Replies to post #417915 on Anavex Life Sciences Corp (AVXL)

[kevindenver]

It's a known issue within the Rett community that the best endpoints to use are up for debate, whether they are RSBQ, RSBQ AUC alone or anchored to CGI-I are up for debate.

What is important is that the FDA and Anavex have mutually agreed on them, and as of today we know that discussion has occurred. That is very bullish and team FUD hates that fact.

In communication with the FDA, the Company received the Agency’s input on the study endpoints, which were utilized in this clinical study. The Rett Syndrome Behavior Questionnaire (RBSQ) total score and Clinical Global Impression Improvement Scale (CGI-I) score are co-primary endpoints in the statistical analysis plan with specified linear mixed-effects models for repeated measures (MMRM) as the primary analysis methods.

[Investor2014]

Well the proposal would likely have been rejected by the FDA since AUC is nonsensical with just baseline and two sample points and hence the AVATAR trial was non pivotal P3 fail with interesting P2 signals.

In the latest Excellence PR, AUC is not mentioned hopefully because Anavex and Missling have been educated by the FDA to use EOS mean.

So what happens if the baseline to EOS mean is not clearly stat sig, whereas AUC might be?

I think we need to hope the EXCELLENCE coin flip comes up with a baseline to EOS success.

So far Missling have declined to release the AVATER eos mean result, why given the latest FDA guidance Anavex have received?