October 23, 2023) - NervGen Pharma Corporation announced today that the U.S. Food and Drug Administration has granted Fast Track designation for its proprietary lead compound, NVG-291, in individuals with spinal cord injury. FDA's Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as part of the FDA's goal to get important new drugs to patients earlier. Fast Track also provides eligibility for both Priority Review, which can shorten the New Drug Development (NDA) review process, and for Accelerated Approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical endpoint.
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However, in order for NervGen's drug, NVG-291, to receive early approval, it must meet its clinical endpoints. Then it will get an early review of its results (Priority Review) and if the review is favorable, it will be evaluated for Accelerated Approval.
Exceeding its clinical endpoints, especially if its subjects have a return of motion, even partial motion, of previously paralyzed extremities, will virtually ensure the approval of its drug NVG-291, most likely a fast approval of its drug.