The FDA mentioned that approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions.

Nov 8, 2022 / CEO / receipt, needs a key / Jack Katar, CEO | earnings call 2022-11-08 | transcript bf02d686-47ce-4d4a-9306-955b0d60b417 | chars 5606-5753 | segment 5