Replies to post #193833 on Amarin Corp Plc (AMRN)

[isaeed]

I am at all not worried about the approval which I am 100% sure we will get (the label addons) but I had a bad taste in mouth left after the Anchor Adcom. The management also modified the NDA from what the Anchor study was originally for which then resulted in the adcom disaster. I just want to avoid it if possible. I am extremely excited about getting approval in 4 months. I am so proud of what JT and his team have achieved. This is the best management team i have ever seen in any biotech. He is continuously underpromising and overdelivering.

I am so proud to be part of this history in the making. I am still in shock.

[jessellivermore]

rose...

Quote: "But I just have not been able to find out whether PR applications fail as often as SR or not."

WTF is wrong with you people...Vascepa is not going to fail..I don't give a shit if every other drug who ever got a PR failed...Vascepa is not going to fail...That's what we learned in Sept and later at the AHA meeting in Nov...

Most of you don't deserve the good fortune you lucked into...Don't deserve it at all...You look a gift horse in the mouth...You vilify FDA for doing their job...News flash..Its not FDA which is petty and childish...Go look in the mirror..

":>) JL

[Biobillionair]

Rose- Have you been paying attention lately with the Cardiovascular Standards of Care changing due to R-I? The FDA “has accepted” the application, the rest is label negotiation. I have faith that Amarin and the FDA will resolve the label in a timely fashion and we could see the target date being crushed with an earlier approval.
BB

[sts66]

PR for an NDA does not necessarily indicate better chances for approval, but PR for an sNDA should, since it's just an expansion of the label - only if new safety issues popped up (like A-fib for R-IT) would you question whether PR is good or neutral. In any case, R-IT approval is a slam dunk.



P.S. Ignore JL's petty angry response - he's not looking at the question you asked from the correct perspective - you asked whether the PR would change the market's expectations for approval, NOT if R-IT will fail to gain approval - and based on today's action, the answer appears to be "yes" - stock wouldn't pop +12% if the market didn't believe receiving PR was a good indicator of approval. Unless it was just a short squeeze, of course.......won't know whether it was until tomorrow, but since 5/10/19 only one day has seen new shorts > short covers.