Anavex Life Sciences Corp (AVXL)

[TempePhil]

YES, agreed, all four designations are intended to speed up the process in various ways. But Breakthrough Therapy and Accelerated approval, are generally linked to accepted “surrogate endpoints” and biomarkers. (Nice for downstream ABeta drugs with minimal clinical benefits!) That leaves Priority Review and Fast Track for Blarc.

Blarc for Alz should qualify for Priority Review and Fast Track designations. Blarc already has Fast Track designation for Rett syndrome. Not sure how this would affect trying to get approval of Blarc for ALZ.

Even ignoring the Blarc Rett Fast Track question...
For Priority Review, Blarc for Alz, meets the requirement of significant improvement based on evidence of increased effectiveness in treatment, prevention, or diagnosis of condition. For Priority Review “FDA’s goal is to take action on an application within 6 months” . Six months seems to be the fastest route there is, nice! This seems like a great path for Anavex to take.