Thursday, July 13, 2023 3:14:04 AM
The question is what will replace Leqembi because it's clearly not the end game with Alzheimer's research. More importantly, what is the hurdle for any successors?
If Blarcamesine runs a proper P3 confirmatory trial and ends up with 20% vs Leqembi's 27%, but it's a pill without side effects, will that be enough to satisfy the FDA?
Will the FDA be more open to approving for Alzheimer's with a limited data set if Blarcamesine is already on the market for Rett?
Lequembi's 27% is going to have its time in the sun. 22% or 27% doesn't matter to me (I think your math is correct for what it's worth). All I care about is whether Anavex has something better than Leqembi.
Where's the evidence that it doesn't? I haven't heard anyone trying to dismiss the science, the MOA, etc recently.
27% may be a tough hurdle to clear for plaque removal drugs, which is why I am betting on something entirely new. Nobody knows if Sigma-1 is the solution but you have to admit the data seems promising, or else none of us would still be here talking about Anavex.
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