“Our biologics license application (BLA) for our ATEV in vascular trauma remains under review by the U.S. Food and Drug Administration (FDA),” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte (HUMA). “FDA leadership has not provided us a timeline for the completion of their review. As noted in our previous announcements, during the course of the BLA review the FDA conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions. Based on these interactions, we remain confident in the approvability of the ATEV in treating vascular trauma.”
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