NanoViricides Inc. (NNVC)

[robi-1-kenobi]

Nicely stated, Steady T and a reasonable approach. I am long NNVC, although I am also concerned that they have been too conservative and that has hurt their timelines. I am also ready to pull out my investment if I see what I judge to be real issues with the company or technology.

I understand your putting importance on the FDA related milestones. The Range Finding Toxicity testing done was good (no toxic effects), but NNVC needs the larger, more rigorous GLP Regulatory Toxicity Study done in order to file an IND with the FDA. And they also need more Efficacy testing done on other Flu strains in order to apply for broad spectrum indication for FluCide.

The timeline committed to in the CEO letter to start the GLP Reg Tox is 2014, but the stretch goal is to start clinical studies as early as the end of 2014 or Q1 2015. My own guess is that this Tox study will be started by June 2014 and the clinical trials in Australia will start by Q1 2015.

I would suggest that in addition to FDA milestones, you may want to consider the potential earlier start to clinical trials by submitting a CTx filing in Australia where the company has said it may start CTs. This could happen sooner than the FDA IND submission.

Another consideration is that the company will likely file their IND with a request for Breakthrough Therapy or another accelerated Reg filing. If granted, they will be able to work with FDA in a real time review setting which may help them get through more quickly any concerns the FDA may have with their manufacturing consistency and scale up. I DO NOT think this will be any help in the short term but may help after they file the IND.

Good luck to you.