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Xenoport, Inc. Message Board

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  • pratik0892 pratik0892 Apr 4, 2011 2:56 PM Flag

    No strong arguments about approval or denial, WHY???

    the company had a female carcinoma at 114 times exposure..in the past pfizer only conducted it at a max dose of 38x..this tells us that pfizer did not conduct these studies at extremely high doses.. also if fda wanted them to conduct tests in female rats.they would have told them either in the last CRL or during end of review meeting and the company would have done so..

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