Amarin Corp Plc (AMRN)

[SocialBoom]

BB,
FDA "WILL" approve the expanded label before or on the PDUFA date but in a limited way.

The expansion will be limited to TG above 150, and nothing for Diabetes, family history, or history of past Ischemic events.

The Adcom, "WILL" be held to discuss whether the label should expand further and will be built around the reality that TG are a marker/indicator but are TG the only thing physicians should be using to determine who should be on Vascepa?

Post Adcom the FDA will expand the label further to TG of 135, and a host of other qualifiers.


This is my prediction.