Amarin Corp Plc (AMRN)

[exwannabe]

Can they pull the approval on Vascepa, which is being used for Marine indication?

No.

The main reason is that for those with trigs>500 the FDA still believes that these need to reduced regardless of CVD outcomes. I assume they can cause liver issues and other problems. This is as opposed to 150<trig<500 where they now think your doctor is an idiot for telling you to reduce the trig level.

High trigs>500 also might cause one to get a "fat head" and decide to reject the AMRN SPA

Ok, back to serious mode.

The part about trig>500 being something that MUST be brought lower is the Marine indication, and nobody argues this. Furthermore, the FDA very rarely pulls a drug w/o safety problems.