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I stand by what I said. The platform for NanoViricides is approved when the FDA approves the first Cide. The science for all cides is the same. No need to reinvent the wheel.
Once the FDA approves FluCide the platform for all nano virus drugs will be established. There will be no need to duplicate. That's why the Cides will go to market at warp speed. Human trials will only take a few weeks.
NNVC up 06. or 1.17% at close of trading.
Source Breakthrough Technology Alert: priority review vouchers (PRV). Designed by Duke University economists as a means of encouraging the development of drugs for unaddressed tropical diseases, PRVs were made law in 2007. Essentially, they are transferable go-to-the-front-of-the-regulatory-line “chits” awarded to companies that develop approved drugs for these orphan diseases. Estimates of the financial value of these chits range from $200 million to well over a half billion.
Because many tropical diseases afflict populations that are either very small or poor, they represent bad targets for companies that must make profits to survive. As I’ve pointed out many times, Forbes magazine estimated that the pharmaceutical industry spends $4 billion per new drug approval. Even low estimates have the total cost at over a billion.
The cost for individual approvals is considerably less, of course, but the total cost figure is a good proxy for the risk involved in drug development. It is no surprise, therefore, that startups and established pharmaceuticals are unwilling to spend tens of millions on medicines that are unlikely to provide a return on investment.
The Duke economists who designed the vouchers cleverly recognized that the delays associated with regulatory approval could be exploited to encourage orphan drug development. Real FDA reform would, of course, be a superior solution, but I don’t see that happening anytime soon.
Because it can take years to get through the regulatory maze, a shortcut to the front of the line is immensely valuable to Big Pharma. Not only would it reduce the cost of financing, but it could be used to get a drug to market before the competition. In lucrative, but competitive areas, this advantage can be worth billions. Here’s Duke’s overview. This is Wikipedia’s.
As you know, most drug development companies depend on partnerships with Big Pharma to fund extremely expensive Phase 3 trials. If a company that won approval for an orphan drug were to be awarded a PRV, it would change the entire risk/reward picture. At the very least, it could lead to a much bigger cash payout for the developing company in a Big Pharma drug deal. At best, a well-funded company could take a drug through the approval process and sell the PRV on the open market.
This scenario is not as unlikely as it may first seem, for one reason. The drugs eligible for PRVs are, by definition, orphan disease drugs. As a result, orphan drug candidates get valuable special treatment by regulators. It also makes it much easier to raise the money for trials.
So what is an orphan disease? In many cases, the answer is complicated and subject to FDA determination. Fortunately, a number of important diseases were specifically named in the original law, sparing them the uncertainty of bureaucratic discretion. Among truly unpleasant maladies such as snail fever (schistosomiasis) and guinea worms (dracunculiasis) is dengue/dengue hemorrhagic fever.
Unlike many of the other diseases, dengue afflicts hundreds of thousands of people, and a billion people are at risk of catching it. There are four variants or serotypes of the virus and catching one is a minor inconvenience. Catching a second, however, results in dengue hemorrhagic fever, a leading cause of child mortality in the tropics. The appearance of two serotypes in Florida has alarmed public health officials.
A few years ago, when NanoViricides (OTCBB: NNVC) was developing and validating a dengue drug, it was assumed by many that it would be their first drug candidate — because of the PRV. Instead, the company decided to focus on the much bigger influenza market.
This was, I’m convinced, the right strategy. A worldwide pandemic is coming, and NanoViricides has to be prepared for humanitarian as well as financial purposes. Their influenza drugs, including the world’s first oral nanomedicine, could easily save your life if things develop as expected.
Thank you daBoze for giving me some questions to answer. I have the first one as follows: The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
2014 is going to be a busy year for NanoViricides!
Puffer, after DengueCide there will be priority review vouchers every six months for each of the following: Marburg
Rift Valley Fever
West Nile Fever
Junin virus
Machupo virus
Lassa Fever
Hanta Virus
CMV Eye
Hepatitis B & C
Chukungunya Fever
This will be quite a haul. GOOOO......CTIX
Has anyone on this board noticed that some posts are Complete Nonsense?
I enjoy posters who educate us and make us think. I don't enjoy posters who are bombastic. Why do they bother to post? They're not playing "devils advocate" as some do which helps us see both sides of the coin. These posters seem to have an agenda counterproductive to our civilized board. Now, that's off my chest.
If the funds are there, it's not a bad buy. He will dig up technologies and is a terrific writer.
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Would it be too much to ask what your scientific background is or are you self educated in biotech. Either way I am glad you own NNVC and appreciate the science. Dr Diwan deserves the Nobel for NanoViricides Thanks for your posts.
Can't wait!!
noretreat, what are your thoughts about how far we've come and do you still stand on your head?
SEPTEMBER 25, 2013 from a dream to a reality. Time has flown since the split.
Bravo!!! Very well put.
Good thoughtful post falling on deaf ears. My only resentment is giving him or her attention. We should go yada, yada, yada and tune to something else. Our noses are easily twitched.
Would the good Drs bury the loot in barrels ?
Have you got anything showing the foot serving? That would be interesting . Also, hand eye coordination and foot eye coordination shown simultaneously . You always come up with something.
Maybe you right. We could sell the Cides on medical ebay.
It requires a large sales force to detail Drs. A computer center to process orders and a forecast for manufacturing to keep customers supplied. I believe Big Pharma does this on a daily basis and can add NNVC to its marketing and make this a worldwide effort. I don't see NNVC ever being able to do everything Big Pharma is already doing. It would be much more efficient for Big Pharma to do the marketing and sales and allow NNVC to grow into a major mfg. pharma creating new products at a fast pace without the burden of sale and marketing.
I don't believe Dr. Diwan would allow another company to do their own manufacturing and accept royalties when it's his creation and he has manufacturing in place.
When the plant is up to full scale production and human trials have been proven there will be Cides to sell. NNVC at this time has no distribution network , but Big Pharma does. It seems to me that NNVC will license its products to big pharma for worldwide distribution.
It takes years and mult millions of dollars to put together a sales network. Big Pharma already has this capability. NNVC will accept bids from all the leading BP'S and manufacture and control its products. This is how I see it evolving. Anyone care to respond.
This is what I subscribed to: http://www.mauldineconomics.com "Yield Shark" I'm pretty sure this is the news letter Cox will be published from.
Patrick Cox is who introduced me to NNVC. This is great news. I am going to subscribe right now. I know you enjoy reading his investigative reports as his analysis is thought provoking. With his new collaboration, I am excited to see where he takes us. This is important to me, as Pat has led me to some great stocks. Thanks leifsmith.
Thank you for the article. I read the complete piece and came away with NNVC being a perfect fit for NYSE MKT. This will be the first giant step up to world class investors.
"As long as you have a story that makes sense," says Bonfiglio, "success will come." That fits NNVC to a "T". Success is starting.
I posted about a little league coach a few years back ,around 2010, who contracted aand died of West Nile Virus. It was on this board. You posted back that a coach in your area also died of WNV. We corresponded a few times and talked about where we lived etc. No mystery, I just happen to remember it. It might be the view from your" Eagle Peak" that I won't forget.
Well said. Thanks
One of Patrick's close friends and an associate that took over as editor of Breakthrough Technologies is Ray Blanco. Ray probably knows Patrick's plans.
Patrick Cox is no longer with Agora Financial. He left the company to start investing in the companies he had been researching. He as much as said that NNVC was about to become a success and the only way he could invest was to resign because of the companies rules that he could not own shares of those companies. He has been right as the company is showing great stock growth of over 100% since he announced his decision.
NanoViricides Inc. (OTCBB: NNVC)has announced that it has retained Australian Biologics Pty. Ltd., a regulatory affairs consulting firm, “to coordinate the regulatory review and approval to conduct the first human trials in Australia for FluCide, the company’s broad-spectrum anti-influenza drug.” This is a brilliant move because Australian data are accepted by the U.S. FDA, but the process is significantly faster in the land down below. I expect that six-nine months will be shaved off the process via this move.
Another influenza pandemic is, by the way, inevitable. NanoViricides has already registered its drug candidate in numerous countries, so that authorities will have access to information when an emergency arises. Remember, this is not a vaccine. It is polymer-ligand nanobots that disassemble viruses in the bloodstream — several orders of magnitude better than existing flu medications. In fact, I predict it will be a cure for influenza.
The construction of the Connecticut manufacturing facility, by the way, is on schedule.
Things are getting really exciting. The economy has held back biotech significantly, but progress is beginning to get past the barriers regardless.
Yours for transformational profits,
Patrick Cox
Another_voice, you and I have corresponded before. You have a magnificent view from your home. I am glad you are moderating this board. Thank you.
I'm south of you in the Sangre de Cristo Mts. Cotopaxi, Co. Aloha!
I would like to compliment all the posters on this board. I read all the information that you bring each and every day and am learning quite a bit. We have a great stock and great stockholders. We will succeed with our investment and NNVC will be one of the most important scientific breakthroughs in modern medicine. There is now light at the end of the tunnel.
NO, everything comes to a head within the next twelve months. All the tests ongoing and everything for 2014 lead to 2014 as" THE YEAR." It will be awesome !!
This is the kind of article that will make NNVC stock climb, imho.
TTJ, you and are on the same page,paragraph,sentence,and word. This is the easiest money and" Baker Bros" are nowhere to be seen. This doesn't surprise me even the high and mighty get it wrong .
GO.......CTIX
I purchased 14,200 shares today to go with what I have accumulated because of everything you mentioned, especially Leo's report. Wild 4 Nano's list of questions was the best info I could get. Thanks
What is different about the nano particles tested in this article and NanoViricides. I believe that this shows the fears of some is misplaced. Fellow stock holders, this is at least equal to a cure for most if not all cancers. It's mind boggling. When virus is defeated a lot of cancer is not far behind. We hold one of the greatest stocks of all time.
Thanks Puffer. I called LRRI at Kirtland Air Force Base - Albuquerque, NM and asked if they wouldn't mind giving an approximate date when FluCide testing would commence. One of their Docs is supposed to call me back. They're a big testing facility, employing 1200 people including 150 PHDs. They handle some pretty nasty stuff. Pharmaceutical and Biotechnology Capabilities:
Aerosol Technology
Analytical Chemistry
Bioanalytical Chemistry
Cardiopulmonary & Safety Pharmacology
Drug Deposition in Lungs Using Gamma Scintigraphy
Efficacy Animal Models
In Vitro Models
Pharmacokinetics
Preclinical & Nonclinical Safety
Respiratory Infection & Host Defense
Environmental, Workplace and Human Health Risks:
Aerosol Technology
Biosafety Level Three (BSL-3, ABSL-3) Facilities
Cardiopulmonary & Safety Pharmacology
Immunotoxicology
In Vitro Models
Inhalation Toxicology
Radiation Dosimetry & Toxicology
Toxicokinetics
As I recall, the FDA set testing for 17 viruses. This could be the answer.