In particular the company states the trials are 2.5X bigger than the P2s.
2.5x bigger than the subgroup from the ph iib that would meet the entry criteria for this ph iii.
Why 15 patients in the palceboe arms of the 4 trials, especially when you know many will drop out?
Valid question - did they account for the drop out rate. But note that if the trial is 2.5x bigger and the ph iib drop out rate for placebo was 'only' 30% they are still in ok shape.
Why no SPA?
Valid point - my guess as to the rationale is that it takes months to negotiate an SPA and the whole point of the anemai trial is to get in early. E.g. if the goal of this trial was to save 8 months on the NDA and it took 8 months to negotiate the SPA, ... what's the point? (Not saying it is that extreme a trade, but trying to clarify.).
PS No, I haven't gone native (yet -g-), but just pointing out that there is enough data out there now to understand that some thought went into the trial even if 15 patients sounds wacko. Plus debate is good for the DD process.
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