Replies to post #206999 on Amarin Corp Plc (AMRN)

[Markipeach]

So FDA gives priority review only to call an ADCOM cant meet for 6 weeks AFTER Sept 28 deadline. This thing smells. I dont trust an ADCOM.

[alwayswatching1]

Exactly! We fight or we’re FCKED! Pretty simple. This is a Goddamn repeat of 2013! Don’t anyone be naive here. The FDA is up to some serious bullshit and lives will be the cost. Our money is important but possibly millions of lives lost because of some revengeful vendetta over getting your shit kicked in court twice SERIOUSLY! I hope this is just another SRPT type situation.look them up if you don’t know my reference. However I’m having serious doubts as to our managements ability to navigate the treacherous waters the fda sharks are swimming in. Good luck all WE ARE GONNA NEED IT!

[Mellowmood77]

I’ve searched and searched and cannot find one example of a drug that was given priority review, then scheduled for an ADCOM after the pdufa date.

There are plenty of PDUFA extensions with no ADCOMS. But I can’t find one example where the PDUFA was extended because an ADCOM couldn’t be scheduled in time.

The FDA is a joke!! They need to explain why they waited so long to issue their ADCOM. If there isn’t a good reason, Amarin needs to take them to court 100%!

Can anyone find ONE example? Or is this the only time it happened in the history of the FDA.

[invest2992]

I’m beginning to wonder if AdCom is not in retaliation for the FOIA requests.

[raistthemage]

For what it is worth write the White House (I referenced my RNC # I got for donating). I was sure wrong about JT's cap raise but he needs to hire lobbyists, lawyers... potentially more unsavoury characters and go to the mattresses.

[zumantu]

Raf, completely agree. It’s 2013 all over again

FDA and Amarin are at war