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A Phase III Clinical Trial of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Trial Profile

A Phase III Clinical Trial of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Planning
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2018

At a glance

  • Drugs FCX 007 (Primary)
  • Indications Epidermolysis bullosa
  • Focus Therapeutic Use
  • Most Recent Events

    • 01 Nov 2018 New trial record
    • 25 Oct 2018 According to a Fibrocell Science media release, the company had Type C meeting with the FDA and the FDA provided guidance on various design aspects of this proposed Phase III clinical trial. Fibrocell plans to submit the protocol in the fourth quarter of 2018 and will provide details on the clinical trial design once it is finalized. The company plans to initiate this trial in first half of 2019.
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