RE:and this is why You are here;)From The 13 May 2020 MD&A
Regulatory Activities
We plan to resubmit a Biologics License Application, or BLA, with the U.S. Food and Drug Administration, or FDA, based on the results from our completed open-label Phase 2/3 clinical trial. Due to the impact of COVID19 on our workforce and ongoing operations, we are currently unable to predict the timing of our BLA resubmission. Further, it is possible that when we submit, we could experience delays in the timing of review and/or our interactions with FDA due to, for example, absenteeism by governmental employees, inability to conduct planned physical inspections related to regulatory approval, or the diversion of FDA’s efforts and attention to approval of other therapeutics or other activities related to COVID-19, which could delay approval decisions and otherwise delay or limit our ability to make planned regulatory submissions or obtain approvals.