PolyPid announced that a Type D meeting has been scheduled for January 2023 with the U.S. Food and Drug Administration to discuss the results of SHIELD I Phase 3 study and regulatory requirements to support the indication of D-PLEX100 for the prevention of abdominal colorectal surgical site infections. In advance of the meeting, PolyPid recently provided the FDA with currently available data from the completed SHIELD I study.
Published first on TheFly
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Read More on PYPD:
- PolyPid Announces Scheduling of Type D Meeting with U.S. FDA to Discuss SHIELD I Phase 3 Results and Regulatory Pathway for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Colorectal Surgery
- PolyPid Announces Receipt of Nasdaq Minimum Bid Price Notification
- PolyPid receives noncompliance notification from Nasdaq
- PolyPid implements cost reduction plan including 20% decrease in headcount
- PolyPid expects cash to fund operations into 3Q23
