New Trial With Longer Liver Elevation Needed For Iclaprim, US FDA Tells Motif Bio
Longer follow-up is part of regulatory path forward, the struggling antibiotics firm says after meeting with US FDA to discuss complete response letter.
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The UK biotech is in dire need of further funding after US regulators requested an additional clinical trial for its much-delayed skin infection antibiotic.
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.