If there is a decision today regarding NCE, will we have to wait for The Orange Book to be updated (what time would that be at?) or would AMRN be notified in advance and issue a PR prior to the on-line update?
Sentiment: Strong Buy
1) The OB can be updated ANYTIME during the day there is no set time
2) The OB can come out a day or two early OR late. So it may come out today but also Monday next week
3) There is NO communication to Amarin before release of the OB. Check the FDA website, it has explicit info. The OB is the ONLY way NCE status is announced, Amarin has to wait just like us and everyone else for the OB to be released to find out.
There is some mix-up in the question.
If a decision was reached no later than November 30, it will be posted in the November update (due today, or next Monday the latest).
If no decision made yet - it's obvious, nothing posted in the upcoming edition.
But if a decision has been reached between December 1 and today, it will only be posted in the December update (to be published in January).
Hard to say, AMRN insinuated they would get the response letter sent to them but unclear if that would be after OB update. Last month OB updated at 2:15 but never a set time. One month was around 4:30. Could even be Monday in theory but likely today in the afternoon but really unknown