Amarin Corp Plc (AMRN)

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ACCORD trial used fenofibrate, which raised HDL, lowered LDL and trig., failed its CVOT.

AIM-HIGH trial used extended release niacin, which raised HDL, lowered LDL and trig., failed its CVOT.

HPS2-THRIVE trial also used extended release niacin, which raised HDL, lowers LDL and trig., failed its CVOT.

JUPITER trial used Crestor, which lowered LDL, trig., inflammation markers and raised HDL modestly, succeeded in its CVOT.

Reduce-IT trial uses Vascepa, which lowers trig., inflammation markers and LDL (modestly) while being HDL neutral.

Eric Coleman called the failure of ACCORD, AIM-HIGH and HPS2-THRIVE trials "NEW" scientific evidence for rescinding ANCHOR SPA. First of all, the timing of those CVOT failures made those evidence "NEW" untrue. Second, Vascepa is not a HDL raising drug, so those "NEW" evidence shoudn't even be applied here. Lastly, since both Fenofibrates and Niacin also lower LDL, do all future LDL lowering therapies requires CVOT too. The answer is "NO", not according to the same Eric Coleman (e.g. his comments on PCSK9.) Why couldn't FDA and those PHD panel members look more closely at the success of JUPITER trial and draw a more favorable conclusion on the potential success of REDUCE-IT?