Motif Bio Confirms Meeting Date with U.S. FDA regarding Iclaprim
MOTIF BIO PLC ADRS (MTFB)
US:NASDAQ Investor Relations:
ir.motifbio.com
Company Research
Source: GlobeNewswire
NEW YORK, July 26, 2019 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announced today that the U.S. Food & Drug Administration (FDA) has granted the Company’s request for a Type B meeting related to a proposed clinical study for the Company’s lead product candidate, iclaprim. The in person meeting has been scheduled for September 19, 2019. As previously announced, Motif Bio submitted a meeting request and clinical study proposal to the FDA based upon the minutes from a May 3, 2019, Type A meeting with the Agency, which indicated that an additional clinical trial will be required prior to granting marketing approval for iclaprim. The Company was encouraged by the FDA to put forth a proposal for such a study, and Motif Bio plans to discuss the proposed patient population and study design with the Agency at the upcoming meeting. Official meeting minutes are received from the FDA typically
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