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FDA grants QIDP status for RedHill's RHB-104 for Nontuberculous Mycobacteria infections

Jan. 11, 2017 8:21 AM ETRedHill Biopharma Ltd. (RDHL) StockBy: Douglas W. House, SA News Editor5 Comments
  • The FDA designates RedHill Biopharma's (NASDAQ:RDHL) RHB-104 a Qualified Infectious Disease Product (QIDP) for the treatment of Nontuberculous Mycobacteria (NTM) infections.
  • QIDP status provides for accelerated review of the New Drug Application (NDA) as well as a five-year period of market exclusivity for the indication, if approved.
  • The company plans to consult with the FDA on a development plan for NTM. RHB-104, a combination antibiotic, is currently in Phase 3 development for the treatment of Crohn's disease.

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