Not being flippant, but do you seriously think we'll find out what the exact pre-specified analysis is for the cox primary endpoint?
They won't publish it in all of its details, but if the FDA signed an SPA with Cox Regression as the primary endpoint you can ABSOLUTELY bet that virtually all of the wiggle room is removed. (I've been saying for almost 2 years that it was virtually guaranteed that the "Prespecified Cox Regression" of 9901 would have too much wiggle room BECAUSE it was not documented well enough BECAUSE it was not the primary endpoint.)
Will there be some hole in the 9902b prespecified Cox - absolutely. But it will be a *lot* smaller. This is not anywhere near the first Cox Regression that the FDA has allowed as a primary endpoint - not even the first to go with an SPA. They know how to plug the holes.
If log rank, i bet HR is less than 1.3. If you want a number, i'll go 1.21. If I'm not entirely mistaken, an HR of 1.21 in this 500 patient trial will have difficulty coming in at p < 0.05.
Yep, a log rank measured HR of 1.21 would not be stat sig. But a trial with a measured HR of 1.21 would be 60 pct odds (a mild WAG) of being stat sig after Cox Regression - see previous comment. (Remember that Cox Regression is essentially an analytic form of stratification - it is not getting something for free, but is instead correcting for imbalances in things KNOWN to be predictive of survival time.)
Absolutely no immune response to a physiological antigen. No reasonable MOA explanation (i don't concur with David's suggestion that it "picks" away at specific cells in vivo).
Thanks for the clarification. (If I'd been asked to predict your response to my question I'd have guessed MOA.) But I'll point out that it does have plenty of stimulating effects on the immune system. CD54 upreg, the Stimulation Index referred to in the P-11 data, ... . Which is good enough for me (not being sarcastic - but you and I have different view when it comes to MOA)
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