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WolfofMia

04/29/25 8:23 AM

#488864 RE: Investor2014 #488862

Good thing our approval is being judged based on our wholistic data, and not just your black and white approach.

But if you are very confident 2-73 will not be approved, I sure hope you are putting your money where your mouth is.
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crescentmotor

04/29/25 11:35 AM

#488870 RE: Investor2014 #488862

Anavex to date have not run a single clinical trial labelled a P3 trial designed and of an appropriate size and duration. Instead the company have run P2 maybe P3 too small trials, none of which have had successful topline outcomes.



You repeatedly demonstrate that you are unable to see the big picture and only focus on rigid regulatory requirements that should be evaluated in light of an disease where current SOC is simply not acceptable. In a sizable blinded trial, Blarcamesine has demonstrated efficacy and safety results never before demonstrated by any drug for Alzheimer's patients. Those results have been further confirmed and amplified by longer-term OLE results. Common sense would lead rational minds to a conclusion that Blarcamesine should be approved ASAP perhaps with the requirement that a larger confirmatory trial should be conducted. Important decisions applying to patients without safe and better alternatives should not be made by small thinkers.