Replies to post #193821 on Amarin Corp Plc (AMRN)

[rosemountbomber]

Isaeed, the historical question concerning PR and chances of Adcom when not mentioned is interesting. I have had a question (which I have not been able to find an answer to) concerning the odds of approval based on whether PR or SR.

IF it was well known that PR upped the chance of approval by a great deal, then one would think this news this morning would be accepted by market participants extremely well and our pps should leave this stalled territory for good. But I just have not been able to find out whether PR applications fail as often as SR or not.

[sts66]

Sorry if this has already been mentioned, was out of the house most of the day and came back to see almost 400 new posts, had to skip 250 of them - but answer to your question "how many times has FDA announced a PDUFA without indicating an Adcom and then announced adcom later" is that this is normal behavior - ANCHOR was submitted in April 2013 and FDA didn't inform AMRN of Adcom until June. I looked at some PRs announcements earlier this morning for other drugs (all sNDA's), and none of the ones I found had FDA announcing PR, assigning PDUFA and stating an Adcom will be held at the same time - doesn't mean it never happens, I just couldn't find any, but that's also akin to looking for a needle in a haystack - all I found was hay. I'm now leaning towards no Adcom - the BD's are huge, take months to create, not sure FDA has the manpower to write them in a short period of time - unless they already started.