FDA gives thumbs-down on hearing loss drug, citing manufacturing issues, and sends Fennec stock reeling

The FDA handed down a complete response letter to Fennec Pharmaceuticals $FENC for its Pedmark drug late Monday night, citing manufacturing issues with the company’s supplier. Fennec hopes to meet with regulators sometime within the next month or two, CEO Rosty Raykov said in a call with investors Tuesday morning, in order to resolve the issue.