NanoViricides Inc. (NNVC)

[changes_iv]

Puffer, it was late September 2013 when the KARD Scientific non-GLP efficacy studies started (unannounced) and it was late October 2013 when it was reported.
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NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") reports that its optimized injectable FluCide® drug candidate was found to be well tolerated in a non-GLP small animal safety/toxicology study. This study is an important step in the drug development pathway for FluCide. This study will provide guidance for the IND-enabling GLP safety and toxicology study. The Company previously had a pre-IND meeting with the U.S. FDA to discuss and receive guidance on the FluCide drug development pathway. This non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts.

Dr. Krishna Menon, VMD, PhD, CEO of KARD Scientific, advised the Company after the completion of this short study, that mice treated with the maximum feasible dose of FluCide in a one hour infusion protocol remained healthy throughout the course of the study. No overt behavioral or clinical signs of any toxicity were observable, even at this highest possible dose level. The Company expects to receive a complete report of all laboratory and clinical data including blood chemistry and histopathology analysis soon.

These preliminary results support the Company's positive findings in efficacy studies using animal models of different influenza A virus strains wherein no safety or toxicology concerns were observed. The Company has previously reported that our injectable FluCide drug candidate was highly effective in animal models of different influenza A virus strains.
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From hereon forward, most of what I type is pure speculation on my part.

I believe that by mid to late October 2013 NanoViricides, Inc. knew their FluCide candidate. It is possible that it was mid to late October when the lab was cranked-up to start producing the necessary quantities (reproducible) of the FluCide candidate to start shipping to BASi, Lovelace IRRI , UK PHE.

Toxicology studies are expected to be wrapped up before mid-2014.
source: http://www.proactiveinvestors.com/companies/news/46906/nanoviricides-stock-up-almost-20-hits-new-52-week-high-on-back-of-nda-46906.html

How soon before mid-2014 will Toxicology studies be wrapped up? I figure Efficacy Studies will not be far apart from wrapping up their studies as well. These will strengthen the possibility of beginning clinical trials Q4 2014 and for everyone to get a huge Christmas present, not to mention those that are afflicted with a life-threatening Influenza that will benefit from having it sooner than later.

We also know that Dr. Seymour expects the cGMP Pilot Plant to be ready in a month or so. I take that statement to mean February 2014. I also take that to mean ready to produce the (3) batches in order for it to be certified by the FDA. How long will it take for the (3) identical batches to be produced? They would have approximately (3) months for that important step? Perhaps a month? I don't know this but time will tell. Definitely before mid-2014.

Next year's plans (2014) include: finishing the plant, completing toxicology studies and submitting paperwork to FDA, while awaiting for permission to start human trials.
source: http://online.wsj.com/article/PR-CO-20131223-905949.html

I agree, it would have to be a very aggressive pace to start clinical trials on Q4 2014. It is very likely we will wait for FDA decision (2014) to start clinical trials Q1 2015.