Motif Bio (NASDAQ:MTFB) has received the official minutes of the Type A meeting held with FDA on May 3, to address the points raised in the Complete Response Letter (CRL) related to its iclaprim application for acute bacterial skin and skin structure infections.
Citing concerns about potential liver toxicity, the agency has requested another clinical trial. The Company plans to request a meeting with the regulator to discuss the design of the study, including the appropriate patient population to be evaluated.
Management will hold a conference call today at 8:00 AM EDT to discuss the situation.
Shares were down 35% premarket.
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