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
| Source: PolyPid Ltd.
PolyPid Recently Provided FDA with Currently Available Data from Completed SHIELD I Phase 3 Study in Advance of Meeting
PETACH TIKVA, Israel, Dec. 12, 2022 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that a Type D meeting has been scheduled for January 2023 with the U.S. Food and Drug Administration (FDA) 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 (SSIs). In advance of the meeting, PolyPid recently provided the FDA with currently available data from the completed SHIELD I study.
“We look forward to a constructive dialogue with the FDA with regard to the outcomes of SHIELD I and possible next steps for D-PLEX100 for the prevention of abdominal colorectal SSIs,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “Based on the significant reduction in SSIs in complex surgeries with large incisions demonstrated in SHIELD I, we remain highly confident in the potential of D-PLEX100. The recent open market stock purchases by myself and by our Board Chairman, Mr. Jacob Harel, about five-digit numbers worth each, are indicative of this high level of confidence.”
The FDA established Type D meetings to provide an opportunity for companies to address more focused issues on a shorter timeline than other meeting types normally allow. A Type D meeting is focused on a narrow set of issues and is limited to no more than two focused topics. The FDA aims to conduct Type D meetings with companies within 50 calendar days after receipt of the meeting request.