Amarin Corp Plc (AMRN)

[KCSVEN]

I think this is the crux of the argument

DA -- no conclusive evidence that add on therapy to statin translates into CV benefit.

WE are aware of positive subgroup data however these data should be interpreted with caution. hypothesis generating and have not been confirmed.

I think since they stated in SPA that these other trials would confirm add on to statin works and since they failed they are saying no evidence add on to statins work for anything

AMRN needs to attack the subgroup analysis as being immaterial and continue to hammer the issues with the other studies.

The discussion will be crucial, its the last thing panel will here.

FDA changed from trig lowering to CV benefit proof. Since Reduce it is the CV benefit proof AMRN needs to push safety and push the evidence that CV benefit IS there.

That's it, they make it murky on benefit and get safety known will get votes, they get panel leaning no CV benefit then will vote no.