Tag archive for ‘dcvax direct’
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: A Comprehensive Evaluation of Its Lead Product DCVax-L (NWBO, $1.50)
Perspective and Overview on this Report The still unexplained and unresolved halt in screening for the phase 3 trial of DCVax-L in newly diagnosed glioblastoma multiforme has been a nightmare for the Company and its investors. It seems that almost everything has ground to a halt in the last six months as Northwest awaits guidance […]
Northwest Biotherapeutics: My Thoughts on the New Data from the Phase 1/2 Trial of DCVax Direct (NWBO, Buy, $6.91)
Critical Issue in Interpreting the Data Northwest just recently presented length of survival data for 39 patients evaluated in its phase 1 trial of DCVax Direct. . These patients were suffering from 13 different y types of solid tumors. The common characteristic was they were in the terminal phase of their disease and their tumors […]
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 […]
Comments on Antares, Kite Pharma and Northwest Biotherapeutics
SmithOnStocks Mailbox About the Mailbox: My mailbox comments are brief articles on stocks in which I am involved. These can come from recent events or from subscribers’ questions. They are meant to address specific issues about these stocks and are not full and balanced reports. Please refer to the Reports section of my website for […]
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 […]