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Re: Investor2014 post# 403995

Monday, 02/20/2023 2:40:42 PM

Monday, February 20, 2023 2:40:42 PM

Post# of 463637
After lecanemab example, FDA could approve 2-73, even if Investor2014's analysis is correct. (I overstated that a bit for the headline; please read on.)

I think Investor maybe is right, but I also look at the FDA's approval of lecanemab, on (probably) stronger statistical evidence but piss-poor clinical efficacy, and wonder if the FDA might give conditional approval to blarcamesine with a required P4. There was the strong lobbying effort for lecanemab, of course, but its approval also indicates the FDA wants Alzheimer's drugs on the market if they have even limited promise.

While lecanemab may have more consistent trial results on its side with respect to (its limited) efficacy, it's very likely that blarcamesine will have far superior, and more consistent, results with regard to safety. It seems to me, that with regard to patient well-being -- meaning a combination of both patient safety and impact on the course of the disease -- the FDA could conclude that blarcamesine is at least as good a bet as lecanemab. Additionally, blarcamesine would have on its side cost, not just for the drug but, for Leqembi, the MRIs and infusions.
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