Replies to post #81696 on NanoViricides Inc. (NNVC)

[Ubertino]

tox studies

I'll drink a quart of the stuff - will that help?

[soundc]

Hey Karen, great to have you on board! Have you talk to Doc Seymour? Always good to hear your insight.

[noretreat]

As soon as possible...hmmmmm...I think that means something different to someone who has been talking about it for 7 years already. It could mean within the next 3 years or so...I hope not.

Drs. Seymour and Diwan should view this whole fiasco as a wake-up call. If they don't get off the schnide(sp) and start advancing into trials, their little company is going to be worth a lot less.

[robi-1-kenobi]

The good news is that range-finding Toxicity studies are already done with multiple doses up to the Max Feasible Dose (MFD) with no toxic effects.

The only difference for the IND-enabling, data gathering Toxicity studies will be:
- more thorough documentation and laboratory practices (GLP)
- larger sample sizes (more animals - incl. min. numbers of male & female in each dosage arm), and
- more species (at least one non-rodent - mice and dogs have been mentioned).

Per industry practice, the next Toxicity studies will not include doses greater than MFD. And the principle components of FluCide include:
- PEG - extensively studied and used for drugs due to its extensive safety profile in multiple species and people
- Fatty Acids - naturally occurring and removed from the body through normal metabolic and elimination processes
- Sialic Acid mimics and protein ligands - also naturally occurring with normal metabolic and elimination processes.

There is no reason to suspect any of these component materials will cause a different result with more animals or species.

So the similar results in the next Toxicity study is as close to certain as anything can be in biological science IMHO - not guaranteed, but pretty darned close.