Replies to post #22236 on Amarin Corp Plc (AMRN)

[investorfreak69]

My thoughts are.....who cares! It's thanksgiving and I want to enjoy my days off and not think about this joke of a company.

[Biobillionair]

The letter is the same format as the 7-26-2012 NDA Vascepa approval letter.

Here's the 11-25-2013 Supplemental Approval Letter:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s009ltr.pdf

[DeepBreath]

BB,

This paragraph tells me nothing has changed.


Also within 14 days, amend all pending supplemental applications that includes labeling changes for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this supplemental application