One has to wonder what the rate determining step is now that this little goodie is out of the way...
My guess,... the rate-limiting stage now is scale-up of production beyond 500 g / batch of 'Cide,... and more specifically,... the documentation that a GLP lab has to have in place for each stage of the operation.
From my own lab experience,.... getting something new in a process 'done' is mostly something that requires chutzpah and perseverance. And enough warm bodies that know how to 'do it' doesn't hurt.
It's the documentation that takes almost all the time and brings on most of the aggravation.
And,... that 'step' in the process is not something that has to be completely done before NNVC tries to start clinical testing of Flucide in the USA.
They can get the TOX done with materials done while in process of getting the final designations in place.