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HDGabor

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HDGabor

Re: biowreck post# 46627

Friday, 04/03/2015 8:04:44 AM

Friday, April 03, 2015 8:04:44 AM

Post# of 426489
No, Anchor SPA was written based on the assumption that favorable changes in the lipid profile would translate into a benefit on clinical outcomes.

FDA notified Amarin in October 2013 (rescinded the SPA) that assumption is not enough, "substantial evidence" is necessary to determining the efficacy of V.
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