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Re: Steady_T post# 405812

Saturday, 03/04/2023 7:22:40 PM

Saturday, March 04, 2023 7:22:40 PM

Post# of 462478
You need to understand what an “intermediate endpoint” means. It is ANY clinical endpoint — that is “reasonably likely to predict final/established clinical endpoint” as per FDA.

Is OR “reasonably likely to predict improvement in delta-Cog or delta-ADL”?

I’d say yes, if n is high. Of course. Thus. FDA may easily consider OR as an intermediate-endpoint. But approval may depend upon n and other factors (dose arms, etc) — which imo makes it unlikely.
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