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Posted On: 10/25/2020 10:14:49 AM
Post# of 148908
This is a good point, I would guess the 195 patients did show great results, but the DSMB was likely worried that 195 patients are not enough for the fda. 75% might be the threshold to satisfy the fda and speed up the process to get this approved as fast as possible. The added 42 day readout might be a strengthening of the results to make the argument that waiting for full enrollment is not needed.
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