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Vericel announced on May 7, 2019 that the company would enter into an exclusive license agreement in North America with MediWound Ltd. to commercialize NexoBrid, a product under development by MediWound for debridement of severe thermal burns.
Then, on June 29, 2021, MediWound issued a press release “announc[ing] it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.” It was disclosed by MediWound that following completion of its review of the BLA, the FDA “determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls (‘CMC’) section of the BLA and requested additional CMC information.” It was further disclosed by MediWound that “[t]he FDA also stated that an inspection of NexoBrid’s manufacturing facilities in Israel and Taiwan, are required before the FDA can approve the BLA, but it was unable to conduct the required inspections during the current review cycle due to COVID-related travel restrictions. The FDA stated that it will continue to monitor the public health situation as well as travel restrictions and is actively working to define an approach for scheduling outstanding inspections. In addition, the CRL cited certain observations identified during good clinical practice (GCP) inspections related to the U.S. Phase 3 study (DETECT), and requested the company to provide its perspective on the potential impact, if any, of these observations on the efficacy findings in the study”
On June 29, 2021, Vericel’s stock price fell $10.04, or 14.81%, on this news, to close at $57.77.