Amarin Corp plc (AMRN) Posts Q2 Loss of 7c/Share

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Go back to Amarin Corp plc (AMRN) Posts Q2 Loss of 7c/Share

Amarin (AMRN), FDA Enter REDUCE-IT SPA; Second Efficacy Analysis Added

August 4, 2016 5:51 AM EDT

Amarin Corporation plc (NASDAQ: AMRN) announced that the U.S. Food and Drug Administration (FDA) agreed to an amendment of the company's special protocol assessment (SPA) agreement for the REDUCE-IT cardiovascular outcomes study reaffirming concurrence on critical components of the revised study protocol and analysis plans and incorporating recommendations from the trial's independent oversight committees.

Key new elements reflected in the company's amendment include:

Finalized details of the statistical analysis plan covering both final and interim efficacy analyses;Added a second pre-specified interim efficacy analysis at approximately... More