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Thanks to the consulting firm Cote' Orphan Consulting (COC), headed by Dr. Tim Cote', for assisting with the DengueCide orphan drug applications. NanoViricides, Inc., in consultation with COC, has successfully obtained the award of orphan drug designation to DengueCide, the company's drug candidate for the treatment of dengue and dengue hemorrhagic fever, by the European Medicines Agency (EMA). The Company has recently received Orphan Drug Designation for DengueCide from the US FDA.
FDA's orphan drug regulations are intended to create market-based incentives for manufacturers of products for populations with rare diseases. Per the Orphan Drug Act of 1983, a rare disease is defined as any disease affecting fewer than 200,000 individuals in the US in any given year.
The act allows FDA to give the products approved to treat the orphan conditions special marketing protections (7 years of market exclusivity), tax credits to offset some of the costs of development, faster regulatory reviews and additional assistance from FDA reviewers during the development and review process.
http://www.raps.org/focus-online/news/news-article-view/article/3608.aspx
An approved orphan medicine in the European Medicines Agency (EMA) countries is expected to benefit from ten years of marketing exclusivity protection. An additional two years of exclusivity can be obtained if the drug development has complied with an agreed pediatric investigation plan, with a total of twelve years of market exclusivity for a drug that is approved for both adult and pediatric usage.
Applications for orphan designation are examined by the European Medicines Agency's Committee for Orphan Medicinal Products (COMP), using a network of international experts. This designation is recognized by all 27 countries within the European Union.
http://www.barchart.com/headlines/story/1004976/nanoviricides-denguecide-receives-orphan-drug-designation-from-the-european-medicines-agency
Looking forward to 3 to 4 consecutive days of 10 - 25% pps daily followed several days of consolidation and resume the climb in pps.
NanoViricides Announces that DengueCide(TM) Has Received Orphan Drug Designation From the European Medicines Agency (EMA)
http://www.barchart.com/headlines/story/986601/nanoviricides-announces-that-denguecide-tm-has-received-orphan-drug-designation-from-the-european-medicines-agency-ema
May all have a good week!
We may be waiting for the report from KARD Scientific from Massachusetts, Monday...
A good PR this coming Monday should take NNVC beyond $7.59 pps. Monday...
Traders should now look for long-biased trades in NNVC as long as it's trending above its 50-day at $5.01 or above more support at $4.85 and then once it sustains a move or close above those breakout levels with volume that hits near or above 224,697 shares. If that breakout hits soon, then NNVC will set up to re-test or possibly take out its next major overhead resistance levels at $6.50 to its 52-week high at $7.59.
NNVC was a company - yes - is this authorized by the company - no
I'm in however I don't think the use of NNVC or Nanoviricides will be permissible. The Founding Members may want to consider a name like "Disruptive Nano Club" or "Disruptive Sci-Club" or some other variation or similar. For all we know, once the club is created, Members will be posting mostly about NanoViricides, Inc. but there won't be any chance of legal conflict with the use of the name "NanoViricides" or its symbol "NNVC". Good luck to all!
"...probably '15 assuming all goes well. The truly inspiring aspect of that is that if the stock gets to that level, it would signify success in humans and with that it would certainly go much, much higher than $70 (equates to a market cap of only $3.5B). So we would ultimately need a planning committee for the numerous follow-on bashes. I'm thinking Weedie will help us out with that...
One side note.... the increasing spread of MERS with it's very high rate of lethality will get more and more gov't attention in the months ahead. With solid test results out of PHE on MERSCide the company could get quite a boost, along with gov't assistance, as we may very likely be the only solution on the horizon." ~ Puffer
How do you like those odds?
No Tox effects ~75-99% odds... ~ Robi-1-kenobi
No Tox effects: ~75-99% odds
I think there are very good odds of perfectly clean MFD (max feasible dose) Tox results - IMHO odds of maybe 75-99% (I would make a more precise prediction if I knew the MFD used in g/kg). Stock should go up hugely, but many investors may not bid it up due to waiting on GLP Tox start and results.
But my DD findings are that GLP testing will not exceed the MFD used in this non-GLP study and more animals and different species are not likely to be affected differently as the mechanism of action for FluCide is extracellular and elimination is principally glomerular filtration by kidneys - and both will be similar across species. If the stock price gains are muted, this might be a good opportunity to buy. ~ Robi-1-kenobi
I totally agree, a lot of good posters here. I make some wild, "nontraditional and almost unmeasurable" calls, like $200 pps by 2014 but again, take all posts with a grain of salt.
There are many savvy investors/traders/posters here and if anything I am a student here. We are all in agreement that NNVC has some disruptive, transformational technology and when I read some of nanopatent's posts I say to myself, "...FluCide should and will be approved 2014, soon enough I hope, all for the common good/health".
And how about the story on Fritz Andersen, "To combat cancer, turn to a virus..." http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92536655
Thank you for your comments of encouragement to all on this board!
I take it you don't want me to auto-censor...hmmm Roger that!
Expressing yourself in your Signature Area is not a problem with me and I seriously doubt with others on this board (or TOS). TOS are likely similar to that of YouTube for at least the Signature area. I wish to continue posting videos and/or quotes, on the area designated as My Signature, in relation to NNVC, science, economic theory, good government theory/quotes, history, comedy/satire, political (supported by history), music, all as long as it is not sanctioned by TOS and/or our current government. I agree, fair is fair. If I violated TOS from what I've posted in the area designated as My Signature I am sure I will hear from the board admin or have my post summarily deleted (which has happened in recent past) although there are other means for individual posters to deal with the so-called offensive material. I am sure they will publicly or privately e-mail me as well.
Everyone should take all posts with a grain of salt. I enjoy reading most of your posts and the fact you take your time to logically construct them. Most of all, I agree with you on NNVC prospects for the near future.
I am sure that when you post you will be asking yourself how much of this is truthful and supported by history and what is not. That is what I expect you to be aiming at because, after all, you like to edit. Not to worry, I will post more music!
From nanopatent's post...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93749888
In a pandemic emergency in the US, the government has a program called "emergency use authorization", which means that if a drug has completed Phase I/IIa safety and efficacy trials, and it is manufactured under current good manufacturing practice (cGMP) conditions, then the government is eligible to buy the product to treat people with the current circulating strain of the flu virus.
"That is why we are pushing now to get FluCide into human trials as quickly as possible," added Dr. Eugene Seymour, CEO NanoViricides, Inc.
"...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..." ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
Since NanoViricides Incorporated (NNVC), and their ambitions are, by traditional standards, almost immeasurable, how about $200 pps by the end of 2014 for the nontraditional and immeasurable?
...Consider for a moment what it is that fuels innovation. What is it that motivates someone to innovate? Why do some of us choose to take on the task of solving problems currently without solutions? Why do some of us even feel capable of such? These are difficult questions to answer, because the fact is that innovation, on some level, requires audacity. At some point during the innovative process one looks at a challenge and says to oneself "I can succeed where all others have failed." Innovation requires confidence, knowledge, resources, and a complete immunity to the fear of failure that so often plagues the common man. These types of people, these "innovators", are the backbone of the biotechnology world. As the calendar prepares to turn into 2014, there is one company that is showing signs of being the most ambitious innovator of them all. That company is NanoViricides Incorporated (NNVC), and their ambitions are, by traditional standards, almost immeasurable. ~ The Behavioral Economist, contributor for SeekingAlpha
The news embedded in the news...
WEST HAVEN, CONNECTICUT -- August 7th 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that DengueCide™, its drug candidate for the treatment of dengue and dengue hemorrhagic fever, has been officially designated as an orphan drug by the US FDA.
This orphan drug designation qualifies NanoViricides for certain tax credits and marketing incentives under the Orphan Drug Act. In addition, the Company will qualify for the waiver of certain FDA fees when it files the New Drug Application (NDA) for DengueCide with the FDA. Further, the Company will also be eligible for a “Priority Review Voucher” (PRV) from the US FDA when the Company files a NDA for DengueCide.
“Now we intend to accelerate our dengue drug development programs to take advantage of these benefits,” said Eugene Seymour, MD, MPH, CEO of the Company. DengueCide is in pre-clinical development at present. If the pre-clinical development is successful, the Company will need to file an “Investigational New Drug” (IND) application to the US FDA and perform human clinical trials. If the human clinical trials are successful, then the Company has to file a NDA to the FDA to obtain approval to market the drug. There is no guarantee that DengueCide will successfully result in an NDA or a marketable drug product.
If the Company receives a Priority Review Voucher, it can be applied to accelerate the review of another one of our own drugs or it can be sold to another pharmaceutical company for a consideration. Priority review means that the FDA aims to render a decision on the NDA in 6 months. In contrast, the FDA aims to complete a standard review in about 10 months, and it often takes even longer. The estimated economic value of a PRV depends upon the drug class, and could be as high as a few hundred million dollars, according to Duke economists (Ridley et al. 2006; Grabowski et al. 2009). (https://faculty.fuqua.duke.edu/~dbr1/voucher/).
The Company has already filed a letter of intent as required for filing of an orphan drug designation application for DengueCide with the European Medicines Agency (EMA). A committee has already been established by the EMA to perform the evaluation. The criteria employed for orphan drug designation at the EMA are somewhat different from those employed by the US FDA. The benefits of an EMA orphan drug designation are different from those of the US FDA orphan designation. There is no guarantee that the Company will receive an orphan designation for DengueCide under the EMA.
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 EMA.
...
The Company continues to advance its injectable and oral FluCide™ broad-spectrum anti-influenza drug candidates towards clinical trials. Both of these drug candidates have shown extremely high effectiveness and substantial superiority to Tamiflu®, the standard of care, in the unrelated influenza virus types H1N1 and H3N2 in a high lethality animal model. ~ nanoviricides.com
Several posts condensed into one ...from Agora Financial Jul 30, 2013...In our last update, we mentioned NanoViricides’ application for FDA orphan drug status for its dengue drug, DengueCide. Successfully receiving this designation, which is designed to encourage development of rare and tropical disease therapies, would greatly speed DengueCide’s commercialization ramp. This would not only be a boon for NanoViricides and its investors, but for dengue patients as well.
“Now we intend to accelerate our dengue drug development programs to take advantage of these benefits,” said Eugene Seymour, MD, MPH, CEO of the Company.
Nanotech Current Medical Applications...let NanoViricides, Inc. add "Search and Destroy Viruses" to the list...
http://www.nanotechproject.org/inventories/medicine/apps/
http://www.nanotechproject.org/news/archive/6697/
Still a very interesting and almost prophetic article on nanotechnology. Thank you.
Generally forward splits are done when the SP gets well above $100...ZincFinger
I hope that 3.5 forward split is next year, 2014! Confidence on NanoViricides Inc., and the team of expert companies providing guidance through the regulatory maze, is high!
Excellent article, very encouraging! From a recent past article of "Tomorrow in Review" - Addisson Wiggin writes, "I get up in the morning," our friend Juan Enriquez told us during an interview one day late in 2011,
"I read the paper and see all the bad things going on with the debt, deficits, wars and the economy. Then, I step into a lab and see all the potential breakthroughs the scientists I work with are about to unveil."
FluCide will open more opportunities. Once FluCide's "railway to the market" is complete more drugs will be tracked to the market.
Great! This is good advice for the people on this board as well. Many thanks!
In the video below Dr. Diwan says they would like at least a drug/yr. approved (advance video to 11:55). I believe he is being conservative and that is good. One drug/year could change to two drugs/yr. once FluCide is approved. If they expand the capacity of the cGMP plant then even better. For now we will have to wait and see.
The video is from Jul 2013 but you may be right and there was another communication from NanoViricides, Inc. indicating otherwise. Several months ago I speculated they would be moving FluCide and DengueCide at the same time but I was wrong.
ZincFinger/FORZANANO, based on ZincFinger's advice I found these videos on Hepatitis C from Lloyd Wright.
nanopatent, assuming NanoViricides, Inc. did fill an application Nanotechnology Award I am sure come November 4 they/we will be singing...
Oops! That is the other "H..-Cide"! Noted.
http://www.marketwatch.com/story/nanoviricides-reports-it-has-successfully-improved-hivcide-drug-candidate-in-cell-culture-studies-2013-09-16
Blzzy! You are right on the mark and we are winning!
Do you know when Sofosbuvir will be in the market? Is it 2015? Dr. Seymour mentioned HCV-Cide in the SNN video and crashco brought forth the September 2013 news article indicating they are developing/optimizing the drug.
NanoViricides, Inc. is bringing to completion the cGMP plant soon.
FluCide is the first candidate for clinical trials.
Dr Anil Diwan has said in the past they will be bringing one therapeutic drug per year and they have (10) in the pipeline.
Is the patent protection on the "bio-nanotechnological mechanism" for 7 years or 10 years? I don't recall.
If at some point NanoViricides, Inc. were to expand the cGMP pilot plant they could process more than one per year.
Once FluCide moves through the clinical trials with "flying colors" and approved to market do not discount the possibility that US FDA will further beyond their documents and create a "FASTer-TRACK" to the market.
We are getting closer to "Independence Day" from one huge threat to mankind. Influenza "Independence Day" As drkazmd would say, "Onward"!!!
Now this is what I call an Executive. Dr. Seymour is a CEO for a limited in size company, a decision maker, a leader, a manager and most of all, a good executor.
In this video we can see he communicates well with the press/interviewer, the outside world (us). I would say, based on two to three year events, he is a good organization manager; his decision-making role involves high-level decisions about policy and strategy and I would say that as a leader of the company, he motivates; he is a driving force that presides over NanoViricides, Inc. day-to-day operations. We are fortunate to have Dr. Seymour as the executive.
Now this is what I call an Executive. Dr. Seymour is a CEO for a limited in size company, a decision maker, a leader, a manager and most of all, a good executor.
In this video we can see he communicates well with the press/interviewer, the outside world (us). I would say, based on two to three year events, he is a good organization manager; his decision-making role involves high-level decisions about policy and strategy and I would say that as a leader of the company, he motivates; he is a driving force that presides over NanoViricides, Inc. day-to-day operations. We are fortunate to have Dr. Seymour as the executive.
I meant $2000/s by the end of 2014 which to me would have been a case of "irrational exuberance". I mistyped $2000/s and ended up with $200/s, however judging by the mixed reaction on this board I think I will stick with the more conservative estimate of $200/s, by the end of 2014, for the disruptive and transformational technology of NanoViricides, Inc.. Are we winning?
I agree with your assessment. The ROI will dictate which therapeutic drug gets to the market first.
I expect $200 by the end of 2014? U.S.A. "Flag pattern" steady climb. If true, many here will be very happy...
Dr. Seymour said, "...we are a company...with the ability to rapidly create drugs, and when I say rapidly create drugs I'm talking about weeks instead of years..."
"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
FORZANANO, this is great news! Best to you and family!
Well you answered the question that was in my mind and provided confirmation, to some extent, to what seems logical to me.
If the government can give green-light to "Big Pharma" for development of a vaccine in 6 mos. (instead of millions of dollars and years of development) whereby we become the "Guinea pigs", I figured it could do the same for "low toxicity" NanoViricides, Inc. FluCide.
GLP "Tox studies" should take a few short weeks.
The clinical trials then should be...
by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
That means these GLP TOX TESTS WILL BE COMPLETED VERY QUICKLY - FURTHER ACCELERATING THE PATH TO FIRST HUMAN CLINICAL USE. ~ Robi-1-Kenobi