Recent

% | $
Quotes you view appear here for quick access.

Amarin Corporation plc Message Board

you are viewing a single comment's thread.

view the rest of the posts
  • billbixby1889 billbixby1889 Nov 14, 2012 7:34 PM Flag

    Chiral Switch and the NCE

    Per the approval letter from the FDA, AMRN filed a 505(b)(2). YMB won't let me link it, but it's on the FDA website. I copied and pasted below:
    "Dear Ms. Berry:
    Please refer to your New Drug Application (NDA) dated September 25, 2011, received
    September 26, 2011, submitted pursuant to 505(b)(2) of the Federal Food, Drug, and Cosmetic
    Act for VASCEPA (icosapent ethyl) Capsules, 1 gram.
    We acknowledge receipt of your amendments dated September 26 and 28, October 7,
    December 30, 2011; and January 27 and 30, February 2, 6, 9, and 28, March 5 and 22, April 5,
    11, 19, and 30, May 4 (2), 16, and 29, June 15 and 27, July 13 and 18, 2012. We also
    acknowledge receipt of your email dated July 25, 2012, stating your agreement to the labeling
    revisions that we communicated to you by email on July 25, 2012."

    Sentiment: Strong Buy

 
AMRN
2.23+0.08(+3.72%)10:57 AMEDT