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.