Amarin Corp Plc (AMRN)

[zumantu]

JL, so far I agree, except on this point, I believe the FDA has a legitimate "out".

And if challenged in court, an FDA lawyer would simply point to outcomes studies that indicate that; "contrary to prior science (as in 2008 ) lowering TGs has not been proven to reduce CV events. Furthermore, the preponderance of evidence from these studies indicates with a fair amount of certainty that lowering TG does not reduce CV events.

Amarin would then be forced to prove that the science has not changed since 2008 and in fact lowering TGs do reduce CV events

What science can Amarin point to prove their position? I cant think of one (other than JELIS) which is easily dismissed as relevant since it does meet the accepted FDA standards for outcomes studies (not placebo controlled, etc)

The FDA policies I've read on SPA's indicate they are not as binding as we would like them to be - especially when the science has been deemed to have changed.

Lastly, going to court is not an option for Amarin. Perhaps for BP, but not Amarin.

It will be far easier to simply re-apply for another expanded label that does not challenge the science as directly as the current SPA does - another words, don't try to force FDA to eat something they will choke on- unless you have so much "muscle" you can shove it down regardless of them choking. ( sorry for the metaphor : - )


So in the end the FDA has a big problem as does Amarin

AACE guidelines for Diabetics with dyslipidemia state the target TG is under 150 mg /dl .

That is a very large population that will not be treated if the Vascepa label is not expanded and so it hard for me to conceive the FDA simply turning its back on this group.

No, I think the FDA orchestrated the ADCIOM vote for negotiating leverage with AMRN and for a revised , more narrow label which would given Endo's a needed tool for millions with T2DM but not make the FDA look like its purporting the world is flat. Let them have their science .... but lets get Vascepa out to Diabetics ASAP