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Thursday, 02/25/2021 10:15:41 PM

Thursday, February 25, 2021 10:15:41 PM

Post# of 232325
Don’t know if this has been answered but because we went with full trial results does that lock us into PE at 28 day mortality ? Does the DSMC recommendation at 293 75% at 42 day mortality not matter because we filled trial and said we would go with completed enrolled trial PE.? These endpoints that have changed recently with DSMC recommendation as well as updated FDA expanding trials out to 60 days will hurt our results if we can’t use them. Trials that have not been completed will gain an advantage with the loosened timeframes.
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