Replies to post #115165 on NanoViricides Inc. (NNVC)

[Nanotoday]

This is not the first time NNVC has done this. They have bifurcated almost every stage of development to make it appear they are making progress when in reality they are still at "phase 1".

Tox, Scale-up, Facility,...the only thing that they do 100% is refinancing and payment of salaries and bonuses. Those NEVER get done in pieces.

[changes_iv]

Three Phases of Toxicology Testing:
Phase 1
Exposure

Phase 2
Toxicokinetics: absorption, distribution, metabolism, excretion

Phase 3
Toxicodynamics: Mechanisms by which drugs affect cells; includes determining dose limiting toxicity, maximum tolerated dose, and estimated safe starting dose for human trials.

Easily Googled: https://www.google.com/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=toxicology%20phases ~BigKahuna

Nanoviricides Reports that the FluCide Candidate was found to be Very Safe in cGLP-like Safety and Toxicology Study in Rats Performed by BASi

WEST HAVEN, CONNECTICUT -- Thursday, January 22, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reported a good safety profile of an optimized FluCide® drug candidate in a GLP-like toxicology study in rats. These results are extremely important since they indicate that FluCide continues to look very promising as one of the most advanced candidates in the Company's drug development pipeline.

No direct adverse clinical effects were found upon administration of the FluCide candidate intravenously at doses of up to 300mg/kg/day for 14 days (a total of 4,200mg/kg) in rats. Organs were examined for gross histological observations. Microscopic histological tissue analysis was also performed. There were no adverse histological findings in gross organ level histological examination, nor were there any adverse findings in microscopic histological analysis. Equally importantly, there were no meaningful effects observed on animal weight gain, food consumption, hematology, or clinical chemistry at the end of the 14 day dosing period.

The study was conducted at BASi (Bioanalytical Systems, Inc., NASDAQ: BASI) in Evansville, Indiana. The study was performed in a cGLP-like fashion, compliant with BASi Evansville standard operating procedures. BASi has over 40 years of experience providing contract research services and niche instrumentation to the life sciences, primarily drug research and development.

These results are in agreement with the previously reported results of a non-GLP toxicology study in mice. The current study results also support the Company's positive findings in animal models of infection with different influenza A virus strains in which no safety or toxicology concerns were observed. The Company has previously reported that many of its FluCide candidates demonstrated extremely high anti-influenza activity in those models.

This study was developed in collaboration with BASi and conducted by BASi in a c-GLP-like fashion in order to understand the safety parameters of FluCide intravenous dosing.

The next phase of the toxicology package studies will involve larger animals, and will require much larger quantities of the drug candidate. The Company is in the process of commissioning operations at the new 1 Controls Drive, Shelton, CT facility in order to perform the scale up studies needed for making the large quantities of materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies.
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http://www.prnewswire.com/news-releases/nanoviricides-reports-that-the-flucide-candidate-was-found-to-be-very-safe-in-cglp-like-safety-and-toxicology-study-in-rats-performed-by-basi-300024776.html

Furthermore, GLP is a regulation. Can you point the NNVC board to a source that indicates breakdown of Safety/Toxicology Studies GLP into parts (studies) or phases, is prohibited?

Aim at drug development acceleration, underway...

Accelerated Development/Review

Accelerated development/review (Federal Register, April 15, 1992) is a highly specialized mechanism for speeding the development of drugs that promise significant benefit over existing therapy for serious or life-threatening illnesses for which no therapy exists. This process incorporates several novel elements aimed at making sure that rapid development and review is balanced by safeguards to protect both the patients and the integrity of the regulatory process.
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http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm176522.htm

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"I suppose" the "con blogger", "Pump Terminator", could soon be coming out of his closet to reiterate everything he has blogged about our small company in the past, plus an update on why he/she/they believe the risk has jumped from 80% to 99%. "I must confess", I feel pretty confident the sociopath/white-collar criminal will not be outdoing himself and instead rely solely on minimum wage cons/alias/anonymous posters.

Recent “Bear” Attack

As many of you know, a malicious and possibly criminal attack on our common stock was carried out on February 11, 2014, through the publication of a false and misleading article on Seeking Alpha. The intent of the article was to dramatically drive down our stock price. The article resulted in a highly increased daily trading volume of eight million shares, approximately 20 times our daily average. The information we have gathered suggests that this was an organized attack using false and inaccurate information designed to benefit short sellers in the stock. We have reported this conduct to the regulatory authorities and have retained legal counsel to investigate both the website that hosted this article and the anonymous blogger who authored it.

www.nanoviricides.com/2014-ceo-letter.pdf