Replies to post #34697 on Amarin Corp Plc (AMRN)

[biowreck]

I don't see how the FDA can refute the language...after all, it's only stating the facts and not going too far by stating an indication.

[ziploc_1]

JL:"Maybe Amarin is going First Amendment." This scenario has occurred to me previously. I would rather not face off with the FDA in court, of course. But if it has to happen, I would prefer to see the FDA suing Amarin rather than visa versa. In either case, the details of the FDA treatment of Amarin in the Anchor matter will come out for all the public to see and judge. I do not feel this would be the FDA's strongest moment.

[mrmainstreet]

Sorry JL, but what part of this would be objectionable to the FDA? What am I missing?

[hipfreejazz]

Change from baseline in lipid parameters is documented in Vascepa prescribing information.

I doubt that FDA would object to disclosure of prescribing information. Reference page 7 for details:
http://www.vascepa.com/full-prescribing-information.pdf