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Expert Financial Analysis and Reporting

Tag archive for ‘DCVax-L’

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 […]

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: Going Over My Thoughts (NWBO, $0.62)

Overview The naming of five distinguished scientists with extensive knowledge and expertise in immune-oncology to Northwest’s scientific advisory board is the first of what I hope will be a number of steps that Northwest will take to fight back against a massive short selling attack on the Company. This has destroyed the stock price and […]

Northwest Biotherapeutics: The Company Provides an Operations Update (NWBO, $1.23)

Report Overview I usually start my reports with a summary and investment thesis. However, in this report I am putting this section at the end of the report. Northwest issued a press release on May 3 that gave an important operational update on the Company. The press release makes six distinct comments and in this report […]

Northwest Biotherapeutics: Why the Failure of Celldex’s Rintega in Newly Diagnosed Glioblastoma Probably Has No Implications for the DCVax-L Trial

Investment Thesis Some subscribers have asked me if the failure of Rintega in the phase 3 ACT-IV trial in newly diagnosed glioblastoma has any implications for success or failure of DCVax-L in its phase 3 trial in newly diagnosed glioblastoma. This note explains why I believe there are no negative or positive implications. Subscribers have […]

Implication of the Juno Celgene Deal for Emerging Immuno-Oncology Biotechnology Stocks in General and Northwest Biotherapeutics in Particular

The Terms of the Juno Celgene Deal Celgene and Juno announced a ten year collaboration for drug development using CAR-T therapy for both cancer and autoimmune diseases. Celgene has the option to commercialize Juno programs outside North America and co-promote certain programs globally. Juno has the option to co-develop and co-promote select Celgene programs. Celgene […]

Observations from ASCO on Immuno-oncology with a Focus on Northwest Biotherapeutics’ (NWBO, Buy, $9.43) DC-Vax-Direct© and the Checkpoint Inhibitors of Bristol-Myers Squibb and Merck

Key Investment Points Stemming from ASCO I have been going over data presented at ASCO on immune-oncology products and have been listening carefully to the presentations by Northwest Biotherapeutics and other companies active in this space, particularly Bristol-Myers Squibb and Merck. Let me summarize some of my key takeaways which will be addressed in more […]

Northwest Biotherapeutics: FDA Panel Recommendation to Approve Amgen’s Cancer Vaccine is Hugely Significant In Regard to Possible Approval of DCVax-L and DCVax Direct. (NWBO, $7.86, Buy)

Overview An FDA advisory panel on April 30 recommended by a vote of 22 to 1 that Amgen’s cancer vaccine talimogene laherparepvec be approved for the treatment of later stages of inoperable metastatic melanoma. The final decision will be made by the FDA, but it would be very surprising for the FDA to go against […]

CAR-T Companies-Kite (KITE, $55.09) and Juno (JUNO, $47.30): Is The Bloom Coming Off The Rose? Are Investor Expectations Unrealistic?

Introduction to This Thought Piece Emerging biotechnology stocks obviously are very hard to value on an absolute basis because they usually have no or minimal sales and huge operating losses. Many Wall Street analysts arrive at price targets by making long term sales and earnings projections; risk adjusting the estimates through predicting probability of successful […]

Northwest Biotherapeutics: Comments on Two AACR Posters (NWBO, $8.62, Buy)

Introduction I have included an abstract on DCVax Direct and another on DCVax-L that will be presented in poster presentations at the American Association of Cancer Research (AACR) meeting during April 18 to April 22. I have included the entire abstract for your review DCVax Direct Poster This poster dealt with the phase 1 trial […]