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Biobillionair

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Biobillionair

Re: None

Tuesday, 05/23/2017 7:54:59 AM

Tuesday, May 23, 2017 7:54:59 AM

Post# of 423548
REDUCE-IT New Drug Application & PDUFA potential timeframes Best case scenieros:
1) 60% interim, didn't happen...but FDA and Amarin penned an amendment to track 30 types of events

2) 80% interim, Covered in R-I SPA amendment recommendation from DSMC based on trending events only.
2017 Q3 (6 months accelerated review) February 2018 earliest

3) 80% interim, Covered in R-I SPA amendment recommendation from DSMC based on trending events only.
2017 Q3 (10 months cycle-normal review) June 2018 earliest

Mr. McGee, don't make me angry. You wouldn't like me when I'm angry---David Banner

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