Posted by Michael Wonder on 19 Sep 2017
U.S. FDA grants fast track designation to Pluristem's PLX-PAD for the treatment of critical limb ischemia
18 September 2017 - Pluristem’s on-going phase III CLI trial has been selected for accelerated approval pathways in both the U.S. and Europe.
Pluristem Therapeutics today announced that the U.S. FDA has granted fast track designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization.
The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With fast track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.
