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Re: tschussmann1 post# 415188

Saturday, 05/13/2023 1:04:49 PM

Saturday, May 13, 2023 1:04:49 PM

Post# of 463867
I don't understand your Q.

AA is based on surrogate marker (it can be based on an intermediacy clinical endpoint too -- but lets ignore that, since it doesn't apply here).

That means for AA:

(i) the evidence needs to show drug's impact ON SURROGATE MARKER (not necessarily on clinical endpoints -- such as Cog, ADL, etc).

(ii) And, the surrogate marker needs to be valid.

So, yes -- if AVXL goes AA-route, the biomarker results ARE MUCH MORE IMPORTANT and CENTRAL to the approval -- then the endpoint results shown till date.
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