Priority and Breakthrough Drugs -FDA

FDA's Expedited Approval Mechanisms for New Drug Products - PMC

Starpharma’s DEP carbaxitaxel and DEP irinotecan definitely meet FDA criteria for accelerated approval. Time frame: 6 months from application. Have SPL filed? Hopefully carbaxitaxel is in already. Hopefully they can file irinotecan quickly.

“The primary benefit of receiving Priority Review is a reduction of four-months in the projected review time by FDA. FDA aims to complete review of an NDA for a compound with a Priority Review designation within six months; the goal for a compound with a Standard Review designation is to complete review within ten months. In addition, FDA intends “to direct overall attention and resources to the evaluation of applications for” Priority Review drug products.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326266/