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I figure the sponsor (NNVC) got it in writing. What if the consultants like what they see in studies results/data? What then? Would they, like Patric Cox, resign in order to buy stock?
Now, for all we know, NNVC is in the process of producing sufficient quantities of FluCide (reproducible)final candidate. However, this does not mean BASi is waiting with arms crossed for NanoViricides, Inc. to provide the first batch, meaning they are working on other projects. Maybe Tox and Safety studies have begun (to be announced Monday?). If not perhaps they could begin next week if BASi is open for the project to start. Possible?
BASi was with Nanoviricides, Inc. in the pre-IND meeting and the US FDA gave guidance beyond their documents. Is it possible that BASi's GLP Tox and Safety Studies were modified and shortened?
I know, we are not FAST TRACKed yet but thinking US FDA has gone way beyond their documents, even before fast-tracking further.
I'm not an advocate for a buyout. NanoViricides, Inc. technology is transformational in several ways already mentioned by others on this board. I say let it grow to become the "Thoroughbred" company it is meant to be.
I'm not sure if the consultants of firms like BCG, BASi or others, can be stopped from buying NNVC as private individuals. They may be gagged and kept from talking about NanoViricides, Inc. candidates/results/information they come across but they cannot be kept from buying the stock.
Is it AES Clean Technology, Inc. (“AES”)?
AES Clean Technology, Inc. (“AES”), for the design, engineering, and construction of the Cleanroom Suite for its laboratory and cGMP pilot production facility project.
WEST HAVEN, CONNECTICUT -- January 14th, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained AES Clean Technology, Inc. (“AES”), for the design, engineering, and construction of the Cleanroom Suite for its laboratory and cGMP pilot production facility project. The Cleanroom Suite comprises the main cGMP manufacturing sections of the pilot plant. This Suite provides for walk-in, process scale, Class 100 laminar hoods; walk-in, process scale chemical fume hoods; Class 1,000 and Class 10,000 work areas; entry airlock and egress systems.
AES is the leader in turnkey design, manufacturing, and construction, of modular cleanroom systems (www.aesclean.com). Modular cleanroom technology delivers more speed, cleanliness, quality, and repeatable performance to the cleanroom project. AES is the leading vendor in cGMP-compliant manufacturing facilities for Pharmaceutical and BioPharma Manufacturing industries. Their pharma client list comprises several industry leaders and can be found at Leading Industry Leaders in Pharma, Biotech, Medical Device, Semicon, Micro | AES (http://www.aesclean.com/aes-portfolio/industry-leaders).
Agreed. Time is on the side of NanoViricides, Inc., in more ways than one.
If the consulting firms are dealing with data/information that would give them an advantage over investors/public that do not have this kind of access, I doubt it. Perhaps someone on the board has addressed this question before.
I neglected to mention Biologics Consulting Group, Inc. (BCG) for the preparation and submission of Investigational New Drug (IND) applications to the FDA for its nanoviricides® drug candidates against various viral diseases. It is quite a list of companies, checks and balances. Reputations of individual professional companies are at stake.
We are moving forward in two fronts, the US FDA and the PHE (Europe). I think it was nanopatent who said that if not here in the US, it will be there, in Europe. I think we have good people, companies with vested reputations, in the success to the clinical trials. We also have two candidates, FluCide and DengueCide, with unprecedented and consistent test data results in efficacy (pre-IND) and now we know they have "low toxicity". I find that if anything, "Big Pharma" is trying to figure out how much will they agree to pay for licenses or acquisition, IMHO. Anticipation will build and the pps will climb.
more on Big Pharma and the FDA: http://www.news-medical.net/news/2005/12/12/14938.aspx
Hear-hear! NanoViricides, Inc. is not alone in this trek to the marketplace. Other companies, successful/experienced professionals in several fields, are involved in making sure Nanoviricides, Inc succeed in their efforts to bring their "shifting-paradigm of antiviral drugs" to their market. NanoViricides, Inc. doctors are doing what they do best, preparing the final candidates for the clinical trials (2014).
They have signed contracts/agreements (2012 - 2013), in preparation for Investigational New Drug (IND) submission to the FDA and human trials (2014), with:
1) Id3A, LLC as the architect for its lab and cGMP pilot production facility
2) MPH Engineering, LLC (“MPH”), to help with the overall project management and design engineering of its laboratory and cGMP pilot production facility
3) BASi for Toxicology and Safety studies (initiate GLP Safety/Toxicology studies)
4) Lovelace Respiratory Research Institute for IND-enabling Efficacy Studies on FluCide® and for Testing its Novel Drug Candidates against the Highly Lethal MERS Human Coronavirus
5) Public Health England to Test Nanoviricides Against H7N9, MERS
Nanoviricides, Inc. has been "laying down the tracks of the railway", path that will lead to the human trials (2014).
When the cGMP Pilot Plant is fully integrated the process to commission it will begin (1Q 2014), equipment will be moved into the plant and setup. The process to create the (3) identical batches of the FluCide final candidate (kg scale)should be fairly quick and easy. Everything is on-track and whatever delays we've come across will be relatively short. Lost time should be recovered, at least in part, as we move along the controlled path/track.
The better catch is NNVC. We are not the only ones here and everyday more are coming!
I Need Help...that FLAG pattern is powerful. I hope you're right!
If true and we have arrived at the final FluCide candidate (no toxicity and optimized candidate) then this is what NanoViricides, Inc. was waiting for to give the go-ahead and start producing/delivering batches (reproducible) of the final candidate to BASi. We must then be close to hear news on this. The GLP results, as you say, will be uneventful. Just confirmation. The start of the GLP IND-enabling Toxicology and Safety studies is what matters (catalyst). Soon.
They missed the "i" from NanoViricides, Inc...likely a human puppet behind the digital ticker-tape.
NanoViricides Says Early Results Indicate that FluCide(R) Was Extremely Safe in a non-GLP Small Animal Tox Study Business Wire
http://www.barchart.com/quotes/stocks/NNVC
Infectobesity From Wikipedia, the free encyclopedia
The term "infectobesity" refers to obesity of infectious origin and the emerging field of medical research that studies the relationship between pathogens (disease-causing organisms, such as viruses and bacteria) and weight gain. The term was coined in 2001 by Dr. Nikhil V. Dhurandhar, at the Pennington Biomedical Research Center. (Dhurandhar, 2001).
Bacteria
The study of the effect of infectious agents on metabolism is still in its early stages. Gut flora has been shown to differ between lean and obese humans. There is an indication that gut flora in obese and lean individuals can affect the metabolic potential. This apparent alteration of the metabolic potential is believed to confer a greater capacity to harvest energy contributing to obesity. Whether these differences are the direct cause or the result of obesity has yet to be determined unequivocally.
Viruses
An association between viruses and obesity has been found in humans as well as a number of different animal species. The amount that these associations may have contributed to the rising rate of obesity is yet to be determined.
The fat virus is the popular name for the concept that some obesity in humans and other animals has a viral source. The AD-36 adenovirus has been observed to increase the amount of body fat on laboratory animals, an effect that has been duplicated on chickens and monkeys.
Ad-36 is known to cause obesity in chickens, mice, rats, and monkeys and was present in 30% of obese humans and 11% of nonobese humans. The prevalence of Ad-36 positivity in lean individuals increased from 7% in 1992-1998 to 15-20% in 2002-2009, which paralleled the increase in obesity prevalence.
NanoViricides, Inc. is on-track to the clinical trials 2014, and with its transformational-technology it will make the nation's, the world's, healthcare less expensive and more effective. We need affordable healthcare, out of the hospital healthcare, and NanoViricides, Inc. is a company that is making the case with scientific breakthrough-technology, independent from the immune system, fast-acting and life-saving medicine! To me it is a forgone conclusion. We will be fast-tracked to market, IMHO.
I am just anticipating, speculating that for the FDA doctors, NanoViricides, Inc. bio-nanotechnological FluCide will be a therapeutic drug to assess in terms of toxicity to humans and then give it green-light to prove efficacy...at the marketplace, again IMHO.
On second thought, if the host (bacteria) cell is destroyed by the virus within, the viruses will be directly in the human host awaiting the immune system to pick them up. Right assumption or not?
But then...viruses that kill their infected host cell are called virulent. The DNA in these type of viruses reproduces through the lytic cycle. When these viruses reproduce, they break open, or lyse, their host cells, resulting in the destruction of the host. The whole cycle can be complete in 20 - 30 minutes depending on a variety of factors such as temperature. Phage reproduction is much faster than typical bacterial reproduction, so entire colonies can be destroyed very quickly.
http://biology.about.com/od/virology/ss/Bacteriophage.htm
Kill the host (bacteria)...
http://biology.about.com/od/bacteriology/a/spices-kill-bacteria.htm
...then a nanoviricide to end the virus.
Thank you BigKahuna. The article linked to your post is very encouraging for the remainder of 2013 and should help build anticipation for 2014, the year of the "shifting-paradigm of antiviral drugs", NanoViricides, Inc.
Nanoviricides: A New Hero in Antiviral Science
Revolutionizing the archaic vaccine system.
http://www.bu.edu/synapse/2011/11/27/nanoviricides/
"As a nation that has always prided itself on being at the forefront of progress, the reality is that the United States has reached a point of stagnation regarding the development of the current vaccine system. The U.S. is losing ground and needs to act quickly in the face of growing viral diseases and unfortunately, the present vaccine system doesn’t allow for this. With more research and development, the United States can support and look forward to the development of better, safer vaccines that allow us to battle disease on its own terms. Nanoviricides present a compelling war plan.
We would like to thank the CEO of NanoViricides, Eugene Seymour, for kindly agreeing to provide input and insight on this article."
Excerpt from 2009 Jain Report: Structure and function of nanoviricides
source: http://allallan.blogspot.com/2009/04/nnvc-why-so-special.html
Advantages of NanoViricides
§ The biological efficacy of NanoViricides drugs may be several orders of magnitude better than that of of usual chemical drugs. This in itself may limit the potential for mutant generation.
§ Low cost of drug development, manufacture, distribution.
more: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=91021791
Eliminating Viruses the NanoViricides Way
NanoViricides' nanotech drug delivery platform has the potential to eliminate viruses, the firm says as construction began on a manufacturing facility to support upcoming clinical trials.
http://www.in-pharmatechnologist.com/Drug-Delivery/Elimiating-Viruses-the-NanoViricides-Way
Highly Contagious Honey Bee Virus Transmitted by Mites.
June 7, 2012 — Researchers at the University of Sheffield have discovered a parasitic mite has caused the deformed wing virus to proliferate in honey bee colonies.
This association is now thought to contribute to the world-wide spread and probable death of millions of honey bee colonies. The current monetary value of honey bees as commercial pollinators in the United States alone is estimated at about $15-$20 billion annually.
The research conducted in Hawaii by researchers from the University of Sheffield, the Marine Biological Association, the Food and Environment Research Agency and the University of Hawaii, and reported in the journal Science, showed how the Varroa mite caused deformed wing virus (DWV) -- a known viral pathogen -- to increase its frequency among honey bee colonies from 10 per cent to 100 per cent...
source: http://www.sciencedaily.com/releases/2012/06/120607142357.htm
"We don't care if you are a man, a whale, a mouse or a salamander, as long as you have a virus in your circulation, we destroy it..." Dr. Eugene Seymour, CEO - NanoViricides, Inc.
What I meant to say is that this is healthy advice. Thanks.
Thank you for the advice. I have purchased masks and use them, specially when flying, just in case. My excuse, "If I cough, others won't catch my cold".
This is very good and is good others can read it as well.
---(face masks don't merely protect by prevent you spreading your own or inhaling others droplets: they also protect by preventing you touching your nose or mouth)
---(the above considerations are part of the reason why very young children are at such high risk of catching infections. Another is that they don't have cross-immunity from prior exposure to similar viruses.)
***If flue is at high levels, avoid taking children with you unnecessarily to public spaces. If their presence is not required, leave them at home. And wash your hands immediately upon returning home.****
Avoid any unnecessary exposure to crowds during epidemics.
CDC Says “Take 3” Actions To Fight The Flu
Flu is a serious contagious disease that can lead to hospitalization and even death.
CDC urges you to take the following actions to protect yourself and others from influenza (the flu):
Step One
-Take time to get a flu vaccine.
-Take time to get a flu vaccine like this young boy from an older female nurse.
-CDC recommends a yearly flu vaccine as the first and most important step in protecting against flu viruses.
-While there are many different flu viruses, a flu vaccine protects against the three viruses that research suggests will be most common. (See upcoming season’s Vaccine Virus Selection for this season’s vaccine composition.)
-Everyone 6 months of age and older should get a flu vaccine as soon as the current season's vaccines are available.
-Vaccination of high risk persons is especially important to decrease their risk of severe flu illness.
-People at high risk of serious flu complications include young children, pregnant women, people with chronic health conditions like asthma, diabetes or heart and lung disease and people 65 years and older.
-Vaccination also is important for health care workers, and other people who live with or care for high risk people to keep from spreading flu to high risk people.
-Children younger than 6 months are at high risk of serious flu illness, but are too young to be vaccinated. People who care for them should be vaccinated instead.
Step Two
-Take everyday preventive actions to stop the spread of germs.
-Take everyday preventive actions to stop the spread of germs like this mother teaching her young child to wash hands.
-Try to avoid close contact with sick people.
-If you are sick with flu-like illness, CDC recommends that you stay home for at least 24 hours after your fever is gone except to get medical care or for other necessities. (Your fever should be gone without the use of a fever-reducing medicine.)
-While sick, limit contact with others as much as possible to keep from infecting them.
-Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
-Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.
-Avoid touching your eyes, nose and mouth. Germs spread this way.
-Clean and disinfect surfaces and objects that may be contaminated with germs like the flu.
-See Everyday Preventive Actions Adobe PDF file [257 KB, 2 pages] and Nonpharmaceutical Interventions (NPIs) for more information about actions – apart from getting vaccinated and taking medicine that people and communities can take to help slow the spread of illnesses like influenza (flu).
Step Three
-Take flu antiviral drugs if your doctor prescribes them.
-Take flu antiviral drugs if your doctor prescribes them like this older woman listening to her doctor.
-If you get the flu, antiviral drugs can treat your illness.
-Antiviral drugs are different from antibiotics. They are prescription medicines (pills, liquid or an inhaled powder) and are not available over-the-counter.
-Antiviral drugs can make illness milder and shorten the time you are sick. They may also prevent serious flu complications. For people with high risk factors Adobe PDF file [702 KB, 2 pages], treatment with an antiviral drug can mean the difference between having a milder illness versus a very serious illness that could result in a hospital stay.
-Studies show that flu antiviral drugs work best for treatment when they are started within 2 days of getting sick, but starting them later can still be helpful, especially if the sick person has a high-risk health or is very sick from the flu. Follow your doctor’s instructions for taking this drug.
-Flu-like symptoms include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. Some people also may have vomiting and diarrhea. People may be infected with the flu, and have respiratory symptoms without a fever.
http://www.cdc.gov/flu/protect/preventing.htm
Will Step Three be replaced with "...take FluCide and be done with it?" Perhaps, sometime in a fast-tracked future?
Will NNVC bounce off (50)DMV 4.57 tomorrow and continue moving up/sideways in a narrow channel, until we get news? All that while the market trend is bearish?
I understand...it must be frustrating for you, and others, not being unable to find "competition" to compare with Nanoviricides, Inc.. To compare "big pharma" employed standard technology with Nanoviricides, Inc. "shifting-paradigm of antiviral drugs" is like comparing apples and oranges. Makes anyone arguing against NanoViricides, Inc. look desperate.
Now we are fully aware of the "low toxicity" of a nanoviricide...dang, there goes another uncertainty that the "others' negativity" liked to harp on but, no more.
Let me know which company, among the competition, can develop a therapeutic drug, a "low-toxicity" antiviral-drug, in a week, two weeks, like NanoViricides, Inc. can. Be nice and share with the NNVC board :P
Yes, we do have competition. So did Secretariat when it won the first race of the triple crown. Many didn't know Secretariat then, as it is the case today with NanoviriCides, Inc. For many today the bio-nanotechnology employed by NanoViricides, Inc. is new and not well known. Those that are interested in this nano-tech science, like myself, better understand it because of what I read out there in the WWW and what I read/learn from posters in this forum/board.
NanoViricides, Inc. has other well-seasoned companies providing guidance because we want to get it right the first time.
=> The Company engaged the consulting firm Coté Orphan Consulting (COC), headed by Dr. Tim Coté, to assist with our DengueCide orphan drug applications to both the US FDA and the E
DengueCide is a nanoviricide® that has shown very high effectiveness in an animal model of dengue virus infection. These animal studies were conducted in the laboratory of Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley. Professor Harris has developed a mouse model of antibody-dependent-enhancement (ADE) of dengue infection that simulates dengue hemorrhagic fever (DHF/DHSS) using a special laboratory mouse strain called AG129.
In humans DHF/DHSS is associated with a high fatality rate. In this model, infection with a dengue virus, when the mice are left untreated, is 100% fatal. In contrast, in the same study, animals treated with NanoViricides' DengueCide achieved an unprecedented 50% survival rate. <=
more: http://www.marketwatch.com/story/nanoviricides-reports-that-the-denguecidetm-orphan-drug-application-has-been-submitted-and-received-by-the-european-medicines-agency-2013-09-03
We have competition but it won't be long before people discover that we are out in front of the competition and "DengueCide is the only game in town" ~ Dr. Anil Diwan
...As a result, the required quantity estimated for GLP safety/tox study is much larger than our current synthesis capability. The Company has undertaken process development, scale-up, chemistry optimization and control program to enable large scale synthesis of FluCide in a reproducible manner. This work is currently in progress...
My understanding from the highlighted piece above is that they are working to produce identical batches. Perhaps, they may have achieved that goal already. If so, is it possible that BASi has started IND-enabling "tox studies" and it could be announced next Monday?
OTC Signal Daily Stock Watch - NanoViricides, Inc. (NYSE: NNVC)
Today's alerts include: NanoViricides, Inc. (NYSE: NNVC) $5.00
NanoViricides, Inc. has initiated the initial non-GLP toxicology evaluation of its optimized injectable FluCide(R) drug candidate. This study is an important step in the drug development pathway for FluCide. The Company previously had a pre-IND meeting with the U.S. FDA to discuss and receive guidance on the FluCide drug development pathway.
The non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts. The results of this study will provide the basis and focus for the IND-enabling GLP safety and toxicology studies of FluCide that are required for the IND submission to the U.S. FDA. These IND-enabling GLP safety and toxicology studies will be performed by BASi Toxicology Services in West Lafayette, IN. The Company has previously reported that its FluCide candidate was highly effective in animal models of different influenza A virus strains. In those efficacy studies of FluCide, no safety or toxicology concerns were observed. As a result, the required quantity estimated for GLP safety/tox study is much larger than our current synthesis capability. The Company has undertaken process development, scale-up, chemistry optimization and control program to enable large scale synthesis of FluCide in a reproducible manner. This work is currently in progress.
The Company is considering two separate indications for this injectable FluCide drug. The first is hospitalized patients with severe influenza. In the USA, there are approximately 300,000 severe influenza cases that require hospitalization every year resulting in approximately 40,000 to 50,000 deaths. A pandemic would increase those numbers by an order of magnitude.
more: http://www.barchart.com/headlines/story/133862/otc-signal-daily-stock-watch-nanoviricides-inc-nyse-nnvc
Dengue - Pipeline Review, H2 2013
...report provides information on the therapeutic development for Dengue, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Dengue. Scope - A snapshot of the global therapeutic scenario for Dengue. - A review of the Dengue products under development by companies and universities/research institutes based on information derived from company and industry-specific sources. - Coverage of products based on various stages of development ranging from discovery till registration stages. - A feature on pipeline projects on the basis of monotherapy and combined therapeutics. - Coverage of the Dengue pipeline on the basis of route of administration and molecule type. - Key discontinued pipeline projects. - Latest news and deals relating to the products. Companies Mentioned F. Hoffmann-La Roche Ltd. GlaxoSmithKline plc GenVec, Inc. Merck & Co., Inc. Takeda Pharmaceutical Company Limited Biological E. Limited Biotron Limited AVI BioPharma Inc. Medivir AB NanoViricides, Inc. SIGA Technologies, Inc. Panacea Biotec Limited Functional Genetics, Inc. Advinus Therapeutics Pvt. Ltd. Protein Potential, LLC TechnoVax, Inc. MacroGenics, Inc. PTC Therapeutics, Inc. Chimerix, Inc. Wittycell S.A.S. Immunotope, Inc. ImmunoVaccine Technologies Inc. Ortho-McNeil Pharmaceuticals, Inc. and many more...
http://www.barchart.com/headlines/story/132991/dengue-pipeline-review-h2-2013
The CEO of credit rating agency Moody’s ruled out the chance of a U.S. government default, even if an agreement over raising the debt ceiling is not achieved by mid-October.…http://www.moneycontrol.com/news/world-news/moodys-ceo-us-default-extremely-unlikely_964478.html
NanoViricides, Inc. is one of many companies that live within their means and set priorities to spend their money wisely. They are a frugal company. Can our government do the same?
Nanoviricides, Inc. said it had determined after several years of studying cGMP manufacturing options, that building a pilot facility for clinical drug manufacturing was the most appropriate move.
"This will be a unique, state-of-the-art cGMP facility for the pilot scale production of nanomedicines," said president and chairman of NanoViricides’ Anil R. Diwan.
"Along with his great experience, Andy Hahn brings an acute grasp of a wide range of issues that is critically important in making such a challenging endeavor a success."
Hahn, who holds a BA in Architecture from Princeton University, has almost 30 years of architecture, design, and project management experience in the creation of new and refurbished facilities from his time at the Bristol-Myers Squibb Company.
He was the senior director of engineering, pharmaceutical facilities, and global engineering at this company, and is recently retired.
His responsibility at Bristol-Myers Squibb entailed the worldwide design and construction of pharmaceutical plants, pilot plants, clinical supply facilities, and research laboratories and offices, all relevant to NanoViricides’ current project.
"Mr Hahn will assist the company in realizing its goal of a first class cGMP manufacturing plant as well as laboratory space," said NanoViricides’ CEO Eugene Seymour.
"Andy Hahn will be instrumental in helping the company achieve this goal that will enable us to expedite our various drug development programs."
So it is written, so it shall be done!
Puffer..."...The construction is on schedule to be completed by the end of December, 2013. However, the schedule may be adversely affected if delivery of certain key pieces of equipment with relatively long lead times does not occur in a timely manner..." http://www.nanoviricides.com/press%20releases/NanoViricides%20Reports%20on%20Construction%20Progress%20of%20its%20New%20Facility%20and%20cGMP%20Pilot%20Production%20Plant.html
I am assuming completion of cGMP integration beginning December, 2013 and no problems with "certain key pieces". Commissioning of the cGMP plant on 2014. Optimism on my part.
JoseM...it seems NNVC may get near your $4.00+/s buy range after all.
Thank you for relaying the words, from the "good doctor" Seymour, to the forum. I found the following, which I had to look-up to better understand the content of his message:
he he he..that's the spirit! Have a great weekend! I will try to do the same!