NanoViricides Inc. (NNVC)

[changes_iv]

No business in the U.S. of America, no small biotech company in the U.S.A., none, operates in a vacuum. You must recall the company that was given US $140 million to do some research on Ebola. Years later, after all that research the drug was tested in Ebola infected patient(s)...

Dr. Thomas Frieden, director of the U.S. Centers for Disease Control...

Asked about TKM-Ebola, Frieden said it "can be quite difficult for patients to take" and "can actually make someone sicker."

http://www.reuters.com/article/2014/10/06/us-health-ebola-experimental-idUSKCN0HV1S020141006

What did NNVC got from the U.S. of America's government or FDA? A mandate to find the toxic dose on FluCide! The mandate was equivalent to find the toxic dose on PEG.

Abstract

PEG is used to improve pharmacokinetic properties of biologicals. Concern has been expressed about the toxicological effect and/or fate of the PEG. This paper reviews the available toxicity, metabolism and clearance data of PEG and PEGylated products in order to place such concerns in to appropriate context. The available data demonstrates that PEG itself only shows toxicity at high, parenteral doses and the usual target organ is the kidney as this is the route of excretion for unchanged PEG. A large therapeutic window (approximately 600-fold) exists between the maximum PEG burden from a current biological agent and the doses of PEG associated with human toxicity. Pathological changes which results in no functional deficit, PEG containing vacuoles in cells, have been observed with PEGylated biologicals. There is evidence that these PEG vesicle can resolve with time. In conclusion the doses used clinically for current and many future PEGylated biologicals are low and will result in exposures to PEG significantly lower than that required to elicit PEG toxicity. In all cases the routine regulatory toxicology studies would identify relevant pathology should it occur.

http://link.springer.com/chapter/10.1007%2F978-3-7643-8679-5_8

Recall what Dr. Seymour said,...

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

For the first time in years we will have the opportunity to demonstrate our drug platform, with fewer obstacles from government. The drug, second generation EbolaCide. It took an emergency due to a fast spreading, evolving, life-threatening virus to make it possible.

In a few days ahead we will be testing second generation EbolaCide at the USAMRIID BSL-4 facilities.

1) Proving superior efficacy against Ebola will mean success, we get peer reviewed and the news get splashed arround the world. Remember this, we are NOT using two doses but one dose, 5cc's (5ml). We aim to prove efficacy with very low toxicity.

2) Proving superior efficacy against Ebola will mean success, and we quickly move to combine effective EbolaCide candidates into one drug (development) and synthesize the needed quantities for clinical trials.

3) Proving superior efficacy against Ebola will mean success, it means we move on to Clinical Trials to prove low-toxicity and efficacy in humans. And how long is that going to take, a few weeks? Remember this, Dr. Brantley (Samaritans Purse) was feeling better after 48 hours of taking ZMapp, good enough to get back up on his feet. With second generation EbolaCide we aim to search and destroy the Ebola virus in a human subject, in the trillions, in a matter of hours, and with no side effects, restore health.

It took life threatening Ebola to provide an opportunity, and this small biotech company, NanoViricides, Inc. is taking the opportunity, the challenge, to prove second generation EbolaCide and its drug platform.

The following sets us appart from other biotech companies:

"...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." ~Dr. Eugene Seymour, CEO Nanoviricides, Inc.

"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.

We are days away from starting efficacy testing of second generation EbolaCide by the USAMRIID and no contrarian/doubter/naysayer will be able to claim we are just a shell, a drug making troll that just make drugs that never get tested. They will no longer be able to claim we are afraid to test nanoviricides(TM) and fail. Our small biotech company, NanoViricides, Inc. has succedded in 6,000 animals with no side effects, we aim to succeed with humans and we will, IMHO!

=============================================

Government's influence in business --- the bottom line,...

The Bottom Line

Governments may be the most terrifying figures in the financial world. With a single regulation, subsidy or switch of the printing press, they can send shockwaves around the world and destroy companies and whole industries. For this reason, Fisher, Price and many other famous investors considered legislative risk as a huge factor when evaluating stocks. A great investment can turn out to be not that great when the government it operates under is taken into consideration.

http://www.investopedia.com/articles/economics/11/how-governments-influence-markets.asp

Everyone wants the items they buy to be safe to use or consume. Prof. Howard Baetjer of Towson University explains that when products undergo third-party certification processes to determine their safety, market forces are able to optimize the amount of testing conducted and consumers can use the information provided by certification firms to make their own decisions. It is difficult to say how much testing is enough: another test can always be run on a product, but at some point the benefit of the extra testing outweighs the costs. In a free-market system, competition among certification firms allows the market to work as it should and prevents both under- and over-testing of products. Conversely, when the government holds the monopoly on safety standards, products are likely to be over-tested, delaying their entry into the market and making them more expensive. Sometimes the costs of such delays cannot be quantified; lives can be lost while life-saving medicines are held up in safety-testing processes.