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A Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study, Performed in Subjects With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid Compared to Gel Vehicle and Compared to Standard of Care

Trial Profile

A Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study, Performed in Subjects With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid Compared to Gel Vehicle and Compared to Standard of Care

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Aug 2019

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At a glance

  • Drugs Bromelains (Primary)
  • Indications Burns
  • Focus Registrational; Therapeutic Use
  • Acronyms DETECT
  • Sponsors MediWound
  • Most Recent Events

    • 06 Aug 2019 According to a Vericel Corporation media release, the company confirmed plans after meeting with the U.S. Food and Drug Administration (FDA) to submit a Biologics License Application (BLA) for NexoBrid to the FDA in the second quarter of 2020.
    • 22 Feb 2019 Last checked against ClinicalTrials.gov record.
    • 22 Jan 2019 According to a MediWound media release, the Company plans to submit the BLA in the second half of 2019 based on the available acute primary, secondary, and safety data with the twelve-month safety follow-up data submitted during the BLA review, subject to FDA concurrence at a pre BLA meeting planned for first half of 2019.
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