Anavex Life Sciences Corp (AVXL)

[nidan7500]

This PR suggests the FDA redo:

(Recently in June 2023, Anavex Life Sciences announced that all participants had been dosed in the placebo-controlled phase 2/3 EXCELLENCE (NCT04304482) study assessing blarcamesine, a small-molecule activator of sigma-1 receptor, in pediatric patients with Rett syndrome.3 The trial, which features 92 pediatric patients with Rett syndrome, aged 5 to 17 years old, is a multi-center, double-blind trial assessing the safety, tolerability, and efficacy of the therapy, otherwise known as ANAVEX 2-73.

After discussions with the FDA, EXCELLENCE plans to use the RSBQ total score and CGI-I as coprimary end points. Effects on these end points will be calculated through a statistical analysis plan that includes specified linear mixed-effects models for repeated measures. "We are looking forward to the topline data from the EXCELLENCE phase 2/3 ANAVEX2-73-RS-003 Rett syndrome pediatric clinical trial in the second half of 2023,” Missling said in a statement.1).

Tells us again that , since FDA does not have or understand clinical evidence of RSD Root Cause they default to STATSPEAK to get guidance on what to do next?? Sound familiar?