Replies to post #212251 on Amarin Corp Plc (AMRN)

[couldbebetter]

Yes, except Vascepa may not be available in Europe until sometime in
2021...well over a year from now!

[NickHous]

Yeah! ESC and EAS have included us in their guidelines and Vascepa is only available in the U.S. currently. Now that is saying something! What an embarrassment the FDA is, in dragging out label expansion with an adcom to boot! BP being the FDAs "puppet master"? IDK, but it sure is circumspect at this point. Everything pointing to blockbuster drug. Only roadblock is FDA at this point in time. JT better have a handle on production capabilities. He's gonna need a lot of Vascepa in a very short time horizon.

[stoneroad]

Will be next to impossible and inconceivable for expanded label not to be approved in US.

[KCSVEN]

I don't see where it says without statins, it says "despite statins" several times meaning you should take it even if on statins, where does it recommend without statins?

[ziploc_1]

A...Vascepa label should really be Trig free plus statin free...But I fear that it will take another successful R-IT style study before the FDA agrees to a statin free label...IMO it will eventually happen...and the sooner the better.

Patients could start with Vascepa, which has a placebo like side affect profile...and then proceed to statins if necessary.