Amarin Corp Plc (AMRN)

[KCSVEN]

A whole Adcom over mineral oil? What would that accomplish? Is anyone on committee going to come up with something not already discussed? This has been peer reviewed and analyzed to death where even the harshest critic can only say, yes Vascepa works but it’s overstated due to MO, if FDA believes MO was big issue they Just send crl saying you must do something to prove MO not an issue.
So what is the vote question? Is reduce it invalid because the mineral oil was not inert? Well that’s a slam dunk unanimous vote against. Are results overstated due to mineral oil? I don’t know why they would ask that question because it doesn’t answer whether Drug works or not so that leads back to the previous question which the committee will dismiss just like everybody else that has looked at the results.
MO is coming up and FDA is not convinced it is inert but unlike Anchor this data goes on for many years and does not show effects as time goes on
I think we get stuck on mineral oil because it’s the only thing that the naysayers have come out with That can lead to approval being denied or delayed.

The evidence that it is not inert and materially skewed results is just not supported in a way advisory committee experts would buy it invalidates results.

This Adcom can’t come fast enough