Amarin Corp Plc (AMRN)

[HDGabor]

"...They are awaiting response from FDA..."

"Good morning. There is no deadline to submit a next level appeal. At this point we are awaiting a respond from FDA on the ANCHOR sNDA prior to making a determination." by Amarin's IR

And the fact is that V is approved for MARINE without a CVOT coz of other drugs successful trials and validated science. So the situation is more or less same for the news drugs.

"By the way, I agree with you. It's hard to imagine an event-driven pancreatitis trial for super-high triglycerides. I kind of smile when you think about that because that's just by inference that it's actually going to be good. We don't know that, really. So the only reason to treat these mid-range triglycerides is to prevent heart attack, stroke, and death." (AdCom / Dr. Hiatt)