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Re: Fireman02360 post# 366669

Monday, 07/18/2022 4:47:09 PM

Monday, July 18, 2022 4:47:09 PM

Post# of 462122
An Opportunity.

"If Anavex can replicate what was done in the Phase 2a, its a slam-dunk, plain and simple, end of story". End quote --- from a professional “who has sat on the FDA Advisory Panel many times for CNS and gives testimonies often in regards to drug approval GO/NO GO.”

Thanks for posting this. Exactly what would be expected, from a real professional working in or with the FDA.

Yes, all of the clinical outcomes from blarcamesine being tested in real humans (Phases 1 and 2) have been extremely positive; without adverse events (side effects), even. There is no reason, no apparent mechanism by which the results (to be announced) from the big, long, statistically-valid Phase 3 trial will be any different. They will only substantiate what has already been discovered and demonstrated.

But, now an opportunity. We'll all be delighted to ponder and scrutinize postings that can tell rather specifically how and why the Alzheimer's Phase 3 results will fail, preventing the FDA from approving the drug. Please, tell us how and why the Phase 1 and 2 results won't or can't be replicated in the big Phase 3. This will be a wonderful chance for various posters to set things up for an "I told you so!" pronouncement when blarcamesine fails. Let's hear just how it will fail in the Phase 3 study. Inquiring minds want to know, right now. Experts here should be able to tell us. Please.
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