Replies to post #208453 on Amarin Corp Plc (AMRN)

[Mellowmood77]

Bio,

The FDA is definitely pissed off. Go to regulations.gov and search for Amarin and see how many other companies have already used Amarin’s trial as precedent. It’s quite a few :)

[rafunrafun]

If the ADCOM is about MO (or anything else other than the label), PDUFA will be delayed by 3-4 months.

If the ADCOM is ONLY about the label, there is no logical reason not to find a way to split the SNDA and have a timely approval of the noncontroversial part (secondary & TG >135) then have the ADCOM in November to debate the controversial part.... yes, this would be a bureaucratic nightmare for the FDA, but that should not result in a delayed treatment for millions of Americans, where there is no controversy over the label.... this is where the Amarin management gets to earn their big bucks. If they can pull this off, they would be first ballot hall of famers.

Not to mimic BB, but I communicated this to both, Amarin and FDA and received responses from both.

[Atom0aks]

How about United States v. Caronia (https://www.reuters.com/article/us-offlabel-conviction/u-s-court-voids-drug-reps-conviction-cites-free-speech-idUSBRE8B21DC20121204)? Isn't that the preceding case that Amarin used as the foundation for their argument? What about United States v. Pacira (https://www.reuters.com/article/us-pacirapharma-fda-lawsuit/pacira-fda-reach-agreement-on-pain-drug-marketing-restrictions-idUSKBN0TY0E820151215), which shortly followed Amarin's settlement? They seem to be doing pretty well.

In any case, arguing that something is a "unicorn event" and therefore the rules don't apply is exactly the kind of speculation that I was talking about in my first post. The FDA is like any other regulatory body with strict rules that are enforced by normal people. If you don't believe me, feel free to talk to anybody with a public sector job that deals with the FDA or USDA about how overbearing those departments are.