ARTICLE | Clinical News
FDA issues CRL to NDA for Vernalis' CCP-08
August 11, 2017 2:45 PM UTC
Vernalis plc (LSE:VER) said FDA issued a complete response letter to an NDA for CCP-08 to treat cough and cold. The letter follows a CRL issued in April for its other cough and cold candidate CCP-07 (see BioCentury, May 1).
Vernalis said the CRL for CCP-08 "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." The company did not respond to inquiries regarding the content of the letters...