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arvitar wins by landslide!!!!
NNVC is quite successful at ripping off naive investors. Congrats on the winners!!!!
Plus that turkey has had more biotech success and been far more honest while is far closer to a real personality A that actually gets work done while refusing to hire shady, immoral promoters.
Saving the big bullshit fraud PRs for Q1 so he can float another butt-ugly pipe?
Sounds like concerning NNVC, we should be looking either in the Fantasy section or the True Crime section of the library.
Or likely both would qualify.
So far Seymour, Diwan, family, and friends get all the gold while all the shareholders get a bag to hold.
Perfect call on LIVE, SSkillz. Nice going.
Interesting post. Thanks.
What's the code name for the the SEC investigation -- Nanoviricides-icde?
There is always a lag between SEC investigation and formal charges.
Stay tuned, my friend!
No comment.
He looks more likely stoned out of his skull to me.
That would also explain a lot if he actually believes 10% of what he says.
Well, in Seymour's defense, who wants to bother writing a letter when you can be sipping cocktails in first class?
After about 3 minutes of research, I can say with strong confidence that isn't the real Seymour. Certain words the fake Seymour used are popular by somebody else but not Seymour.
lol
Got me.
Seymour!!! So glad you are so glued to IHUB 24/7 instead of actually ever accomplishing anything. It makes true crime enthusiasts entertained that much more.
Within an hour, you managed to read a post, create an account, and respond all before the original post was an hour old. Who cares about curing viruses? We have IHUB to deal with, right?
I doubt Senator Murphy is stupid enough to fall for an obvious biowreck scam.
Thousands of people met Bernie Madoff in person too. Who gives a shit? What good is meeting Seymour unless one has a polygraph machine in tow?
Many people have met Seymour and came back with glowing reports of imminent fortune over the last 11 years. Who cares? Does meeting potential con men give one magical insight that is any better than the obvious God-awful poker face Seymour shows on his pump videos?
Some of us with an iota of street smarts can see right through Seymour like glass on his YouTube videos which is why we enjoy watching them over and over again. They're so bad it is stunning. Almost as bad as Miss Cleo's psychic commercials.
When it comes to biowrecks scams like NNVC, sticking to savvy analysis is better than sticking to known facts.
Anti-HIV NanoViricide Drug Candidate Demonstrates Significant Therapeutic Efficacy In Animal Trials
NanoViricides, Inc. (OTC BB: NNVC.OB), said that its anti-HIV drug candidates demonstrated significant therapeutic efficacy in the recently completed preliminary animal studies. The studies were performed at a Bio-Safety Level 3 Laboratory (BSL-3) facility in Boston, MA. These mouse model studies were conducted by Dr. Krishna Menon, PhD, VMD, MRCS, a world-renowned authority in preclinical and toxicological studies of innovative therapeutics.
"Dr. Menon has indicated to us that the results of the study validate the Company's HivCide-I as a potential treatment for HIV/AIDS," said Eugene Seymour, MD, MPH, CEO of NanoViricides, adding, "Over the next several weeks, we expect to release additional study data." The Company's scientists are now designing the protocol for a follow up anti-HIV study to be performed at a major United States government research facility.
The Company also said that animal studies for its drug candidates against bird flu (H5N1) are due to be scheduled at a major United States government research facility. The company has previously reported that animal studies against Ebola would be undertaken following the success of in vitro studies. These studies are continuing.
NanoViricides, Inc. is using injectable nanoviricides for its initial HIV studies. Future plans call for the development of a long-acting anti-HIV skin patch. The Company feels that this delivery method will result in markedly improved patient compliance.
About NanoViricides
NanoViricides, Inc. is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricide™ class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H5N1 bird flu, seasonal influenza, HIV, hepatitis C, rabies, dengue fever, and Ebola virus, among others.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements of the company to be different from those expressed or implied including the success of the Company's research and development efforts, the availability of adequate financing, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process, described in the "Management's Discussion and Analysis" section of the Company's Form 10-KSB and other reports and filings with the Securities and Exchange Commission.
NanoViricides, Inc.
Christa ?? 16:00
NanoViricides Announces that DengueCide™ Has Received Orphan Drug Designation From the US FDA
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.
DengueCide is a nanoviricide® that has shown very high effectiveness in an animal model of dengue virus infection. These animal studies were conducted in the laboratory of Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley. Professor Harris has developed a mouse model of antibody-dependent-enhancement (ADE) of dengue infection that simulates dengue hemorrhagic fever (DHF/DHSS) using a special laboratory mouse strain called AG129. In humans DHF/DHSS is associated with a high fatality rate. In this model, infection with a dengue virus, when the mice are left untreated, is 100% fatal. In contrast, in the same study, animals treated with NanoViricides' DengueCide achieved an unprecedented 50% survival rate.
There is currently neither an effective drug treatment nor a vaccine for dengue virus infection. No vaccine or drug candidate has succeeded in clinical trials towards approval as of date in spite of significant development efforts. Several dengue virus vaccine clinical trials are ongoing. Previously, a drug called poly-IC-lC received an orphan designation in 2003 for dengue treatment. This drug is supposed to act as an immune booster and is in several clinical trials. Three additional treatments for dengue fever are found in a search of the clinical trials database (http://clinicaltrials.gov/ct2/results?term=dengue&pg=5&show_xprt=Y). These include chloroquine, balapiravir (Roche), and celgosivir.
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.
About Dengue and Dengue Hemorrhagic Fever
Dengue fever, a very old disease, has reemerged in the past 20 years with an expanded geographic distribution of both the viruses and the mosquito vectors, increased epidemic activity, the development of hyper-endemicity (the co-circulation of multiple serotypes), and the emergence of dengue hemorrhagic fever in new geographic regions. In 2013, this mosquito-borne disease is one of the most important tropical infectious diseases globally, with an estimated 400 million cases of dengue fever, over one million cases of dengue hemorrhagic fever, and 50,000-100,000 deaths annually. Dengue virus occurs in four primary serotypes. Although the disease is endemic in many tropical parts of the world, it is considered an orphan disease in the USA and Europe. (From Clinical Microbiology Reviews).
NanoViricides Pipeline
NanoViricides is developing broad-spectrum anti-influenza drugs as part of its rich drug pipeline. The Company believes that its FluCide™ drug candidates will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. The injectable FluCide drug candidates have shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The Company believes that these animal model results should translate readily into humans.
NanoViricides has also developed an oral drug candidate against influenza. This oral version is also dramatically more effective than TamiFlu in the animals given a lethal influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.
In addition, NanoViricides has developed drug candidates against Dengue, HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown strong effectiveness in relevant animal and/or cell culture models.
About Cote Orphan Consulting - Expertly Guiding Orphans Through the FDA
COC was established by Tim Coté, MD, MPH, as a consulting service to pharmaceutical companies working in the area of rare and neglected diseases. Dr. Coté was the Director of the Office of Orphan Product Development (OOPD) at the FDA, from 2007 to 2011. In this role heading OOPD at the Agency, he was responsible for the implementation of the Orphan Drug Act, a system of grants and drug development incentives designed to create therapies for 6,000+ rare diseases. He served as the Chief Medical Officer (CMO), National Organization for Rare Disorders (NORD), Washington, DC, after leaving the US FDA. He has held several other illustrious positions with increasing responsibilities during his career, including CDC Country Director for Rwanda, Senior Research Investigator in the Viral Epidemiology Branch of the National Cancer Institute, and Branch Chief, Therapeutics and Blood Safety, CBER, FDA. He is currently Professor of Regulatory Practice at the Keck Graduate Center, Claremont, CA, in addition to his role as the Principal at COC.
About NanoViricides
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
Contact:
NanoViricides, Inc.
Amanda Schuon, 310-550-7200
info@nanoviricides.com
Just like a 100% chance of a CEO letter in October?
lol
Many have taken it to the SEC and the SEC may be busy investigating and putting together its detailed case as I type to you. Part of that case may even involve emails from Seymour that contradict information contained in previous security offerings. Who knows? ;)
Stayed tuned for exciting times!!!
SEC regulations require companies to have a "reasonable basis" when making forward-looking statements.
https://www.law.cornell.edu/cfr/text/17/240.3b-6#b
Seymour's mathematically impossible timelines and pattern of massive misses proves his statements are lacking a "reasonable basis" and are not made in "good faith." According to the SEC, this constitutes fraud.
Brave.
Brave.
With so many small cap medical-related stocks reporting profits lately, why bother with this scam?
ZYXI -- about my thinking too. And the real question is with whatever revenue increase in the Q4 can it be sustained and grown like they claim?
Even at $0.03 for Q4 as you mentioned that's annualized $0.12 and a PE of less than 3 which is insanely cheap for a sustainable earnings growth stock. At $0.04 to $0.05 sustainable as you mention it just gets dizzy.
Interesting post. Thanks.
More fraud from years ago:
"The Company has already successfully scaled up the synthesis to multi-gram scale, sufficient for animal testing, and can easily scale the processes to make kilogram quantities for widespread application in human patients if they are found to be effective and safe."
Easily?
Oh my what bullshit. lol lol lol lol wow lol
The devil is in the details for starters. How many trials failed miserably? Is Seymour only reporting the ones that randomly were a success, post hoc style?
If they were such a perfect success, why the need to find brand new candidates?
I'm not going to sit here and attempt to explain all of the details of the fraud going on. That's for the multi-millionaires. They are the fraud experts.
Back to the claim that anybody ever said that?
ABSURD STRAWMAN FALLACY
"The Company...is producing Injectable FluCide™...in the large quantity needed for the Safety and Toxicology ("Tox Package") study...The Company reports that it has successfully scaled up the production of injectable FluCide at its current facility."
~~NNVC in a PR on April 2014
FRAUD
Words of a sociopath liar don't qualify as pre-clinical data.
It is a scam. As I've been warning with facts, they've accomplished nothing and will continue to accomplish nothing.
The 10Q revealed they are still working on scaling to 200g batches years after this scam claimed scale-up was completed for TOX -- something that required kilogram quantity batches.
Meanwhile Seymour and Diwan have banked millions since that material lie while investors kept blinding sinking millions into this scam.
Fact.
Dude, it's a scam. Period.
Interesting post. Thanks.
Given how complicated apparently figuring out what a basic PE ratio even is some (lol), how are we to figure out what a properly valued PE is as it pertains to PFHO?
lol
It's much easier when a nanoscam medical company fails for 11 years straight to calculate the fair value.
Not verified = no achieved. Furthermore the 10Q says "we have scaled most production operations to 200g scale"
Not all!