NanoViricides Inc. (NNVC)

[robi-1-kenobi]

18mo from preIND to formal Range Finding Tox which is complete and successful with no toxic effects for a dose ~100x the efficacious dose used to save 100% of mice from a lethal dose of Flu that killed 100% of mice not treated.

The claim about Tox not starting ignores these multiple doses tested up to the Max Feasible Dose (100x therapeutic dose) in extensive testing in mice with hard histology, blood draws, autopsies, end organ inspections and behavioral observations for endpoints of Toxicity in the RF Tox study - which is an industry standard for Toxicity testing - as indicated in a previous post of mine this month.

Since RF Tox in September, ~6mo have passed. I did think their scale up would go quicker, but the batches manufactured for scale up will be used for Regulatory GLP Tox and without further delay.

The batches for Reg GLP Tox at BASI are being scaled up at the existing plant.
THESE BATCHES ARE NOT cGMP or cGMP-like and so do not need commissioning.
Identical equipment and processes will be used in the new production facility to minimize changes for the move.

It is unclear whether they will take a conservative route (too conservative in my strong opinion) and wait until the new facilities, equipment and processes are complete and repeat batches to confirm they match the batches being used for the Reg GLP Tox. This would be an unnecessary delay in my opinion because bridging studies are done all the time. But even if they did wait, these batches are not required to be cGMP. This is an R&D test that confirms for the company that they will not be wasting money and time by testing Reg GLP Tox with materials that are not consistent with new materials to be made in the new facility. Because of this, the R&D confirmation studies could go much faster than a full cGMP commissioning.

Won't be able to answer more today as I am late for real work.