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Re: scorman1 post# 437701

Tuesday, 10/31/2023 2:32:10 PM

Tuesday, October 31, 2023 2:32:10 PM

Post# of 517467
Neuren/Acadia had an SPA for trofinetide in Rett and had agreed upon entry criteria, endpoints, method of analysis, and n -- this led to smooth sailing for the NDA and approval after their successful P3 . AVXL stated in June they will be using the same endpoints/method of analysis that Neuren had worked out with the FDA in their SPA. So if Missling doesn't go off script again, AVXL has a clear path --- assuming significance is reached and assuming the FDA is cool with the lower n. .
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