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Old 11-22-2012, 07:46 AM   #17
El Diablo
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Join Date: Feb 2004
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(not sure what data re the FDA is being suggested here --- none, it would seem --- but half of all initial submission New Drug Applications in the U.S. are rejected by the FDA. Companies can then re-submit, and re-submit again, but over twenty percent are never accepted after multiple rounds of request for approval.)
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