Vericel Corp

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Vericel Corp Says Development Partner Mediwound Received CRL From U.S. FDA

Published: 06/29/2021 13:08 GMT
Vericel Corp (VCEL) - Vericel Corp - Co's Development Partner Mediwound Received a Complete Response Letter (crl) From U.S. Food and Drug Administration (fda).
Vericel Provides Regulatory Update for Nexobrid.
Vericel Corp - Crl is Regarding Biologics License Application (bla) for Nexobrid.
Vericel Corp - FDA Communicated to Mediwound That It Had Completed Review of Bla and Has Determined That It Cannot Approve Bla in Its Present Form.
Vericel Corp - FDA Identified Issues Related to Chemistry, Manufacturing and Controls (cmc) Section of Bla.
Vericel Corp - FDA Requested That Mediwound Provide Additional Cmc Information.
Vericel Corp - FDA Also Stated That Inspections of Manufacturing Facilities in Israel and Taiwan Are Required Before Bla Can Be Approved.
Vericel Corp - Crl Referenced Observations That Were Made During Good Clinical Practice (gcp) Inspections Related to Detect Study.
Vericel Corp - FDA Also Requested That Mediwound Provide a Safety Update As Part of Its Bla Resubmission.