NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

[GlobeCitizen]

Robert A. Hefner III Biography - Oklahoma Hall of Fame​

 

[GlobeCitizen]

Feuerstein's Flab on Northwest Bio (NWBO) Dives Stock on Meritless Claims After Nailing Primary Endpoint

Northwest Biotherapeutics (OTCMKTS: NWBO) is now a risk-off biotech trading at a significant discount; in a “sell the news” market, there are no more milestones to sell as the company completed its phase 3 trial successfully and met its primary endpoint. The well-known architect of the sell-off...

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Feuerstein’s Flab on Northwest Bio (NWBO) Dives Stock on Meritless Claims After Nailing Primary Endpoint​

Northwest Biotherapeutics (OTCMKTS: NWBO) is now a risk-off biotech trading at a significant discount; in a “sell the news” market, there are no more milestones to sell as the company completed its phase 3 trial successfully and met its primary endpoint. The well-known architect of the sell-off is none other than STAT Reporter Adam Feuerstein. His usual MO is: “the company missed the endpoint and they cherry-picked the data in post hoc analysis.” What is so amazing about this latest STAT News concoction criticizing NWBO is that the company nailed its phase 3 primary endpoint and its glioblastoma drug is a likely candidate for approval. Investors should be dismissing this “washed up” reporter with epic fails on his pick list. NWBO is extremely undervalued for a company that has a treatment that could very well become the standard of care for glioblastoma patients after a 17 year hiatus since the last advance in treatment for these cancer sufferers. NWBO is scaling up manufacturing in anticipation of approval and the epitaph on Feuerstein’s Reporting Career could read “Another 10-year fight Settled with FDA Approval.”

Examples of Feuerstein’s Pans About Endpoints​

Feuerstein has been neurotic about commenting on topline data readouts but for the past 10 years he has been infatuated with NWBO with only a brief affair with CytoDyn (OTCMKTS: CYDY), and now he is back to NWBO. We cannot forget about Cel-Sci Corporation (NYSE: CVM) as Feuerstein reminisces.





CytoDyn Missed primary Endpoints



Amarin Missed Primary Endpoints



Anavex Changed Primary and Secondary Endpoints



BridgeBio Misses Primary Endpoint



Ampio No Better than Saline



Keen investors can see his obvious pattern, in that he coordinates his attacks on these biotechs around the timing of the announcements. Now the good news for NWBO investors is that there are no more announcements except the potential drama of an FDA advisory panel. This is probably the last hurrah for Feuerstein with respect to NWBO, but you never know because he has defined his career claiming how utterly worthless the technology is. There has got to be one more punch left in him. The only real chance he has to save face is if another technology magically rushes in to become the standard of care. It is highly unlikely but possible if you follow the galectin science in oncology, but then he’d be rooting for his nemesis Galectin Therapeutics (NASDAQ: GALT) that he panned early in his career and the company currently isn’t anywhere near this disease indication in cancer.

Feuersteins Track Record on Auto Destruct​

The game of musical chairs is about to end for Feuerstein and he goes into the twilight of his career. A number of FDA approvals in companies he has attacked should be hitting the news wires in the coming years. His unprecedented attack on CYDY should be resolved with an HIV BLA submission and subsequent approval in 2023 provided NWBO doesn’t steal the show first.

Cytokinetics Failed Primary Endpoint and 4-5 Secondary Endpoints
https://twitter.com/adamfeuerstein/status/621014107446226944




A huge blemish on Feuerstein’s track record is his pan of Cytokinetics (NASDAQ: CYTK). Back in 2015 he thoroughly bashed the science and here they are, seven years later with a $3.3 billion market cap and huge returns for patient investors. Long term investors that listened to him missed out on a 13X return over 7 years. Feuerstein is far from infallible as he would have investors believe and his influence has been waning as investors see his clearly biased and uneducated responses lacking solid scientific basis. Could it be his Political Science degree, or just laziness? Time will tell. His recent showing at ASCO, the premiere oncology industry conference, bordered on desperation as he approached NWBO shareholders in this following encounter.


Feuerstein’s tactics are well documented. He bullies CEOs, doctors, and patients in clinical trials, and here he was basically caught on camera spewing lies to investors. The man depicted clearly has no shame, and just look at how he dressed for ASCO. You have to love the “Feuerstein flab” that investors highlighted on Twitter. Investors have to ask themselves if they would entrust their hard-earned money to this pathetic individual in the mask?

Feuerstein’s May 10th Attacks​

In a typical fashion, Feuerstein attacked on Twitter and also in an article in STAT News on May 10th after NWBO’s release of their phase 3 glioblastoma data. As usual, he did little to no analysis, but legions of his followers started shorting and selling the stock. NWBO shares slid after releasing its phase 3 topline results for its immunotherapeutic vaccine treatment (DCVax-L) for patients with glioblastoma (GBM), whereby the multinational, 331 patient study met its primary and secondary endpoints. Patients in the drug arm exhibited a marked increase in overall survival, a gold standard of efficacy in a clinical trial like this.

Feuerstein based his career on attacking companies for missing their primary endpoints in clinical trials. Many times science requires adjusting what is being measured in order to be able to identify clinical effects. This happens a majority of the time making it easy for him to maintain a winning track record in order to prey on small biotechs. In the case of NWBO he cannot even claim that they missed their primary endpoint because they very clearly hit it.

NWBO has been Feuerstein’s pet project since 2014 in what many believe to be a stock manipulation scheme. His first attacks on Twitter misrepresented NWBO’s phase 3 clinical trial design enhancements as a conspiracy to move the bullseye after they saw a grouping of outcomes. He has published over 20 negative articles on the company.





His Twitter attack focused on how the company was supposedly doing post-hoc analysis and changed the endpoints using the historical changes feature on clinicaltrials.gov. The crux of his online attack was published in his STAT article, which examined the meaningless endpoint of progression free survival, an endpoint the company reasonably jettisoned.





What makes Feuerstein’s attack on this company so reprehensible is that this is potentially the first systemic treatment improvement for GBM patients since 2005, when Temodar was approved for newly-diagnosed GBM, adding a mere 2.5 months of survival. In 1995, the Gliadel wafer was approved for recurrent GBM and offered patients only 2 months additional survival. Treatment options for GBM are dismal.

Meeting Primary and Secondary Endpoints​

Debunking the attack was Neurosurgeon Keyoumars Ashkan, Professor of Neurosurgery & Lead for Oncology. He is a well-respected neurosurgeon in the UK and viewed the Phase 3 trial results are an incredible step forward in treating both newly diagnosed and recurrent GBM





Autologous Tumor Lysate-Loaded Dentritic Cell Vaccination for Glioblastoma (DCVax)

“We cannot use progression-free survival to look at these patients because it’s totally pointless. What you are seeing on the scan is not necessarily tumor changes, it could simply be the effect of treatment. It could actually be a good thing rather than a bad thing, and clearly, it’s been nonsense to use a biomarker of response when it is totally false from the outset.“

Northwest Biotherapeutics’ DCVax-L and Phase 3 Trial​

NWBO’s phase 3 clinical trial was a resounding success because it met its primary endpoint, median overall survival (p<0.002), for newly diagnosed glioblastoma, but the Feuerstein Mob is attempting to distort the fact that the vaccine was found to be efficacious by convoluting the truth. Investors need to know the details to identify his deception. So first let’s examine the phase 3 trial and then what Feuerstein claimed, and why it’s wrong.

NWBO’s GBM vaccine is comprised of a patient’s autologous dendritic cells cultured in tumor cell lysate, allowing for a potent immune reaction. These trained cells are then reinjected intradermally into the patient to attack any residual cancer cells and/or prevent a recurrence. The company’s phase 3 trial took GBM patients through standard of care—surgery and chemo—before starting treatment with DCVax-L or placebo.




DCVax-L Phase 3 Topline Results Presentation

The trial initially used a crossover design to make it worth it for the patients who would have to undergo invasive procedures to obtain their blood samples but then might get placebo treatment. When these placebo patients progressed, they would cross over to obtain the vaccine. Because of this, the endpoint was progression-free survival (PFS) and not overall survival, which would be convoluted by the crossover design—PFS can be measured before the crossover and OS cannot, for those crossover patients.

This trial started before immunotherapy was really gaining acceptance, and before the concept of pseudoprogression was identified as a potential issue in measuring PFS. Pseudoprogression is often associated with favorable outcomes but initially causes the tumor to grow because it means that the tumor is being infiltrated with immune cells that are beginning to identify it and attack it, causing it to swell. The secondary endpoint, progression free survival, was not met, but that is actually a good thing because it is common in this disease for the tumor to get bigger before it gets smaller due to pseudoprogression—the growth of tumor size due to significant infiltration of immune cells attacking the tumor. Attracting immune cells is the hallmark of the treatment actually working which means if it works its going to cause inflammation at the tumor site and that will be picked up in the imaging. That blip up in tumor size means the treatment is working but that temporary increase in tumor size still stops the clock on the progression free survival measurement. This effect in NWBO’s trial was widely expected so any shock value implied by the short mafia is just drama and an attempt to confuse investors.




Handbook of Neuro-Oncology Neuroimaging (Second Edition). Chapter 55 – Pseudoprogression in Neuro-Oncology: Overview, Pathophysiology, and Interpretation

Since the crossover arm couldn’t be used as placebo, NWBO gathered data from a variety of other recent trials, using contemporaneous patient data, closely matched using an array of criteria, in newly diagnosed as well as recurrent GBM. They performed sensitivity analyses as well as adjustments for patient characteristics, and in each case the clinical result was the same. 1,366 nGBM and 640 rGBM patients were used in total for placebo, making the comparison very robust.

The outcome of the trial was that DCVax-L increased mOS from 16.5 months to 19.3 months for nGBM, with a survival tail (the few patients that do survive much longer) of 13% versus 5.7%. In recurrent GBM, mOS increased from 7.8 to 13.2 months, with a survival tail of 11.1% versus 5.1% at 30 months after recurrence. All of this was accomplished withough the safety issues that might make patients want to forego standard-of-care therapy; there was no cytokine storm or autoimmune reactions, and only 5 serious adverse events potentially related to the vaccine.

According to the analysis, the long-term survivors had consistent immune memory (T-cell) phenotypes, potentially changing the natural history of GBM from a uniformly fatal to a chronic, manageable disease for these patients.

More About Glioblastoma​

GBM is a disease that is aggressive, heterogeneous, and immunologically “cold” (the immune system will typically not recognize the tumor and deal with it, so developing a therapy for the disease is very difficult; the heterogeneity additionally makes any type of targeted therapy difficult and this is potentially why NWBO’s personalized vaccine is a better approach.

Standard of Care (SOC) for GBM is still stuck in the dark ages of cancer therapy as patients typically undergo surgery and 6 weeks of daily chemo and radiation, transitioning to monthly chemo, only to be brought to the brink of death to survive another 16 months on average with very poor quality of life. Given the aggressive nature of GBM and the immunological ignorance of its existence, the tumors tend to recur 7-8 months later (near 100% recurrence rate), whereby the patient has another 8 months to live. In summary, treatment is almost ineffective and quality of life is extremely poor. 5-year survival is less than 5%. A new treatment is desperately needed; in the 2005-2016 timeframe, there were 417 clinical trials for GBM, with only 16 phase 3 trials, and one positive phase 3 trial (a device, not a drug). Since 2016, more approaches have failed, including CAR-T therapies, checkpoint inhibitors, peptide vaccines, gene therapy, chemo, and dendritic cells with standardized peptides.

Compared to these almost ineffective treatment options that offer a year or two of poor-quality life to patients, NWBO’s results really stand out as it offers significantly more time to the patients without the safety risks. So wait, how could Feuerstein convolute this? He just makes up lies!

Feuerstein’s Flabs​

Feuerstein made up a bunch of lies in his hit piece; not all of them are even worth reviewing, but certain ones stand out:

First, Feuerstein implies that DCVax missed its primary endpoint of PFS (the old endpoint), by saying that the treatment performed worse than placebo, ignoring the concept of pseudoprogression:

“Patients administered the Northwest Bio Treatment, called DCVax, went a median 6.2 months without their brain tumors returning compared to a median of 7.6 months for patients offered a placebo.”

This is not correct. Residual cancer progressed in size, not full-blown recurrence. The PFS threshold was met but the primary endpoint measures overall survival, whereby the patients receiving treatment did better and survived longer.

Feuerstein’s second flab stated that the company simply threw out the placebo arm when in reality the placebo patients went to the crossover arm, the recurrent GBM part of the study:

“The company discarded the overall survival data from the 99 patients randomized to treatment with a placebo. Those original, prespecified data were thrown out, and replaced on a post-hoc basis with survival data collected from 1,366 patients who participated in five entirely separate and previously completed clinical trials.”

There are two flabs within this flab. The first is simple; the placebo data were not thrown out. Due to the clinical trial design explained earlier in this article, the placebo patients were later enrolled in the rGBM arm and therefore couldn’t be used for long-term placebo analysis. As such, the company used external control, analyzed by an independent third party. The other sneaky fib in this statement was that the analysis was post-hoc. This technically isn’t true since the analysis plan was run past regulatory authorities before unblinding the data.

Feuerstein’s final flab was implying that NWBO concocted an alternate reality with the data, showing their trial was a success. However, over 40 trial investigators involved in the phase 3 trial signed affidavits certifying the honesty of the results.

This kind of blatant lying was likely taught to Feuerstein when Jim Cramer hired him when he worked for TheStreet.com. There is an infamous interview with Cramer from over a decade ago where he explains how funds manipulate shares using fear tactics and misinformation. Distorting the truth is Feuerstein’s bread and butter.

The only negative to the trial was its misrepresentation in the fraudulent media. The trial was a resounding success and the short mafia, and perhaps some investors willing to believe the lies, are the only reasons shares are down.

Investment Summary ​

It’s an amazing phenomenon to see that Feuerstein’s tactics are still effective in this day and age of social media. Investors at NWBO are infuriated that he gets away with telling his alternative facts. The unfortunate fact is that his legion of followers is bigger than NWBO zealots. We hope this article exposes the washed-out biotech commentator for who he really is. He’s a cyber bully—plain and simple. Investors should study his demeanor at ASCO and how his track record costs both investors and patients in the long run. His tactics are tiring and his track record is going to be under serious attack as FDA approvals start rolling in on the companies he has panned over the years. His analysis is a joke because it’s a preplanned attack in advance. He preys on investors’ fears, getting them to sell first and ask questions later.

NWBO has a very high likelihood of getting DCVax approved. The timing of potential approval is unknown, but the drug is slated to change the Standard of Care (SOC) in glioblastoma, both newly diagnosed and recurrent. Investors with a little bit of patience could see a multibillion-dollar valuation (perhaps up to $7 billion dollars) in the coming months to years just as Novocure (NASDAQ: NVCR) saw after succeeding in glioblastoma with its device (as opposed to a systemic treatment). The company is commercializing its operations and scaling up manufacturing. The overall slump in biotech may be depressing prices but much of the risk in NWBO is gone. The high likelihood of approval, the neutralization of Feuerstein, and the ramping of manufacturing are elements of a sunny outlook for NWBO. The stock is at extremely oversold levels and every share that is bought and held is another nail in Feuerstein’s biotech coffin.

WHEN INSIDER FINANCIAL HAS A STOCK ALERT, IT CAN PAY TO LISTEN. AFTER ALL, OUR FREE NEWSLETTER HAS FOUND MANY TRIPLE-DIGIT WINNERS FOR OUR SUBSCRIBERS. WE SPECIALIZE IN FINDING MOMENTUM BEFORE IT HAPPENS!​

Disclosure: Insider Financial and its owners do not have a position in the stocks posted and have posted this article for free without editorial input. This article was written by a guest contributor and solely reflects his opinions.


Related Items:Adam Feuerstein, CEL-SCI, CVM, CYDY, CYTK, CytoDyn Inc., Cytokinetics, DCVax-L, Featured, Galectin Therapeutics, GALT, glioblastoma, Northwest Biopharmaceuticals, Novocure, NVCR, NWBO

 

[GlobeCitizen]

 

[GlobeCitizen]

happy to make all our family's RRSP and TFSA contribution this year be added new NWBO shares, about 133k added (about $0.63 per shares) to well over seven figure of shares. It's a clear pass to UK approval this year and other RAs will follow.

Northwest Biotherapeutics Announces Presentations On DCVax®-L Personalized Vaccines, Manufacturing and Scale-Up, and DCVax®-L Clinical Program

/PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor...

www.prnewswire.com

Northwest Biotherapeutics Announces Presentations On DCVax®-L Personalized Vaccines, Manufacturing and Scale-Up, and DCVax®-L Clinical Program​

---

News provided by
Northwest Biotherapeutics
Jun 05, 2022, 21:23 ET

BETHESDA, Md., June 5, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, reported that yesterday on June 4, 2022, in the Industry Expert Theater during the ASCO 2022 conference, Dr. Marnix Bosch made a presentation discussing the Company's DCVax-L technology for personalized dendritic cell vaccines, the Sawston, UK facility, the manufacturing technology, the development of automation, and preparations for manufacturing scale-up. In addition, a video presentation about the DCVax®-L clinical program was screened in the Company's exhibit booth in the ASCO Exhibit Hall.
These presentations are now available online at https://virtualtrials.org/dcvax
The Industry Expert Theater is not an official event of the ASCO Annual Meeting. It is not sponsored, endorsed or accredited by ASCO®, CancerLinq®, or Conquer Cancer® the ASCO Foundation. It is not CME-accredited.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company's lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed and recurrent Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." This Phase III trial reached data lock and top line data was recently presented. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
SOURCE Northwest Biotherapeutics

 

[Henri]

2 days ago, NWBO released a PR announcing British approval for two pediatric glioblastoma vaccine trials, which is a British requirement for any drug that will be marketed for adults.
How long is the pediatric trials going to take? Years?

 

[GlobeCitizen]

Yes PIP (Pediatric Investigation Plan) is a prerequisite for submitting a Marketing Authorization Application (MAA) of DCVax-L for GBM for commercial use in UK. So with that approved (the PIP pediatric trial plan), NWBO can now submit MAA for DCVax-L to be commercially used to treat GBM patients. Note NWBO secured a deferral for the approved pediatric trials until after the submission of MAA. Now my understanding in regards to what will happen is 1) NWBO submits MAA; 2) NWBO secures a license for manufacturing in UK (currently under review); 3) announces start of pediatric trials (two small trials involving 20+ patients); and 4) regulatory approval of MAA for DCVax-L for GBM.

Note the following paragraph in the news release is very important:

"The Company's approved PIP includes 2 clinical trials: one for newly diagnosed pediatric high grade glioma (HGG), and one for recurrent pediatric HGG. In each of the 2 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 glioblastoma patients."

It reinforces UK regulatory agency (Medicines and Healthcare Products Regulatory Agency (MHRA)) is readily acceptable to NWBO's updated endpoint changes, which further increases the chance of MAA approval. I give the chance above 80%.

Good luck to you. I have recently added a lot shares in the range of low $0.60s. The company has also offered me to participate in C round of financing (C-shares).

 

[GlobeCitizen]

The next few months will be very interesting for NWBO holders: Manufacturing license, Start of small pediatric trials, MAA approval. The stock is currently pretty much de-risked, and after MAA approval it would be completely de-risked with share price anywhere below $5, because the chance of approvals by other regulatory agencies would be instantly raised.

 

[GlobeCitizen]

 

[GlobeCitizen]

画大饼时刻: there is a saying that only sky is the limit. The potential of DCVax (center in pic below) as an essential element of future cancer cures - combinational therapies for all solid cancers can only be depicted by that exact saying above.

Form this Nature article Cancer vaccines: the next immunotherapy frontier - Nature Cancer

"Overall, anonymous antigen ex vivo vaccines are promising for their greater potential to present the full spectrum of tumor antigens as compared to predefined antigen vaccines and their demonstrable efficacy in inducing systemic tumor regressions" --- DCVax-L.

NWBO share price in the process? Double digits, triple digits? Anything possible!

 

[GlobeCitizen]

Good to see share price follows through last Friday's gain despite Wall Street bloodshed. The price has been heavily suppressed. One reason is that the US media biotech mafia has so far collectively ignored this biotech company and one outlet (Cramer in the past and now the Statnews) has sent AF to write two dozen of hit pieces to manipulate the market and aid short sellers. Because of that here is the opportunity to get in at low price before the naked short selling mafia collapses.

 

[Henri]

Good to see share price follows through last Friday's gain despite Wall Street bloodshed. The price has been heavily suppressed. One reason is that the US media biotech mafia has so far collectively ignored this biotech company and one outlet (Cramer in the past and now the Statnews) has sent AF to write two dozen of hit pieces to manipulate the market and aid short sellers. Because of that here is the opportunity to get in at low price before the naked short selling mafia collapses.

浏览附件1059500 浏览附件1059501

What’s this talk about November 11th TLD announcement?

 

[GlobeCitizen]

Sorry Henri, I don't understand your question, but TLD was essentially reported at NYAS on 10 May by a clinician who paritipated in the trial. Yes the company has not yet officially announced TLD as of today. Anyhow some events are scheduled in the near future:


Dr. Prof. Keyoumars Ashkan presenting at the Advanced Therapies Symposium by King's College Hospital NHS Foundation Trust on Friday, September 9, 2022 - "Dendritic cell vaccination for glioblastoma" $NWBO #DCVax https://eventbrite.co.uk/e/advanced-therapies-symposium-tickets-381630857167

Dr. Linda Liau will be presenting as well on Sunday, 20 Nov (note in the title: Improves survival in patients with newly diagnosed and recurrent glioblastoma):

 

[GlobeCitizen]

Plus other events to be looked forward to:
When time is right, the company will have to announce annual shareholders meeting; official TLD announcement/journal publication; Manufacturing license; MAA acceptence.

The good thing is NADAQ,, the DOW, & S&P 500 have lost about 10% recently but NWBO has held steady and in a slight uptrend.

 

[GlobeCitizen]

 

[GlobeCitizen]