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Re: Roman516 post# 520305

Sunday, 10/09/2022 3:29:09 PM

Sunday, October 09, 2022 3:29:09 PM

Post# of 822411
You can't "infer or imply" adaptive trials. Read the FDA Adaptive Trial Guidance -- the NWBO trial doesn't meet any of the requirements.
The trial has to be designed as adaptive and approved BEFORE the trial starts as such -- NWBO certainly didn't do that. It requires and interim review and decision tree on adapting the trial -- NWBO certainly didn't do that. NWBO did all of the protocol changes AFTER the data gathering had been gathered.

https://www.fda.gov/media/78495/download
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