Amarin Corp Plc (AMRN)

[KCSVEN]

Mostly agree with post, the Adcom panel list will be telling. FDA mentioned mineral oil before at Anchor, they will bring it up again, I think even the harshest critics have suggested at very worst case it enhance result but even if you determined an effect the results are still positive so I cannot see it derailing but it will come up and be discussed. Outside of that there is question of MOA that will be discussed.

It seems this will address a VERY large population of people and having an Adcom was expected....UNTIL they took so long to say anything, but is it railroading Amarin or just poorly staffed and poorly run FDA cardiovascular division?

The side effects are almost zero so seems hard for a panel to not be pretty unanimous in approving Vascepa, I'm sure questions will be there about label with LDL level or without but I expect a unanimous approval of label expansion and FDA will not go against that.

Very unfortunate for FDA to delay 3 months, killer for longs in the short term and just adds more stressful days to wait, but in the end no reason to believe this won't be approved. What are they going to say, run a new 6 year trial? Deny the drug despite science saying it works regardless of any placebo effect?

Wish had bought some short term puts, had sold a small amount of covered calls for this month but not enough to make up for this drop.

Hopefully it can settle back to at least 15 in short order.

Delay is Bad for the psyche that's for sure.