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Re: Zadie420 post# 725701

Saturday, 10/12/2024 1:58:18 PM

Saturday, October 12, 2024 1:58:18 PM

Post# of 817780
The only limiting factor I could imagine would be the speed at which they get that DC/CI analysis to the MHRA, that is if the MHRA wanted too see those two combos, which I think they do. It might even have been the thinking all along.

The earlier combo was never masked and very small, so that’s probably already done (preliminary analysis), the second combo was around 35??? patients when unblinded, and I’d bet (but I’m less certain here) that preliminary analysis is nearly if not also already wrapped up.

People don’t realize the phase iii trial could be treated as a surrogate type endpoint, so those combination results might avoid any post (assuming) approval study requirements.

When the unblinding was accelerated from August 2025 to December 2024, I didn’t think the MHRA wanted a peak prior to decision, but when the unblinding was moved to September 11, 2024, I’ve become more convinced the MHRA will
take a look at those trials before their decision.
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