NanoViricides Inc. (NNVC)

[robi-1-kenobi]

I agree the Maximum Feasible Dose should be enough. To me it does not make sense that you need to go beyond that to find toxic or even lethal doses.

When the toxic or lethal effects are not due to your drug but due to side effects like electrolyte imbalances such as water poisoning, that just doesn't make sense.

Some FDA CDER guidance states that MFD is enough, but others still hold to the older (and in my opinion outdated) requirements for lethality findings.

As for PEG, I am not worried about it alone. You have to drink something like 2 gallons of the stuff before you get a colonoscopy. It alone is not a concern.

But there are potential issues with competitive inhibition (FluCide sialic acid shouldn't be a problem, but EbolaCide NPC1 is more complicated).

And low potential risks for the micelle structure. The micelle is composed of PEG plus pendant fatty acids. PEG macromolecules are stable, nontoxic and safe, but PEG interspersed with fatty acids may not be as stable and may result in breakdown before excretion. The glycol monomers liberated from PEG would not be safe.

I do not consider these to be high or even moderate risks. But they do need to be tested properly to be proven out - in GLP Regulatory Toxicity and Safety studies - and submitted for independent review.

All other companies' drugs that have been used (ZMapp) or likely have been used (TKM-Ebola) or likely will be used (GSK-vaccine) have been through or plan to go through these most basic, fundamental tests.

This is why efficacy testing alone is not enough. Safety testing is also needed. We can't risk killing more people than we can help.

If EbolaCide tests in BSL-4 facility and if found to be highly efficient, why not employ it right away to fight Ebola? How far did Zmapp go, in meeting goals according to FDA regulations, before it was employed in the US and in Liberia, Africa?