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Re: kevindenver post# 429252

Monday, 09/04/2023 12:09:16 PM

Monday, September 04, 2023 12:09:16 PM

Post# of 463363
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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