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sab63090

08/10/24 7:25 PM

#467119 RE: 12x #467117

12x

I think the early drop outs were because of worrisome COVID fears....but that cannot be proven....the OLE results should help clear up some of the mystery
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boi568

08/10/24 8:05 PM

#467121 RE: 12x #467117

The 2b/3 trial was fully blinded. That means that the protocols among the three arms would look identical to trial participants and caregivers, notwithstanding that the pills themselves differed. Apparent "titration" would have been universally applied.
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frrol

08/10/24 8:58 PM

#467124 RE: 12x #467117

Just so it's clear: There were two distinct dosing arms. No one from the 30mg arm was allowed to go higher. That would violate trial protocol.

What Missling was saying was that there were many in the 50mg arm who did not reach or couldn't sustain 50mg, so many in fact that the two arms were analyzed not only separately but also as one single cohort.

And since 50 is not much higher than 30 anyway (his assertion, which is a strange one, but typical Missling), he says he "pre-specified" a single cohort analysis.