Cempra Gets Easier Path To CRL Response, But Who Will Fund The Study?
The biotech now only needs to investigate liver toxicity in 6,000 patients – down from 9,000 – to refile its NDA, but Cempra made clear that it won't initiate the study without an external funding source.
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A look at recent developments tracked by the Complete Response Letters chart on the Pink Sheet's US FDA Performance Tracker.
Cempra Pharmaceuticals appears to be one of the first companies exploring the newly enacted “limited use” pathway for novel antibiotics. The company cited the approach as an option for fusidic acid for use against MRSA – but it sounds like it may also be on the table for the company’s recently rejected solithromycin.
Cempra's plans to get an old antibiotic product approved at last in the US have received a boost with positive Phase III data, but it still needs to see if the FDA wants another pivotal trial, and analysts are wondering where sales will come from.