Wednesday, April 07, 2021 12:45:41 PM
Re re: FDA dates, why would 4/15 matter for last patient follow-up when data was locked in December? At that point, anything afterwards is pointless, right? Analysis starts after data lock & no new data can be introduced, right? So is the "Study Completion" definition on the FDA site incorrect and/or too generic?
In which case, Multikine has already advanced past the FDA's definition of "Study Completion Date", by default since data was locked in Dec 2020.
Unless Geert didn't understand what "data lock" meant when they gave the December timeframe for lock?
Or, maybe the data can't be changed (since it was locked in Dec) but the FDA still allows patient follow-ups until 4/15 (just, can't include it in the database) which means that 4/15 date is fairly meaningless in reference to "completed data analysis". Maybe no correlation whatsoever.
In which case, Multikine has already advanced past the FDA's definition of "Study Completion Date", by default since data was locked in Dec 2020.
Unless Geert didn't understand what "data lock" meant when they gave the December timeframe for lock?
Or, maybe the data can't be changed (since it was locked in Dec) but the FDA still allows patient follow-ups until 4/15 (just, can't include it in the database) which means that 4/15 date is fairly meaningless in reference to "completed data analysis". Maybe no correlation whatsoever.
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