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FDA OKs Animal Rule regulatory path for MediWound's NexoBrid for sulfur mustard exposure

Published 05/29/2018, 10:22 AM
© Reuters.  FDA OKs Animal Rule regulatory path for MediWound's NexoBrid for sulfur mustard exposure
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  • MediWound (MDWD -0.8%) announces that the FDA has signed off on using the Animal Rule for its planned marketing application for the use of NexoBrid to treat injuries from the chemical warfare agent sulfur mustard.
  • The Animal Rule allows for the supporting efficacy data to be generated from animal studies because human studies are not possible or ethical. In this case, the FDA has agreed that single-species studies will suffice.
  • Now read: Afrezza Scripts Stay Above 500 While Company Uses Shares To Pay Some Debt


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