NanoViricides Inc. (NNVC)

[changes_iv]

"NEWSFLASH! Absence of toxicity at a dose 100 X the therapeutic dose is one of the explicit criteria for an FDA fasttrack!" ~ ZincFinger

This FAST TRACK objective is very much in-line with the following excerpts...

"The design of the studies was reviewed by the FDA in a pre-IND meeting, as previously announced by the Company.

The Company has previously reported successful results of the Company's FluCide(TM) drug candidates in pre-clinical animal studies using two different phylogenetically distinct types of Influenza A, viz. H1N1 and H3N2. The Company has also reported that the drug candidates have been found to be extremely safe in these animal studies. The Company intends to conduct additional efficacy studies as required for the IND application in parallel with the safety/toxicology studies.

The Company anticipates that it will need very large quantities of the drug candidate for these “tox package” studies. The Company has found FluCide to be safe in animals at large dosages, and will need to determine certain safety and toxicology limit parameters. The Company is currently performing scale-up studies in order to produce the necessary quantities of the drug candidate." ~ thefool.com

http://www.marketwatch.com/story/nanoviricides-signs-agreement-with-basi-for-toxicology-and-safety-studies-2012-11-13

FAST TRACK is also very much in-line with the following statement by Dr. Seymour...

"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.

After years of waiting some will have dig deeper for greater patience. Think about it, for the first time in years, Nanoviricides, Inc., a pioneer in bio-nanotechnological therapeutic drugs has brought a team of companies together to provide the necessary guidance through the clinical trials (2014) and a successful FDA Review to market.

There is light as we come out of the tunnel (2013)...

Nanoviricides, Inc.(NNVC) projected Milestones (2013 - 2014)

-cGMP/R&D Center Shelton CT integration completes (equipment moved in) ~ 4Q 2013
-Commision new cGMP plant (identical batches of FluCide produced) ~ 2014
-Receive initial results toxicology studies FluCide ~ 4Q 2013 or 1Q 2014
-Prepare IND for submission to regulatory authorities ~ 4Q 2013 or 1Q 2014

Once the injectable Flucide "train rolls down the FDA approved pathway" (2014) others will follow. For example, FluCide will be the first nanomedicine in the world that is orally active. Oral FluCide will open up a very large market. DengueCide is "the only game in town".

Nanoviricides, Inc. is led by a Japanese-like culture, a very frugal company, doing what it takes to protect shareholder's value. Just think how revolutionary this company is! People struck by a deadly Influenza virus will be able to spend hours at the clinic to be diagnosed, prescribed and administered a "low toxicity" therapeutic dose of FluCide, survive and avoid having to spend (2) weeks or more at the hospital quarantine ward. We live in great times and Nanoviricides, Inc. will make us wealthier in more ways than one!