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Posted On: 02/23/2021 3:46:28 PM
Post# of 153964
Re: MD VIROLOGIST #79532
The new FDA release is guidance. For trials still underway or where extended data is available I'm sure the FDA would take into consideration an additional timeline but it wouldn't be mandatory.
https://www.fda.gov/media/137926/download
Quote:
The choice, time frame, and interpretation of endpoints may differ depending on the population evaluated in the trial.
In a trial in severe and/or critically ill patients, examples of appropriate endpoints could be
https://www.fda.gov/media/137926/download
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