Fast track designated therapeutics are eligible for priority review, meaning that the review is completed within six months instead of the customary twelve. Also, the review of portions of the marketing application may occur prior to the completion of the final registration package.
The fast track program was created to facilitate the development and expedite the review of new therapeutics that are intended to treat serious or life threatening diseases, and that demonstrate the potential to address unmet medical needs.
“Receiving this Fast Track designation is another step in our regulatory strategy that is designed to afford us the opportunity to accelerate the development of VEGF-2 to commercialization.” stated Richard Otto, president and CEO of Corautus.