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PolyPid advances FDA meeting, NDA submission, and commercial manufacturing readiness.
ByAinvest
Wednesday, Nov 12, 2025 7:40 am ET1min read
• PolyPid to meet with FDA in early December for NDA submission • D-PLEX₁₀₀ NDA submission on track for early 2026 • Phase 3 trial results positive • Advancements in discussions with potential US partners • IMOH GMP inspection completed successfully • Commercial manufacturing readiness on track
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