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Re: Sluicebox post# 217509

Thursday, 10/03/2019 12:05:47 PM

Thursday, October 03, 2019 12:05:47 PM

Post# of 425967
JT commented the number of events in the control arm matched pre-trial estimates Amarin shared with FDA in setting up the SPA, I assume with all the statin trials, you could reasonably guess the number of events in that size population but he did not share the formula. He also stated they predicted and shared with FDA pre-trial the revert to mean of the placebo group #'s and that was expected as well.
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