Ann: Quarterly Activities Report and Appendix 4C, page-240

To cut TK some slack, the FDA notified us in early March last year that we didn’t adequately demonstrate the benefits outweigh the risks. Apparently they are ultra conservative. That was only 10 months ago. And then the most disruptive virus in decades hit and the FDA didn’t know which way to turn. I guess it is a situation where you take a number and wait your turn.
As @DickyB correctly states we sink or swim on Medgate’s successful pilot program. And I think we will swim. Fast.