perhaps i should be more specific...the FDA issues a 10 month...

perhaps i should be more specific...

the FDA issues a 10 month review window for standard NDA's and a 6 month window for priority reviews.

additionally priority review NDA's have a higher rate of approval than normal NDA's (oddly). first pass approval rates in 2008 were about 68% for standard and 75% for priority.

the the benefits to QX would be 4 months and an improved chance of receiving approval.

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/UCM243358.pdf