NNVC still has to do the "data gathering" phase of the toxicity study. Because the toxicity is so low it will take a great deal more drug to do the study than usual so they have to wait for the new manufacturing facility to open before they can get enough drug to do the data gathering phase (which uses a lot more animals than the dose ranging phase).
It appears that they will not have to go to other animals first. Many drugs have to do preclinicals all the way up to primates but AFAIK when the toxicity is so low that isn't necessary. Frankly I haven't had any experience with any company with a drug with such remarkably low toxicity before. It is exceptionally rare!
Many things about the drug are exceptionally rare. The heart of what is so good about it is that
1) it requires no interaction at all with host metabolism for its effects.
2) that's because it acts as a "decoy" to trap and destroy the virus. That a genius workaround of the basic reason why viruses are so resistant to anti virals: they have such a high mutation rate that they can evolve around them with ease. But they have to use a receptor to infect and if they evolve to not use the receptor(s) that NNVC uses to trap them then they thereby evolve away from their ability to infect!
That "heads you lose, tails you lose" situation is why NNVCs drugs are so effective. The lack of any need to interact with host metabolism is why it can be made to be so extraordinarily non toxic.
This whole situation is very extraordinary and exceptional and IMHO the market just does not get the huge implications. Which is exactly why, IMHO, it is such a very rare buying opportunity. When the first drug gets approved the SP will go up many tens of "X"s IMHO.
Currently there are very few anti virals and they are all of limited range and of limited effectiveness. Nothing on the market now will be remotely competitive with NNVC's drugs if they meet even a fraction of their potential.
PS the remarkably low toxicity MASSIVELY increases the odds of effectiveness because it means you can use a very large dose if necessary. It also means that you can probably use any route of administration you want to: oral if the virus is mainly gastro intestinal, inhalation if mainly respiratory, intravenous if mainly in the bloodstream, etc. thereby concentrating it most exactly where the "action" is taking place.