Leerink sees ‘silver lining’ in Aquestive CRL given defined path to approval

Leerink analyst Roanna Ruiz was not surprised that Aquestive Therapeutics (AQST) received a Complete Response Letter for Anaphylm given the FDA’s prior deficiency letter. That said, the “silver lining” is that this outcome appears recoverable with a relatively defined path to approval, the firm adds. The good news is that no additional studies beyond these seem to have been requested by the FDA, the CRL does not appear to raise any concerns about comparability data or CMC, and Leerink sees these studies ar ...