Wednesday, December 25, 2019 4:19:30 PM
I believe that Dave is being sincere in telling us what he can, and is careful not to commit to something which may not happen on schedule. I believe all the company is saying should happen will happen in time, but clearly not everything happens as quickly as they, or investors, think it should. I do believe the SAP is done, so at this point the company, not others, should be in control of when they can release top line data, and when they can present it for peer review.
January could be a great month for investors if I'm right about ASCO as I believe at some point in January they will release top line data. It may already be unblinded, that's something most companies don't generally announce, and I suspect that's the case here as well. Summarizing all that's happened in over a decade in trial into a matter of a few paragraphs is something that needs some time to get it right. In reality, most such releases, even for drugs which have no trouble gaining approval, may not seem as optimistic as the results really are because the regulators, both SEC and FDA, abhor what they consider hype. I would certainly hope they tell us how many patients remain alive, and that they update the prior figures given for the top 100 by Dr. Liau. I would also hope they draw comparisons between historical data and what occurred in the trial. Because of the cross overs, I really doubt that they can accurately say what would have occurred had the entire control been run without cross overs. In reality this trial permitted most in it to gain advantage of the vaccine, and I suspect that those who didn't choose to may have passed on before they had the opportunity. I wouldn't be at all surprised if every patient still alive received the vaccine either up front, or on crossing over. That's the sort of information I hope we'll hear in top line data. When the company presents at ASCO or other peer review opportunities you'll see a variety of better technical information, probably several different K-M plots, etc, but it won't be in the top line data.
Gary
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