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Regarding the attacks against NanoViricides, Inc. "good doctors"/executives...for those insecure about their lives, enamored by degrees and titles, here is a little bit of wisdom...
First off, there are many, many bad reasons that people think of when it comes to getting a PhD. Here are some of the most common that I’ve run across:
1-Do not get a PhD in science because you think it will make you smarter. A degree — a piece of paper — never made anyone smarter, and you are not the exception.
2-Do not get a PhD because you think being a professor would be a great career choice. Getting a PhD is no guarantee that you will get a professorship, and even if it were, the promise of this future reward is not enough incentive on its own.
3-Do not go after a PhD because you have dreams of money or glory or respect. Any of these accolades are rare for PhDs, and those that get them almost universally were recipients of a tremendous amount of luck in addition to their talents and merits.
4-Definitely do not pursue a PhD because you majored in something in college, you don’t know what to do next, and graduate school seems like the next logical step.
It may seem obvious to you that these are bad ideas, but let me elaborate a little further. A PhD is not evidence that you are a genius. In fact, the vast majority of people with PhDs are not of any extraordinary intelligence, but merely people who did the hard work necessary to earn a PhD. There are plenty of brilliant people who get them, of course, but there are also plenty of people of average or even below-average intelligence who get them. All a PhD signifies, at the end of the day, is that you did the work necessary to earn a PhD. There are many people who have PhDs who will dispute this, of course. There are plenty of people who are insecure about their lives, too, and base their entire sense of self-worth on their academic achievements and accolades. You probably have met a few of them: they are called jerks.
NanoViricides Announces Issuance of a Fundamental Patent in the USA
WEST HAVEN, CONNECTICUT -- May 7th, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that a fundamental patent, on which the nanoviricides® technology is based, is due to be issued in the USA on May 8, 2012. The issuance notification was received from the US Patents and Trademarks Office last week.
The US Patent (No. 8,173,764) is granted for "Solubilization and Targeted Delivery of Drugs with Self-Assembling Amphiphilic Polymers." It will be issued on May 8, 2012. The patent term is expected to last through October 1, 2026, including an anticipated extension, with the possibility of further extensions in compensation for time spent in clinical trials.
The US Patent has been allowed with a very broad range of claims to a large number of families of chemical structure compositions, pharmaceutical compositions, methods of making the same, and uses of the same. The disclosed structures enable self-assembling, biomimetic nanomedicines. NanoViricides, Inc. holds exclusive, perpetual, worldwide licenses to these technologies for a broad range of antiviral applications and diseases.
Based on international PCT application number WO 2007/1084126, which was filed in 2006, corresponding patents have also been issued in New Zealand and South Africa, and as a regional (OAPI) patent valid in sixteen other African states. Additional issuances are expected in Europe, and in several other countries around the world.
“It is rewarding to see that the US Patent and Trademark Office (USPTO) recognized the novelty and the broad utility of the entire ‘pi-polymer’ class of materials as defined by the inventors, and granted a patent with sufficient scope to protect the whole of the invention, for all foreseeable pharmaceutical applications, including the nanoviricides® anti-viral substances,” said Dr. James Demers, PhD, JD, now with Gotham Patent Services LLC, who represents the inventors before the USPTO and directs the international patenting effort. He further added, “The application was drafted so as to describe and claim Dr. Diwan's invention, on which the nanoviricides® technology is based, as broadly as possible, and we anticipate that other countries around the world will also grant claims similar to those allowed by the USPTO.”
NNVC, a small company...secrets well kept
Reversal to the upside coming! Fair value estimate, $7.51/share. Let it be! Amen!
henrique_stare979, you posted...
"Guinea has received confirmation that a mysterious disease that has killed up to 59 people in the West African country and that may have spread to neighboring Sierra Leone, is the hemorrhagic fever Ebola, the government said Saturday.
Cases of the disease - among the most virulent pathogens known to infect humans, with a fatality rate of up to 90% - have been registered in three southeastern towns and in the capital,Conakry, since Feb. 9. It has never before been recorded in Guinea."
Will someone tell me why NNVC has not pursued a Nanoviricide for Ebola? To me, anything that looked it had half a chance of success would surely have been fast-tracked by the government. This bothers me.
In reference to nanopatent/Dr. E. Seymour email exchange...
Re: Early Access to Medicines Scheme (EAMS)
...
I’ll be over there in two weeks so I’ll find out what the procedure will be and to lay the groundwork for our eventual application.
It seems like they’ve harmonized with the US Compassionate Use program. However, I need to find out if the “specials” program will continue or be rolled into this one
My initial reading suggests you need to have completed Phase IIa trials, thus early 2015 looks like a reasonable target date to apply. My goal is to have significant output by the beginning of the 2015 flu season in both Europe and North America.
"You can fool all of the people some of the time, and some of the people all of the time, but you can not fool all of the people all of the time." ~ Abraham Lincoln
Sorry Larson1 but I don't like the raw...
I missed that post to larson1 that caused him to laugh. Keep in mind that for any future special event, anyone can change their moniker to something other than what we are used to know them for. For example, from Raw_one to party_crasher.
Changing the topic somewhat, find in here a post from robi-1-kenobi worth internalizing, or keeping in mind.
nanopatent, the work is cut out for NanoViricides, Inc..
After reading your post and others here...http://investorshub.advfn.com/boards/read_msg.aspx?message_id=99202823
I believe we should see a chart for NNVC similar to that of ICPT but NNVC's should be time compressed.
It won't be long for the fireworks to start...
A comprehensive virus survey now could save billions in avoided health care costs later, experts say --- 03 Sep 2013 | 00:20 EDT | Posted by Liz Devitt
...
A consortium of scientists, funded by the US Agency for International Development (USAID), headquartered in Washington, DC, estimated that at least 320,000 viruses remain unidentified in the world’s 5,500 mammals. They argue that the cost of systematically searching for those new viruses would pale in comparison to the estimated $16 billion another epidemic such as SARS could cost.
source: http://blogs.nature.com/spoonful/2013/09/a-comprehensive-virus-survey-now-could-save-billions-in-avoided-health-care-costs-later.html
source: http://mbio.asm.org/content/4/5/e00598-13
Nearly four decades have passed since the world last saw an influenza pandemic, many believe we are long overdue for another. Dr. Michael Osterholm and Helen Branswell mark the inauguration of the Global Health Initiative.
Mammals harbour 'at least 320,000 new viruses'--- By Rebecca Morelle Science reporter, BBC World Service
Flying fox
Nearly 70% of viruses that infect humans, such as HIV, Ebola and the new Middle East Respiratory Syndrome (Mers), originate in wildlife.
But until now, the scale of the problem has been difficult to assess.
To investigate, researchers in the US and Bangladesh looked at a species of bat called the flying fox.
This animal carries the Nipah virus, which if it spreads to humans can kill.
By studying 1,897 samples collected from the bats, scientists were able to assess how many other pathogens the animal carried.
They found nearly 60 different types of viruses, most of which had never been seen before.
The team then extrapolated this figure to all known mammals, and concluded there were at least 320,000 viruses that have not yet been detected.
source: http://www.bbc.com/news/science-environment-23932400
another_voice_2, you mentioned it in one of your posts and it stuck in my mind because I was an avid fan of the sport during the years of Jimmy Connors, Bjorn Borg, Chris Evert, Ilie Nastase, John McEnroe, Guillermo Vilas, Vitas Gerulaitis, to name a few.
If Dr. Seymour is leaving this week for Europe, perhaps we may get a PR today. Go NNVC!
Don't try to answer on their behalf. Up to this point all I have is suggested to contact the broadcast companies with a request. Let us know which one and hopefully many of us will jump in and contact them.
If NBC got in trouble it would likely be because they editorialize and gave their opinion instead of reporting objectively. Got to go...have a great weekend!
daBoze, in what post did I state that appearances on popular TV would accelerate the work by NanoViricides, Inc.? I definitely believe that "reality tv" could use some competition from what NanoViricides, Inc. has to offer, a low-toxicity and healthier world today. Patience is good advice, thanks!
another_voice_2, HI sounds great and happy to listen. Have a great weekend and I hope you win your tennis match, if you are playing any.
Here is the video...
NBC news is good and would be better with NanoViricides, Inc. story on delivery of future science, today. I don't think that if you were to post Maury Povich as possible contact you would have many takers. If you you were to suggest to this board Maury Povich you would get angry posts in return.
When you get a chance, take a look at the video. When Dr. Seymour is asked, "Dr., what is the essential value proposition for mankind today, the answer will be???
Perhaps a more fitting tv program/show for NanoViricides, Inc. to be showcased is Tomorrow Today!
Well, the idea about the Dr. Oz show was just one as I was trying to have others come forward with their own ideas , then I would go to others tv show suggested website (hopefully many of us would) and request invitation for Dr. Seymour. The producers of any given show would evaluate and determine if it would be good fit for them to include NanoViricides, Inc. in their programming. The cost to us investors/traders would be zero other than the time spent to contact the show. Even if one of the tv shows were to get in contact with Dr. Seymour to make arrangements for a show appearance we don't know if Dr. Seymour's schedule would allow it. Still the cost to us investors is zero.
This train (NNVC)will soon be leaving for higher ground. Traders are positioning themselves and hopefully small investors out there have hopped in for the ride that will turn out to be the ride of their lives.
OK- So it is your belief that the Dr. Oz show is or should be in the Food Channel. Fair enough. What is your suggestion and contact link?
CBS 60 Minutes --- swine flu?
Great soundc! I have sent my request, to your suggested organization. I asked them to extend an invitation to Dr. Seymour to discuss the transformational and life-saving technology of NanoViricides, Inc.. If you will, remind us everyday to send our request for an invitation to Dr. Seymour (organization + contact link) until next Friday (or the end of the month). I believe you will agree it is best to spend time making important things happen than to just wait for them to happen.
leifsmith, alright, alright, alright! Contacting Dr. Oz producers to invite Dr. Seymour to a segment on his show may be a way to bring more women angels And entrepreneurs to NanoViricides, Inc..
New Tang Dynasty (NTD) Television is a television broadcaster based in New York City, with correspondents in over 70 cities worldwide. Its stated mission is to bring truthful and uncensored information into and out of China; to restore and promote traditional Chinese culture; and to facilitate mutual understanding between the East and West. ~ wikipedia
On April 22, 2013 NTD broadcasted/captioned a PR from NanoViricides, Inc., "NanoViricides Anticipates FluCide(TM)Drug Candidates to be Effective Against H7N9" (advance video to 1:16 minutes).
Thinking of the why a 2nd Generation nanoviricide(R) is needed...beyond the Brain Blood Barrier.
Q: How does virus get into the central nervous system (CNS)?
One of the hypotheses suggests direct infection of microvascular endothelial cells as a major route of entry of the virus into the CNS, followed by replication of the virus in CNS-based cells. As we know that microvascular endothelial cells (MVEC) are the major constituent of the blood-brain barrier, HIV-1 can either cross the barrier by transcellular migration or the infection may alter the tight junction property of MVEC, creating a breach which allows viral entry.
Another hypothesis supports the idea of cell-associated HIV-1 entry into CNS. According to this hypothesis, CD4+ T-cells and monocytes that traffic across the blood-brain barrier potentially transfer the infection to other CNS-based cells. It has also been suggested that certain cytokines, HIV-1 proteins, and a number of cellular factors may induce alterations in the blood-brain barrier creating a breach in the tight junctions of microvascular endothelial cells. This breach helps the virus gain entry into CNS-based cells
Hepatitis C Virus Infects the Endothelial Cells of the Blood-Brain Barrier
Treating brain diseases -- overcoming the blood-brain barrier: Devin Wiley at TEDxCaltech
The past week had some very interesting posts:
Early on the week...
1-
ABC News Reports Seeking Alpha Sued by Billionaire Investor
online.wsj.com/article/PR-CO-20140311-907231.html~ nanopatent
Excerpt of a new release from Transformational Technology
The Next Pandemic
I see signs nearly every day that the next influenza pandemic is mutating in the wild. The NanoViricides cGMP production facility is progressing as planned, following delays caused by awful weather in Connecticut. Critically, it should be online just about the time the next killer virus is most likely to emerge.
There will, I predict, be a market for the company’s influenza drug as soon as it can be made even if the drug hasn’t been approved. This, as I’ve explained, is what sets influenza drugs apart from other medications. Cancer may kill more people, but the deaths don’t happen in huge concentrations.
Because epidemics create massive media coverage and public fear, government health agencies have a history of panicking when large numbers of people start dying of the flu. Budgets have been thrown out the window to buy drugs that have only marginal effects on influenza survival rates. NanoViricides’ drug, on the other hand, actually works.
Unlike conventional flu drugs that affect the ability of viruses to penetrate cell walls or reproduce, nanoviricides kill target viruses as soon as they’re encountered. They are, in a sense, nanobots. They contain bioelectric triggers that send signals, once triggered by a virus, to polymer nanostructures that are mechanically altered to trap and kill viruses. Animal studies show that influenza symptoms end within hours, and I have no doubt that the same will happen in humans.
For saying so, I am regularly accused of being in some sort of cabal with NanoViricides. History, however, will be the ultimate judge. Moreover, I think the judge is coming sooner than almost anybody expects.
I’ve been similarly slandered as a co-conspirator based on my confidence in companies like Inovio (INO) and Galectin Therapeutics (GALT). If this is the price of making a decision based on science and evidence, I have no choice but to put up with it. On the other hand, we’re only a few years from getting indisputable evidence, and I wouldn’t want to be in the camp of those who are on record scoffing at these transformational companies.
Log in/sign up page link: www.mauldineconomics.com/members/login
~ BigKahuna
UK: Early Access to Medicines Scheme Announced
This could be important! For NNVC among many others ...
www.mhra.gov.uk/NewsCentre/CON392899
Quote:13 March 2014
The government has today announced a new scheme which aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation.
Dr Ian Hudson, Chief Executive of the Medicines and Healthcare Products Regulatory Agency said:
“We are delighted that the Early Access to Medicines Scheme will be launched in April 2014. The scheme is intended to enable patient access to medicines for treatment of life threatening or seriously debilitating conditions where there is an unmet need. This is a major new development in medicines policy in the UK.
“The scheme offers a way by which unlicensed medicines can be available to patients before approval of a licence to benefit public health. It will also enable companies to gain additional knowledge and experience of these medicines in clinical use.”
Find out more about the Early Access to Medicines Scheme
"The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe." —
http://www.mhra.gov.uk/Aboutus/index.htm
~ Leifsmith
Government response to the UK Early Access to Medicines Scheme consultation – March 2014
www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con392877.pdf
~ Leifsmith
Dear Gene,
Thanks for the positive feedback
Our current laboratory is very busy doing the following:
Preparing material for Dr. Harris’s dengue testing
Preparing material for Viroclinics
Preparing material for Public Health England
Preparing material for Lovelace
Doing the scale-up with the equipment that will be used in the cGMP production space. Once the plant come-on line, we will be able to dramatically step up our production. The fact that the scale-up is on-going is important in that there will be no slow down in the scale-up process once we segue to the new plant. And, the current laboratory will simultaneously be producing material for the tox studies
So after the initial tox studies were done and reported, we focussed on getting all these other projects done. Now we’re back, focussing on the upcoming tox studies
It’s really great that FluCide has turned out to be so unbelievably safe. We have yet to find the dose that is lethal in 1/2 the animals tested. That’s great to have a safe drug but it requires so much material for the tox studies that we’re straining to satisfy everyone’s needs. We will use more drug in the tox studies that we will in the human studies. Quite unusual
It’s all about the therapeutic index (from Wikipedia). The FDA wants a number!
The therapeutic index (also known as therapeutic ratio) is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes death (in animal studies) or toxicity (in human studies).[1]
Quantitatively, it is the ratio given by the lethal or toxic dose divided by the therapeutic dose.
In animal studies, the therapeutic index is the lethal dose of a drug for 50% of the population (LD50) divided by the minimum effective dose for 50% of the population (ED50).
Lethality is not determined in human clinical trials; instead, the dose that produces a toxicity in 50% of the population (TD50) is used to calculate the therapeutic index.
While the lethal dose is important to determine in animal studies, there are usually severe toxicities that occur at sublethal doses in humans, and these toxicities often limit the maximum dose of a drug. A higher therapeutic index is preferable to a lower one: a patient would have to take a much higher dose of such a drug to reach the lethal/toxic threshold than the dose taken to elicit the therapeutic effect.
\mbox{Therapeutic ratio} = \frac{\mathrm{LD}_{50}}{\mathrm{ED}_{50}} in animal studies, or for humans, \mbox{Therapeutic ratio} = \frac{\mathrm{TD}_{50}}{\mathrm{ED}_{50}}
Generally, a drug or other therapeutic agent with a narrow therapeutic range (i.e. having little difference between toxic and therapeutic doses) may have its dosage adjusted according to measurements of the actual blood levels achieved in the person taking it. This may be achieved through therapeutic drug monitoring (TDM) protocols.
The therapeutic index varies widely among substances: most forgiving among the opioid analgesics is remifentanyl, which offers a therapeutic index of 33,000:1; tetrahydrocannabinol, a sedative and analgesic of herbal origin (cannabis), has a safe therapeutic index of 1000:1, while diazepam, a benzodiazepine sedative-hypnotic and skeletal muscle relaxant has a less-forgiving index of 100:1 and morphine, a sedative, antidepressant, and analgesic also of herbal origin (genus Papaver) has an index of 70:1[2] (which, however, is still considered very safe).
Less safe are cocaine, a stimulant and local anaesthetic; ethanol (colloquially, the "alcohol" in alcoholic beverages), a widely available sedative consumed world-wide: the therapeutic indices for these substances are 15:1 and 10:1 respectively. Even less-safe are drugs such as digoxin, a cardiac glycoside; its therapeutic index is approximately 2:1.[3] Other examples of drugs with a narrow therapeutic range, which may require drug monitoring both to achieve therapeutic levels and to minimize toxicity, include: paracetamol (acetaminophen), dimercaprol, theophylline, warfarin and lithium carbonate. Some antibiotics require monitoring to balance efficacy with minimizing adverse effects, including: gentamicin, vancomycin, amphotericin B (nicknamed 'amphoterrible' for this very reason), andpolymyxin B.
The effective therapeutic index can be affected by targeting, in which the therapeutic agent is concentrated in its area of effect. For example, in radiation therapy for cancerous tumors, shaping the radiation beam precisely to the profile of a tumor in the "beam's eye view" can increase the delivered dose without increasing toxic effects, though such shaping might not change the therapeutic index. Similarly, chemotherapy or radiotherapy with infused or injected agents can be made more efficacious by attaching the agent to an oncophilic substance, as is done in peptide receptor radionuclide therapy for neuroendocrine tumors and in chemoembolization or radioactive microspheres therapy for liver tumors and metastases. This concentrates the agent in the targeted tissues and lowers its concentration in others, increasing efficacy and lowering toxicity.
Sometimes the term safety ratio is used instead, particularly when referring to psychoactive drugs used for non-therapeutic (e.g. nonmedical) purposes.[4] In such cases, the "effective" dose is the amount and frequency that produces the desired effect, which can vary, and can be greater or less than the therapeutically effective dose.
A therapeutic index does not consider drug interactions or synergistic effects. For example, the risk associated with benzodiazepines increases significantly when taken with alcohol, opiates, or stimulants when compared with being taken alone.[medical citation needed]Therapeutic index also does not take into account the ease or difficulty of reaching a toxic or lethal dose. This is more of a consideration for recreational drug users, as the purity can be highly variable.
Protective index is a similar concept, except that it uses TD50 (median toxic dose) in place of LD50. For many substances, toxic effects can occur at levels far below those needed to cause death, and thus the protective index (if toxicity is properly specified) is often more informative about a substance's relative safety. Nevertheless, the therapeutic index is still useful as it can be considered an upper bound for the protective index, and the former also has the advantages of objectivity and easier comprehension.
EUGENE SEYMOUR, MD, MPH
Chief Executive Officer
NANOVIRICIDES, INC
Nanotechnology-based targeted anti-viral therapeutics
www.nanoviricides.com
eugene@nanoviricides.com
310-486-5677
A New York Stock Exchange Company~ I Need Help
nanopatent's email to Dr. Seymour:
Quote:On Mar 15, 2014, at 6:50 AM:
Gene;
Will NNVC apply in April 2014?
Ref:
News
13 March 2014
The government has today announced a new scheme which aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation.
Dr Ian Hudson, Chief Executive of the Medicines and Healthcare Products Regulatory Agency said:
“We are delighted that the Early Access to Medicines Scheme will be launched in April 2014. The scheme is intended to enable patient access to medicines for treatment of life threatening or seriously debilitating conditions where there is an unmet need. This is a major new development in medicines policy in the UK.
“The scheme offers a way by which unlicensed medicines can be available to patients before approval of a licence to benefit public health. It will also enable companies to gain additional knowledge and experience of these medicines in clinical use.”
Find out more about the Early Access to Medicines Scheme
www.mhra.gov.uk/NewsCentre/CON392899
Doctor Seymour's email/reply:
Quote:Re: Early Access to Medicines Scheme (EAMS)
eugeneseymourmd@mac.com
3:18 PM (6 hours ago)
To nanopatent:
I need more details
I’ll be over there in two weeks so I’ll find out what the procedure will be and to lay the groundwork for our eventual application.
It seems like they’ve harmonized with the US Compassionate Use program. However, I need to find out if the “specials” program will continue or be rolled into this one
My initial reading suggests you need to have completed Phase IIa trials, thus early 2015 looks like a reasonable target date to apply. My goal is to have significant output by the beginning of the 2015 flu season in both Europe and North America.
Gene
PS Just remember that the US government paid $2200/dose of peramivir, a drug that had failed all of its trials. The question is really about how much we can get for a drug that REALLY works!
EUGENE SEYMOUR, MD, MPH
Chief Executive Officer
NANOVIRICIDES, INC
Nanotechnology-based targeted anti-viral therapeutics
www.nanoviricides.com
eugene@nanoviricides.com
310-486-5677
A New York Stock Exchange Company
I agree with rosalieone's post that when the PR's start to roll out, it will be like fireworks...
We all know that NanoViricides, Inc. spends about 2M a quarter to move along a predifined track and/or government regulatory framework in order to take the chosen FluCide candidate to clinical trials/market. A multi-million dollar cGMP Pilot Plant, possibly the only one of its kind in the world, not just because of the building but also because of what the building conceals: computer(s)/software, access to nanoviricides(R) library, high-tech instruments/equipment that would make scale up production of the FluCide canditate possible to meet rigorous standards required for clinical trials.
“By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success,” said Eugene Seymour, MD, MPH, adding, “NanoViricides continued to search for available contract manufacturing capability even after Diwan’s purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property.”
WEST HAVEN, CONNECTICUT -- Monday, December 2, 2013 -- NanoViricides, Inc. (NYSE MKT: NNVC) reports that it has received results of detailed lab analysis studies from the initial non-GLP toxicology studies of intravenously administered FluCide™. No overt adverse safety and toxicology effects were observed in this study of the Company's optimized FluCide broad-spectrum anti-influenza drug candidate, even at the maximum feasible dose level. These results are consistent with the preliminary findings of this study that the Company has previously reported, and provide greater details of the safety of FluCide.
Detailed laboratory analyses of samples from this non-GLP safety and toxicology study showed no overall systemic effects and no direct effects on the primary organs. This includes liver and kidney tissues as well as liver and kidney function. This is important as the liver and kidneys are major organs involved in drug toxicity. In addition, FluCide showed no adverse effects on the lungs from the treated animals. This is very important because the respiratory system is a primary site of influenza virus infection and tissue damage. These strong safety findings were seen at all doses tested, even at the maximum feasible dose (MFD). MFD was much higher than the therapeutic dose range used to treat influenza virus infections in our animal model efficacy studies. FluCide was administered intravenously by tail-vein injections or by infusion in this study. The non-GLP safety/toxicology study was conducted at KARD Scientific in Massachusetts.
These results support the Company's positive findings in animals that were infected with different influenza A virus strains. In those studies, no safety or toxicology concerns were observed. The Company has previously reported that its FluCide candidate demonstrated extremely high anti-influenza activity in lethal infection animal models using multiple influenza A subtypes. The extremely high anti-influenza activity coupled with the strong safety data were the basis for the selection of this FluCide candidate for further drug development.
In addition, the Company is developing a flexible, multi-product, pilot manufacturing facility capable of manufacturing any of its drug candidates in c-GMP compliant manner. This facility will be able to provide the cGMP clinical drug substances for its future human clinical studies. (“c-GMP”= current Good Manufacturing Practices, a set of guidelines developed by the US FDA that the manufacture of a drug must adhere to for human clinical trials and future sales. Internationally, there are similar guidelines promoted by local regulatory agencies, and ICH harmonization guidelines promoted by the WHO). A group of private financiers that includes our founder Dr. Anil Diwan has acquired an 18,000 sq.ft. building on 4 acres with possibilities of expansion, in Shelton, CT, via Inno-Haven, LLC, a company formed specifically for that purpose. This building is now undergoing a total renovation to facilitate setting up a modern cGMP drug substance manufacturing facility with injectable drugs capability, as well as supporting analytical and chemistry laboratory facilities.The Company reported that the renovation of the facilities at 1 Controls Drive, Shelton, CT is now in Construction phase, and is expected to be completed in the first calendar quarter of 2014.
Any good reason why we shouldn't go quickly to market and test low-toxicity FluCide in a human population in need, to save lives?
Here are (2) prominent examples of drugs making it to government stockpile and/or the market with no clinical trials:
1)U.S. federal government are stockpiled millions of doses of smallpox medication in alleged preparation for a potential "bioterrorism attack," according to The New York Times (NYT).
Even though smallpox was supposedly eradicated back in 1980, with the only known remaining virus currently being held in government-owned laboratories, the U.S. federal government contracted with Siga Technologies, a small vaccine and antiviral drug company, to produce two million doses of an antiviral drug known as Arestvyr, which is administered following a viral infection.
The $463 million order ($200-per-dose price), which was made by the U.S. Department of Health and Human Services (HHS), is allegedly enough to contain a smallpox outbreak in a large American city, according to Robin Robinson, Director of the Biomedical Advanced Research and Development Authority (BARDA).
Despite all the glowing endorsements for Arestvyr, which some are claiming will "save lives" in the event of a pandemic, the drug has never been approved for use in humans by the U.S. Food and Drug Administration (FDA). In fact, Arestvyr has never even been tested in humans at all, according to the NYT, because smallpox has already been eradicated in humans.
This means that, should the government one day declare a smallpox or other pandemic, whether real or fictional, millions of Americans will instantly become human guinea pigs for a drug that has never been shown to be safe, let alone effective. Even claims surrounding the benefits of Arestvyr in mitigating damage caused by the smallpox vaccine itself are bunk, as those who recovered the drug were admittedly also given other treatments in conjunction with it.
2)Opponents of legalizing cannabis for medicinal purposes are fond of arguing that the plant must be subjected to the same standards of clinical study and FDA review as conventional medicines. What they fail to mention is that cannabis and its active components have already been subjected to a greater degree of scientific scrutiny than many FDA-approved pharmaceuticals.
According to a just-published analysis of some 200 newly FDA-approved medications, few conventional drugs are tested in multiple, large-scale clinical assessing safety and efficacy trials prior to market approval. “[A]bout a third won approval on the basis of a single clinical trial, and many other trials involved small groups of patients and shorter durations,” reports The Washington Post in its summary of the study, which appears in the January edition of The Journal of the American Medical Association. “Only about 40 percent of approvals included trials in which the new drug was compared with existing drugs on the market.”
By comparison, there exists over 20,000 published studies or reviews in the scientific literature referencing the cannabis plant and its cannabinoids, nearly half of which were published within the last five years, according to a keyword search on PubMed Central, the government repository for peer-reviewed scientific research. Of these, more than 100 are controlled clinical trials assessing the therapeutic efficacy of cannabinoids for a variety of indications...
source: http://www.hightimes.com/read/cannabis-has-been-studied-more-many-fda-approved-pharmaceuticals
How Long Does Weed Stay in Your System? | Marijuana Facts
Diwan Presentaion to FDA 10/6/2006
Outline of Powerpoint Presentation
Title: NanoViricides, Polymeric Micelle-based flexible Specifically Targeted Drugs, Regulatory Implications for (a) IND-enabling Study, and (b) a Novel "War-like" Bio-threat Response Mechanism
Brief Description:
1. A nanoviricide is a polymeric single chemical chain with covalently attached ligands that specify the virus target. The antiviral spectrum of the drug is determined by the specificity of the set of ligands attached to the chain, in addition to other functionally important aspects inherent in the chemistries.
2. The following aspects distinguish these materials from usual drugs and biological materials seen by the FDA:
2a. As a polymer, it is not possible to manufacture a single molecular weight species. It is possible to operationally define a molecular weight distribution, such as "retained by membrane with NMWL xxx and passing through membrane with NMWL yyyy". The actual MW distribution can be characterized, but the result values are strongly dependent on the technique of measurement.
2b. These are not hard particle species. Therefore, SEM/TEM/AFM characterization is not possible.
2c. These are amphiphilic materials, limiting the use of many standard procedures.
2d. The polymer chemistries only enable "substantially complete" attachment of ligands, and this is essentially true for most of the chemistries used in the process.
2e. The material product can be defined operationally (i.e. in terms of processes used to make it), and further can be characterized in terms of average result values of chemistries (e.g. average MW, and MWD, average number of ligands per chain, etc.).
3. The biological efficacy of nanoviricides drugs may be several orders of magnitude better than that of usual chemical drugs (test case- influenza - preliminary studies). This in itself may limit the potential for mutant generation. There are also other key aspects of the design of nanoviricides that are expected to lead to minimizing mutant generation.
The above discussion relates to normal drug development of nanoviricides drugs. In addition:
4. "War-like" Bio-threat Response:
4a. In case of an unknown threat, it is possible to generate antibodies in the field, fragment them, and use well-specified fragments as ligands, attach them, and build a specific nanoviricide drug against the unknown, uncharacterized threat agent. Such scenario can occur in bioterrorism as well as in natural outbreaks (e.g. SARS).
4b. This is a different level of "Emergency Response", relating to scenarios where stockpiling is not possible because pathogen itself is unknown.
4c. This new scenario enabled by the naoviricides systems solution to biothreats may require additional regulatory perspectives. Such as (a) standard or EUA approval for the core nanomaterial, enabling its stockpiling, and (b) very limited, life-threatening-use approval for the nanoviricide generated in-field using the approach outlined in (4a) or a variant thereof such as using some small chemicals or peptides instead of antibody fragments.
4d. The purpose of such regulatory perspective would be to enable treatment within 2-3 weeks of threat event notification - or shorter if feasible - in order to limit casualties and morbidity and contain the threat at its source thus limiting the potential that it can convert into an epidemic or a pandemic.
www.fda.gov/nanotechnology/meetings/Diwan_files/Diwan%20NanoViricides26%20for%20%20FDA%20%202....
Onward leifsmith...ONWARD!!!
Onward drkazmd65...ONWARD!!!
Nanoviricides(R) therapeutic drugs are low-toxicity, life-saving and will soon have its own "breakthrough technology" track, a track for a "flying horse", not a track for the loaded mules some people are accustomed to! Enjoy the ride...up!
Against all odds...onward!
“By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success,” said Eugene Seymour, MD, MPH, adding, “NanoViricides continued to search for available contract manufacturing capability even after Diwan’s purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property.”
Tables are turning! Are we joining a class action lawsuit? Hmmm...
NNVC is "not so silently" moving forward. Not even a hint in that letter to shareholders that we are changing plans, or slowing down. No company likes to spend 2M a quarter unless they are getting results. PRs will soon start to roll out and when they do they will be about the CGMP plant being commissioned by the FDA, Tox package preliminary results followed by final results, and efficacy studies!
The enemy of business...uncertainty! Business leaders move, and move decisively, when they are sure about where they should move to. This letter to shareholders from Dr. E. Seymour, CEO of NanoViricides, Inc. removes a lot of uncertainty! BULLISH!
davidmorse42, NNVC CEO Letter to Shareholders--- March 11, 2014
Read more here: http://www.nanoviricides.com/2014-ceo-letter.pdf
The more you dig, the more you realize the disruptive potential of NanoViricides, Inc. science and transformational technology. Here is a bit more about the human circulatory system in comparison to plants and trees (flora).
Paul Smiths, NY, May 24, 2012 — Do plants have blood? How does the human circulatory system compare to that of plants and trees? Martha Foley and Dr. Curt Stager tackle the question.
According to Dr. Curt Stager of Paul Smith’s College, the first step in determining whether or not plants have blood is to define ‘blood.’ Though plants don’t have the red blood that humans do, they contain green chlorophyll in their leaves. The structure of a chlorophyll molecule is very similar to a hemoglobin molecule, which makes human blood red.
“The main difference would be that there’s a metal atom in the middle of each of those molecules, and in the case of plant chlorophyll, it’s magnesium that gives it a green color. In our case, it’s a red color,” said Stager. The molecules do different things in plants and humans. Chlorophyll’s job is to trap sunlight, and hemoglobin’s job is to trap or let go of oxygen.
Another purpose of blood is to transport fluids, such as water, around the body. Sap in trees functions in the same way that human blood does in this respect. A key difference is that human blood circulates, while sap goes into leaves and then evaporates out. Stager said, “Another thing blood will do is move food around. Like when we eat our food, blood comes from our digestive system and gets pumped around to feed out cells. And you could say plant sap does that too.”
Plant Nutrition and Transport
Puffer, now we have rumor tug o'war. One is keeping the pps down while the latest will likely try to pull the pps up.
As usual, one key quote to provide some perspective.
Nanoviricides are currently binary: they either work in humans as they have in animals, or they don't. IMO, there is nothing in between. If they work in humans, then $10 billion will be leaving $40 billion on the table. Pharmassette went for $11 billion with one drug completing Phase 2 and ready for Phase 3. Do the math with that and 5 antiviral drugs plus 200 more in development. ~ BigKahuna
"...He [Dr. E.Seymour] presented an extremely bullish picture, answered many questions - and so I bought some more, of course! It was hard not to become more excited due to his great enthusiasm, especially when he talks about cures and predicts this year's progress will "blow away" last year's impressive work..."~ KMBJN
FN, the Varroa destructor mite lives by attaching to an immature or adult bee and sucking on the hemolymph or “bee blood.” Not only does this weaken the bee but it allows for the spread of viral diseases.
Anything with the last name of “destructor” has to be bad. Unchecked, Varroa mites will eventually cause the death of a colony, usually between late fall and early spring. Most scientists believe that the spread of this parasite has been the single most devastating development in the history of beekeeping.
The pollinators are fighting back.
Controlling varroa mites in Bee Hives naturally
FN , following your described potential for business in the domestic animals world, here is information on potential business in the insect world.
Economic Value of Commercial Beekeeping Agriculture is a major industry in the United States with a direct connection to one in every twelve jobs. Since the early twentieth century, ‘migratory’ beekeepers have provided a critical service to U.S. agriculture by moving their hives seasonally to pollinate a wide variety of crops. Commercial beekeeping adds between $15 and $20 billion in economic value to agriculture each year.
Without the yield increases made possible by commercial pollination services, food prices would rise, our farm sector rapidly become less competitive globally, and the security and variety of our food supply would diminish. With the wild insect pollinator populations already in serious decline , commercial, migratory beekeeping is more than ever a vital piece of our agricultural economy. This industry faces collapse for reasons having little to do with the great recession – their bees are dying.
The media has focused on the “mystery” behind these bee deaths, and largely overlooked the economic story. We are witnessing the rapid decline of an extraordinarily resilient and productive community, run primarily by family businesses whose members traverse the country to provide irreplaceable services.
Economic Value
Honey bees are the most economically valuable pollinator worldwide, and many high - value crops such as almonds and broccoli are entirely reliant upon pollination services by commercial beekeepers. Globally, 9.5% of the total economic value of agricultural production for human consumption comes from insect
pollination – in 2005, this amounted to just under $200 billion.
source: http://beyondpesticides.org/pollinators/EconomicValueCommercialBeekeeping.pdf
BBC Documentary Who Killed The Honey Bee
A dose of the broad-spectrum FluCide candidate contains approximately 75 trillion low-toxicity nanoviricides(R). Once a dose is injected or ingested by a 100 trillion celled human being,
Nanoviricides are currently binary: they either work in humans as they have in animals, or they don't. IMO, there is nothing in between. If they work in humans, then $10 billion will be leaving $40 billion on the table. Pharmassette went for $11 billion with one drug completing Phase 2 and ready for Phase 3. Do the math with that and 5 antiviral drugs plus 200 more in development.~ BigKahuna
Life-threatening viral diseases afflicting mankind is the targeted near future multi-billion dollar business of NanoViricides, Inc.. NanoViricides, Inc. has identified a nanoviricides(R) product pipeline: H1N1 "Swuine Flu" seasonal influenzas (injectables), H1N1 "Swuine Flu" seasonal influenzas (Oral)
aj348, according to the NYT article,...
Arestvyr is not approved by the Food and Drug Administration except for use in emergencies.
It has never been tested on smallpox in humans because the disease was eradicated. However, it has prevented death in dozens of monkeys injected with what would normally have been lethal doses of smallpox or a related virus, monkey pox.
It also appears to have helped several humans suffering from potentially lethal reactions to smallpox vaccine, which is itself a live smallpox-related virus but is normally harmless. They included a child near death after catching his father’s vaccination virus, a soldier vaccinated just before discovering he had leukemia, and a woman whose immune system was suppressed by steroids and who was infected by touching bait meant for raccoons that contained a combined rabies/smallpox vaccine.
However, those patients were also given immune globulin, other drugs and hospital care, so it is hard to know exactly what worked.
Good question. If Flucide shows low toxicity and completes Phase 1 and 2 studies, then the next type of nanoviricde should only require a bridge study to show that it processes out of the body in the same way. That bridge study might be a PK for both mice and humans, both very quick studies with minimal subjects, or just a dozen humans following submission of an INDA with only PoC in animals and histological results. By the 3rd or 4th version of nanoviricide the PK would probably be included in a Phase 2 protocol.
This is how salts of drugs already approved or in advanced trials are approved for human trials without full testing after PoC and efficacy animal studies. ~ BigKahuna
NanoViricides are currently binary: they either work in humans as they have in animals, or they don't. IMO, there is nothing in between...~ BigKahuna
Federal government purchases two million doses of smallpox drug in preparation for bioterrorism attack
Tuesday, March 19, 2013 by: Ethan A. Huff, staff writer
(NaturalNews) First it was millions of servings of long-term storable food. Then it was billions of rounds of high-powered ammunition and thousands of tank-like armored vehicles. Now the occupying powers of the U.S. federal government are stockpiling millions of doses of smallpox medication in alleged preparation for a potential "bioterrorism attack," according to The New York Times (NYT).
Even though smallpox was supposedly eradicated back in 1980, with the only known remaining virus currently being held in government-owned laboratories, Big Brother has contracted with Siga Technologies, a small vaccine and antiviral drug company, to produce two million doses of an antiviral drug known as Arestvyr, which is administered following a viral infection.
The $463 million order, which was made by the U.S. Department of Health and Human Services (HHS), is allegedly enough to contain a smallpox outbreak in a large American city, according to Robin Robinson, Director of the Biomedical Advanced Research and Development Authority (BARDA). However, if an outbreak were to occur nationwide, the government would need 12 million doses.
But according to Dr. Richard H. Ebright, a bio-weapons expert from Rutgers University in New Jersey, the two million-dose order is excessive because the U.S. government already has about 300 million doses of smallpox vaccine in its strategic reserve. This number is astounding, considering that back in 2001, the federal government possessed a mere 15 million doses of smallpox vaccine.
"Is it appropriate to stockpile it? Absolutely," Dr. Ebright is quoted as saying to the NYT about the purchase. "Is it appropriate to stockpile two million doses? Absolutely not. Twenty thousand seems like the right number."
Not surprisingly, Dr. Eric A. Rose, President of Siga and Vice President of the holding company owned by Siga's multi-billion dollar owner, believes the two million-dose order is appropriate. He has even come out in defense of the $200-per-dose price the government paid for the drug with taxpayer dollars.
Arestvyr is not FDA-approved, has never been safety tested on humans.
Despite all the glowing endorsements for Arestvyr, which some are claiming will "save lives" in the event of a pandemic, the drug has never been approved for use in humans by the U.S. Food and Drug Administration (FDA). In fact, Arestvyr has never even been tested in humans at all, according to the NYT, because smallpox has already been eradicated in humans.
This means that, should the government one day declare a smallpox or other pandemic, whether real or fictional, millions of Americans will instantly become human guinea pigs for a drug that has never been shown to be safe, let alone effective. Even claims surrounding the benefits of Arestvyr in mitigating damage caused by the smallpox vaccine itself are bunk, as those who recovered the drug were admittedly also given other treatments in conjunction with it.
Bill & Melinda Gates Foundation advisor says entire US could be vaccinated for smallpox in three days
But none of this has caused anyone of prominence in the U.S. government to bat an eye, as preparations are being made right now to administer this costly drug to millions of people without proper safety testing. Plans are also apparently in the works to vaccinate the entire U.S. for smallpox, even though the vaccine has been shown to trigger harmful side effects such as encephalitis, an inflammation of the brain.
"If we had to, we could vaccinate the entire country in three days," gloated Dr. William H. Foege, an advisor to the infamous Bill & Melinda Gates Foundation, and perpetrator of the universal smallpox vaccine fraud.
Sources for this article include:
http://www.nytimes.com
http://rense.com/general32/20r.htm
Learn more: http://www.naturalnews.com/039550_bioterrorism_federal_government_smallpox.html#ixzz2ucDFxQr1
NanoViricides, Inc. nanoviricides(R) are low-toxicity, effective and life-saving.