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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 2 of 2. This is the beginning of the thread.
Posted by bogluem on August 9, 2005, at 12:38:44
On June 16, 2005 the FDA indicated it had accepted Somerset's May 26, 2005 response as complete and issued a Prescription Drug User Fee Act (PDUFA) "goal date" of November 27, 2005. Does anyone know what that November 27, 2005 goal date means? Does it mean it is likely that the FDA's final approval will be by that date. I read somewhere that the FDA met the PDUFA goal date in over 90+% cases.
Posted by willyee on August 9, 2005, at 13:36:57
In reply to Emam (selegiline patch) Question, posted by bogluem on August 9, 2005, at 12:38:44
> On June 16, 2005 the FDA indicated it had accepted Somerset's May 26, 2005 response as complete and issued a Prescription Drug User Fee Act (PDUFA) "goal date" of November 27, 2005. Does anyone know what that November 27, 2005 goal date means? Does it mean it is likely that the FDA's final approval will be by that date. I read somewhere that the FDA met the PDUFA goal date in over 90+% cases.
I called the company and no FINAL date has been set still,im there with ya wating.
This is the end of the thread.
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