Re: Farmas USA
DELAYED?!?!?!?
PERO ESTO ES UNA PUTA BROMA O QUE???
http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=815093
Amarin Receives FDA Notification That Action on ANCHOR sNDA Review Will be Delayed
The FDA also communicated to Amarin that it now views Amarin's appeal of the ANCHOR SPA agreement rescission and the ANCHOR sNDA as separate administrative decisions worthy of separate consideration. FDA plans to complete its review of Amarin's request to re-instate the ANCHOR SPA agreement and plans to convey its decision to Amarin no later than January 15, 2014. The FDA provided no additional information on when it expects to complete its review of the ANCHOR sNDA.
Amarin plans to continue to work with the FDA to pursue reinstatement of the ANCHOR SPA agreement and approval of the ANCHOR sNDA. There can be no assurance that Amarin will be successful in this effort.
BEDMINSTER, N.J., and DUBLIN, Ireland, Jan. 15, 2014 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Division of Metabolism and Endocrinology Products (DMEP) within the U.S. Food and Drug Administration (FDA) notified the company today that a determination on Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement will be delayed. FDA previously notified the company that it planned to convey its decision to Amarin no later than January 15, 2014. In today's communication, DMEP provided no definitive date for its planned response. Based on dialogue with DMEP, Amarin does not expect the delay to be for a significant period of time.
There can be no assurance that Amarin will be successful in its effort to reinstate the ANCHOR SPA agreement or obtain a label expansion reflecting the ANCHOR clinical trial data.