Cempra’s Antibiotic Likely Needs Bigger Trial – But Might Be Able To Do It In Phase IV
FDA advisory committee votes 7-6 that the strong efficacy profile of Solithera (solithromycin) outweighs its unknown safety risks; panels agreed that more data was needed, but were split on whether it was needed pre- or post-approval.
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FDA has three NDAs set for public advisory committee review at the end of March and early April, the first 'real' committee meetings in five months. Oops. Make that two.