Tag archive for ‘NWBO’
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 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: Two Lead Investigators on DCVax-L Phase 3 Trial Believe That It Could be a Major Therapeutic Advance in Treating Glioblastoma Multiforme (NWBO, Buy, $0.29)
Reason for this Note I was prompted to write this note after listening to a July 2017, You Tube segment in which Dr. Keyoumers Ashkan spoke about his belief that DCVax-L could be a major advance in the treatment of brain tumors. Here is the link to this approximately 13 minute video. His comments on DCVax-L […]
Northwest Biotherapeutics: Issues to Focus on in Pending Manuscript Dealing with Blinded Data from Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma (NWBO, Buy, $0.23)
Purpose and Summary of This Report My key takeaway points are summarized at the end of this report. I urge you to first go through the full text, but if for whatever reason you are impatient, you can start from the back of the report. The primary purpose of this report is to provide data […]
Northwest Biotherapeutics: Thoughts on Why the Phase 3 Trial of DCVax-L is Ongoing (NWBO, BUY, $0.17)
Overview The phase 3 trial of DCVax-L in newly diagnosed glioblastoma is continuing even though it has passed the 248 PFS events (mPFS is a primary endpoint) and has probably surpassed 233 OS events (mOS is an independent co-primary endpoint). Reaching either or both of these events is not an automatic stopping point for the […]
Northwest Biotherapeutics, Bristol-Myers Squibb: Success for the Yervoy-Opdivo Combination in CHECKMATE-214 Trial Obviously is a Major Positive for BMY, but also has Important Implications for NWBO (NWBO, Buy, $0.19) (BMY, $60.80, Buy)
The stoppage at an interim analysis of Bristol-Myers Squibb’s’ CHECKMATE-214 trial provides meaningful information into assessing the potential fro success of Northwest Biotherapeutics’ phase 3, DCVax-L trial. CHECKMATE-214 compared a combination the immunotherapy drugs Opdivo and Yervoy to Sutent (standard of care) in previously untreated, advanced or metastatic renal cell carcinoma (RCC). The trial was […]
Northwest Biotehrpeutics: How Does DCVax-L Clinical Data Compare to the CAR-T Therapy Axi-Cel? (NWBO, $0.18, Buy)
New Seeking Alpha Article on Seeking Alpha An article on Seeking Alpha called Northwest Biotherapeutics: Statistically Satisfying was just published by an author who uses the pseudonym Bohsie. He looks at the unblinded data from the phase 3 trial of DCVax-L and hypothesizes that the data seems highly supportive of the hope that the phase […]
Northwest Biotherapeutics: Why I Believe That the Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Patients Has a Very Good Chance for Success (NWBO, Buy, $0.17)
Overview This report is an extensive update on almost everything I know about the DCVax-L phase 3 trial and is over 20 pages long. The catalyst for this report was the recent information on the still blinded phase 3 trial presented in June at ASCO. It will take dedicated investors a great deal of time […]