Replies to post #115606 on Amarin Corp Plc (AMRN)

[Biobillionair]

Jo mama- ITC will not outright deny an Amarin victory...it will be a “slow walk” to inaction. Amarin would then report the violations to FDA, likely not public. After an FDA noncompliance and failure to enforce Amarin will have an actionable argument... The FDA is aware of R-I and the FDA’s abilities to win any argument decreases as we approach the final R-I results. It’s not a matter of if the FDA loses, but how much they lose. I haven’t emailed Woodcock lately, but I certainly plan to in the coming months...if she wants her career to end with R-I that’s fine by me.
BB

[sts66]

Why would FDA go after respondents if amrn loses ITC?

Just thinking off the top of my head, not saying this is even a possible outcome - what if ITC consults with FDA, FDA says EE-EPA DS are unapproved drugs, but for some reason ITC declines to take action - perhaps the prez rejects the ITC decision, for instance - couldn't the FDA/FTC/DEA then take action on their own against DS for selling unapproved drugs?

[Biobillionair]

Jomama-

Why would FDA go after respondents if amrn loses ITC? I appreciate your opinion but law is not my strong suit.

If ITC rules wrong jurisdiction it goes to FDA.

If ITC rules the complaint is not cognizant due to inability to determine drug status it goes to FDA.

If the FDA fails to properly enforce laws at the request of Amarin, it is arbitrary and capricious "regulation". The answer here is yes, it is arbitrary and capricious. Next question, what are the damages done to Amarin for the FDA's failure to act? IMO this moves into a phase of discussions regarding NCE, ANCHOR, First Amendment and now the additional failure to apply laws to imported drugs that cross into Amarin's IP and new drug application. The damages to the above actions and inactions are cognizant under a "takings" claim against the United States. Amarin wins this law suit IMO if the FDA fails to act on ITC "loss".

I do not think Amarin will lose ITC action, but if they do the FDA is on-the-hook.

BB