Anavex Life Sciences Corp (AVXL)

[georgejjl]

Phase 4 not Phase 3 is a confirmatory study

Directly from the US FDA:

Accelerated approval allows for earlier access to drugs and biologics based on initial evidence of safety and effectiveness, and while confirmatory studies required to verify clinical benefit are ongoing.


https://www.fda.gov/about-fda/oncology-center-excellence/project-confirm

Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. The Company plans to proceed in parallel with the initiation of a confirmatory Alzheimer’s disease study.

GOD bless,