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I'm not an attorney but I believe the Supreme Court ruling on the "Chevron" case makes this alleged SEC letter moot.
I'm guessing we will find out soon.
It could be a human case of Bird Flu in Texas.
Cattle are now catching it.
To me, that means it can infect other mammals more easily than before.
https://www.politico.com/news/2024/04/01/first-human-avian-flu-case-texas-00149949
I could see NNVC starting Phase II trials with NV387 to treat Dengue. Plenty of cases in India.
From what I see, there have been zero covid cases in India recently. Perfect!
I don't know if the chemistry is applicable, but I can imagine NV-387 test results on Type A flu strains supporting the off label indication.
That would build a pretty strong case for NNVC's broad spectrum antiviral drug candidate.
It's Phase I. Your start with relatively health people so that comorbidities won't play a role in the results. Its designed to be conservative as a first step into human trials. My understanding is efficacy is normally performed in Phase II, but they designed it to get some efficacy data in phase I in this case. Phase II will expand the demographics. Your questions will become OBE with all the positive outcomes.
Disclosure agreement with Gilead Sciences?
Doesn't NanoViricides Inc. need to have an agreement with Gilead Sciences to be able disclose research of encapsulating Remdesivir in their Nano-mycell COVID19 candidates?
I think you are confusing Confucius with the confused.
Yep - Harder to make it in after today however.
Russell 2020 Microcap - Nanoviricides Inc. made the first cut - today will confirm it. Good luck traders.
https://content.ftserussell.com/sites/default/files/rmicro_additions_20200605.pdf
The SEC Order
https://www.sec.gov/rules/exorders/2020/34-88465.pdf
In response to all the innuendos that NNVC received an order from the SEC
Fujifilm Pharmaceuticals U.S.A., Inc
1 Broadway, Cambridge, MA 02142
What happens if a coronavirus vaccine is never developed? It has happened before
https://www.cnn.com/2020/05/03/health/coronavirus-vaccine-never-developed-intl/index.html
Here are the positives I was referring to:
https://finance.yahoo.com/news/nanoviricides-presentation-covid-19-shingles-101500849.html
SHELTON, CT / ACCESSWIRE / April 29, 2020 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, today announced that the Company's presentation with an update of its drug development programs for the treatment of Shingles and for COVID-19 made at the Planet MicroCap Showcase 2020 on April 22nd is now available for viewing. Anil R. Diwan, PhD, President and Executive Chairman of the Company, presented this Corporate Update.
The archived presentation is now available for on-demand playback by accessing the following link: https://www.webcaster4.com/Webcast/Page/2059/34392
The archived presentation has the full audio track linked to the slides. There was a technical error whereby the slides were not changing during the live presentation. Therefore, the Company encourages people to visit the archived presentation.
Key takeaways from the presentation are as follows.
COVID-19 Update:
The Company has drug candidates that were highly successful in cell culture studies against multiple coronaviruses.
The observed broad-spectrum anti-coronavirus activity of these drug candidates provides confidence that even as the virus mutates, the selected nanoviricide drug would continue to be effective against it.
The Company's technology goes well beyond antibodies in attacking the virus particle. Whereas an antibody binds to the virus only at two points, a nanoviricide is designed to bind to the virus at several points, like a nano-scale "Velcro" tape, and further to encapsulate the virus, thereby disabling it from infecting a cell.
Viruses can escape antibodies due to genomic changes including mutations. However, a virus continues to bind to the same cellular receptor with the same "footprint". A nanoviricide is designed by attempting to mimic this footprint, and therefore, it is expected that it would continue to be effective in spite of changes in the virus.
A nanoviricide is designed to act like a "Venus-fly-Trap" for viruses.
The Company is anticipating a collaboration to enable testing against SARS-CoV-2, the virus that causes the COVID-19 disease.
The Company has worked on developing an animal model to test anti-coronavirus effectiveness in vivo using a model coronavirus that binds to the same ACE2 ("angiotensin convertase enzyme 2") receptor as SARS-CoV-2, namely human coronavirus NL-63 (hCoV-NL63). The Company anticipates using this animal model to obtain indications of effectiveness of the nanoviricide test drug candidates against the model coronavirus in vivo.
Shingles Candidate IND Update:
The Company's first IND application for the use of NV-HHV-101 Skin Cream for Shingles Rash treatment is being prepared by us and is being reviewed by the Company's regulatory consultants.
The Company is currently working on establishing collaborations with clinical regulatory consultants and is evaluating clinical site selections.
The Company has developed a preliminary clinical plan and is preparing the more detailed clinical plan to be included in the IND application.
The Company is developing broad-spectrum drugs against coronaviruses by developing mimics of the ACE2 receptor to which SARS-CoV-2, SARS-CoV-1, hCoV-NL-63 and possibly some other coronaviruses bind. The Company has previously developed a broad-spectrum anti-herpesvirus drug candidate. This candidate, originally developed to be active against HSV-1, the virus that causes cold sores, was found to be effective against HSV-2, the virus that causes genital ulcers, and also against VZV, the virus that causes chickenpox and shingles. Of these, HSV-1 and HSV-2 are known to bind to the HVEM ("herpesvirus entry mediator") cellular receptor, which the Company mimicked to produce the drug candidates against herpesviruses. It is not definitively known whether VZV binds to HVEM. NV-HHV-101 is the Company's lead drug candidate that has completed IND-enabling studies, and is ready for human clinical trials, once the IND process is completed.
NanoViricides is one of a few biopharma companies that has its own cGMP-compliant manufacturing facility. The Company intends to produce its drugs for clinical trials in this facility. The Company has the capability to produce sufficient drug for about 1,000 patients in a single batch of production, depending upon dosage. This production capacity is anticipated to be sufficient for first-in-human use in the current SARS-CoV-2 pandemic, as well as for the anticipated clinical trials of NV-HHV-101.
It will be. The COVID19 pandemic situation is different. Entire world economies and tens of thousands of lives are at stake. That has a way of filtering out the BS. NNVC is ready for that level of scrutiny.
Of course, I don't make it my career to post only negative interpretations and comments about all things NNVC like some do. I do read most of the posts here and many are informative. Hearing both sides is necessary. However, when one side can only repeat the same arguments over and over, without acknowledging the positives, then that actually works against their credibility and version of reality.
I read and know a lot more than what I see here. NNVC's highly effective anti-viral for COVID19 will soon be on many news venues.
Well founded humble wisdom and foresight has worked well for me in my life's endeavors. Many times there are deliberate deceptions that must be endured before the truth wins out. This is that moment for NNVC from what I see.
The overwhelming demand and pull for a COVID19 treatment, like NNVC's will overcome all the years of naysayers very quickly. No short cabal will be able to stop it. In fact, it has not been able to stop NNVC thus far. It has only made the team at NNVC stronger.
Time will tell -recycled opinions mean nothing for the present COVID19 pandemic. Science will matter and does matter.
I for one, am inspired by Diwan's persistence and abilities to mature NNVC's technology over the last 15 years - to the point that they likely have the only COVID19 therapeutic that attacks that virus directly, at the human cell ACE2 receptor site, and is 100% nontoxic. NNVC's anti-viral will also works whether the virus mutates or not. Its amazing what Diwan has accomplished with his small team of motivated experts.
The latest video on NNVC's progress on a COVID antiviral is so cool. The amount of info packed into this was much greater than any PR could produce. Just because NNVC paid to have the video made doesn't mean its not true. Three highly trained experts solving one of worlds most challenging health issues. Only in America.
Source of COVID19
This video is a bit long but very good. NNVCs approach to binding with the ACE2 enzyme on COVID19 looks like a good choice.
https://mail.google.com/mail/u/0/?tab=rm&ogbl#inbox/FMfcgxwHMsMBbJScNwBxdsWqxZMQDBbh?projector=1
Again, its a 50-50 probability.
“There are two ways to be fooled. One is to believe what isn't true; the other is to refuse to believe what is true.”
- Soren Kierkegaard
cytokine storm
This doctor discusses how to detect it prior to it happening in COVID19 patients that come into the hospital. It is likely the COVID19 induced kill mechanism.
This would be where an anti-viral like one that NNVC might have, would be indicated. This is important, as the number of COVID19 patients in the verge of this syndrome is just are less than a thousand in any given day.
https://video.foxnews.com/v/6147709943001#sp=show-clips
Therapeutics includes anti-virals last time I checked.
Here are the salient statements:
"Scientists examined an antibody from a SARS patient and tracked how it latched on to a specific area of the SARS virus.
The team then observed how the SARS antibody gripped on to the same spot on the coronavirus sample
The scientists observed this at a "near-atomic-scale resolution".
The antibody that latched on in the coronavirus sample wasn’t identical to the SARS sample, but it did help identify a spot of weakness.
He said: "The knowledge of conserved sites like this can aid in structure-based design of vaccines and therapeutics against SARS-CoV-2."
NNVCs approach is right on target
https://www.express.co.uk/news/science/1265422/coronavirus-us-vaccine-news-SARS-drugs-covid-19-latest
LOL - Or, I may see an infinite return on the investment. Time will tell.
I have the free trial
Benzinga Pro
I just saw a transaction for NNVC at 8.16 on Benzinga after hours. The bid ask did not change but it is starting to move. Something is up.
So we should use an IV drip of alcohol or bleach for Ebola and COVID-19.
That never occurred to me.
It flipped from Chinese to Hebrew a couple of days ago, on my computer anyway. Maybe its a sign.....
There is a decent argument to be made if NNVC finds an effective drug. This could speed up the new drug process, if so. It does not have to be perfect, just cut the recovery time in half or something like that.
If the COV-19 virus infects a significant portion of the medical professional layer due to quarantine requirements, there could be a shortage in that sector effecting the whole population. An effective antiviral, even in KG batches, could save at least that sector, which is a multiplier for the rest of the population's recovery rate.
NNVC has a much higher chance today of pulling that off than they did even 1 year ago. Never say never. If there ever were a time for NNVC to come through, this is it. I believe they are working as hard and smart as they can on this effort.
We should all be rooting for their success.
That works - at least it is more relevant.
Yep - just used your post for context.
Then maybe its time to take down the sticky note above from 7/12/18.
News!
NanoViricides Announces Completion of Production of its Lead Candidate for Upcoming GLP Tox Package Studies
Print
NanoViricides, Inc. (AMEX:NNVC)
Intraday Stock Chart
Today : Monday 13 May 2019
Click Here for more NanoViricides, Inc. Charts.
SHELTON, Conn., May 13, 2019 /PRNewswire/ -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to meet unmet medical needs in treating difficult and life-threatening viral diseases, reports that it has successfully completed manufacture of the drug for the upcoming GLP Safety/Toxicology study of its lead candidate in several kilogram quantities.
Targeted Virus-Killing Nanomedicines (PRNewsFoto/NanoViricides, Inc.)
The Company has successfully completed production of kilogram-scale quantities of the drug substance, NV-HHV-101. Additionally, the Company has also successfully completed its formulation into the skin cream drug product at several kilograms scale, as is anticipated for the upcoming GLP Safety/Toxicology study.
The Company has achieved an extremely important milestone with this accomplishment. The manufacture of the drug substance and its formulation into drug product were both accomplished under cGMP conditions, at our own facility in Shelton, CT.
The Company believes it has de-risked the cGMP manufacture of not just NV-HHV-101, but that it has also substantially de-risked the entire nanoviricide® platform regarding cGMP manufacturing capability. It is well known that cGMP manufacture of nanomedicines is a challenging aspect in nanomedicines drug development.
The Company further provides an update that it is awaiting comments from the US FDA on its pre-IND application for NV-HHV-101. Those comments, when received, will inform further studies towards IND filing. Once the GLP Tox Package studies are complete, and associated analyses are complete, the Company expects to receive reports from relevant external parties. These reports and a plan of the clinical studies will then be developed into an IND application for NV-HHV-101.
Thus, the Company is successfully executing rapidly on all fronts towards the goal of filing an IND as soon as possible.
The Company is developing NV-HHV-101 as a broad-spectrum drug against a number of herpes viruses. The Company has chosen shingles rash as the first indication for this drug candidate. It is being developed as a dermal topical cream. It is designed to reduce the local viral load, thereby minimizing rash progression and further nerve damage.
There is a significant unmet medical need for the topical treatment of shingles rash. An effective therapy has been estimated to have a market size into several billions of dollars, if it reduces PHN incidence. An effective therapy against shingles rash reduction alone is estimated to have a market size of several hundred million dollars to low billion dollars. These market size estimates have taken into account the potential impact of the new Shingrix® GSK vaccine and the impact of the existing Zostavax® vaccine.
NanoViricides has previously shown that the NV-HHV-101 drug candidate as well as several related candidates in the pre-clinical optimization phase were highly effective against the shingles virus, VZV (Varicella-Zoster-Virus), in a human skin organ culture ex vivo model of the disease. Further, the non-GLP Safety/Toxicology studies of NV-HHV-101 have shown an excellent safety profile, with no adverse events even at the highest dosages tested in the safety/tox studies.
The Company is also developing drugs against HSV-1 "cold sores" and HSV-2 "genital ulcers", both based on this same drug candidate, although final clinical candidates are in pre-clinical optimization stage for both of these indications at present.
The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into several tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials.
Existing drugs given systemically may not reach required concentrations at the site of shingles outbreak, limiting effectiveness. In addition, VZV does not have an effective TK enzyme that is required for producing active drug from the acyclovir class of pro-drugs, requiring frequent administration of large doses. While shingles presents with a debilitating "pins-and-needles" pain associated with the characteristic rash that is self-limiting within 2-3 weeks in most patients, in a substantial percentage of patients, it presents as a severe, debilitating disease that leads to complications including hospitalization(s) and in some cases may result in extended treatments including subsequent surgeries, as highlighted in NBC-News recently in the article Chickenpox is a lifelong herpes virus that comes with a serious side effect.
Limiting initial viral load is expected to minimize the occurrence of such complications, and is also expected to reduce the incidence of post-herpetic-neuralgia ("PHN"), which is defined as persistent pain six months or longer after the initial rash has subsided. Shingles occurs when the immune system weakens due to age, stress or other factors such as other immune-compromising diseases (such as HIV or other viral infections) or conditions (such as organ transplant or anti-immune therapeutics against auto-immune diseases). The epidemiological incidence rate of shingles suggests that almost every person will have shingles at least once in lifetime if he/she reaches an age of 85. The available Zostavax® and other live attenuated virus vaccines often lead to "rebound shingles", a less severe form of the disease. The new Shingrix® GSK vaccine does not contain live virus, but is reported to have debilitating side reactions in as many as 20-25% of persons that receive it. Such side reactions may be expected to limit the vaccination rate since shingles is not a life-threatening disease. Besides, Shingrix is not yet widely available, due to limited production capacity. Thus there continues to be a significant unmet medical need for new, effective, therapeutics against shingles.
The present indication for NV-HHV-101 is for the treatment of shingles rash caused by reactivation of the shingles virus, VZV (varicella-Zoster-Virus). VZV causes chickenpox in children as a result of primary infection, and then becomes latent. Reactivation occurs in adulthood when immune surveillance weakens, due to age, stress, or other immune-compromising factors, including other diseases.
NV-HHV-101 is a broad-spectrum nanomedicine designed to attack herpesviruses that use the HVEM ("herpesvirus entry mediator") receptor on human cells. This drug candidate is composed of a flexible polymeric micelle "backbone" to which a number of small chemical ligands are chemically attached. The ligands in this case are designed to mimic the binding site of the herpesviruses on HVEM, based on molecular modeling. NV-HHV-101 is expected to bind to VZV via a number of binding sites (i.e. the ligands), thereby encapsulating the virus particle and destroying its ability to infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide® strategy is distinctly different from the mechanism of action of existing antiviral drugs against VZV.
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.
FDA refers to US Food and Drug Administration. IND refers to investigational drug application. API refers to active pharmaceutical ingredient.
View original content to download multimedia:http://www.prnewswire.com/news-releases/nanoviricides-announces-completion-of-production-of-its-lead-candidate-for-upcoming-glp-tox-package-studies-300848606.html
SOURCE NanoViricides, Inc.
Copyright 2019 PR Newswire
Negative. He was trying to hand off the question to Dr Seymour. Barry was interrupting him before he could fully respond.
Listen and see for yourselves:
www.virtualshareholdermeeting.com/NNVC2017
No control number required.
Dr Vivien Bonuik's presentation at OMIG posted:
http://www.nanoviricides.com/OMIG_Vivien_Boniuk/assets/player/KeynoteDHTMLPlayer.html#0
Ok, loanranger, I understand this prospectus filing a bit better, thanks.
I am not an expert at reading these filings. And, no, there is no filings that indicate he has bought or sold those 5.5M shares.
I don't understand why the company would have to register an addtional 5.5M shares, for him to sell it, if he already owns 6,868,648? Those shares were awarded but not registered?
You and KMBJN were correct about the number of shares that he currently owns at it is closer to 11.8M shares.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=136246600
I do think you left off his IRA holdings of 1,362,648 in your grand total calculation.
If true, and you take into account his IRA holdings, the total number of shares that Dr Bonuik owns or controls should be: 11,831,517, exactly 20% of the common shares outstanding, and he has yet to sell 1 share.
That does speak to Dr Bonuik's belief in the company's future. It is interesting that the date of the offering for 5.5M shares was almost, if not exactly the date that Dr Vivian Bonuik presented the test results for NNVC's two leading VZV/HSV-cide candidates effectiveness on HSV induced vARN.
If you go down the path of, "is Dr Bonuik preparing to sell?", then you would wonder why now? - at today's price? Why not earlier? He has never indicated the inclination to sell his shares or gouge the company via determination of share price for payments owed to him in stock. He could have. They have always been rules based and fair, if not generous to the company.
However, if he is preparing to sell some shares on a future event, then that would be bullish.
OK, from the recent prospectus page 7:
Dr Milton Boniuk owns 6,868,648 NNVC shares prior to the offering
He was offered 5,500,000 NNVC
Subtotal: 12,368,648 NNVC shares Class C
Other investment vehicles
and classes owned or
co-owned by
Dr Milton Boniuk:
Class A NNVC Stock 337,000 NNVC Class A
Privately held 166,000 NNVC Class C
with wife 657,142 NNVC Class C
IRA 1,362,648 NNVC Class C
LTD 2,776,793 NNVC Class C
Subtotal: 5,299,869 NNVC Class A and C
Total without warrants: 17,668,517 NNVC Class A and C
Warrants to purchase: 542,856 NNVC Class C
Warrants to purchase: 257,143 NNVC Class C
Subtotal: 799,999 NNVC Class C
Grand total: 18,468,516 NNVC Class A and C
Yes, I agree, I did not mean to put in the $ sign.
It's 17,776,793 NNVC shares without warrants to purchase and
18,468,516 NNVC shares that he owns or controls in various accounts with 799,000 warrants to purchase.
So your point is they are late filing the Form 4?
You haven't read this:
https://ih.advfn.com/p.php?pid=nmona&article=76153648
Do the math.
So far, not true.
So what?
It just makes the "buy low - sell high" strategy more attractive.
Yes, it is a speculative stock. Development stage Bio Tech companies are, by definition, speculative. You can always bet against them or not.
Any objective observation should say that the stock is a much better risk reward speculative buy today than just about anywhere in the past.
Dr Milton Boniuk thinks so with both feet. He owns $18M shares now. That is likely a large chunk of his personal wealth.
Thanks to many here, we are all aware of all warts.
We are also aware that the company has taken a more conservative approach to bringing a cide to market. From what we read in the various public filings, they are on track with that plan.
I think looking back 13 years is irrelavent today.
There has been significant infrastructure build out and advancement of their technology and capabilities since 13 years ago.
I will agree that the company needs to "show me" and the rest of the market in the next 10 months, "aggressive progress towards an IND". I believe they will.
Place your bets......