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Re: Steady_T post# 449971

Monday, 01/29/2024 12:32:02 AM

Monday, January 29, 2024 12:32:02 AM

Post# of 462980
I think we should distinguish between the status of the EXCELLENCE trial and the status of Anavex's Rett program. They seem to have been conflated.

EXCELLENCE did not meet its CGI-I endpoint, and had a nonfatal near miss on RSBQ. Unlike its 2b/3 AD trial, the company did not claim EXCELLENCE met its endpoints, except for safety. So that grades EXCELLENCE as a fail.

However, the RSBQ near miss was clearly affected by the placebo response, and the CGI-I may have failed based on a faulty trial design. Consequently, it can't be said that the Anavex Rett program has failed. Per the PR, which references the company's intent to explore Rett options with the FDA, this program is still alive.
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