Vernalis PLC: FDA Issues a Complete Response Letter on CCP-07 NDA
WINNERSH, UNITED KINGDOM--(Marketwired - Apr 21, 2017) - Vernalis PLC (
LSE: VER
21 April 2017
Vernalis plc announces today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-07.
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.
The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014. Upon the publication of this announcement this inside information is now considered to be in the public domain.
