Anavex Life Sciences Corp (AVXL)

[imho]

RE: Biogen's AD drug approval, for comparison -

https://www.cnn.com/2022/12/29/health/biogen-aduhelm-alzheimers-drug-investigation/index.html#:~:text=When%20the%20FDA%20approved%20the,according%20to%20the%20new%20report.

"When the FDA approved the drug, Kesselheim and two other members of the advisory committee resigned in protest. He later labeled it “probably the worst drug approval decision in recent US history.”

The FDA often follows the independent committee’s recommendations, but in this case, it changed course and used its accelerated approval pathway, which sets a different standard of proof that a treatment could work.

The committee members said senior FDA leadership told them that the shift in how the drug would be approved came after an FDA expert council meeting in April 2021 provided “unfavorable feedback” for the traditional approval process, according to the new report."