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Re: Doc328 post# 429255

Monday, 09/04/2023 12:31:43 PM

Monday, September 04, 2023 12:31:43 PM

Post# of 461946
Trofinitide set the precedence and Anavex is following it. My comment was regarding the future, you're addressing the past as if set in stone.
The FDA is lame, but I do believe they adapt to science as presented.

The FDA likes precedence. Trofinetide had an SPA and the decision by the FDA was RSBQ and CGI-I baseline to EOS. They successfully used these for approval with MMRM imputation Anavex confirmed these exact endpoints in June. Anavex can add supplementary endpoints like anchoring but must do the coprimary endpoints for approval

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