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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...
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!
How do you like those odds?
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.
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?
The news embedded in the news...
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.
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.
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,
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..."
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...