Thursday, October 01, 2020 1:26:46 AM
The 8/12 story was " we will have 102 patients enrolled next week ...for an interim look " This implied a fairly quick enrollment and thus full enrollment by end of Sept. .
In which case we would have had the full data set...144 patients .... for the FDA to consider re an EUA in Oct.
In the original story ...the FDA would already have had access to the 102 patients via the second interim .
So new story ...Interim data on 102 patients in roughly 28 days at which time the DMC can probably say either ...continue as planned to completion or stop for over whelming efficacy.
Or some combination of limited EUA but continue the IV trial till they have a full data set on the 144 planned enrollment ....the 144 has to do with powering the study to show statistical significance .
Kiwi
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