Anavex Life Sciences Corp (AVXL)

[kevindenver]

Regarding endpoint guidance, notice that the agreed endpoints are RSBQ and CGI-I and will not use AUC (Area under the curve) as was used in the adult Rett trial analysis.

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.

https://www.anavex.com/post/anavex-life-sciences-announces-completion-of-anavex-2-73-blarcamesine-excellence


Adult Rett syndrome PR from February 2022 using AUC for reference.
https://www.anavex.com/post/anavex-2-73-blarcamesine-avatar-phase-3-trial-met-primary-and-secondary-efficacy-endpoints