MDWD - MediWound: Adjusting My Strategy After NexoBrid CRL

• The FDA sent MediWound a Complete Response Letter for their eschar removal treatment, NexoBrid. The FDA was not able to inspect the company’s manufacturing facilities due to pandemic travel restrictions.
• I believe they will be able to address the cited issues in the CRL, however, the facility inspections could be a major concern for an extended period of time.
• The company recently reported encouraging NexoBrid data in the pediatric population. The study hit three primary endpoints with a high degree of statistical significance.
• I discuss my revamped strategy for MDWD following the CRL.

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