Motif Bio plc (LON:MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today provided an update on the status and timeline for submission of its New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for its targeted, Gram-positive investigational antibiotic, iclaprim, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). In consultation with its advisers, the Company has decided that in order to ensure a complete and high quality submission, it would be prudent to take additional time and consequently, the Company now expects that the NDA will be submitted to the FDA during the second quarter of 2018.
Graham Lumsden, Motif Bio plc Chief Executive Officer, said: “There are many components that go into an NDA submission and our aggressive timeline was contingent upon all outstanding items being completed to provide sufficient time to quality check and then publish the document. Most components are complete, but given the importance of the submission, we made the decision that it was in the best interests of the Company and all stakeholders to allow more time to ensure we submit the strongest possible application.”
