NanoViricides Inc. (NNVC)

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The world is watching the government agencies that will give "green light", to Nanoviricides, Inc., to market.

Nanovircides, Inc.(NNVC) is "laying down tracks for a railway" to market.

Nanoviricides, Inc. is a pioneering company in bio-nanotechnology. They have a "design platform technology" or mechanism, to plug-in ligands/receptors on the small surface of a micelle, and these components, plugged together, are the most lethal to a human-killing virus. The nanoviricide mimics a host's cell and fools the virus structure into binding with it. The virus particle is then encapsulated and destroyed. The "design platform technology" employed by Nanoviricides, Inc. is unique and is patented.

Nanoviricides, Inc. is projected to have 100+ strong Intellectual Property (IP) protection; well over 100 countries expected to approve patent applications by 4Q 2013; patents issued as "first in class" with no prior art.

FluCide and DengueCide are two of the most developed drugs that Nanoviricides, Inc. is employing as engine thrusters towards human trials (2014) and to the market.

They have signed contracts/agreements (2012 - 2013), in preparation for Investigational New Drug (IND) submission to the FDA and human trials (2014), with:

1) Id3A, LLC as the architect for its lab and cGMP pilot production facility
2) MPH Engineering, LLC (“MPH”), to help with the overall project management and design engineering of its laboratory and cGMP pilot production facility
3) BASi for Toxicology and Safety studies (initiate GLP Safety/Toxicology studies)
4) Cote' Orphan Consulting, to submit Orphan Drug Applications in the U.S. and the European Medicines Agency for DengueCide, a drug candidate for the treatment of dengue and dengue hemorrhagic fever
5) Lovelace Respiratory Research Institute for IND-enabling Efficacy Studies on FluCide® and for Testing its Novel Drug Candidates against the Highly Lethal MERS Human Coronavirus
6) Public Health England to Test Nanoviricides Against H7N9, MERS

Nanoviricides, Inc. has been "laying down the tracks for a railway" to market, a path that will lead first to the human trials (2014).

On Aug 12, 2013 Nanoviricides, Inc. announced that DengueCide(TM), its drug candidate for the treatment of dengue and dengue hemorrhagic fever, has been officially designated as an orphan drug by the US FDA.

This orphan drug designation qualifies NanoViricides for certain tax credits and marketing incentives under the Orphan Drug Act. In addition, the Company will qualify for the waiver of certain FDA fees when it files the New Drug Application (NDA) for DengueCide with the FDA. Further, the Company will also be eligible for a "Priority Review Voucher" (PRV) from the US FDA when the Company files a NDA for DengueCide.

Nanoviricide, Inc. has also started sub-kg scale production of the injectable FluCide™ anti-influenza drug candidate at its current facility. Safety and toxicology studies of the injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from the in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies (“Tox Package”) studies of the injectable FluCide drug when the requisite large amount of drug substance is produced.

Jayant Tatake, PhD, Vice-President of R&D,is a co-inventor of the Company’s nanomedicine technologies. Dr. Tatake has over 23 years experience with pharmaceutical production from lab scale through cGMP manufacture. It is very likely that Dr. Tatake and MPH Engineering, LLC (“MPH”) were involved in making this sub-kg scale production, at the current lab facilities, possible and the experience should prove helpful when the process to produce (3) identical batches (kg scale), at the newly integrated cGMP plant (1H 2014), gets underway. Dr. Tatake and the "well seasoned" MPH Engineering, LLC will be present when the cGMP pilot plant gets commissioned.

The injectable and oral FluCide drug candidates have already shown strong effectiveness against distinctly different subtypes of influenza viruses, namely H1N1 and H3N2, in highly lethal animal models. This indicates that the FluCide drug candidates are “broad-spectrum”, i.e., they should work against most, if not all, influenza viruses. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The oral FluCide is also dramatically more effective than TamiFlu in these animal studies. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth. The Company believes that these animal model results of both injectable and oral FluCide drug candidates should translate readily into humans.

Nanoviricides, Inc. "has the money" for human trials Phases I/IIa. As Dr. Seymour has stated, "...we are on a path, it's like being on a track...".

Nanoviricides, Inc.(NNVC) projected Milestones (2013)

-cGMP/R&D Center Shelton CT integration completes ~ 4Q 2013
-Commision new cGMP plant ~ 4Q 2013 (equipment moved in/3 identical test batches)
-Receive initial results toxicology studies FluCide ~ 4Q 2013
-Prepare IND for submission to regulatory authorities ~ 4Q 2013

FluCide will be the first nanomedicine in the world that is orally active. Oral FluCide will open up a very large market. On the other hand, DengueCide is "the only game in town" ~ Dr. Anil Diwan.

Other Dengue drugs have failed in clinical trials. Once approved by US FDA, DengueCide will gain extension for patent life (7 years) and be a candidate to earn a Priority Review Voucher (minimum $200 million).

The world is waiting for Nanoviricides, Inc. and their life-saving medicine.