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August 10, 2011
05:53 EDT AMRN theflyonthewall.com: Amarin announces agreement from FDA on SPA for AMR101 outcomes study
Amarin announced that it has reached agreement with the U.S. FDA on a Special Protocol Assessment, or SPA, agreement for the design of the previously described cardiovascular outcomes study of AMR101 formally titled REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial). Amarin previously announced that it achieved the primary endpoints of two Phase 3 studies of AMR101, both of which were conducted under separate SPAs. Consistent with prior comments, Amarin estimates that the study will require approximately 8,000 patients and take approximately 6 years for completion. The Company anticipates that if, as intended, it commences Outcomes study activities i n 2011 that it will be positioned to achieve approximately 50% enrollment before the end of 2012
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