As of today, the FDA has not scheduled or conducted the pre-approval inspection of our Northern California manufacturing facility due to COVID-19 related travel restrictions.

May 10, 2021 / CEO / receipt, needs a key / Mark Foley, CEO | earnings call 2021-05-10 | transcript 1bb3c6f4-c807-4f63-8521-0bcceb48cd53 | chars 3699-3873 | segment 3

As a reminder, the approval of our BLA by the PDUFA date of November 25, 2020, was deferred due to FDA's inability to conduct an inspection of our facility due to COVID-related travel restrictions.

May 10, 2021 / CEO / receipt, needs a key / Mark Foley, CEO | earnings call 2021-05-10 | transcript 1bb3c6f4-c807-4f63-8521-0bcceb48cd53 | chars 4580-4777 | segment 4