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Northwest Biotherapeutics: How the Right to Try Remarks in President Trump State of the Union Could Favorably Affect Regulatory Action on DCVax-L and DCVax Direct (NWBO, Buy, $0.33)
Introduction This report deals with comments made by President Trump in the State of the Union address in which he indicated that he wants to give terminally ill patients the right to receive experimental drugs, even though they might only be in phase 1 development. This could have positive implications for DCVax-L and DCVax Direct […]
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 […]
Northwest Biotherapeutics: Is There Any Chance for DCVax-L to be Successful in the Phase 3 Trial? (NWBO, Buy, $0.24)
Acronyms Used in this Report SOC: The standard of care in newly diagnosed glioblastoma patients is surgical resection followed by treatment with radiation and the chemotherapy drug temozolomide PFS: Progression free survival is the time from which the surgery is performed until the tumor begins to regrow mPFS: The median time at which half of […]
Northwest Biotherapeutics and Agenus: What Are The Implications for These Companies in the Aftermath of Two Recent Cancer Vaccine Trial Failures? (NWBO, $0.38, Buy) (AGEN, $3.99, Buy)
Two Recent Cancer Vaccine Trial Failures Spurred this Report On February 22, 2017, Argos reported that the Data Monitoring Committee for the phase 3 ADAPT trial of its cancer vaccine AGS-003 in combination with Sutent in metastatic renal cell carcinoma recommended that the trial should be discontinued. Following an interim analysis, the DMC concluded that […]
Northwest Biotherapeutics: 8-K Document Released Today Provides New and Very Interesting Data on Patients Treated with DCVax-L. (NWBO, Buy, $0.48)
Substance of 8-K Regulatory Document Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been raised due to some postings on message boards. Negative blogs have contended that NWBO has included the clinical data from 32 pseudo-progressors in the clinical data base of 331 patients enrolled in the phase […]