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Posted On: 02/26/2021 11:58:19 AM
Post# of 149265
This would be more persuasive if Nader hadn't been in discussions with those same agencies in the past, for example with CD-10 data, which to turned out to be a non-starter. I don’t think we can conclude anything from the fact that they are having “discussions” (whatever that even means) except that the trial wasn’t a complete failure, which we already knew from the interim analysis.
I’m more interested in the revised guidelines that call for 42- and 60-day mortality benefits. This could explain the changing timelines and play directly into our strengths as a therapeutic.
Of all the known facts, the claim that we had 87 deaths shortly before the end of the trial is the one that gets my attention. I don’t see any plausible way such a number could fail to result in an EUA.
I’m more interested in the revised guidelines that call for 42- and 60-day mortality benefits. This could explain the changing timelines and play directly into our strengths as a therapeutic.
Of all the known facts, the claim that we had 87 deaths shortly before the end of the trial is the one that gets my attention. I don’t see any plausible way such a number could fail to result in an EUA.
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