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Amarin gains 'rare' 3rd SPA with US FDA for fish oil pill CV study

This article was originally published in Scrip

Executive Summary

Amarin has reached another agreement with the US FDA for a special protocol assessment (SPA), this time on the design of the firm's cardiovascular outcomes study evaluating the effectiveness of AMR101, a semisynthetic, 96% ultra-pure ethyl ester of eicosapentaenoic acid (EPA), in reducing the first major cardiovascular events in an at-risk patient population.



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