PolyPid: Positive Regulatory Update for D-PLEX₁₀₀ for Prevention of Surgical Site Infection

 Regulatory Pathway for a Potential NDA Submission Clarified Following Recent Interactions with the FDA

• FDA Acknowledged that SHIELD I Pre-specified Subgroup Results May Provide Supportive Evidence and Proposed that Current SHIELD II Trial Could Potentially Serve to Complete Clinical Testing for NDA

• FDA Also Recognized that D-PLEX₁₀₀’s Proposed Indication is for the Prevention of Infection and Has the Potential for Wide Use

https://www.biospace.com/article/releases/polypid-provides-positive-regulatory-update-for-d-plex-for-the-prevention-of-surgical-site-infections-in-abdominal-colorectal-surgery/