The FDA is forcing a small antibiotic player back to the clinic for a new trial — 10 years after first rejection
Motif Bio $MTFB got a clear enough answer from the FDA on what regulators will need to see before they reconsider an OK on their antibiotic iclaprim. And it’s not what their dwindling band of investors wanted to hear.
The little biotech confidently reported Thursday morning that the FDA is requiring another clinical trial to clear up its stubborn concerns about the potential for liver toxicity — a worst case scenario that will once again significantly delay a program that has been trying to make a comeback at the agency for the past decade.
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