The meeting is scheduled to take place on May 3, 2019.
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 A meeting to discuss the points raised in the Complete Response Letter received from the FDA related to the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections. The meeting is scheduled to take place on May 3, 2019.
Graham Lumsden, Chief Executive Officer of Motif Bio, said: “We are pleased that the FDA has granted our meeting request and that critical personnel from the FDA have been invited to attend the upcoming meeting with our internal and external experts. We look forward to a collaborative meeting and to discussing with the Agency the best way to move iclaprim towards marketing approval.”
Official meeting minutes are received from the FDA typically within 30 days of a meeting. After this, Motif Bio will be in a position to provide an update to the market on the path forward for iclaprim.
As previously announced, the Company needs to raise additional capital in the near term. A further update regarding financing will be made in due course.
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