The FDA has issued a Complete Response Letter (CRL) regarding remaining GMP observations at the contract manufacturer NerPharMa, which has been engaged to produce the drug candidate Dasynoc for Xspray.
The letter also includes a request for additional commercial batch data following the corrective actions already implemented. Xspray emphasizes in a press release that the FDA has not raised any questions regarding Dasynoc’s clinical data, bioequivalence, or stability.
BREAKING