Vernalis has this morning announced that it has received a Complete Response Letter (non-approval) from the FDA in relation to CCP-08, its follow-on prescription cough cold medicine for the US market. This follows the CRL for CCP-07 in April 2017 and represents a further significant setback for the group. Vernalis will provide updates on its progress with both products in the coming months. We also continue to look forward to two sets of proof-of-concept data (CCP-05 and CCP-06) later this year.
07 Aug 2017
N+1 Singer - Vernalis - Complete Response Letter for CCP-08
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N+1 Singer - Vernalis - Complete Response Letter for CCP-08
Vernalis has this morning announced that it has received a Complete Response Letter (non-approval) from the FDA in relation to CCP-08, its follow-on prescription cough cold medicine for the US market. This follows the CRL for CCP-07 in April 2017 and represents a further significant setback for the group. Vernalis will provide updates on its progress with both products in the coming months. We also continue to look forward to two sets of proof-of-concept data (CCP-05 and CCP-06) later this year.