Replies to post #480871 on Anavex Life Sciences Corp (AVXL)

[boi568]

I don't believe Sagan ever worked for a regulatory agency. They apply the same standards to every applicant.

You think Anavex is applying to get a Ph.D.

[Graniteguy]

Oh "Doc" so full of crap per usual. I always enjoy the relentless negative spin you manage to regurgitate in various forms dependent on context! It's truly a gift to humanity.

[crescentmotor]

He has lost >18 months by not starting a real phase 3 in mid 2023.

Total BS. The extraordinary results of the extended OLE data resolve all doubts regarding Blarcamesine efficacy. If they want to cover their arse, the regulatory agencies can, when they approve Blarcamesine for AD, require a follow-up confirmatory trial. No problem there whatsoever.

[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."