It might pay to consider1) The stock price is up circa 100%...

It might pay to consider
1) The stock price is up circa 100% since March, and critically
2) The Company is now profitable; revenue is now larger in each quarter when compared to the previous quarter.

Covid cases are again surging in Europe, this is the geography that moved first outside of Australia not even 6 months ago.
Regardless of the industry, there is always a lag from market entry point to sales generation.
European sales will rise with the surge in cases

Yes, the FDA EUA is taking longer than expected.....or is it?
The FDA aren't exactly known for their speed in decision making under normal circumstances, let alone in the middle of a pandemic.
US approval will come though, and eventually so too will US sales.

I'm not trying to be the Grinch who stole Xmas, but I think its worthwhile stepping back and remembering that everything takes longer than you think, or want it too.....particularly with science.