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DewDiligence

08/02/16 4:23 PM

#203075 RE: Whalatane #203074

No idea, but I doubt that it's a data leak from REDUCE-IT.
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DewDiligence

08/04/16 10:57 AM

#203113 RE: Whalatane #203074

AMRN -4% on REDUCE-IT statistical changes:

http://finance.yahoo.com/news/amarin-fda-reaffirm-concurrence-reduce-094500500.html

A new interim analysis at 80% of the number of final-analysis events has been added (in addition to the pre-existing interim analysis at 60% of final events), and AMRN has an SPA for the changed protocol.

The new p-value thresholds for statistical significance are: 0.0076 at the 60% interim (results expected in next two months); 0.022 at the 80% interim (results expected in mid 2017); and 0.0422 at the final analysis (results expected in 2018).

The SPA also includes several new secondary endpoints.