I had the same sense that Larry did -- that is the paper will likely come out in "weeks" -- and I'd add my sense was probably not months.
I can speculate that the paper will be blinded, as the investigators who contributed to it were still blinded. I'd also guess, that it has to do with what NWBO put in their last PR. Emphasis on the long-tail multiple year survival consistent throughout several trials, including what appears to be the phase III trial, plus the objective responses in the preclinical and pilot combination studies.
I'd add speculation that this might be something regulators might look at as another avenue for AA. Remember, we don't even know if there has been one efficacy IA completed in this trial. So I have no idea if the FDA would look at something like that. Again, I'm not trying to state what Les was discussing, because it did go too fast for me.
If this were the case, they'd be trying to replace uncertainty with more certainty. With a very smart and progressive FDA climate, there would be a lot to like. As Dr. Bosch basically put it, what if you were told you had 12 months to live....and four years later you were watching his presentation?
Look, if there are something like 71 patients in treatment that did not progress, and zero or nearly zero from placebo. (My Guess) Then if there is obvious crossover impact for OS that can't be unconfounded for a long time, this ( stong long tail with multiple year survival) may be another way to demonstrate obvious efficacy on the front side of results. It is basically landmark analysis. I have no idea if this is a route they are looking at.
If I were the FDA I'd give them AA then give NWBO and BMY some very very tight timelines. Note, by late summer / fall of this year, I think the 32 psPD patients who are still alive in the parallel trial will all have at least four years under their belts.
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