Motif Bio Poised For Filings As Iclaprim Succeeds Again In Phase III
Positive data from a second Phase III trial sets up Motif Bio for an NDA filing by the end of the year for novel antibiotic iclaprim – but success for the product has been a long time coming.
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Longer follow-up is part of regulatory path forward, the struggling antibiotics firm says after meeting with US FDA to discuss complete response letter.
Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise funds and fast to stay afloat and prepare a meeting package to discuss the next steps for iclaprim with the agency.
The latest drug development news and highlights from our US FDA Performance Tracker.