NanoViricides Inc. (NNVC)

[changes_iv]

IF it is true that the Flucide Clinical Trials are delayed by a year, from 2015 to 2016, that represents a minimum burning US $2 million a quarter doing, what again? Drowning mice/rats in FluCide?

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

If Dr. Seymour says we are not delayed, are you suggesting we adopt an outsider's timelines, over what the CEO states? Not to mention an individual who engages in "character assassination" of Dr. Anil Diwan, the mind that made this journey possible, calling him a "control freak".

The FDA remained quiet while our government gave a lawless pass to toxic Cannabis...go forward to market with a simple democratic vote? Sweet, is it? Overnight, the lawless drug cartels stop being psychopaths-r-dem to become productive citizens of this nation! All thanks to a new democratic law. So, how does it work? Toxic Cannabis can do its clinical trials after it goes to market to rack up millions from the impoverished! I think we could also use a sweet deal like that with the difference we are low toxicity, effective, and we will be saving millions of lives.

All of this always takes me back to the time when we discovered that the FDA had imposed the requirement to find the toxic dose (MFD) for full tox study. They imposed this MFD requirement on low toxicity FluCide and our small biotech. Low toxicity FluCide has an excellent safety profile and has been successful with 6000 animal subjects, we cannot fail on our own, but the FDA is helping?

The FDA Is Evading the Law
Europeans are approving important new drugs more rapidly than we are.

DECEMBER 23, 2010
By SCOTT GOTTLIEB

This year, the Food and Drug Administration rejected the only medicine capable of treating the rare and fatal lung disease known as idiopathic pulmonary fibrosis. Pirfenidone, which has been available in Japan since 2008 and was just approved in Europe, was spurned by the FDA because the drug only showed efficacy in a single big trial—not the two large studies the FDA now requires. The decision to ban the drug is one of a rash of recent decisions that shows the FDA is making it more and more difficult for promising drugs to reach severely ill patients.

http://online.wsj.com/article/SB10001424052748704034804576025981869663212.html?mod=googlenews_wsj

Excerpt from Scott Gotliebb article on Ebola experimental drugs --- Forbes magazine

...The World Health Organization said last Thursday that the scope of the Ebola outbreak may be vastly underestimated, and will grow worse before they are able to get the epidemic under control.

Amid these dire warnings, and facing a virus with no proven remedies, treatments, or vaccines, a panel of WHO ethicists approved the use of experimental therapies in stricken patients.

It was the right decision for a host of reasons. In fact, it shouldn’t have been ethicists who reached such a conclusion. Drug regulators should have taken this decision.

Patients facing a deadly virus with no proven treatments deserve access to experimental drugs, so long as they provide informed consent to receive them. Such forward deployed drugs should already have established basic proof of safety, and there should be a plausible reason to believe that these agents could also prove effective.

But there’s another reason to forward deploy these experimental treatments. It’s the only way we are ever going to find out if they work, and put them to wider use.

In fact, regulatory policies in the U.S. allow for drugs to be approved on the basis of studies in animals alone when there is no ethical way to test a medicine in sick patients. In the case of Ebola, you can’t purposely infect someone with the virus so that you have a subject to test a treatment on. You need to wait for an outbreak.

The only way we’re going to find out for sure if these experimental Ebola drugs are effective is to use them in sick patients. Given the state of science, this initial use is going to based on little more than information about their effectiveness in animals.

FDA issued a so-called “animal rule” almost a decade ago (amid fears of bioterrorism after the deadly anthrax attacks) outlining how a drug could be approved on the basis of only efficacy studies in animals. It was rightly acknowledged that animal testing alone would have to form the basis of approval when we were dealing with therapeutics that targeted rare and deadly diseases that could be used as weapons.

http://www.forbes.com/sites/scottgottlieb/2014/08/18/as-the-ebola-outbreak-expands-these-experimental-drugs-could-see-action/

FDA Moves On Tekmira's Ebola Drug While Sarepta's Sits Unused

The second drug is a different type modified RNA molecule, AVI-7537, from Sarepta Therapeutics. AVI-7537 is directed against one of the three Ebolavirus genes (VP24) targeted by Tekmira’s drug. But its chemistry platform, called PMOplus, is distinctly different from that of Tekmira’s TKM-Ebola. AVI-7537 also works via a different mechanism to block the viral protein from being made.

For those interested in the technical aspects of the chemistry and mechanism, this open-access 2012 paper in the journal, Viruses, is invaluable.

AVI-7537 has already shown effectiveness in non-human primates against the Zaire Ebolavirus, the species implicated in the current outbreak. Moreover, Sarepta had been conducting Phase 1 safety trials with the drug alone and together another Ebola-directed PMOplus molecule (AVI-7539, with the combination called AVI-6002).

The work, done with the support of the Department of Defense, was part of a project put on hold in 2012 during the fiscal cliff fiasco.

The Ebola drug proved to have an excellent safety profile in a single dose escalation study and a two-week, daily dosing regimen. So the discontinuation was more likely due to economics than medical concerns. In support of that speculation, the DoD continued to support Sarepta’s Marburg virus program.

Sarepta’s drug remains available

Sarepta’s president and CEO, Chris Garabedian, told Barron’s earlier this week that the company had a drug that could be deployed and shipped if a request was made of the company and all permits and authorizations were cleared.
...
We contacted USAMRIID’s Dr. Sina Bavari, for more information on the potential clinical utility of AVI-7537. Bavari is the lead investigator in the government partnership and senior co-author on peer-reviewed publications with the Sarepta drugs. While he promptly acknowledged our request, press officer Cmdr. Amy Derrick-Frost, USN, from the Office of the Assistant Secretary of Defense for Public Affairs responded, “At this time, we are not doing interviews.”

http://www.forbes.com/sites/davidkroll/2014/08/07/fda-moves-on-tekmiras-ebola-drug-while-sareptas-sits-unused/

No interviews. It is taxpayers money they are throwing at companies but John Q. Taxpayer does not need to know how they determine what company gets taxpayers money and what company does not (that also means us).

The question always remains, how does our government pick'em? And if they fail? Well, that was a market failure! Government will not say, we failed in picking and "greasing the skids" to the tune of tens of millions of taxpayers money, of this or that drug company, do they?

If we are not delayed then,

We expect the scale up of injectable FluCide in our current facility to be completed in 2014. We would then have sufficient material to begin the FluCide “Tox Package” studies, and expect to initiate the same. We are eagerly awaiting the move into the new facilities. A lot of invisible work will go into preparing for the move, moving, and then bringing the new facility to an operational status. We are planning to perform this with as little disruption of our existing programs as possible. Once operational, we plan to implement our scaled up processes in the new facility, and then perform another scale-up step to the full scale that the facility is designed for. We plan to make multiple product batches of FluCide, evaluate them for consistent quality, and set up the necessary cGMP manufacture as well as QA/QC procedures and processes. We anticipate the tox package report on FluCide about 6 to 9 months after commissioning the study. We are hoping to have c-GMP compliant FluCide production batches completed at around the same time. This will then enable us 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. ~ NanoViricides CEO's Letter to Shareholders, March 11, 2014

And what about this???

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.

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

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=105461656

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

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=104959756

"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

Are we still delayed for Clinical Trials (2015)?

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Burger King has left the U.S. for Canada. The combined federal, state and local corporate tax rate in Canada is 26.3%, according to the Organization for Economic Cooperation and Development. The combined U.S. corporate rate is 39.1%. Buffet, an advocate for higher corporate taxes, greased the deal to the tune of $11B. Get the feeling that we are losing the war on poverty!



As a part of the Great Society, Johnson believed in expanding the government's role in education and health care as poverty reduction strategies. These policies can also be seen as a continuation of Franklin D. Roosevelt's New Deal, which ran from 1933 to 1935, and the Four Freedoms of 1941.