Re: FDA dates. From another board, someone posted this which indicates that April 15th only references final patient follow-up, COLLECTION OF DATA, etc.
"The Study Completion Date is defined as “the date the final subject was examined or received an
intervention for purposes of final collection of data for the primary and secondary outcome
measures and adverse events (e.g., last subject’s last visit), whether the clinical trial concluded
according to the pre-specified protocol or was terminated.”
...
"Both dates [primary completion and study completion] are determined by when data were collected, not the date data were analyzed, the date the study was published or the date the study closed with the IRB."
IMO, the fact that Cel-Sci announced DATA LOCK in December contradicts this. Data lock means additional data CANNOT BE ADDED to the database? Meaning, further patient follow-up is moot because it can't be part of the data analysis. Unless Cel-Sci is allowed to "unlock" data. Never heard of that.
If data was locked in December, then final analysis is what's in progress now. Not additional patient follow-up. Why are people still discussing items that would have to occur prior to data lock?
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