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Re: Hoskuld post# 502079

Friday, 10/03/2025 11:45:51 AM

Friday, October 03, 2025 11:45:51 AM

Post# of 517508
The existing (not draft) EMA guidance requires FDA reviewers to apply the ADL endpoint in AD trials. In order for this not to occur, the FDA would have to find a good reason to make an exception. You are arguing as if the presence of a relevant guidance has no meaning.

I am conceding on your overall argument -- in other words, in your favor -- that I no longer trust the FDA today to honor their policies, so that an existing guidance may well, against all good administrative practices, simply be ignored. That would be a bad thing overall for the public, but a good thing in this instance for AVXL stockholders (and the public, given the merits of the draft guidance). Why follow rules and guidances if you don't want to -- or even the laws and the Constitution if they are inconvenient?
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