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Re: sage4 post# 446824

Tuesday, 01/09/2024 2:40:31 PM

Tuesday, January 09, 2024 2:40:31 PM

Post# of 462360
First, you really need to understand AA.

Second, you need to understand Sareptr’s failure better — in particular, NSAA endpoint.

Third — most importantly — LAW doesn’t say anything about “primary endpoint” or p<0.05 requirement. All it says is “substantial evidence”. Point being — FDA decides what is substantial evidence, which in almost all cases is TWO successful trials or ONE compelling and successful trial. Again — AA vs ffull approval is the same criteria — just the “endpoints” differ.
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