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Senorita Roachita

02/10/12 9:26 AM

#801 RE: Big_R #793

With the FDA if you dot an "i" wronng on the application they will send it back. Obviously the gel was not denied since they rescheduled the PDUFA date.

CBRX must have not presented it correctly and it must have been some tiny error because the FDA didn't say try again in 2 years. JMO :-)