Acronyms Used in This Report MHRA    Medicines and Healthcare products Regulatory Agency is the United Kingdom regulatory counterpart to FDA. The two agencies have a close, collegial working relationship. Approval of DCVax-L by MHRA would carry great weight in the FDA’s decision making GMP   Good Manufacturing Practice is a system required by regulatory agencies for ensuring that drugs are consistently manufactured according to carefully defined quality standards. ​​Guidelines address issues such as process validation, quality assurance assays, record keeping, personnel qualific ..read more

DCVax-L Impressive Phase 3 Results Are Validated by Independent, Expert Scientists and Physicians; Supports Strong Upward Stock Move The final results of the phase 3 trial of DCVax-L were first released on May 10 at the New York Academy of Sciences conference. They were extremely encouraging showing that glioblastoma (GBM) patients treated with DCVax-L plus standard of care experienced an impressive increase in survival when compared to what is now achieved with standard of care alone. However, trial results reported by a company are always viewed with caution until they are validated by a pee ..read more

Executive Summary I have tried to make this report as short and readable as possible so that in many cases I provide links to a previous article I have written or other pertinent data, rather than recreating the information in this report. So, you will find lots of links. The intent is to give the reader my conclusions in short form in this executive summary, but also to provide access to in-depth information for those seeking more detail. Adam Feuerstein and his employer, Stat News, continue to falsely allege that the phase 3 trial of DCVax-L failed. This is a jaw dropping accusation given th ..read more

Overview This article puts into perspective the importance of a peer reviewed article on the Phase 3 Trial of murcidencel (better known as DCVax-L) that was published today in the Journal of the American Medical Association. This is a landmark event in which independent experts in an exhaustive process (which I will shortly describe) resoundingly validated previously reported clinical study findings. Here is the link to the article. The major findings presented in the JAMA article are consistent with those presented at the New York Academy of Sciences on May 10, 2022 although there is muc ..read more

I’m Back Earlier this year I decided to end subscriptions to SmithOnStocks.com. Researching and writing articles on biotechnology companies required a significant amount of time and effort that detracted from other things that I wanted to do. I am very curious by nature and get genuinely excited when learning new things. My interests include biology, of course, which drives the biotechnology and pharma companies that I focused on in my blog, but it doesn’t end there. I now spend anywhere from four to eight hours a day studying all manner of interesting subjects such as anthropology, history, p ..read more

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 the most respected neurosurgeons in the UK and Kings College is the premier teaching hospital in the UK. He was the chief investigator in the European segment of the phase 3 DCVax-L trial. Needless to say, these are impeccable credentials. Dr. Ashkan believes that DCVax-L is ..read more

Key Conclusion Let me ask you a question? If F-stein is trying to convince you that DCVax-L has no chance of being effective in glioblastoma multiforme (GBM), wouldn’t you expect him to have a good understanding of the biological basis for the product, its mechanism of action and how it is manufactured (especially the case for a living cell product)? Of course you would. Failing this, everything else he says is meaningless or highly questionable. This report unequivocally establishes that Adam Feuerstein has no such understanding. In searching through the plethora of articles he has written on ..read more

F-stein Challenges Members of the Oncology Community Who Treat Glioblastoma Multiforme Adam Feuerstein has thrown down the gauntlet in alleging that over 40 practicing oncologists who participated in the phase 3 trial of DCVax-L have misrepresented the findings. The results of the phase 3 trial were presented at the New York Academy of Science on May 10 and the physician participants who conducted the trial had to sign affidavits attesting to the integrity of the results shown in the paper. The key conclusions as presented by one of the clinical trial investigators were that DCVax-L was very s ..read more

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 confident that you will share my conclusion. I also dissect a note from Adam Feuerstein of Stat News that claims in a poorly written and worse reasoned article that the trial failed. This was cited by short sellers as the reason for a collapse in the stock price on May 10. F-ste ..read more

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 the short term they have succeeded, but over time I believe that the market will come to the belief that DCVax-L is a major advance in the treatment of the most aggressive form of brain cancer, glioblastoma multiforme. My wife was a social worker and is one of the mos ..read more