Pain Therapeutics Inc. (PTIE) announced that Pfizer Inc. (PFE), its commercial partner for pain relief drug Remoxy, is reviewing its continued participation in Remoxy development program. But, Pfizer said that it cannot provide an exact time frame for its decision.
The U.S. Food and Drug Administration had rejected their application for Remoxy through a June 2011 complete response letter.
In a letter to Pain Therapeutics dated on May 9, Pfizer said it is reassessing timelines given the new guidance and while they are not yet firm, it believes its response to the June 2011 complete response letter will not be submitted to the FDA before mid-2015. Given the years of delay, additional cost incurred to bring the program to this point and development work left in the program, there will be much to consider when it seeks management endorsement.
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