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This is from Ray Blanco, Patrick Cox's investigative partner. Notice he mentions Lovelace (LRRI) as doing the toxicology for FLUCIDE. This should settle the Tox worry.
NanoViricides (OTCBB: NNVC) has also made regulatory progress recently. The company has received Orphan Drug designation for DengueCide.
Like Fast Track, Orphan Drug designation accords a special status to an investigational drug in order to help speed development. These incentives include tax credits and marketing incentives for drugs with the potential to improve treatment for rare or otherwise unaddressed diseases.
Orphan Drug status also waives certain hefty FDA fees applied to marketing approval and creates the potential for moving the prospective therapies to the head of the line with a Priority Review Voucher. A Priority Review Voucher doesn't necessarily have to be applied to the drug that earns it. It can also be sold, making it a valuable commodity. NanoViricides is also pursuing an orphan drug designation with the European regulatory authorities.
By the way, NanoViricides has secured the services of the Lovelace Respiratory Research Institute (LRRI) to perform efficacy studies on its influenza and MERS (Middle East respiratory syndrome) coronavirus candidates. MERS appeared earlier this year in Saudi Arabia, but cases are cropping up in Europe as well. Mecca is a major religious destination for millions of Muslims worldwide, creating an ideal situation for the virus to move internationally, and the possibility for it spreading beyond that country worldwide is very real.
This has public health officials in the U.K. very worried, and they are investigating NanoViricides at a secure facility. LRRI will do similar work in New Mexico.
Regarding FluCide, LRRI will be performing important pre-IND (Investigational New Drug) work. This includes toxicology work both in vitro as well as in vivo. Data from these preclinical studies will be used to support FluCide's FDA application so it can move on to human clinical trials. Testing will be performed on various unrelated strains of influenza Type A, including the new and deadly H7N9 strain that recently appeared in China. H7N9 is considered a pandemic threat.
I'm happy to report that my dead money in NNVC is starting to breathe and is showing a healthy recovery.
With all the traveling Dr. Seymour does, I bet he never picks up a virus because he loads up on the cides. He would make a great traveling companion. Doc may I have one of those pills you're taking? Sure, help yourself just don't tell where they came from.
Do you know when testing commences in England? I just read your post that addresses my question. I need to catch up before posting.Never mind.
DrBig,....................................you're FIRED!!! 8>)
Isn't it bella to own NNVC. Happy days are here again. I'm going to open a bottle of wine and toast NNVC.
Puffer, I would prefer that you be in charge. Maybe NanoPatent could be your assistant.
Nano, I have to say I'm glad your not in charge because 2-3 billion is so far from where the value of NNVC'S viral pipeline is. Each cide would bring in that much. How many viruses are there?
I sent an email to Agora after Patrick released his NNVC report. Breakthrough Technology Alert Patrick Cox "Britain’s equivalent to the U.S. Centers for Disease Control, Public Health England (PHE), is now working with NanoViricides (OTCBB: NNVC) to develop cures for both diseases. Read the press release here." The press release is not the announcement for the working agreement between the PHE and NanoViricides. Can Patrick send the correct press release as this is an important part of his report? Also, thank you Patrick for your terrific work. You will be missed. This was sent last wednesday. Agora says all inquires are to be answered within 48 hrs. I called back yesterday and was told that NNVC had released the information. It seems that the timing was off between Patrick and Dr Seymour. No harm no foul as it was quickly reported to the SEC.
There is no way Patrick Cox would do anything unethical. He announced exactly why he was leaving and in no way did anything that violated any laws. Davidc is way off base with his accusation and could be accused of libel.
Dr BIG, Cox resigned for the very reason you stated. He is now free to invest in NNVC or any other stock he covered in his five years with Arora. His last piece was the announcement of the agreement in England which was not approved for him to release. NNVC has since released the information.
The original post was omitted because I left my real name and email address on the post. What I posted to Ovi is what her response was, also she stated that her findings were to be released by NNVC and that she wasn't allowed to publish her findings separate from NNVC because of their agreement. She's excited about DengueCide and the orphan drug status filing. It looks as if NNVC is pulling itself out of the mud and starting to gain some momentum. GO NNVC!!!!!
As soon as a world wide pandemic comes along. Heaven and NNVC will be moved then!!!
One fact that we are overlooking is that with the agreement with England, NNVC has access to one of the top biohazard labs in the world which gives NNVC a huge proof of concept against all these nasty viruses. I don't think there's any question that the agreement with England is HUGE, HUGE, HUGE and will speed up the approval process enormously especially if a pandemic occurs. Now if we can get the WHO to study what is happening between the testing in England and NNVC then maybe they will put on a concert. Excuse me the wrong WHO.
Ovi, I got an email from Dr Eva Harris last week and shared it with the board. She is excited about NNVC applying for orphan drug status and looks forward to using DengueCide to treat Dengue Virus. All of her testing which was reported by NNVC per their agreement was highly successful and she knows what NNVC means to the public health of the poor nations of the world.
Does this make you clairvoyant when your socks are knocked off ? I would like visual proof. Trust but verify.
The market closed early. No wonder streaming quotes were screwed up. Never mind.
Do you think he has an announcement forthcoming?
Someone is playing games. On my streaming quotes, the ask is .789 and the bid is .5001. Does anyone else see this?
I've sent an email to Patrick Cox asking that he substantiate the PHE affiliation with NanoViricides. It takes up to 48 hours for a reply. I sent the email yesterday after your question of where the announcement came from. When I hear, I'll get back to you. I hope for good news. Like you say this could be huge.
You are right. I can't find anything to back up Patrick's reference to the cooperation he mentioned. Maybe if I ask Dr Seymour, he can shed some light. You have to admit that this is very interesting if Dr Seymour says it happened while he was there.
It's part of what was posted yesterday regarding the European Union. But I concur that this is super huge. Remember Dr Seymour's trip to England, now it's official, WOW.
More from Patrick Cox: NanoViricides Signs Agreement With Public Health England
Speaking of viruses, you're undoubtedly aware of the growing concern, if not outright fear, that a new and lethal virus is about to emerge. The two most pressing viruses are N7N9 and MERS, which is similar to SARS. Both N7N9 and MERS have fatality rates of about two-thirds. If either breaks out, we've got big trouble. Worse, either could mutate into a highly contagious version, in which case we've got an apocalypse -- unless there's a cure available.
Then, of course, there's the possibility that somewhere there is a biotech version of the Pakistani nuclear scientist A.Q. Khan. Khan, as you know, helped Iran and North Korea develop nuclear capabilities. Just as Osama bin Laden found a haven in Pakistan, virus hackers could quietly set up shop there with little fear of interference.
Mutating lethal viruses, however, is far, far less challenging than developing nuclear weapons. The simple lab equipment needed for inducing these mutations is easier to buy than fertilizer for homemade bombs. Moreover, viruses are far, far easier to transport than nuclear weapons. If you infected multiple individuals just before boarding planes, there'd be no way that the carriers could be identified and prevented from contact with other people.
Britain's equivalent to the U.S. Centers for Disease Control, Public Health England (PHE), is now working with NanoViricides (OTCBB: NNVC) to develop cures for both diseases. Read the press release here.
You may not see the impact of the Public Health England agreement on NanoViricides' stock price immediately, but this is always the case with these things. Like similarly underpriced Star Scientific, NanoViricides has been the subject of massive unscrupulous short attacks. You may not see it skyrocket, in fact until the day that a desperate move is made to accelerate production of the company's drugs. Then, it will be too late to get in early.
As you know, I intend to join you soon as an investor in some of these companies as well as others. With that, I turn you over to the capable hands of Ray Blanco.
Forzanano, you are a man of the world and know the economic mind set of the countries you gave examples of. Guess what? You are funny.
Echo20, you chose the defining moment which clearly states the time has come for him to invest in NNVC because the stock is about to explode. How anyone can read what he said and not see that's what he means is "bull headed". Bull is the metaphorical term of the moment.
If you take a bath, it will be in the profits, and you and everyone will enjoy the improvement.
Yes Dane, #69076. He announced this out of the clear blue. He made it clear he would invest in NNVC after his resignation.
Let me say this about that. Cox has been very important to NNVC because he saw the science and the huge platform, maybe the best in all of biotech. That being said for him to honor NNVC with his swan song into the private sector of investing is putting your money where your intellect is. This is one of the defining moments of all my investments. BigKahuna please expand on what this means for our investment. I think you've had time to digest this as it is out of the clear blue.
I couldn't have said it better myself!!!
Patrick Cox is leaving Agora so that he can invest in some of the companies he has covered over the last few years. He says it is now time for him to invest in NNVC. Here is his latest report:
June 26, 2013
Orphan Drug Status for NanoViricides One Step Closer to Priority Review Voucher
Dear Breakthrough Technology Alert Readers,
Unless you're new here, you know about 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.
On the other hand, there's actually a lot of international money available for tropical orphan diseases. This makes the probability of obtaining a partner that would finance a dengue drug relatively high. Inovio (NYSE: INO), in fact, has received significant aid for the development of a vaccine for malaria, which is also on the list of orphan tropical diseases. The odds that NanoViricides could get major financial help have just risen with the company's application for orphan drug status.
The bigger point, however, is that the science behind NanoViricides is revolutionary and enormous. Because these polymer/ligand constructs attack viruses directly, rather than by altering the body's reaction to viruses, they are incredibly safe. In every test thrown at the technology so far, NanoViricides' efficacy has been verified.
Given that there are dozens of virus targets for this technology, we're looking at a pipeline that could produce blockbusters for decades. Already, the company has shown it can knock down herpes in the eyes of animals using a topical form of the drug. Right now, we're looking at the development of MERS. NanoViricides could develop a drug for this SARS-related virus in a relatively short time. Rabies, Ebola and Marburg drugs already in the pipeline. HIV/AIDS will come. There are too many rare tropical disease viruses, but each could generate a PRV for the company.
The company's technology, however, goes beyond viruses. Already, it has been awarded a patent on conjugate drugs that include polymers. For that reason, the NanoViricides platform extends far, far beyond the diseases we've been discussing. You can try to time your purchase of this company, but I honestly don't believe a few years of stable stock prices are going to matter when this company takes off. In fact, I'm beginning to think that the time for me to invest has to be soon.
A Personal Announcement
As you know, Agora Financial doesn't allow analysts like me to own the stocks that we recommend. While I complain about this policy incessantly, I also recognize that it is a very legitimate way to deal with widespread conflict-of-interest issues in the financial research business. The other strategy, of course, is full disclosure, but that wasn't Agora's choice.
So I've decided that it's time for me to join my readers and start investing in some of the once-in-a-lifetime opportunities that I've been writing about for over five years now. My colleague Ray Blanco is going to take the Breakthrough Technology Alert ball, with help from an impressive team that you'll hear about soon. I'm going to join you, the investor class, in a matter of weeks.
Incidentally, Ray and I were friends and neighbors researching disruptive technologies before we began writing here, and we'll continue doing so in the future. I value his perspective and superior investment analysis skills immensely. I'll be passing on anything I can give him to continue and improve this newsletter, which I'm sure he will do.
Nevertheless, after this month, I'll be giving up any and all responsibility for the contents so that I can put my money where my mouth has been. On a personal level, I'll be focusing my research more narrowly on emerging and effective life-extending technologies -- as I would like to avoid senescence and death for as long as possible.
Thank you!
KarinCA, I read all your posts and imo you are very astute. You mention CUR as one of a few stem cell stocks you currently own. Is IS.O in your portfolio? I read your posts for CT.X and it is my #1.
Let me just say that CUR is going to revolutionize spine and brain injury treatment and has already shown strong results with LGD.I am proud to invest in these wonder stocks and the future of medicine.
Thank you KarinCA.
BK, don't you think there may be a shift in attitude at the FDA? They seem to have awakened to a more urgent need for new cures so they seem to be streamlining their regulations to speed up the process or am I just hoping and wishing?
BK, didn't you contract dengue some years ago? Has it shown up in Hawaii, or do you not have mosquitos?
The KEY to invention was started by B. Franklin. He was a kite flying son of a gun! I guess this will be deleted unless I mention NNVC.
You little toot, you!
VEAL!!! Do Italians know VEAL!!! Bella
I went back and read the statement. When I first read it I thought flu testing but having read it again, it does look like it says tox testing will be completed before the middle of next year. Maybe the author of this piece misunderstood the time frame?
Thanks Nanopatent, we need all the publicity we can get. Bring it on.
Now that's funny!!! Thanks for the laugh!!!