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Re: Anshu2 post# 448847

Tuesday, 01/23/2024 12:28:45 PM

Tuesday, January 23, 2024 12:28:45 PM

Post# of 465854
I agree with you that efficacy is the agencies' #1 consideration and that the P2b/3 did not meet all endpoints, which is why my first question for Doc was his estimate of the chance of approval if ADCS-ADL had met statistical significance for it such that all endpoints were met. Even though meeting all endpoints would have been better, I do give credence and weight to Jin's p<0.025 maneuver. You apparently don't. Adding in the clearly excellent brain shrinkage biomarker, and hopefully the amyloid and tau biomarkers, and maybe the OR results, I believe efficacy is probably sufficiently proven.

I think you dodged Hosai's legitimate question:

So which drugs would you be recommending to AD patients instead?

If blarcamesine were approved, so that you could choose between it and an approved MAB, which would you recommend? (Or which would you be inclined for yourself or a loved one to take?) Working from what we know of these drugs, I would choose blarcamesine. I believe agencies would come to the same conclusion, and, because they look at the totality of the evidence, I think they probably will approve.

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