Replies to post #43011 on Amarin Corp Plc (AMRN)

[couldbebetter]

You are correct...it seems as if they mention this in their conference calls and press releases...it does raise expectations which is a dangerous thing to do if those expectations do not work out. I do hope they complete enrollment soon.

[rafunrafun]

I'd bet that AMRN & FDA have some sort of an agreement for interim... clue 1- SPA appeal dropped, clue 2- FDA is 18 months late on ANCHOR and complete silence from both sides, clue 3- AMRN confirmed their devotion to REDUCE-IT, clue 4- AMRN hinted at interim reading. What I don't understand is why not just issue CRL now (or even right after AMRN agreed to drop SPA appeal) and officially leave it up to REDUCE-IT. Could FDA be waiting for the NCE ruling, even though I don't see what that has to do with ANCHOR.

I'm 90% confident that both sides have some sort of agreement.

[ggwpq]

Zum, in the latest Amarin's press release on Feb 26, it contains the following language regarding REDUCE-IT (4th paragraph):

"REDUCE-IT enrollment of an estimated 8,000 patients is expected to be completed in 2015, with a protocol pre-specified interim data analysis of efficacy and safety results at 60% of targeted events anticipated in 2016 by the independent Data Monitoring Committee (DMC). Completion of the REDUCE-IT study, if not stopped earlier based on the interim analysis by the independent DMC, is expected in 2017 with published results expected to be available in 2018."

That shows me increased confidence by Amarin's management regarding interim R-I data not previously shown.