Amarin Corp Plc (AMRN)

[ziploc_1]

The FDA approved the Marine study for Vascepa's trig lowering effect on LDL in patients with VERY HIGH TRIGS in 2012...then in 2013 the FDA was confronted with Amarin's Anchor request...to approve Vascepa for patients with 150 to 500 trigs/dcl...At this period of time, the FDA still didn't believe that Trigs could be lowered without raising LDL in high or...especially in very high trig patients(i.e. the Marine group)...and they felt that increased LDL would lead to more CVD... This is the reason why the FDA refused to approve Vascepa for the Anchor designation...and insisted on the completion of a CVD test(i.e. the Reduce-It study)to see if Vascepa could lower trigs and NOT RAISE LDL, thereby lowering/not increasing the incidence of CVD....Only AFTER the R-IT test did the FDA become convinced that Vascepa could lower trigs without raising LDL in high trigs in as well as VERY high trigs...