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Amarin Corporation PLC says FDA delays decision on Vascepa trial design-Reuters


Wednesday, 15 Jan 2014 05:55pm EST 

Amarin Corporation PLC:Says U.S. health regulators delayed their decision to reconsider a rescinded agreement that could support a marketing application for an expanded use of the company's blood fat-lowering drug-Reuters.Says the U.S. Food and Drug Administration had in October revoked a Special Protocol Assessment (SPA) agreement covering a large late-stage trial of the drug, Vascepa.Says following an appeal from Amarin, the regulator said it would determine by Jan 15 whether it would reconsider that decision. 

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