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The FDA indicated that PolyPid's proposal for a single Phase 3 pivotal study (SHIELD I) would be sufficient to establish clinical efficacy and safety to support approval of D-PLEX100 for the prevention of surgical site infections (SSIs) in colorectal surgery.
To date, over 200 patients are enrolled, and the topline data is expected by the end of 2021.
The trial's primary endpoint is the combination of incisional SSIs and mortality rate within 30 days post-surgery.
The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients.
Price Action: PYPD shares are up 0.98% at $9.29 on the last check Wednesday.
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