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HDGabor

04/03/15 8:04 AM

#46628 RE: biowreck #46627

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FDA notified Amarin in October 2013 (rescinded the SPA) that assumption is not enough, "substantial evidence" is necessary to determining the efficacy of V.

BioChica

04/03/15 8:27 AM

#46635 RE: biowreck #46627

Yes and that is why the Amarin should bring FDA to trial for misconduct and unprofessional behavior. I think the Lawyers are testing the waters with the NCE lawsuit.