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MediWound issued a press release on June 29, 2021, “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.” Following completion of its review of the BLA, MediWound disclosed that 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.” MediWound further disclosed 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, MediWound’s stock price fell $1.57 per share, or 27.84%, on this news, to close at $4.07 per share.