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Re: bas2020 post# 431775

Wednesday, 09/20/2023 1:34:31 PM

Wednesday, September 20, 2023 1:34:31 PM

Post# of 463369
Whether the ADL means miss is irrelevant or not, the FDA will decide this. And I'd encourage everyone to read from the source and not just the speculation on this board (including my opinion).

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-endpoints-clinical-trials-guidance-industry

Interestingly, an older draft specifically mentioned Alzheimer's and specified that both ADCS-ADL and ADAS-Cog had to be met. But that specific example was removed in the latest version. I'm not sure why and what that means, but interesting nonetheless!

https://www.fda.gov/files/drugs/published/Multiple-Endpoints-in-Clinical-Trials-Guidance-for-Industry.pdf
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