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Monday, 03/03/2014 9:15:03 AM

Monday, March 03, 2014 9:15:03 AM

Post# of 6939
TRLPF ($0.73) Trimel Provides Update Regarding CompleoTRT(TM) FDA Review. ON WATCH HERE.

TORONTO, ONTARIO, Jan 17, 2014 (Marketwired via COMTEX) -- Trimel Pharmaceuticals Corporation CA:TRL +1.22% today announced that the United States Food and Drug Administration ("FDA") has decided to extend the Prescription Drug User Fee Act (PDUFA) target action date for the CompleoTRT(TM) new drug application ("NDA") from February 28, 2014 to May 28, 2014. This will provide the FDA with the required time for a full review of the submission in light of the previously announced decision by the Company to amend its proposed label.

"As the FDA considered the change in labelling a major amendment, we understand that this extension is consistent with their normal practices in these circumstances," stated Tom Rossi, President and Chief Executive Officer. "We will continue to work closely with the FDA in order to obtain approval for this important therapy as quickly as possible."

REF> http://www.marketwatch.com/story/trimel-provides-update-regarding-compleotrttm-fda-review-2014-01-17-7173565

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