I've tried to be objective toward the FDA since before Labor Day. I've made the best case that I can in their support.
But, I'm looking at the clock, and we don't have much time. In your previous post, you mentioned raising cash differently, than by revenue.
But, our OS hasn't increased since resuming the Cantor equity offering. I can't remember, maybe our OS reflects those shares already. But that avenue may not be open, since the FDA did not approve our EUA. The same thing could be said for our ability to borrow more from Hercules. That may not be possible.
Meanwhile, our share price continues to be manipulated, and we are getting uncomfortably close to penny-stock designation, which could cause our institutional holders to exit.
I was thrilled to hear Durrant say that we were not gong to wait for the NIH trial to conclude, before resubmitting our EUA application. I'm not sure we have that much time. I hope, though, that we get regulatory approval from MHRA and/or Asia/Pacific before re-submitting the US EUA application. That may stave off the necessity of being forced into re-submitting our data a little too early. It could even force some scrutiny of why we had to be approved overseas before being approved by the FDA. But, even a Compassionate Use authorization could help.
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