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poorgradstudent

08/29/12 6:31 PM

#147913 RE: reddymade #147910

EXEL:

If it is Accelerated why would the mgmt say the pdufa date still intact....Seems to me another setup..



huh?

Accelerated approval is a designation to assess an application based on surrogate markers. There is no reason for the PDUFA date to change simply from the cancellation of an ODAC panel.