>Maybe the agency was thinking after the positive advisory panel vote that since it could take another six to eight months after the 5/15/07 PDUFA date for DNDN to satisfy the mfg inspectors, then why not wait just a few more months for the 9902B interim survival data to be unblinded?<
You could be right, but the non-disclosure of an event as consequential as a Form-483 report is not going to simply be forgotten. Moreover, who is now going to believe that the deficiencies cited in the 483 are minor just because Dr. Gold says they are?
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