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PolyPid Receives FDA Support for NDA Submission of D-PLEX100 for Surgical Site Infections
ByAinvest
Wednesday, Dec 3, 2025 8:33 am ET1min read
PolyPid Ltd., a biopharma company, received pre-NDA meeting minutes from the FDA supporting its NDA submission for D-PLEX100, a product candidate for surgical site infections in abdominal colorectal surgeries. The FDA agreed that the existing clinical data is adequate and will conduct a rolling NDA review starting in early 2026. PolyPid concludes that the objectives of the pre-NDA meeting have been accomplished.
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