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Re: boi568 post# 417198

Monday, 05/29/2023 4:26:52 PM

Monday, May 29, 2023 4:26:52 PM

Post# of 517499
I think you are mixing up something here:

“The ab/tau biomarkers pertain to anyone with AD, so an accelerated approval will not care about subgroups. This makes an AA route the more attractive commercial option, in my opinion;”

It similar to saying everyone with AD have AD, so no subgroup analysis is needed.

You are missing here that not every trial patient will respond to A2-73 in way that changes the abeta/tau ratio biomarker value to indicate assumed improvement and thus reasonable likely to reflect a clinical benefit.

Maybe only a small proportion of patients exhibit a positive change in abeta/tau, for example only those that have APOE3 alleles plus this and that characteristic. Those would then be selection biomarkers in a Precision Medicine trial ensuring a homogeneous cohort of presumed responders only.
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