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
Price : $35 *
At a glance
- Drugs Bromelains (Primary)
- Indications Burns
- Focus Registrational; Therapeutic Use
- Acronyms DETECT
- Sponsors MediWound
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History