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Posted On: 02/25/2021 5:10:07 PM
Post# of 153996
This is from CYDY's press release:
I might be wrong but the 75% interim is out: "forego the second interim analysis" ,however the 42-day post-enrollment is not clearly excluded ...or I am reading it upside-down ??
Any comments ???
Quote:
On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients were enrolled and completed a 42-day post-enrollment period. The Company has concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the U.S. Food and Drug Administration, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available.
I might be wrong but the 75% interim is out: "forego the second interim analysis" ,however the 42-day post-enrollment is not clearly excluded ...or I am reading it upside-down ??
Any comments ???
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