7 August 2017 - Vernalis announced today that the US FDA has issued a complete response letter regarding the new drug application for CCP-08.

A CRL is issued by the FDA when it has completed its review of an new drug application (NDA) and questions remain that preclude its approval at this time. This complete response letter (CRL) indicated that the outstanding items which resulted in the CRL for CCP-07 remain and that they need to be addressed prior to the resubmission and approval of both NDAs.

"Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08. The approval of both CCP-08 and CCP-07 are of the utmost importance to Vernalis, and we are working closely with our partner Tris and the FDA to resubmit both NDAs as quickly as possible," said Ian Garland, CEO of Vernalis plc. "We look forward to providing additional updates on our progress with this in the coming months."

Read Vernalis press release