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NervGen Pharma aligns with FDA on Phase 3 study
Globenewswire·
NervGen Pharma has achieved alignment with the U.S. Food and Drug Administration (FDA) following a successful End-of-Phase 2 meeting. This crucial step paves the way for RESTORE, a planned Phase 3 registrational study evaluating NVG-291 for chronic tetraplegia. The FDA's agreement on the study parameters, including its 16-week duration, marks significant progress in the development of potential treatments for spinal cord injuries.
Tags
healthtech
regulation
clinical trial
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Globenewswire — www.globenewswire.com