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Re: Hosai post# 476713

Saturday, 12/14/2024 9:16:51 AM

Saturday, December 14, 2024 9:16:51 AM

Post# of 516486
Thanks, I was looking at Sabbagh's CTAD presentation which omits the ADL slide. The ADL shows clear decline (regardless of volatility) on a 9-point graph scale for both cohorts. It's nice to hear there is arguably separation in the OLE, but it's only separation, and only stat-sig at week-192. This is why it's important to see the OLE's graph; hopefully there is earlier positive trajectory change in both the early and delayed cohorts, which is a far more compelling outcome in a long-term study. New guidelines or not, ADL will be a source of contention for skeptical evaluators (with trial size and dropouts) so we need a strong argument. As the guidelines state, "positive trend" for a functional endpoint will be supportive.

As for CGI-I, that's a clinician score, not by the patient/care-giver. It's exploratory, and rightly so.
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