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Joseph_K

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Joseph_K

Re: abew4me post# 414933

Thursday, 05/11/2023 5:09:16 PM

Thursday, May 11, 2023 5:09:16 PM

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I don't believe a P3 confirmatory trial allows the company to commercialize their product while the trial is going on.

I guess I'm confused. Isn't what you describe precisely the Leqembi situation? I thought Biogen got approval to sell the product, based on surrogate biomarkers under Accelerated Approval, while they still didn't have the Phase 3 all wrapped up, and that the approval could be revoked if the FDA turns out to be not satisfied once the whole Phase 3 package is submitted and assessed.

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