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Courtesy of BSB in iHub:
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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GlobeCitizen
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New article:
www.heraldtribune.com
DEDUCED RECKONING: Northwest Bio awaits trial results
By Joan Lappin
My column last month about Northwest Biotherapeutics generated a global response from readers as distant as Northern Belfast and Japan as well as throughout Florida seeking more information. You gotta love the internet. Readers are fascinated by this company struggling against great odds to develop a treatment for the very deadly glioblastoma that took the life of President-Elect Joe Biden's son, Beau.
NWBO, which we are invested in, has spent the last 14 years working on its product DCVAX-L. The last improvement in treatment protocol was approved in 2005. Only 6% of patients survive for five years using that combination of surgical removal of the tumor, radiation therapy and Merck’s highly toxic Temovar. On average, patients survive about 18-20 months.
Because there are patients walking around cancer free many years after receiving DCVAX-L, the company persisted through constant attacks that the drug was not effective and extended the trial for a full five years after the last of 331 patients was enrolled in 2014. Over 400 other trials have failed in this interim.
This summer, the company announced that it had locked data from all global treatment sites. Due to COVID-19, it was difficult for some data to be rechecked for accuracy and groomed for analysis. On Oct. 5, NWBO announced the data was ready for submission to the independent statisticians for final calculations shortly thereafter.
In an earlier press release, NWBO suggested that “within a couple of weeks” of submission the statisticians should complete their work. “Only then will the company be unblinded to the data.”
It is now over four weeks since the data lock so shareholders have been nervously awaiting (TLD) Top Line Data detailing its ultimate effectiveness. We do know that the company, per SEC rules of material corporate developments, had four days to announce if anything had been amiss. Happily, that, has not happened.
In the 14 years since this trial was initiated, there have been many medical discoveries with regard to both genetic testing and treating glioblastoma. Remember that the mapping of the human genome was only completed in 2003. It is only recently that genetic testing has become cheap and affordable. Genetic biomarkers are now identified that help indicate which persons might most benefit from a particular personalized treatment like this one. It is now known that 40% of the population have MGMT, a DNA repair enzyme that facilitates curing glioblastoma.
In just the last few years, Dr. Linda Liau, NWBO’s lead investigator, and others researched IDH, another genetic factor, that is present in 10% of patients. Some time this year was spent to go back through detailed patient records and tumor slides to retrospectively determine the presence of both MGMT and IDH in the cohort of 331 treated patients.
The regulators in the four countries to which NWBO is applying for approval (UK, Germany, Canada, and USA) are well aware of the vast improvement in knowledge about this dread disease since the trial began. That is why the UK and the EU recently accepted revised Statistical Analysis Plans adjusting for this new information on which approval may be granted. Those announcements were a significant factor in the recent upward trajectory of the stock.
NWBO has amassed an incredibly complex set of data that is both at least five years long for each patient and broad in its depth. Therefore, it seems to be taking the statisticians longer to analyze than originally forecast. The company reserved speaking spots at various conferences this fall but not yet having been unblinded to the data, it is not yet ready for a robust presentation. Therefore, several were canceled including the SNO conference on Nov. 20. The next such 2020 opportunity I found online is at the Glioblastoma Conference on Dec. 8. Or, alternatively, the information could be first presented in a major medical journal.
This is a small company undertaking a giant task with a very small, overworked staff. Its timelines are rarely correct. It also thinks that “silence is golden” when its guidance is optimistic instead of issuing updates which investors might appreciate. Insiders and very patient long-term holders own most of the stock and are inured to this annoying reality. The price action is now determined by recently arrived retail day traders who have been attracted by the stock’s sharp gains in 2020. Many such momentum players are losing money now adding to the wild swings in price.
So, we nervously await Top Line Data from this trial which can still fail. I repeat: buy this stock only with money you are prepared to lose if the trial fails and is not approved.
Joan Lappin CFA has been called an “investment guru” by Business Week and a “top manager” by the Wall Street Journal. The Sarasota resident founded Gramercy Capital Management, a registered investment adviser, in 1986. Email her at JLappincfa@gmail.com. Follow her on twitter: @joanlappin. Her past columns appear at heraldtribune.com/business/columns.
DEDUCED RECKONING: Northwest Bio awaits trial results
Readers are fascinated by this company struggling against great odds to develop a treatment for the very deadly glioblastoma.
www.heraldtribune.com
By Joan Lappin
My column last month about Northwest Biotherapeutics generated a global response from readers as distant as Northern Belfast and Japan as well as throughout Florida seeking more information. You gotta love the internet. Readers are fascinated by this company struggling against great odds to develop a treatment for the very deadly glioblastoma that took the life of President-Elect Joe Biden's son, Beau.
NWBO, which we are invested in, has spent the last 14 years working on its product DCVAX-L. The last improvement in treatment protocol was approved in 2005. Only 6% of patients survive for five years using that combination of surgical removal of the tumor, radiation therapy and Merck’s highly toxic Temovar. On average, patients survive about 18-20 months.
Because there are patients walking around cancer free many years after receiving DCVAX-L, the company persisted through constant attacks that the drug was not effective and extended the trial for a full five years after the last of 331 patients was enrolled in 2014. Over 400 other trials have failed in this interim.
This summer, the company announced that it had locked data from all global treatment sites. Due to COVID-19, it was difficult for some data to be rechecked for accuracy and groomed for analysis. On Oct. 5, NWBO announced the data was ready for submission to the independent statisticians for final calculations shortly thereafter.
In an earlier press release, NWBO suggested that “within a couple of weeks” of submission the statisticians should complete their work. “Only then will the company be unblinded to the data.”
It is now over four weeks since the data lock so shareholders have been nervously awaiting (TLD) Top Line Data detailing its ultimate effectiveness. We do know that the company, per SEC rules of material corporate developments, had four days to announce if anything had been amiss. Happily, that, has not happened.
In the 14 years since this trial was initiated, there have been many medical discoveries with regard to both genetic testing and treating glioblastoma. Remember that the mapping of the human genome was only completed in 2003. It is only recently that genetic testing has become cheap and affordable. Genetic biomarkers are now identified that help indicate which persons might most benefit from a particular personalized treatment like this one. It is now known that 40% of the population have MGMT, a DNA repair enzyme that facilitates curing glioblastoma.
In just the last few years, Dr. Linda Liau, NWBO’s lead investigator, and others researched IDH, another genetic factor, that is present in 10% of patients. Some time this year was spent to go back through detailed patient records and tumor slides to retrospectively determine the presence of both MGMT and IDH in the cohort of 331 treated patients.
The regulators in the four countries to which NWBO is applying for approval (UK, Germany, Canada, and USA) are well aware of the vast improvement in knowledge about this dread disease since the trial began. That is why the UK and the EU recently accepted revised Statistical Analysis Plans adjusting for this new information on which approval may be granted. Those announcements were a significant factor in the recent upward trajectory of the stock.
NWBO has amassed an incredibly complex set of data that is both at least five years long for each patient and broad in its depth. Therefore, it seems to be taking the statisticians longer to analyze than originally forecast. The company reserved speaking spots at various conferences this fall but not yet having been unblinded to the data, it is not yet ready for a robust presentation. Therefore, several were canceled including the SNO conference on Nov. 20. The next such 2020 opportunity I found online is at the Glioblastoma Conference on Dec. 8. Or, alternatively, the information could be first presented in a major medical journal.
This is a small company undertaking a giant task with a very small, overworked staff. Its timelines are rarely correct. It also thinks that “silence is golden” when its guidance is optimistic instead of issuing updates which investors might appreciate. Insiders and very patient long-term holders own most of the stock and are inured to this annoying reality. The price action is now determined by recently arrived retail day traders who have been attracted by the stock’s sharp gains in 2020. Many such momentum players are losing money now adding to the wild swings in price.
So, we nervously await Top Line Data from this trial which can still fail. I repeat: buy this stock only with money you are prepared to lose if the trial fails and is not approved.
Joan Lappin CFA has been called an “investment guru” by Business Week and a “top manager” by the Wall Street Journal. The Sarasota resident founded Gramercy Capital Management, a registered investment adviser, in 1986. Email her at JLappincfa@gmail.com. Follow her on twitter: @joanlappin. Her past columns appear at heraldtribune.com/business/columns.
GlobeCitizen
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End of today:
GlobeCitizen
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Not only Taiwan, other countries have used similar vaccines to treat GBM patients, but all are not sanctioned by NWBO, including Germany, India, Israel, and PRC, etc. Doubt they call their vaccines DCVax-L, becaue DCVax-L is a protected trademark. Only treatment of DCVax-L sanctioned by NWBO at present as far as I know is the UK's DCVax-L compassionate use program, open to anyone in the world who can afford.
NWBO holds various and numerous patents regarding DCVax-L, including the state of art process, extraction, purification, timing of maturation, etc. It's quite normal to see other countries have counterfeit treatments, or something similar but inferior.
Like you, most investors have really exhausted in waiting for TLD. Hopefully NWBO will truly exemplify the saying that nothing good comes easily, or in Chinese 好事多磨！
NWBO holds various and numerous patents regarding DCVax-L, including the state of art process, extraction, purification, timing of maturation, etc. It's quite normal to see other countries have counterfeit treatments, or something similar but inferior.
Like you, most investors have really exhausted in waiting for TLD. Hopefully NWBO will truly exemplify the saying that nothing good comes easily, or in Chinese 好事多磨！
GlobeCitizen
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| Dan88 | Tuesday, 11/17/20 11:30:03 AM |
| Re: None | 
|
| Post # of 331452 |
Too much FUDs from long today, and it seems most short takes a break. What a coincident?
For God's sake, if holding a few tens of thousand shares or a few hundreds of thousands of shares make you sleepless, sell enough before TLD if that makes you sleep better;
And the thinking of "but what are the chances our placebo group did better than expected," from a long, please give me a break!
In other trials with other indications, this had indeed happened repeatedly. To the knowledge of the SOC treatment for GBM and its outcomes, and the outcomes of numerous of clinical trials of various agents for GBM, none has indicated placebo (SOC) has had better outcome than the treatment, only exception I saw is with the result of CLDX Phase 3 trial. Nonetheless, in the trial, its placebo is not actually placebo and instead a proven active agent called KLH. In the case of NWBO, the placebo used is autologous PBMC which is known to be inactive substance compared to KLH.
Now what matters is that nwbo has run a lengthy trial and had five years of trial data for all patients, and as of 5 Oct, the trial has been locked for analyses.
What we have known are 1) its primary endpoint will be met, and it's highly likely at least some of its five other secondary endpoints will be met as well, which is enough for FDA approval.
Nobody in FDA in his/her right mind would not agree the above, particularly if more than triple or quadruple of patients in the trial can live five years than SOC patients!
EU approval is guaranteed with approved adapted endpoints, which at least warrants a price of $2-3 now; USA will follow. Even if FDA has not yet bought in with the adapted endpoints, it will be forced to approve with the convincing data.
We are all living in the public eye. FDA's own ADCOM if called upon will deal a huge blow to FDA, and FDA will have a convenient excuse to compromise -- agree to approve (this is of course a speculated worst case. I personally believe FDA like its EU counterpart has bought in the adapted endpoints. No reason why not.
Before the huge running up beginning a month ago, I said buying anything below $1 was no brainier; now I say buying anything below $2 is no brainier.
Facing TLD any day now, manipulation can only have a very short span of life.
Have to run for some errant. No time to spell check, or edit. Sorry for any inconvenience
GlobeCitizen
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People are looking for the next disruptive innovative technology in the area of cancer treatment as tsla is in transport. 众里寻他千百度，蓦然回首，那人却在灯火阑珊处
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GlobeCitizen
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Struggling for a firm ground for a while, and it seemed the floor is around $1.18.
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GlobeCitizen
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一个月内三倍，四倍增益
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One more day passed without news
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This demonstrates why people say the primary endpoint can be readily met:
Courtesy of ATLnsider in iHub:
I updated my table for external contemporaneous control groups for all completed Phase III clinical trials for newly diagnosed Glioblastoma.
As we all know, the new Primary Endpoint for the DCVax-L trial is:
As it turn out, according to this article:
The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?
there were only 8 completed Phase III clinical trials that were initiated for Glioblastoma between January 2005 and December 2016. Out of these 8 Glioblastoma clinical trials, 4 were for recurrent Glioblastoma and 4 were for newly diagnosed Glioblastoma. That means there is only a small finite number of "contemporaneous trials" that NWBio will be able to use in its TLD analysis of the Primary Endpoint.
As we all know, the DCVax-L trial started with its first patient randomized in 2007 and the last patient was randomized in 2015. All of the clinical trials on this Table are "contemporaneous trials".
Based upon my analysis of the completed "contemporaneous trials" for newly diagnosed Glioblastoma, the DCVax-L Phase III clinical trial will easily meet its Primary Endpoint:
Courtesy of ATLnsider in iHub:
| ATLnsider | Sunday, 12/13/20 12:34:55 AM |
| Re: None |
|
| Post # of 338783 |
I updated my table for external contemporaneous control groups for all completed Phase III clinical trials for newly diagnosed Glioblastoma.
As we all know, the new Primary Endpoint for the DCVax-L trial is:
As it turn out, according to this article:
The clinical trials landscape for glioblastoma: is it adequate to develop new treatments?
there were only 8 completed Phase III clinical trials that were initiated for Glioblastoma between January 2005 and December 2016. Out of these 8 Glioblastoma clinical trials, 4 were for recurrent Glioblastoma and 4 were for newly diagnosed Glioblastoma. That means there is only a small finite number of "contemporaneous trials" that NWBio will be able to use in its TLD analysis of the Primary Endpoint.
As we all know, the DCVax-L trial started with its first patient randomized in 2007 and the last patient was randomized in 2015. All of the clinical trials on this Table are "contemporaneous trials".
Based upon my analysis of the completed "contemporaneous trials" for newly diagnosed Glioblastoma, the DCVax-L Phase III clinical trial will easily meet its Primary Endpoint:
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While we are waiting, it is inspirational to watch patient's story on how DCVax-L saves life.
Jamil Newirth was diagnosed with Glioblastoma (GBM) brain cancer in 2012. He was told by his doctors he had about 17 months to live. He found Dr. Linda Liau, and was treated with DCVax-L. Jamil is still alive 8 years later & he founded a non-profit to help other GBM patients.
Jamil Newirth was diagnosed with Glioblastoma (GBM) brain cancer in 2012. He was told by his doctors he had about 17 months to live. He found Dr. Linda Liau, and was treated with DCVax-L. Jamil is still alive 8 years later & he founded a non-profit to help other GBM patients.
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Bristol Myers Squibb Announces Its Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme Has Failed.
Bristol Myers Squibb Announces Update on Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme
BMS Announces Update on Phase 3 CheckMate -548 Trial Evaluating Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme
www.businesswire.com
Once Again DCVax-L is only trial standing as of today. We are patiently waiting TLD.