Whiskey I hope your timeline is off by a year...
Reviewing the Gov report on performance for NDA approvals
Final FY 2015 Review Performance
Final FY 2015 review goal performance is presented in the table below. Final performance for submission types that met the goal (90 percent or more review actions completed by the goal date) is shown in bold text. Applications reviewed under the Program have review goals starting from the 60-day filing date, while other submissions have goals starting from the submission receipt date. FDA met or exceeded the 90 percent performance level for 10 of 11 review performance goals in FY 2015. No Class 1 resubmitted NDA and BLA efficacy supplements were received in FY 2015; therefore, this goal category is excluded from the performance goals. More detailed information on performance is available in Appendix A.
Submission Type Goal: Act on 90 percent within
FY 2015 Performance
Original Priority NMEs and BLAs 6 months from filing date 92% Original Standard NMEs and BLAs 10 months from filing date 100% Original Priority non-NME NDAs 6 months 100%
Original Standard non-NME NDAs 10 months 95%
Class 1 Resubmitted NDAs and BLAs 2 months 100%
Class 2 Resubmitted NDAs and BLAs 6 months 97%
Priority NDA and BLA Efficacy Supplements 6 months 94%
Standard NDA and BLA Efficacy Supplements 10 months 95%
Class 1 Resubmitted NDA and BLA Efficacy Supplements 2 months --
Class 2 Resubmitted NDA and BLA Efficacy Supplements 6 months 64%
NDA and BLA Manufacturing Supplements requiring prior approval 4 months 93%
NDA and BLA Manufacturing Supplements not requiring prior approval 6 months 96%
My rosy outlook, Rett trial data complete by Q1, NDA/BLA summited by March, Fast track, Breakthrough, Marketing Authorization Application drug access by Sept. 30 2018.
Cheers.
