NanoViricides Inc. (NNVC)

[robi-1-kenobi]

If my supposition is correct, GLP TOX will not start until Q1 2015 and will not finish until Q4 2015.

This will also be about the time the new facility is able to start manufacturing cGMP-like materials at the same scale as the existing facility.

The new material could then be dovetailed in with the existing material and would be used to show comparable TOX results between manufacturing sites made with the same scale batches.

Then the next cGMP scale up for clinical studies would be shown to be comparable to the smaller cGMP-like scale for preclinical TOX - both made at the new facility.

I understand this is supposition on my part.

But it is consistent with what FDA likely wants to see for nano-medicines for which safety and consistency is considered to be highly dependent on repeatability and comparability of manufacturing and resulting material properties across sites and scales.