However, we recently were informed that an FDA travel complication relating to scheduling a routine clinical trial site inspection in Eastern Europe will likely delay their decision until after our September 19th PDUFA date.

Aug 3, 2022 / CFO / receipt, needs a key / Bob Landry, CFO | earnings call 2022-08-03 | transcript d2460f26-35af-4e81-9594-2ef6fc22821c | chars 7472-7696 | segment 7