Tag archive for ‘Northwest Biotherapeutics Inc.’
Highly Probable UK Approval of DCVax-L in 3Q, 2024 Would Be a Crowning Achievement for Northwest Biotherapeutics
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 […]
Presentation of DCVax-L Results from ASCO by Dr. Keyoumers Ashkan
Here is the link to a video from ASCO in which Dr. Keyoumers Ashkan summarized the results of the phase 3 trial of DCVax-L in newly diagnosed and recurrent glioblastoma. He is the clinical lead for neuro-oncology at King’s College Hospital in the UK.and heads the Neuroscience Clinical Trial Unit. Dr. Ashkan is one of […]
Northwest Biotherapeutics: Debunking Silly, Fictitious Adam Feuerstein Article Falsely Claiming Phase 3 Trial of DCVax-L in Glioblastoma Multiforme Was a Failure
Introduction I am really outraged. The long awaited phase 3 results for DCVax-L in newly diagnosed and recurrent glioblastoma multiforme were a stunning success. The data was peer reviewed and presented at the prestigious New York Academy of Sciences on May 10, 2022. I discuss the data at length in this report and I am […]
Presentation at the New York Academy of Sciences on Final Results of Phase 3 DCVax-L Trial Showing Impressive Efficacy (Part 3) Analyzing Hedge Fund Stock Manipulation Techniques
Introduction This note describes why I believe that the sharp downward price movement yesterday resulted from stock manipulation by a group of hedge funds that I call the wolfpack. It was a bold and frightening effort to make investors fear that the very positive news from the presentation at the academy was actually negative, In […]
Presentation at the New York Academy of Sciences on Final Results of DCVax-L Phase 3 Trial Showing Impressive Efficacy (Part 2) Incredibly Low p-Values on Median Overall Survival Endpoints
Earlier today, I put out the first of a series of reports that I plan to issue on this presentation. As I write this, the stock is down over $1.00 even through the results were extremely, extremely impressive. The presenter of the paper stated that DCVax-L represented the first major advance in treating glioblastoma (GBM) […]
Presentation at the New York Academy of Sciences on Final Results of Phase 3 DCVax-L Trial Showing Impressive Efficacy (Part 1) Debunking Hedge Fund Misinformation
Overview The much anticipated presentation at the New York Academy of Sciences of final results of the phase 3 trial of DCVax-L in newly diagnosed and recurrent glioblastoma was just completed. Investigators in the trial as well as questioners in the audience not affiliated with the trial described DCVax-L as a major advance in the […]
Northwest Biotherapeutics (NWBO, $0.86, Buy) Addressing Key Questions Relating to the Possible Approval and Commercialization of DCVax-L in Glioblastoma Multiforme
Introduction The catalyst for writing this update was the MHRA certification of Northwest Biotherapeutics’ Sawston, UK plant for GMP production of DCVax-L for compassionate use. This was a critical step on the path to approval and commercialization of DCVax-L. Having taken pen in hand, I decided to update my reporting on other issues relating to […]
Northwest Biotherapeutics: FDA Statement Regarding Use of External Controls in Clinical Trials is a Huge Positive
I put out a blog last week alerting subscribers that I am writing an update on Northwest Biotherapeutics. I continue to work on this report and hope to have it out soon, but I am compelled to address some late breaking news beforehand. As the report stood yesterday, I was highlighting as a major uncertainty […]
Could There Have Been Hundreds of Millions or Even More Than a Billion Counterfeit Shares of Northwest Biotherapeutics Created Through Illegal Naked Shorting?
I am often asked how I can hypothesize that there may be such an unbelievably large number of counterfeit shares of NWBO that have been created through illegal naked shorting? A look at the GameStop short squeeze gives a real world example suggesting that the hedge fund Melvin Capital could have been short the equivalent […]
Northwest Biotherapeutics Issues Encouraging Update on Manufacturing Capabilities (NWBO, $1.59, Buy)
Introduction This report addresses three issues: The capability of the Sawston UK plant to manufacture Northwest Biotherapeutics’ dendritic cell vaccine in accordance with regulatory requirements and to scale up to manufacture it in substantial quantities. (Note that in the US, this product is referred to as DCVax-L, but may go by a different brand name(s) […]