Solithera’s Prospects Look Grim Following Complete Response Letter
Even if Cempra has the funds to conduct another trial, there is no guarantee for approval; if approved, solithromycin’s labeling would likely limit use of the community-acquired pneumonia antibiotic.
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Limited population approval pathway in 21st Century Cures law may not help Cempra overcome US agency's request for new 9,000-patient safety study of the macrolide antibiotic.