NanoViricides Inc. (NNVC)

[changes_iv]

Biologics Consulting Group, Inc. (BCG) is a team of consultants who provide national and international regulatory and product development advice on the development and commercial production of biological, drug, combination and device products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, quality management, pharmacology/toxicology, quality assurance, GLP, GMP, GCP compliance, program management, medical device biocompatibility, and clinical trial design and evaluation. Many of our consultants are former CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry.
Our understanding of the FDA enables us to clarify the tough decisions and bring the right balance of business, scientific, and regulatory to product development.
http://www.biologicsconsulting.com/staff-search/?DepartmentId=undefined&Keyword=nanotherapeutics

Anyone that navigates to the Biologics Consulting Group, Inc. website and does a <Search for a consultant by the keyword> "nanotherapeutics", the search will Dr. Nanda K. Subbarao, Ph.D., Senior Consultant.

Nanda has co-authored numerous scientific publications and frequently an invited speaker at Industry Meetings. As a Senior Consultant with Biologics Consulting Group, Nanda utilizes her strong technical skills and expertise in Analytical cGMP systems for both biologics and conventional drugs to assist clients in the following aspects of drug development:

-Set up of cGMP laboratory systems

-Implementation and management of stability programs

-Technical and GMP evaluation of a wide variety of analytical methods at all stages of product life cycle

-Provide technical guidance on method validation for a wide variety of products such as characterized proteins including biosimilars, vaccines, gene therapy products, stem cell products

-Writing and evaluation of method validation protocols and reports

-Specification setting

-CMC analytical sections preparation and review against current regulatory expectations
http://www.biologicsconsulting.com/staff-detail/nanda-subbarao/

It is very likely anything Dr. Eugene Seymour says are highlights within the Biologics Consulting Group, Inc. designed clinical trials, a design within FDA requirements.

Now, whatever anonymous poster JG36 says has as much credibility as anonymous poster JG36PHD. JG36 is an anonymous poster with biased opinions against NanoViricides, Inc.! Me?!? I am an anonymous poster but I quote/reference my sources in most of my post and provide a link. If you want to add credibility to any counterpoint, drop the attitude and start quoting/referencing your sources.

If Dr. Eugene Seymour, CEO of NanoViricides Inc. says Phase 1 of Clinical Trials in one week, one week it is.

The backbone of all nanoviricides(R) drugs is PEG and PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration.. http://dmd.aspetjournals.org/content/35/1/9.full

On August 10, 2015 PRd their most advanced topical Herpes drug candidate --- NanoViricides Reports that the Dramatic Effects of Its Topical Anti-Herpes Treatment were Reproduced Once Again in an Animal Model in a Different Laboratory
http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Reports%20that%20the%20Dramatic%20Effects%20of%20Its%20Topical%20Anti-Herpes%20Treatment%20were%20Reproduced%20Once%20Again%20in%20an%20Animal%20Model%20in%20a%20Different%20Laboratory.html

The c-GLP Tox Package study will be conducted by BAS incorporated (BASi), a well-known contract laboratory excelling in such studies. As we institute this study, we plan to use the same material for additional efficacy studies of our drug candidate against a number of different influenza virus types, subtypes, and strains. This is required to ascertain the broadspectrum nature of the drug candidate. Our earlier studies have already demonstrated that this drug candidate is highly effective against both Type I and Type II Influenza A viruses in highly lethal animals studies. We believe that it should be capable of attacking almost any Influenza A virus, because it mimics the sialic acid receptor that all influenza viruses use to enter a host cell. After these studies are complete, and we have the reports in hand, we will be able to submit an Investigational New Drug” application (IND) to the US FDA. An IND also requires at least two consistent cGMP batches of the drug to have been produced

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

In the video linked in your post, we heard Dr. Seymour clearly say:

1)NanoViricides, Inc. would commission the new state-of-the-art, multi-kilogram Pilot Plant in Shelton, CT first

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

2) After commissioning the Pilot Plant they would produce three identical batches of FluCide(TM)

3) NanoViricides, Inc then produces the drug for the third and final phase of tox studies. From Dr. Eugene Seymour's email:

June 1, 2015, 9:47 PM

FluCide

Phase I and II of tox successfully completed

Making material for last Phase in large animals
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Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!

Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
[e-mail]
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange

From announcing the commissioning of the new Pilot Plant in Shelton, CT to produce FluCide(TM) to the email of June 1st, 2015 is about 5 months for 3 identical batches. Do the math. We are getting close to a PR announcement that reads close to the following: NanoViricides Reports FluCide™ Samples Were Shipped To BASi For Third and Final Phase of Safety/Toxicology Studies. In my view, it should take approximately 12 weeks to produce (2) 1Kg batches of FluCide(TM).