NanoViricides Inc. (NNVC)

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Barring the meddlers, the world improvers, the Malthusians, (ahem) bureaucrats, the Cides will whisk through human trials and then the era of "host enhancing" vaccines, against virus threats, will come to a close in the western world.

Imagine coursing through the blood stream, chasing through the body (host), grabbing and destroying the offending virus particles. A nanoviricide®, as defined by the Company, is a nanomachine that is armed to destroy a particular kind of virus.

Which virus? That information is programmed into the nanoviricide, akin to the postal address on an envelope. The Cides, after more than 5000 animals tested, are not toxic to the host and don't care if you are a man, woman, young, old, etc.. The Cides have had unprecedented success in their "search and destroy" missions. A vaccine, on the other hand, is trying to find the right host to turn it into a Mr. or Ms. Terrific.

How effective is a vaccine when the subject is an elderly person? What if you kill the host?...you end the virus!

Vaccines are no match to the Cides.

DengueCide has been granted orphan drug designation by the FDA.

In addition to the incentives related to orphan drug status, the Company may be eligible to receive a Priority Review Voucher (PRV) in the USA, upon approval of a drug against dengue viruses.

A request for Priority Review must be made by the drug company or in this case, Nanoviricides, Inc.. It does not affect the length of the clinical trial period. FDA determines within 45 days of the drug company’s request whether a Priority or Standard Review designation will be assigned.

To be eligible for a PRV, the drug (or vaccine) must satisfy at least four criteria.

1-Treat one of the following sixteen diseases:
Blinding trachoma
Buruli Ulcer
Cholera
Dengue <======
Dracunculiasis
Fascioliasis
Human African trypanosomiasis
Leishmaniasis
Leprosy
Lymphatic filariasis
Malaria
Onchocerciasis
Schistosomiasis
Soil transmitted helminthiasis
Tuberculosis
Yaws

2-Be a new drug application (NDA).

3-Be a new molecular entity (NME) or new chemical entity (NCE). It must contain no active ingredient (including any ester or salt of the active ingredient) that has been approved in any other application.

4-Offer major advances in treatment, or provide treatment where no adequate therapy exists, thus earning priority review on its own merit. (In other words, to win a bonus priority review, the treatment must first get its own priority review).

Priority review means that the FDA aims to render a decision in 6 months.

A PRV can be applied by the Company to another drug candidate to obtain a "priority review" to speed up the regulatory process for that other drug. For example, HIVCide-I could be that candidate. If the company is to redeem the voucher it must notify FDA one year in advance. A PRV can also potentially be sold to another pharmaceutical company to obtain an immediate financial benefit. The value of a PRV has been variously estimated to be between $200M to $600M for such transactions.

If there is a coming PR it is likely related to Nanoviricides, Inc. formal request before the FDA for DengueCide Priority Review. Pure speculation on my part. We should then know FDA's decision, granting Priority Review, before end of September 2013. If FDA grants Priority Review of DengueCide, the review should be over by 2Q 2014. The cGMP pilot plant likely has capacity to manufacture/stockpile the DengueCide, alongside FluCide. Human Trials will complete in "...a few short months..." as Dr. Seymour has said in the past. What will happen to NNVC nav in anticipation of Phase I results? Going higher?
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"...Unlike these existing drugs, however, NanoViricides’ technology acts before the virus has had a chance to gain entry into a healthy cell. This is like defeating a besieging enemy army with withering fire before it’s forced the city gates or undermined the defensive walls. The alternative methods used today are the equivalent of a last-ditch house-to-house battle after the defenses have been breached..." ~ Patrick Cox

Well over 100 countries to approve "first in class" patent applications ~ 4Q 2013

Nanoviricides, Inc. has had no failures in 5000 animal studies with FluCide™, "...and none are anticipated in humans because we are agnostic to the host...as long as you have a virus in your circulation, we destroy it..."~ Dr. Eugene Seymour, CEO Nanoviricides, Inc..

Nanoviricides, Inc. engaged the consulting firm Cote Orphan Consulting (COC), headed by Dr. Tim Cote, to assist with the orphan drug application. The Company, in consultation with COC, has determined that its current lead DengueCide drug candidate is eligible for orphan drug status application in the European Union.

"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, Nanoviricides, Inc. CEO.

Where there is knowledge, inspiration and the will, there is a way. We, as a nation, are currently "...Billions of dollars of stress on personal savings, Social Security, and Medicare each year. And the “cost” of illness — both in dollars and pain — only grows with age…" ~ Patrick Cox. Nanoviricides could very well be the company that greatly reduces, if not eliminate, many of those problems. It could cure any virus, from warts and herpes to Ebola and AIDS.

The efficacy of DengueCide™ is unprecedented ~ Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley.

UCLA School of Medicine is one of many Nanoviricides prestigious collaborators

Dr. Seymour explains, "...They have expressed a serious interest in collaborating with us on a number of basic science projects that will yield information that the FDA will require. The amount of time and money that we will save is truly incalculable. Whenever you present a new technology to the FDA, having a prestigious Institute and University behind you is extremely valuable."

The time from Phase II to market is often shorter for orphan drugs due to shorter and smaller clinical trials and FDA Fast Track designation.

Once a compound has been granted orphan designation, the odds for approval are high (82%) compared to traditional drugs (35%).