InvestorsHub Logo
Followers 234
Posts 26887
Boards Moderated 0
Alias Born 01/12/2013

Re: Sam81 post# 60237

Thursday, 10/01/2015 10:28:27 AM

Thursday, October 01, 2015 10:28:27 AM

Post# of 425795
Hey Sam-

Judge Moss clearly lays this out in recent Eisai decision here:
"In other cases, however, the requirements that remain are substantial and will require further substantive review and approval. In those cases, the agency expressly requires further action in its approval letter as a signal that the FDA has concluded that its process is not yet completed"

https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2014cv1346-26

Amarin's application has not been completed, see my prior post.

IMO exclusivity will start when OB os updated, both FDA and Amarin where likely waiting for this decision to determine start.

Hopefully it was made final yesterday and be update Oct 15th or 16th.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117384888

BB

Smash

Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent AMRN News