Vernalis plc (LON:VER) announced it received a complete response letter (CRL) from the US Food and Drug Administration’s regarding its new drug application CCP-07.
As quoted in the press release:
A CRL is issued by the FDA when it has completed its review of an NDA and questions remain that preclude its approval at this time. The CRL did not raise any concerns with the formulation or pharmacokinetic profile of CCP-07 but did identify outstanding items that need to be addressed prior to the resubmission and approval of the NDA.
“We remain committed to the approval of CCP-07 and will work closely with the FDA to resubmit the NDA as quickly as possible” said Ian Garland, CEO of Vernalis plc.