Pluristem Therapeutics

FDA grants Fast Track to Pluristem’s PLX-PAD for critical limb ischemia

Monday, September 18, 2017

Pluristem Therapeutics, a developer of placenta-based cell therapy products, announced that the 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.

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