Amarin Corp Plc (AMRN)

[KCSVEN]

I was readings some the the committees previous minutes, to see how discussions go and get a feel for how these things work. There was discussion on making changes to one item about doing further studies to confirm its use and safety and that most member of the committee agreed it would be helpful but they did not vote for more studies due to the "feasibility" of doing more study.

Which leads to the feasibility of Reduce IT question. If they want to deny and wait for Reduce It they would need to discuss the feasibility of Reduce It completing without Anchor approval.

Just something that might lend itself to approve the expanded indication due to no side effects. Kind of goes back to the FDA wants a definitive answer that REDUCE IT will provide and failing to approve Anchor goes a long way to that goal.

Does the FDA reviewer and member of the review staff have any vote on approval or is there job solely to be the review staff? I would assume they don't get a vote in the end as there goal is to play devils advocate but not sure how it all works? In December, who at the FDA determines and votes on yes or no? Is it the same people for all drugs, different people for different areas, different people every time on a rotating basis...? Anyone know