Replies to post #84437 on NanoViricides Inc. (NNVC)

[robi-1-kenobi]

Thanks for the science post, Dr. HS.

Your points about the surmountable challenges with scale up of nano materials are well taken.

But IMO, the scale up is very much critical path here. I had thought they were farther along here, but I think they are still on track for Q1 plus one quarter tolerance, since Dr. Seymour has said that clinicals in Australia is still a goal for Q4 2014 or Q1 2015.

I suspect they want to get closer to the manufacturing process they will use for clinical builds for the GLP IND Tox materials. That is a one step scale up from the range-finding Tox materials they already produced that they will do in their existing facilities. That would leave only one more scale up to generate the clinical (and commercial) batch quantities of materials in the new plant.

This existing plant scale up is what they have determined they need before they can do IND Tox. And the same material will be used for the IND efficacy studies in PHE, LRRI and ViroClinics. So this is critical path.

At least it looks like Dr. Seymour is getting a bit better at UPOD - under promise, over deliver. He has set 2014 as the timeline for Tox in the letter to shareholders, but still maintains the more aggressive stretch goal of clinicals in 2014.

My speculative timeline is
1. Start of Tox before June 2014 (maybe much earlier for a positive surprise)
2. Completion of Tox and efficacy studies before Dec 2014
3. Submission of Australia regulatory paperwork in Jan 2015
4. Start of Clinical Studies by Feb 2015