Replies to post #115094 on NanoViricides Inc. (NNVC)

[bloomvest]

My Thoughts !!!

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.
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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.
http://www.nanoviricides.com/press%20releases/2015/Nanoviricides%20Reports%20that%20the%20FluCide%20Candidate%20was%20found%20to%20be%20Very%20Safe%20in%20cGLP-like%20Safety%20and%20Toxicology%20Study%20in%20Rats%20Performed%20by%20BASi.html

Ludwig Huber and Paul Lepore, FDA's 'Father of GLP' during a GLP Workshop in Tokyo.

[changes_iv]

What everyone should know about your touted NNVC competition...

-A small-biotech that is privately-held
-with Fludase a first-in-class Influenza drug
-small-biotech skids begin to get greased by a U.S. Federal agency, Aug 8, 2005
-a 50m contract with the NIH, fast-tracked

Why would a privately-held company, that seems to have everything going for them, would feel the urge to defraud the United States of America/taxpayers funded NIH? Cash-flow problems? with a 50m biologic-contract, how can that be?

Since its founding in 2003, NexBio has received at least $73 million in grants and contracts from the National Institutes of Health to develop and test Fludase, according to agency records and a 2009 report from the San Diego industry group Biocom.

After operating solely with government funding, the company in recent years tried to raise money from investors. It isn't clear whether those efforts were successful.

Company officials did not respond to several telephone and email messages.

source: http://www.sandiegouniontribune.com/news/2011/aug/04/feds-raid-san-diego-vaccine-developer/

In January 2015, the U.S. Department of Justice made headlines when it brought criminal charges against a San Diego biotech company for alleged widespread accounting fraud arising from several grants and a $50 million contract awarded by the National Institutes of Health (NIH).1 The company, Ansun Biopharma Inc. (Ansun), received federal grants and contracts from 2004 to 2011 to develop treatments to combat influenza, including an experimental antiviral treatment called Fludase.2 According to settlement documents, top executives at the company: (1) “fabricated timesheets” for company employees to maximize billing on the NIH grants and contract; (2) billed employee project hours to the NIH contract, even if the project did not fall within the contract’s scope; and (3) moved employee hours from nongovernment projects to the NIH-funded grants to recoup money from NIH for work not covered under the awards.3 Ansun agreed to pay the federal government more than $2 million to resolve the allegations of accounting fraud.4

The Ansun settlement is noteworthy for two reasons. First,
although the health care industry is no stranger to civil
lawsuits based on claims of fraudulent accounting,5 the
Ansun case serves as a powerful reminder that improper
accounting practices also can lead to criminal charges.6
Second, the settlement comes at a time when the life sciences industry increasingly is under the microscope.

http://www.jonesday.com/files/Publication/843d4937-8abe-48a7-b13d-78f3ca98e21f/Presentation/PublicationAttachment/cab7f37c-0016-4b04-a81c-7c7f971e8524/HCLL_May15.pdf

Where can anyone go buy stock on this company? Why is it this marvel of a drug is not out there so that Rawnoc, "Pump Terminator", etc. can go buy the stock? Why no comment on private investors?

Phase III Trials

Based on prior studies demonstrating drug safety and potential efficacy, a phase III trial (also referred to as a “therapeutic confirmatory,” “comparative efficacy,” or “pivotal trial”) may be pursued. This stage of drug assessment is conducted in a larger and often more diverse target population in order to demonstrate and/or confirm efficacy and to identify and estimate the incidence of common adverse reactions. However, given that phase III trials are usually no larger than 300 to 3000 subjects, they consequently have the statistical power to establish an adverse event rate of no less than 1 in 100 persons (based on Hanley’s “Rule of 3”).24 This highlights the significance of phase IV trials in identifying less-common adverse drug reactions, and is one reason why the FDA usually requires more than one phase III trial to establish drug safety and efficacy.

Phase IV Trials

Once a drug is approved, the FDA may require that a sponsor conduct a phase IV trial as a stipulation for drug approval, although the literature suggests that less than half of such studies are actually completed or even initiated by sponsors.38 Phase IV trials, also referred to as “therapeutic use” or “post-marketing” studies, are observational studies performed on FDA-approved drugs to: 1) identify less common adverse reactions, and 2) evaluate cost and/or drug effectiveness in diseases, populations, or doses similar to or markedly different from the original study population. Limitations of pre-marketing (eg, phase III) studies become apparent with the statistic that roughly 20% of drugs acquire new black box warnings post-marketing, and approximately 4% of drugs are ultimately withdrawn for safety reasons.39,40 As described by one pharmacoepidemiologist, “this reflects a deliberate societal decision to balance delays in access to new drugs with delays in information about rare adverse reactions.”41
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272827/

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RISING DEBT and the DEATH SPIRAL...

Rising federal debt threatens to choke economic growth within a decade, beginning a death spiral that will sap revenue from government programs even as demands grow, forcing the government to borrow even more, Congress‘ budget watchdog said in a frightening report Tuesday.
http://www.washingtontimes.com/news/2015/jun/16/government-debt-threatens-to-send-us-economy-into-/?page=all