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Re: A deleted message

Sunday, 08/21/2022 6:22:45 PM

Sunday, August 21, 2022 6:22:45 PM

Post# of 518941
While I haven’t looked into this since 2020 and therefore have no sources, I recall that a 500-patient pivotal trial is on the lower-end of acceptable size. Nonetheless, it IS within the range of acceptable power.

EDIT****
It took me exactly three minutes to find the FDA itself cite 300+ patients as a fine size for a pivotal trial.

https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
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