NanoViricides Inc. (NNVC)

[robi-1-kenobi]

I've confirmed Puffer's and JG36's posts are correct regarding clinical trial prerequisites (in contrast to my own incomplete one with a wrong conclusion for this example - I am still new and wading through all the PRs, etc).

Nov. 13, 2012 PR on Agreement with BASi on Tox studies

The Company has designed the toxicology and safety pharmacology studies that will enable the IND submission and the first-in-human clinical trials of its FluCide® investigational anti-influenza product. BASi will conduct the cGLP and non-GLP studies as required (cGLP = current Good Laboratory Practices). These studies are designed to assess overall safety in animals receiving multiple doses of FluCide. Specific safety pharmacology studies will also be conducted to assess the effects of FluCide® on the cardiovascular, respiratory and central nervous systems. These studies are required for US FDA IND submission, as well as for applications to conduct human clinical trials in other countries such as Australia.

So even though the Australian Reg path to clinicals may allow for an independent package of preclinical safety data than FDA, the company has said in the PR that they will need to use some/all of the FDA Tox studies to support safety in application for Australian clinicals.

So the FDA Tox studies do seem to gate the human clinical trials - even for Australia in this case.

On a more positive note - we have confirmation that Tox batches are being made (post 73559) and its possible some Tox testing may have already started in parallel. I am optimistic there will be good news in the days or weeks after the uplist tomorrow. Great progress so far - let's hope it keeps going!