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Posted On: 08/15/2020 5:25:20 PM
Post# of 148870
Like I said yesterday, based on the pace of enrollment (179 as of Aug 7), the severe trial likely will hit 195 pts. by Tuesday. With immediate unblinding, , likely 160+ pts have reached primary endpoint through combination of either passing the 28 day point, hospital discharge (automatic success), or death (automatic failure). This data will be known immediately without 3 weeks data processing unlike the mild to moderate trial since the PE is mortality. If the data for the remaining 30 or so are automatically assigned failures if Leronlimab treated and success if placebo treated, and if by doing that, the PE still shows statistical significance between the 2 groups, we immediately know if the trial is a success before the 28 days are up. This could be conveyed to the FDA in addition to the MtoM data for EUA next week, while still waiting 6-8 weeks for the full data set.
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