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Matricelf Receives FDA Feedback Supporting Key Elements of Proposed First in Human Clinical Trial for NewRal Spinal Cord Injury Program
Source: PR Newswire
Regulation & LegislationHealthcare & BiotechCompany Fundamentals
FDA feedback is supportive of Matricelf’s proposed NewRal NESS clinical development plan, including the target patient population, single-arm open-label trial design, and its primary safety assessments and exploratory efficacy measures. The guidance is intended to steer preparations for a future IND submission as the company advances its regulatory pathway.
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