NanoViricides Inc. (NNVC)

[changes_iv]

Our small biotech company/technology is one that will be stepping on big toes of some big players in Big Pharma. We really don't know who is who posting on this board however, I do know who Scott Gotliebb, MD is. He was once the no. 2 at the FDA and he recently wrote the following when it became evident that Ebola was spinning out of control in West Africa:

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.

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

Before writing on Ebola, Dr. Gotliebb wrote an article on the Wall Street Journal titled "How the FDA Could Cost You Your Life
An aortic valve approved in Europe four years ago will soon be approved in the U.S. Meanwhile, thousands who may have benefited from the device have died."

Read it here: http://online.wsj.com/news/articles/SB10001424052970204831304576597200095602270

Now, the following was the status of Mapp drug, ZMapp, at the time it was employed to treat people diseased with Ebola:

“We definitely would like to ramp up to have an impact on the Ebola epidemic,” Dr. Whaley said. But he added, “We’re not decision makers on many of these issues. There are regulatory and legal issues that have to be addressed.”

The drug had never before been tried in people, though it and some predecessor drugs had been tested in monkeys, showing some effectiveness. Mapp was only now gearing up to start the larger animal toxicity studies typically needed before testing it in humans, with an eye to doing the first human safety studies in healthy volunteers next year. For that reason there were very few doses available when the Ebola outbreak started.

Now the company is trying to move faster and it is likely the drug will be tested in patients rather than healthy volunteers.

http://www.nytimes.com/2014/08/07/business/an-obscure-biotech-firm-hurries-ebola-treatment.html?_r=1

As Ebola mutates, with the probability it could become airborne (if not already), the vaccines are made worthless and antiviral drugs are in limited supply.

I think we longs have good reason to be optimistic.

Dr. Seymour said we (FluCide) are not delayed and that to me means clinical trials 2015.

Dr. Seymour says that with the techniques NanoViricides, Inc. employs today they can dramatically improve efficacy on EbolaCide.

Dr. Seymour says they will announce the BSL-4 partner once agreement is signed.

Scientists are inside the new 5kg cGMP Pilot Plant, racing to get it validated.

We longs await announcement on FluCide GLP full tox study.

I know there is more to come 2014. Longs, what say you?

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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/