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FDA notified Amarin in October 2013 (rescinded the SPA) that assumption is not enough, "substantial evidence" is necessary to determining the efficacy of V.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