So is the s2c still at 51 ish or is it now at half of 390
So is the s2c still at 51 ish or is it now at half of 390 for interim analysis? He seemed to glance over that rapidly like he was trying to avoid it or is waiting for fda to tell them and doesn’t know yet what they’re going to say. Maybe he thinks going bigger will be better for the trial outcome based on information from Patterson? We don’t know what they know and they can’t tell us everything so we’re going to have to assume they’re doing everything they can to get the best outcome.
As for distribution/licensing I believe a contract can say on condition of fda approval so if there’s no approval the contract becomes void.
So it seems like m2m results may come out first if severe is extended.
Will placebo arm count twice for p score? If so that should definitely increase good chances for both trials. I’m still confused on good p score vs. improvement. What percentage would justify approval? Is 10 percent okay? Are they going by p score or just improved outcome vs placebo by a small percentage?
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