Amarin Corp Plc (AMRN)

[MedResCollab]

The FDA has never gotten so much love... -Tastytheelf

Was seeking to usurp the authority granted by congress to the FDA on interpreting and applying the FD&C act, and demanding the ITC rule instead and take nearly all high-purity omega-3 supplements out of the hands of the American consumer, giving the FDA “so much love”?

Let’s not delude ourselves. The FDA will look extensively at all the data surrounding Vascepa and the REDUCE-IT trial, including everything we the public have not seen (which is a lot), and perhaps request data the sponsor did not submit (blood pressure data?)—hence the possibility of PDUFA date extension—and make a scientifically sound judgement that is devoid of partiality...

...unless there are sick kids involved. But, FDA guidance admits as much there too.

Regards,
-MRC