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Re: Hoskuld post# 428572

Saturday, 08/26/2023 6:25:28 PM

Saturday, August 26, 2023 6:25:28 PM

Post# of 462048
By the definition I posted (which, admittedly, is not authoritative; that is, it's not from the FDA, and was the only definition I could find), the P2b/3 is at least not the same as as a pivotal P3. To me the evidence has not shown dispositively P3 endpoints were met. I believe that Doc's comments that he's never seen Odds Ratios as the primary endpoint measurement for sliding scale tests matches what my biostatistician friend said; she explained it by example, but her examples were binary, like whether a cancer patient did or did not die by X number of months. The rest of my objections we've been over. I think this is one where we agree to disagree.

What do you think was the reason for, or significance of, designating the trial as P2b/3 rather than just P3? Was it initially designated just a P2b? What do you mean it was "expanded"?

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