You just proved the point that people are still debating - did or did not AMRN ask for CVE risk reduction on ANCHOR label prior to completion of R-IT?
Based on BD, AdCom transcript:
Amarin indication: “Vascepa 4 grams per day is indicated as an adjunct to diet and in combination with a statin to reduce triglycerides, non-HDL, Apo B, LDL, total cholesterol, and VLDL in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk-equivalent, as defined on the slide.
That's exactly what got them in trouble - if you cut out the red words you have a "pure" ANCHOR label w/o assumption of positive R-IT trial results.