Amarin Corp Plc (AMRN)

[sts66]

Amarin argues the companies admit they are synthetic (and they do) so the draft guidance is enough, but FDA's not comfortable with this obviously....because they have allowed these drugs for years.

Yup, got caught with their pants down - none of these synthetic "fish oil" products filed the proper paperwork for introducing a new dietary supplement (NDI) into the US market, and FDA let them get away with it for years, now have major egg on their faces since AMRN has pointed it out in the ITC complaint. One of FDA's jobs is to keep unapproved drugs off the market, and they didn't do it. The irony is that FDA states fish oil is good for your health and allows DS to advertise it's benefits, but when AMRN wants to say V is REALLY REALLY good for your health, FDA says "spend $200M+ and prove it".