Forum Topic News
  • Conversation: Synthetic Biologics Announces Positive Outcome of End-of-Phase 2 Meeting with FDA on SYN-004 (ribaxamase) Development

    • November 21, 2018 1:01 PM GMT
    • Synthetic Biologics Announces Positive Outcome of End-of-Phase 2 Meeting with FDA on SYN-004 (ribaxamase) Development

      Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics designed to preserve the microbiome to protect and restore the health of patients, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss development of SYN-004 (ribaxamase) for the prevention of antibiotic-mediated Clostridium difficile infection (CDI). Pursuant to the meeting, the FDA has proposed criteria for Phase 3 clinical efficacy and safety which, if achieved, may support submission for marketing approval of ribaxamase on the basis of a single Phase 3 clinical trial. Final agreement on these criteria is contingent on FDA evaluation of a detailed Phase 3 clinical trial protocol.
      Read more: https://lnkd.in/gd7V-Se

Add Reputation

Do you want to add reputation for this member by this post?

or cancel
‚Äč