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Re: Steady_T post# 401402

Saturday, 02/04/2023 5:23:40 PM

Saturday, February 04, 2023 5:23:40 PM

Post# of 462939
I find it very hard to believe that the FDA will require an entirely new Phase 3 AD trial if the 2b/3 shows it met its efficacy endpoints, as announced, and is safe. The FDA's mission is to promote and protect the public health, and putting off for several years a safe and effective AD medication that outperforms the SOC is destructive to that mission and, I'd argue, a violation of medical ethics as well.

More likely would be an AA with a Phase 4, or possibly a decisional delay until the OLE reports out in 2024.
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