Amarin Corp Plc (AMRN)

[Biobillionair]

G & Akanz---

Agree, just because Amarin claims they are not, but acc. to the FDCA they are ... FDA isn't the only one who has expertise and the only one charged by the Congress to interpret laws (ITC has also) ... this case isn't a scientific issue / question ... it is calling strike and ball.

The FDA has historically not enforced "fish-oil" based drugs according to the FDCA; this decision has been made based solely on resource allocation. In the past it wasn't considered a large enough safety issue to warrant significant resources. However, after the R-I results are finalized this changes the level of the known safety issues. DS MUST not be supplemented to treat coronary artery disease, this would mandate the FDA to enforce the FDCA.

I agree the ITC has the authority to call a strike with the improper importation of marine derived drug substances now. After R-I the FDA will HAVE to act in conjunction with ITC actions.

JMO

BB