Amarin Corp Plc (AMRN)

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The following is a paragraph from today’s intraday note from Roth regarding the Adcom:

AdCom agenda, in the words of the Federal Register notice: As stated in the document, the focus of the meeting is to discuss Vascepa sNDA (#202057/S-035) for the following proposed indication: to reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on REDUCE-IT. That's is the extent of what we know based on today's document. However, let's recall five specific aspects of REDUCE-IT that describe its patient population and we believe could be seen in label expansion: 1) Reduction in 5-pt MACE; 2) Not as a statin therapy replacement, but as a separate and incremental treatment option for high-risk CV patients; 3) CV risk beyond cholesterol management to include hight TGs and other risk factor; 4) TG ≥135mg/dL specified as that is the patient pop. studied in REDUCE-IT (elevated TGs are good risk identifier); and 5) Vascepa (icosapent ethyl) at 4 g/day (2 g administered twice daily).