The FDA has also informed us that due to COVID-19 pandemic-related travel restrictions, they may be unable to complete an inspection of one of the AXS07 manufacturing facilities prior to the PDUFA date.

Nov 8, 2021 / CEO / receipt, needs a key / Dr. Ariel Tabuto, CEO | earnings call 2021-11-08 | transcript d016eda9-4bc8-4bfd-96b4-85661f7f344e | chars 4577-4779 | segment 4