWBO is and has been for over a year, the #1 most read and posted on forum at IHub.[50] This isn’t just a one off. NWBO wasn’t the most posted on and viewed board for a single day, but nearly every single day, for years on end. On an average day, you can look at the NWBO IHub board and see the same regurgitated negative narratives often containing false and/or misleading information. These negative narratives are an attempt to drown out any positive discussion.
What does a typical IHub poster on NWBO’s message board look like? Let’s take a look at Exwannabe (“Ex”).[51] Ex started posting on NWBO’s message board in 2014 and is up to 12,183 posts as of writing this article. He posts on weekends, weekdays, and at all hours of the day. Ex has, on multiple occasions, pointed out that he owns no shares of the company. Ex’s posts are always negative, often misleading and sometimes downright false. Ex claims he has been on these boards for nearly nine years and 12,000+ posts because (1) he found the company interesting, (2) he finds the NWBO supporters disgusting, (3) he wants to set the record straight and (4) he loves watching a good train wreck.[52] Could this lone poster just be a white knight that decided to dedicate a large portion of his life to helping the poor retail that invested in NWBO without any financial incentive to himself or herself? Sure, it’s possible, but unlikely, given the very negative comments he has made about NWBO longs. Now, throw in another 20+ Exwannabes that post on the same NWBO forum using the same reasoning for posting. Are the poor NWBO retail investors the luckiest retail investor base on the planet with so many white knights at their disposal or is something else happening here? Enter Poor Man and his team of supposed white knights.
Who is Poor Man? Poor Man is an IHub alias born on October 30, 2015.[53] Poor Man, as of writing this article, has 7,546 posts on NWBO’s message board and 205 posts on USRM’s board.[54] USRM is the stock symbol for U.S. Stem Cell, Inc. This is important for later. Much like Ex, Poor Man has an overwhelmingly negative slant to his NWBO posts on IHub. In August of 2022 I engaged in a private conversation with Poor Man on IHub.[55] It was a colorful conversation.[56] At one point Poor Man wrote to me stating, “If you want to work for short sellers, let me know.”[57] Poor Man went on to state “I helped bring the stock price down and got them delisted. So I’ve already received my bonus. Everything else is just small change at 68 cents. 7 years ago this stock was $10…”.[58] Poor Man also said, “Even if my team doesn’t drive this to zero, we’ve already made a fortune!” (Figure 4).[59] Another relevant tidbit was where Poor Man stated, “My team has already received their bonuses for their work on this stock.”[60].
Poor Man stated that he works with a team on behalf of short sellers to drive the NWBO share price to zero. Perhaps Poor Man has simply been messing with me, a favorite ending statement of his reads, “And remember, everyone is lying.” Initially, I didn’t think much of the Poor Man conversation. That is until I became aware of a case filed on January 28, 2016 in the 17th Judicial Circuit, Broward County, FL, Case No. CACE-16-001616.[61] Remember where I said we would be circling back to USRM, or U.S. Stem Cell, Inc.? They are the plaintiff in the case. The defendants were aliases on IHub and Yahoo message boards including the same Poor Man currently still posting at IHub.[62] The Plaintiff believed Poor Man might have been working in concert with multiple people to publish disparaging and defamatory statements about USRM on the IHub message boards with the purpose of bringing economic loss to USRM (Figure 5).[63] It's important to note the case was dismissed on procedural grounds. The Court didn’t have personal jurisdiction over Poor Man under Florida’s Long Arm Statute. Therefore, the case was never heard on its merits.
Poor Man apparently has a history of trying to destroy largely retail held stocks through disparaging and defamatory statements on social media. Despite this history, which IHub was made aware of when they were served with a subpoena in this lawsuit, they recently made Poor Man a moderator of its’ NWBO message board.[64]
What happens, as in my case, when you don’t fall in line and join the misinformation campaign? Let’s take a look at my interactions with Legend431 at IHub, or murcidencel11 at X, or catmeadowlands at X, or crashoverIHub at X – all the same person. Apparently, they stick the goons on you to try to intimidate you into silence. I have received phone calls which I eventually realized (after letting the entire message save to my VM) were from prankdial.com. I have received numerous threatening messages in private messages on both IHub and twitter, with some of them shown in Figure 6. The personally identifying information has been redacted in Figure 6 and my notations are in red. My home address has been posted publicly on IHub at least twice. My cell phone number has been posted on both IHub and X. My wife’s name has been posted on IHub. There have been requests to meet at a bar next to my house so we can “hash things out”. A sampling of some of the messages can be seen below.
There is a reason NWBO is the number one most active message board on IHub and it isn’t because all the traffic is organic. This is a smear campaign on steroids.
(4) Final Word
The Wolf Pack appear to have made a large bet that NWBO would fail, consequences to GBM patients be damned. There was a time where it looked like they might be right. NWBO had to pause their trial for roughly two years as they ran short on funds. Despite the hurdles, NWBO has now wrapped up their trial and have submitted their first application for regulatory approval in the UK. The overwhelming daily negative social media narratives are an attempt to drown out NWBO’s good news.
I don’t know for certain whether this overwhelming negative social media presence is there to protect any naked, unreported or underreported short position. Maybe this is all organic discussion. Doubtful, but I don’t care. NWBO isn’t a meme stock. This isn’t a fledging movie theater chain that is losing audiences to streaming apps. This isn’t a brick-and-mortar gaming store when everything is moving to online purchases. NWBO retail longs don’t invest in a company for the squeeze despite underlying concerns in said company. NWBO is the opposite. We invest in NWBO for the underlying company. If a squeeze happens, great. That’s karma for betting against a treatment for long suffering cancer patients. If there isn’t a squeeze, great. NWBO will find success either way.
DISCLOSURES: The author of this article holds 100,000+ common shares of NWBO. The author has received no compensation in connection with this article. This is an opinion piece. The information in this article is for informational purposes only. The information contained herein
should not be understood or construed as legal, medical or financial advice.
CITATIONS:
[1] Association of DCVax-L With Extension of Survival Among Patients With Glioblastoma
[2] Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer - Full Text View - ClinicalTrials.gov
[3] Id.
[4] www.nwbio.com
[5] https://ascopubs.org/doi/full/10.12...of care,year survival compared with treatment
[6] Id.
[7] Id.
[8] About Glioblastoma - National Brain Tumor Society.
[9] www.nwbio.com
[10] Id.
[11] Longer-term (≥ 2 years) survival in patients with glioblastoma in population-based studies pre- and post-2005: a systematic review and meta-analysis - Scientific Reports
[12] Current Standards of Care in Glioblastoma Therapy - Glioblastoma - NCBI Bookshelf
[13] The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?
[14] Effect of TTFields Plus Temozolomide vs Temozolomide Alone on Glioblastoma
[15] Association of DCVax-L With Extension of Survival Among Patients With Glioblastoma
[16] Id.
[17] Northwest Biotherapeutics and Advent BioServices Announce Receipt of License for Commercial Manufacturing at Sawston, U.K. Facility - Northwest Biotherapeutics
[18] Big Biz Show - 07.14.2023 by Big Biz Radio Show
[19] Inline XBRL Viewer
[20] Northwest Biotherapeutics Announces that a Marketing Authorization Application has been Submitted to the UK MHRA For DCVax®-L for Glioblastoma - Northwest Biotherapeutics
[21] Dendritic Cell Vaccine for Patients With Brain Tumors - Full Text View - ClinicalTrials.gov
[22]
[23] Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma - Full Text View - ClinicalTrials.gov
[24]
[25] Spoofing (finance) - Wikipedia
[26] Id.
[27] Id.
[28] Northwest Biotherapeutics, Inc. v. Canaccord Genuity LLC, et al.
[29] https://www.cohenmilstein.com/sites/default/files/NWBO v. Canaccord Amend. Complaint- 04102023.pdf
[30] Id.
[31] Id.
[32] Id.
[33] Id.
[34] Id.
[35] Id.
[36] Id.
[37]
[38] https://www.cohenmilstein.com/sites...Canaccord Amd. Comp. - Exbt. 1 - 04102923.pdf
[39] Twitter.com/midwesthedgie
[40] It took years, but the failure of Northwest Bio's brain cancer vaccine is now in the open
[41] https://www.courtlistener.com/docket/66579590/northwest-biotherapeutics-inc-v-canaccord-genuity-llc/, Document #115
[42] Id.
[43] https://www.washingtonpost.com/busi...b99b0a-4507-11e4-b47c-f5889e061e5f_story.html
[44] Id.
[45] https://storage.courtlistener.com/recap/gov.uscourts.nysd.590344/gov.uscourts.nysd.590344.123.0.pdf
[46] https://news.bloomberglaw.com/banki...-traders-sentenced-to-one-year-for-spoofing-1
[47] https://westviewnews.org/2023/01/23/our-capital-markets-are-under-siege/james/
[48] https://investorshub.advfn.com/boards/hubstocks.aspx
[49] Id.
[50] https://investorshub.advfn.com/boards/most_post.aspx?p=d
[51] https://investorshub.advfn.com/boards/profile.aspx?user=81442&page=347
[52] https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172442036
[53] https://investorshub.advfn.com/boards/profilea.aspx?user=546046
[54] https://investorshub.advfn.com/boards/profileb.aspx?user=546046
[55]
[56] Id.
[57] Id.
[58] Id.
[59] Id.
[60] Id.
[61] https://drive.google.com/file/d/1BnnP3lqZoG7GS0-SIWjXl7UfXlkL5_my/view?usp=sharing
[62] Id.
[63] Id.
[64] https://drive.google.com/file/d/1t_XDHaYhSM_dxL_iIpLJJZW89FIV8J9s/view?usp=sharing