Cempra Gets Easier Path To CRL Response, But Who Will Fund The Study?

On the same day it announced its plans to merge with privately held antibiotics developer Melinta Therapeutics Inc., Cempra Inc. revealed that it has worked out a somewhat easier path for responding to a December complete response letter for its macrolide antibiotic candidate Solithera (solithromycin) – but questions remain about who would fund a safety study with an estimated cost of $75m.

Acting CEO David Zaccardelli said Cempra negotiated with US FDA "a smaller, more focused and efficient approach" to obtain the hepatic safety data requested by the agency in its CRL toward the end of last year. (Also see "Cempra's Solithera Draws FDA Complete Response Letter On Liver Risks" - Pink Sheet, 29 December, 2016