Replies to post #402425 on Anavex Life Sciences Corp (AVXL)

[Doc328]

That will give an insight to how low the bar is.

The bar seems to be modest but statistically significant on the prespecified co-primary endpoints of change in RSBQ and CGI-I. Whether Neuren/Acadia set a higher bar with the FDA by having a study with 187 patients rather than 92 is unclear. They did have an SPA so they knew in advance that the trial size, duration and endpoints were acceptable for approval.