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Motif Bio pushes back FDA submission for iclaprim
Clinical-stage biopharmaceutical company Motif Bio updated the market on the status and timeline for submission of its new drug application (NDA) to the US Food and Drug Administration (FDA) on Tuesday, for its targeted gram-positive investigational antibiotic, iclaprim.
The AIM-traded firm said iclaprim was for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
It said that, in consultation with its advisers, it had decided that in order to ensure a complete and high-quality submission, it would be prudent to take additional time.
As a result, Motif Bio now expected that the NDA would be submitted to the FDA during the second quarter of 2018.
"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," said Motif Bio CEO Graham Lumsden.
"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."