Replies to post #401104 on Anavex Life Sciences Corp (AVXL)

[Doc328]

Trofinetide has dual primary endpoints of RSBQ change baseline to 12 weeks and CGI-I. Success required significance in both endpoints. Meeting both endpoints is similar to the single CGI-anchored RSBQ (or CGI-anchored RSBQ-AUC). Neuren had an SPA that their dual primary endpoint would be acceptable. I think the FDA would be fine with either dual CGI and RSBQ (or RSBQ-AUC) or CGI anchored RSBQ (AUC) as long as prespecified as THE primary endpoint (vs. a prespecified analysis of a primary outcome).