Amarin Corp Plc (AMRN)

[HDGabor]

z-

Safety: nobody questioned the safety of V ... but safety (alone) isn't enough, efficacy should be proved also

SPA: They have the right to "cancel" in case of lack of enough evidence ("substantial scientific issue essential to determining the ... effectiveness") which is the case here ... TG reduction isn't a substantial scientific issue.

TG: Meanwhile, Anchor showed that Vascepa lowered triglycerides, which is a good thing, not a bad thing, it is unknown (YTD) that TG reduction will be resulted in event reduction or not. No study (inc. JELIS with 5% TG reduction ...!) proved the theory ... all study (about add-on therapy as matter and related) failed to prove the hypothesis ... and maybe R-IT won't prove it either (just like JELIS) ... FDA did not say anything about EPA / V ... they moved based on TG lowering / add-on science.

The bipolarity on the board is interesting: V isn't about TG lowering, more than TG lowering (e.g. inflammation) on one hand, but should be approved based on TG lowering on the other hand ...

Best,
G