NanoViricides Inc. (NNVC)

[changes_iv]

Echo20...has the FluCide full tox study started?

"We are doing all of the preparatory pre-tox work now and the formal tox studies by BASI will start as soon as the pre-tox work is done and an [sic] sufficient amount of material is available from the existing lab. We're estimating a June start though that could go either way by 2-3 months depending on both BASI's schedule and ours." ~ Dr. E. Seymour, CEO NanoViricides, Inc. --- Apr 2014
....
There are those who complain that the tox studies are delayed. I don’t believe that it is the case at all. Had our drug system not produced such amazing initial tox results, we would be well into the BASi studies at this time. The FDA mandates that we find the toxic dose. To do that requires an inordinate amount of material. When the amount of material needed is produced, the studies will start. I feel that it will be quite soon but I cannot, in good conscience, give a hard date. ~ Dr. E. Seymour, CEO of NanoViricides, Inc. --- Jul 20, 2014
....
To nanopatent on BASi - FluCide full GLP tox study, "...ready to go as soon as we ship..." ~ Dr. E. Seymour, CEO of NanoViricides, Inc. --- Aug 26, 2014

Perhaps an August 2014 late start...?

The longest study in the nonclinical safety assessment is that for genotoxicity, the duration ranging from 13 to 26 weeks. Most studies take 13 weeks or less, including dose ranging studies. One year to complete tox studies for a drug that has shown no toxicity in the histology of 6,000 animals is an absurd claim. Even highly toxic oncological drugs take 9 months on average. ~ BigKahuna

Source: Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations.
edited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown

FluCide tox study is also important for EbolaCide...

Under 505b, tox for FluCide becomes tox for everything that follows. For the second tox following FluCide, they will only need to show bioequivalence, that is, a bridge study would be required to demonstrate that a system processes EbolaCide, DengueCide, X-Cide, in the same way as FluCide. Since FluCide will most probably already be in clinical trials, the second and maybe third X-Cide for clinical trials will need only a bridge study in Phase 1 to advance to Phase 2/3, again that would be an abbreviated PK study showing bioequivalence in processing versions of nanomicelles. ~ BigKahuna

Although NanoViricides Inc. ultimate objective this year is to write the necessary reports, and file the sponsor applications for human clinical trials internationally, and also an Investigational New Drug application (IND) in the USA it does not mean it cannot also do EbolaCide.

All we do is make the drug. The partners do the testing.

We will announce a partnership agreement when everything is signed.

There are very few BSL4 facilities in the world with whom we can work

I think that we explained in the PR why we feel that we can dramatically improve the efficacy with our new improved techniques.

We need a partner to try to get a piece of the available $100M EHO (sic WHO) grant.

This WILL NOT delay the start of the tox studies.

Sent from my iPhone

Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
[e-mail]
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange

There are some serious fireworks coming on this final quarter of 2014.



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How the U.S. Screwed Up in the Fight Against Ebola
http://www.businessweek.com/articles/2014-09-24/ebola-drug-zmapps-development-delayed-by-pentagon-agency