Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that it has submitted a meeting request and package to the U.S. Food & Drug Administration (FDA) related to the Company’s lead product candidate, iclaprim. In the minutes from a May 3, 2019, Type A meeting, the FDA indicated that an additional clinical trial will be required prior to granting marketing approval of iclaprim. The Company has been encouraged by the FDA to put forth a proposal for such a study. Motif Bio has requested a Type B meeting with the Agency to discuss the proposed study population and design. The Company will provide guidance on when such a meeting will occur once FDA issues the meeting granted letter. The FDA typically schedules a Type B meeting within 60 days of request, although it can take longer.
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