Replies to post #47853 on Amarin Corp Plc (AMRN)

[sts66]

"The agreed upon terms in the Vascepa SPA was that the sponsor would run a short clinical trial, ANCHOR, determining the safety and efficacy of the drug. After FDA approval of ANCHOR, then the company would have to design and implement an FDA- approved larger clinical outcomes trial (REDUCE-IT) where Vascepa would be an "add on" drug combined with patients taking statins. The FDA's requirement was that the company meets a 50% enrollment (4000 patients) in REDUCE-IT to complete the FDA's requirements."

Should be:

The agreed upon terms in the ANCHOR SPA was that the sponsor would run a short clinical trial, determining the safety and efficacy of the drug when combined with a statin , and the company would design, implement, and begin a large clinical outcomes trial (REDUCE-IT) where Vascepa would be an "add on" drug for patients already taking statins. The FDA required the company to have achieve 50% enrollment in REDUCE-IT before it would accept the ANCHOR sNDA for consideration of approving the expanded indication.