NanoViricides Inc (NNVC) News

Bring back Uncle Miltie and Gene Gene the Lyin' Machine. Burns and Allen seem to be out of material.

"The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. "
He had to be forced to acknowledge abusing those terms. Ironically he's doing so in a PR in which he doesn't lay claim to his creations possessing either quality.

Oh Boy!!!! Another Conference!!!

How about an update on how a Phase II trial is getting funded and what the actual 'disease' target is going to be?

NanoViricides to Provide Corporate Update at the Spartan Capital Investors Conference 2024, Today at 9:45am
12:02 AM ET 11/4/24 | Dow Jones

SHELTON, CT / ACCESSWIRE / November 4, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, today announces that Anil R. Diwan, Ph.D., the Company's President and Executive Chairman, will be presenting a corporate update at the Spartan Capital Investors Conference on Monday, November 4, 2024 (today) at 9:45 am. The Conference will be held at the Pierre Hotel in New York City.

Event The Spartan Capital Investors Conference
2024
Day & Date Monday, November 4, 2024
----------------------------------------
Location The Pierre Hotel, New York, NY, USA.
----------------------------------------
Talk Title Revolutionizing Antiviral Treatments,
Phase 2-Ready, Broad-Spectrum Lead Drug
NV-387 Addresses a $2.5 to $4.3 Billion
Market for RSV Alone
----------------------------------------
Presenter Anil R. Diwan, PhD, President & Exec.
Chairman, NanoViricides, Inc.
----------------------------------------
Track Collition Room
----------------------------------------
Time 09:45 to 10:00
----------------------------------------

Dr. Diwan will discuss the revolutionary broad-spectrum antiviral drug candidate NV-387, that is enabled by the nanoviricides technology platform. NV-387 has successfully completed Phase I clinical trial.

NV-387 has shown strong antiviral activity, with substantial superiority to existing drugs, against a number of viral diseases in animal models. These include Influenza, RSV, COVID, Influenza, and MPox/Smallpox related animal models.

The overall market size for these indications is anticipated to be more than $10 Billion by 2027.

About Spartan Capital Investor Conference 2024

The conference, organized in partnership with B2i Digital, a leading digital marketing firm specializing in investor communications, will feature presentations from over 30 carefully selected companies. The event will include panel discussions, one-on-one meetings, and networking sessions to maximize interactions between investors and presenters.

For more information about the conference and registration details, please visit Spartan Capital's conference page.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide(TM) class of drug candidates and the nanoviricide(TM) technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour(R) nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

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.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.

info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
SOURCE: NanoViricides, Inc.
View the original press release on accesswire.com

Yep - Diwan set up Karveer - He's skirting around the edges of what he 'has' to tell investors by not mentioning that issue. NNVC/Theracor/Karveer are an inbred set of things.

https://www.sec.gov/Archives/edgar/data/1379006/000110465924108620/tm2426151d1_def14a.htm
The Proxy Statement is a very comprehensive document. NNVC's mentions Diwan 73 times and Karveer an even dozen yet there is no mention of Diwan's relationship with Karveer and we know that he has one.


About Karveer Meditech Private Limited

Karveer Meditech Private Limited is a small and aspiring dynamic pharmaceutical company in India. It has developed and commercialized in local markets more than a dozen different generic and semi-branded pharmaceutical drugs as well as Ayurvedic medicines and vitaminized nutritional supplement protein powder products. It was co-founded by Dr. Anil Diwan, who serves as a Director and is a passive investor. Dr. Diwan is also co-founder of and President and Executive Chairman of the Board of NanoViricides. Karveer Meditech is independently managed by its Managing Director in India.
https://www.biospace.com/nanoviricides-has-shipped-drug-products-for-impending-clinical-trials-of-nv-cov-2-its-covid-drug-candidate

Yet another hype PR/Podcast from Anil.

https://theconferenceforum.org/pharmatalkradio/antiviral-drug-development-how-nanoviricides-is-overcoming-challenges-to-the-current-model

The beating of the PR drum continues - but - when will we find out when/if NNVC gets an actual Phase II trial started, what specific illness and virus are they planning on taking on, and how they intend to actually fund the work?

NNVC..................................https://stockcharts.com/h-sc/ui?s=NNVC&p=W&b=5&g=0&id=p86431144783

Where does AD get the cash to extend a line of credit to NNVC? It presumably comes from NNVC itself in the form of salary. AND from Theracour which also gets its money from NNVC.
Theracour is privately held so we don't know anything about its financial condition. Does AD pay taxes on what he takes out of Theracour?

Nothing new about any of this but it remains confounding.
AD is paid by 2 entities. One of them works for and is compensated by the other. He acts as a lender to the publicly held entity and is the majority owner of the private entity which in turn is the largest shareholder of the public company.

!0-K filed with some interesting exhibits:
Line of Credit with AD increased from $2M to $3M and maturity extended.
New Insider Trading policy established. Any trading of NNVC securities can only be done during certain times and must be previously cleared with the Compliance Officer....Mrs. Diwan.

The fun never stops.

Talk about HUGE cojones!!! After being spanked by the SEC for using "suggestive" language in the filings that he signs he now proceeds to make the ultimate claim:
"In addition to NV-387, certain “Trojan Horse” drugs that can completely cure most viral infections by attacking the virus lifecycle in multiple ways have been developed by the Company."
I believe that the "c" word claim has drawn the attention of Regulators in the past and is likely to do so here. Not to mention the ease with which that claim could be used in a civil action. Investment losses would be measured from the minute that that claim was made.

The equally objectionable "e" word was used as well:
"NV-387, the Company’s lead drug, is proving to be a revolutionary drug that has demonstrated strong effectiveness, surpassing existing drugs, against a number of distinctly different types of viruses in animal studies."

This is the way the SEC and Ms. Vyas addressed the language in their May 2024 correspondence:
SEC: "Statements that conclude your clinical trials demonstrated the “safety” or “efficacy” of your product candidates are improper without regulatory approval, as conclusions related to safety and efficacy are within the sole authority of the FDA and comparable foreign regulators. In future filings, please discuss the objective results of your pre-clinical and clinical trials without concluding that such results demonstrate that your product candidates are safe or effective."
Vyas: "The Issuer respectfully acknowledges the Staff’s comment and will revise future filings to discuss the objective results of our pre-clinical and clinical trials without concluding that such results demonstrate that our product candidates are safe or effective unless so evaluated by applicable regulatory authority."
For civil legal purposes filings and press releases are the same types of documents.

And Diwan self deals yet again. Moving potential future money from one of his pockets and back into another - likely at the expense of NNVC shareholders - yet again.

Nothing good here happens for current shareholders until - or unless - Diwan finds a partnership and gets the drug into an actual Phase II trail against an actual disease/virus.

NanoViricides Executes an Agreement Encompassing All Antiviral Drug Treatments With Theracour, Including “Trojan Horse” Drugs
SHELTON, CONNECTICUT – Thursday, September 26, 2024 -- NanoViricides, Inc. (NYSE Amer.: NNVC) (the "Company"), a clinical stage global leader in broad-spectrum antiviral nanomedicines, reports today that it has now obtained a right of first refusal (ROFR) for all antiviral drug developments from the R&D firm TheraCour Pharma, Inc. (“TheraCour”).

NanoViricides has signed a broad Memorandum of Understanding Agreement (MoU) with TheraCour encompassing all antiviral drugs developments on September 23, 2024, an important step that provides the Company certain intellectual property rights for developing treatments against any viral infections.

NV-387, the Company’s lead drug, is proving to be a revolutionary drug that has demonstrated strong effectiveness, surpassing existing drugs, against a number of distinctly different types of viruses in animal studies. With this MoU in place, the increasing number of antiviral indications of a broad-spectrum drug such as NV-387 can be quickly and easily discovered and added by the Company to its portfolio of drugs in its development pipeline.

In addition to NV-387, certain “Trojan Horse” drugs that can completely cure most viral infections by attacking the virus lifecycle in multiple ways have been developed by the Company. This MoU expands NanoViricides Inc’s abilities to opportunistically and rapidly develop such drugs to treat viral infections of public health importance, even for those viruses that don’t exist today and cannot be predicted.

The new MoU provides NanoViricides with the ability to rapidly progress in such new endeavors and provides the important intellectual property rights to further develop multiple drug candidates towards a multitude of antiviral applications, many of which may have been previously considered to be intractable.

The MoU also codifies the process by which the two parties negotiate licenses to specific antiviral fields. As in the past, a license would not be restricted to a single drug, but rather would encompass all drugs that can be conceivably applicable with the R&D performed against the licensed field of antiviral application.

The revolutionary nanoviricide technology resulting in host-mimetic, direct-acting antiviral drugs is opening up a new era of treating viral infections just as penicillin opened up a new era and revolutionized the treatment of bacterial infections, enabling “one drug - many bugs” model instead of the current “one bug - one drug” model. NV-387, an example of the capabilities of nanoviricide technology, was developed in 2020 in response to the COVID pandemic and has completed a Phase I human clinical trial successfully. The Company is now planning for NV-387 to enter into Phase II clinical trials for evaluation of its efficacy against several viral diseases that include RSV, Influenza, Bird Flu, COVID, as well as MPOX/Smallpox infections.

What is a “nanoviricide”?

A “nanoviricide” is a uniform polymer that self-assembles into nanoscale droplets called “micelles”, that carries on its surface mimics of the cell-side receptor of the virus, and that hides in its belly lipid tentacles. It can also hold other guest APIs in its belly if needed. The nanoviricide thus “looks like” a cell to the virus, and the virus is fooled into binding it. Once the virus binds, we believe, the flexible and shape-shifting nanoviricide micelle would spread over the virus particle by virtue of merging the lipid tentacles that are hidden in its belly into the virus surface, in a well known process called “lipid-lipid mixing.” We believe this would destabilize the virus particle, uproot the viral glycoproteins required for binding to and entering the host cell, and thus render the virus particle incapable of infecting a cell.

What are “Trojan Horse” nanoviricide drugs?

A nanoviricide can hide in its “belly” (i.e. encapsulates) one or more drugs that can attack the virus in other ways. The nanoviricide holding the drugs is expected to attack the virus particle itself and thus block the virus from infecting cells. We call this “Re-Infection Inhibition”. The encapsulated drug can be protected from host’s metabolism and delivered into infected cells to block the virus from replicating inside the cell. If both of these parts of the virus lifecycle are blocked, the viral infection would be cured, except in the case of viruses that create latency. A different encapsulated drug can also be delivered to attack the virus in its latent or dormant phase, although this has been a topic of scientific research rather than drug development as of now. Thus the “Trojan Horse” capability of a naoviricide enables developing drug that can cure most virus infections, and can be developed in the future to cure even viruses that cause latency such as herpesviruses and HIV/AIDS that are non-curable at present.

TheraCour is founded by and substantially owned by Dr. Anil R. Diwan, who is also the Company’s
co-founder. Dr. Diwan recused himself from the MoU discussions that were led by the Company’s Board of Directors in conjunction with legal advice from the Company’s counsel.

About NanoViricides

NanoViricides, Inc. (the "Company”) (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 and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

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.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

Source: NanoViricides, Inc.

Fraud alert here, dumping shares for lawsuits

NNVC is basically selling stock to hire lawyers as they are broke. They also hired TOPSTOCKALERTS at stocktwits to false advertise their company to sell these shares. TOPSTOCKALERTS always has members pay for his picks but this one, NNVC was a "free pick" lol. All should be brought up of charges of fraud and theft.

Nice Warning. NNVC a fraud being sued and using TOPstockalerts on stocktwits as their seller of stock

WARNING !! ONE of the COMPANIES that developed full spectrum antivirals capable of TOTALLY REPLACING/DISRUPTING NNVC’s candidate products is RedHill Biopharma Ltd. RedHill Biopharma Ltd. (Nasdaq: RDHL), a specialty biopharmaceutical company developing Opaganib (ABC294640) an investigational new drug, not available for commercial distribution. Opaganib has been selected for evaluation by two U.S. government countermeasures programs. Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola.

Orally administered sphingosine kinase-2 (SPHK2) selective inhibitor targeting COVID-19, Ebola and other viruses as part of pandemic preparedness. Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication.

Source: https://stkt.co/eaxJhG93

The ruling on "Chevron" involved interpretations of laws/rules that contain amiguity. Accroding to the ruling, courts should rely on their own interpretion of ambiguous laws. In the case of the SEC Letter. There is no ambiguity, since its ONLY related to data when SAFETY and EFFICACY do exist in medical/medicines products according to the review panels and scientific guidelines and procedures.

THE CONTINUING SAGA OF BIOSCAM NANOVIRICIDES (NNVC)
What is overlooked is the spectrum of this new artificial technology that is ingested/injected into body biologics.
According to the research of the original team that developed the chemical polymeric structures (called nanoviricides, or 'cides) this structures (the nano viricides, a synthetic cell polymeric chemical structures) can cause NEUROTOXICITY or GENOTOXICITY and probably INTERGENERATIONAL GENOTIC DEGENERATIONS (Intergenerational transmission of genetic risk).

// DO your DUE DILLIGENCE //

"afraid to try because that means the drugs might fail and the whole gig would be up" (incomplete quote)
That has been my feeling for a long time. I think the same theory applies to Diwan's former co-worker (who has just left his Company to rot in the Expert Market). In his case, however, he finally put himself out on a limb. A Phase 2 Covid trial failed and he could no longer hide the lack of effectiveness of his candidate.
"In order to determine if NNVC's NV-387 IND package is good enough for FDA, NNVC needs to actually submit it to them."
Too busy doing the hokey-pokey.

JMO....scientifically unqualified.

That's a mistaken belief. And it's not an "alleged" letter.....I posted the link to the exchanged correspondences here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174910356

I stand corrected - SEC not FDA.

The primary point of my statement remains correct.

I'm not an attorney but I believe the Supreme Court ruling on the "Chevron" case makes this alleged SEC letter moot.

Yes. It was a SEC Letter. I was clear on that. FDA has no jurisdiction on comuniques done by companies to markets, this is a SEC regulatory field.

The SEC WARNED bioscam company NANOVIRICIDES to ONLY "discuss the objective results of your pre-clinical and clinical trials without concluding that such results demonstrate that your product candidates are safe or effective". Conclusion within the SOLE AUTHORITY of the FDA and comparable foreign regulators.

Note that (nowadays) "comparable regulators" may not be INDIA or CHINA, since quality of data and procedures from foreign countries is being questioned RIGHT NOW by US Congress. Which indeed is a rightful move and things must be corrected before great human life losses befal, just for lack of oversight and the correct application of our western standards.

"So NNVC making official claims that there was no toxicity observed at the tested levels of their drug candidate in public statements is - indeed - something that they should be careful about stating until after FDA review and approval. The FDA emphasized that point in the letter than you cite."

Pretty sure that was an SEC letter, but I'd be very interested to know if the Company has heard directly from the FDA on that score.

I would propose that NNVC is MASSIVELY OVERVALUED According to this Peer Analysis via Simply Wallstreet (at market prices as of 08/13/2024) NNVC was valued at 1.9x of book value (BV).

I would argue NANOVIRASCAM is around 0.5x-1.0x BV, which puts the value of NNVC stock at $0.435 - $0.870 per stock.

While other peer companies [i.e BioAffinity, RedHill, Tiempest, Pieris, SAB Biotherapeuitics] that have ALREADY 3 candidate products in Ph1CT (with partners as Seagen, Boston Pharma and Server), and one Co with 2 candidates in Ph2CT and 5 in Ph1CT. These exemplified in particular are valued between 1x and 1.4x of book value as of 08/13/24.

You would have to be insane to pay for NANOVIRASCAM double price at 1.9x of BV. I would argue NANOVIRASCAM is around 0.5x-1.0x BV, which puts the value of NNVC stock at $0.435 - $0.870 per stock.

@Via SimplyWallstreet: NYSEAM:NNVC Stock Report.

// Do your DUE DILLIGENCE //

SAFETY HAS NOT BEEN PROVED.

Until, not only all data is reviewed by the FDA, data which can be MANIPULATED, but until Phase 3 Clinical Trials done in a Western Country with standards as high as they should be, show the episodes of ADVERSE EFFECTS, and THERE IS A THOROUGH LONGITUDINAL STUDY of cleareance for NEUROTOXICITY and GENOTOXICITY and INTERGENERATIONAL GENOTIC DEGENERATIONS (Intergenerational transmission of genetic risk).

// Do your DUE DILLIGENCE //

And again - you harp on over, and over, and over, and over, and over, and over, with those same partial truths and your projections/assumptions.

Anger is not becoming and is pointless on a message board dude.

SAFETY HAS NOT BEEN PROVED.

Until, not only all data is reviewed by the FDA, data which can be MANIPULATED, but until Phase 3 Clinical Trials done in a Western Country with standards as high as they should be, show the episodes of ADVERSE EFFECTS, and THERE IS A THOROUGH LONGITUDINAL STUDY of cleareance for NEUROTOXICITY and GENOTOXICITY and INTERGENERATIONAL GENOTIC DEGENERATIONS (Intergenerational transmission of genetic risk).

// Do your DUE DILLIGENCE //

BE CAREFUL.... I can inject you "nanoparticles of cyanide" in a saline solution, without you showing any problems....

NNVC CEO Anil Diwan and accomplices may be playing with saturation of the nanoparticles inside body biologics, as a caviat to current Phase 1-2-3 Clinical Trial Studies protocols, manipulating the legal framework and the FDA.
// Do your DUE DILLIGENCE //

You propose a FALUTY LOGIC in EXTREMIS !

SAFETY HAS NOT BEEN PROVED. Until, not only all data is reviewed by the FDA, data which can be MANIPULATED, but until Phase 3 Clinical Trials done in a Western Country with standards as high as they should be, show the episodes of ADVERSE EFFECTS, and THERE IS A THOROUGH LONGITUDINAL STUDY of cleareance for NEUROTOXICITY and GENOTOXICITY and INTERGENERATIONAL GENOTIC DEGENERATIONS (Intergenerational transmission of genetic risk).

BEYOND THAT !!
ANIMAL MODELS are questioned by the scientific literature, for their nearly ZERO merit of PREDICTIVE SAFETY and EFFICACY. For drugs which pass animal tests, 94% will fail during human clinical trials stages (Phases 1 – 3). Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6978558/

// Do your DUE DILLIGENCE //.....it seems you have lecture comprehension problems.

You remain incorrect - if quite adamant about it.

Assuming that NNVC's CRO/associates did not fudge the data - given an possibility I would not entirely put beyond Diwan or somebody he would hire - there was no toxicity shown in any of the dosing types that were tested in the Phase I trial in India. I met the guy about 9 years ago and he seems smart - but he's slippery in getting a straight answer from.

The fact remains - yes - the FDA hasn't agreed with the results and signed off on them as of yet. The FDA hasn't seen any of the finalized results yet. A technicality at this point, but a significant technicality. And I will agree with you on this point.

So NNVC making official claims that there was no toxicity observed at the tested levels of their drug candidate in public statements is - indeed - something that they should be careful about stating until after FDA review and approval. The FDA emphasized that point in the letter than you cite.

That also doesn't change the fact that - again unless the Indian doctors have lied or Diwan is lying (again a possibility I don't completely rule out) - the drugs have shown no toxicity at the dosing levels that NNVC is recommending. And since the drug candidate has shown no apparent toxicity in their animal model studies to date, there is little reason to think that it's going to start showing significant toxicity in humans vs other mammals.

I DO my due diligence. Perhaps you should be more honest about your motivations here. Harping on, and on, and on, and on, and on,... About the same flippin' nonsense daily gets old dude.

This all is why I want Diwan to pull his head out of his behind and get that data finalized so that the company can get it in front of the FDA and so that the FDA can do its thing.

IT DID NOT DEMONSTRATE SAFETY.

There is a SEC LETTER sent to NANOVIRASCAM where it was asked by the regulatory body to drop missleading statements about "SAFETY" and "EFFICACY", of NANOVIRASCAM candidate medicine. There is NO APPROVAL of the results of Phase 1 Clinical Trial in INDIA granted officially by the FDA. I can inject you nanoparticles of "cyanide" in a saline solution, without you showing any problem....

// DO your DUE DILLIGENCE //

Yes, I have read your posts, why do you ask?

Just trying to figure out what you were saying, thus the request for clarification.

This is all you really needed to say, "don't believe their PRs or the results."
You didn't really need to do any analysis about MTD or dose being too low or placebo or whatever, since you don't believe any of it anways.

Just need to say "I think they are liars, even though I don't have any evidence or reasoning behind it, other than it smells like a scam."

Glad you made your viewpoint clear. I hope I didn't misstate it. Thanks.
and yes, most small cap biotechs fail. Very risky investments. and potentially high rewards as well. Caution is well-warranted.

Yes. That Phase I study did demonstrate safety under the planned dosing schemes. You are incorrect and apparently are not ashamed to let any with intelligence know that you are incorrect.

What that Phase I study did not demonstrate was efficacy in any of the planned dosing schemes against any actual human ailment. That's the problem currently.

IT DID NOT DEMONSTRATE SAFETY.

There is a SEC LETTER sent to NANOVIRASCAM where it was asked by the regulatory body to drop missleading statements about "SAFETY" and "EFFICACY", of NANOVIRASCAM candidate medicine. There is NO APPROVAL of the results of Phase 1 Clinical Trial in INDIA granted officialy by the FDA. I can inject you nanoparticles of "cyanide" without you showing any problem....

// DO your DUE DILLIGENCE //

Started big position here going over $5

What will tell the tale in the end - will Diwan EVER get a Phase II trial launched anywhere? India, China, at one point the old CEO talked about clinical trials to be held in Australia.

The only thing that will move this company up, and up to stay, is a partnership that leads to a successful clinical trail that actually treats sick people. Yes, the Phase I did further demonstrate that the drug is generally safe. But it wasn't used to treat anybody with symptoms of COVID or of anything else.

THE CONTINUING SAGA OF BIOSCAM NANOVIRICIDES (NNVC)

As we have seen before, NANOVIRASCAM has faked the Phase 1 CT in INDIA by not curing anyone from any desease or viral infection in its trial. INDIA is one of the most CORRUPT countries on Earth, where you can buy business closings for a price, pay individuals for favors, fake data, and to lie for you, and police are seen in the streets carrying spirits bottles as present for co-option in street corruption. Their helath and medicines regulatory body (CDSCO) has even been engaged in a scheme of quality control abscence whereas children died, news published 14 December 2023, India’s CDSCO medicine regulator is criticised for quality checking only cough medicines destined for export.

This is not particular of INDIA, but even in China Clinical Trials are being questioned right now. US clinical trials in China questioned by US lawmakers, REUTERS 20 August 2024. The International Health Community of regulator bodies and the GOVERNMENT OVERSIGHT from Western Countries must GET TOUGH over THIRD WORLD COUNTRIES CLINICAL TRIALS, and the production of medicines (compounds, etc) and chemicals for the health and food industry.

"Did you see the pre-clinical PRs showing efficacy in animal models, better than existing antivirals? or Phase I PRs about safety?"

Yes. Did you read my post at all? It wasn't long.

I'm in the it looks like a scam, it smells like a scam and it walks like a scam camp, and don't believe their PRs or the results claimed by their (conveniently offshore and unreliable) CRO.

FWIW I've yet to be wrong on my diagnosis of similar penny stock schemes.

RESEARCH STUDY. NCBI. "Animal testing is used in pharmaceutical and industrial research to predict human toxicity, and yet analysis suggests that animal models are poor predictors of drug safety in humans. The cost of animal research is high—in dollars, delays in drug approval, and in the loss of potentially beneficial drugs for human use.
Human subjects have been harmed in the clinical testing of drugs that were deemed safe by animal studies. Increasingly, investigators are questioning the scientific merit of animal research".
Limitations of Animal Studies for Predicting Toxicity in Clinical Trials. Is it Time to Rethink Our Current Approach? Gail A. Van Norman, MD* Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6978558/ (National Center for Biotechnology Information.)

Additionally it’s a commonplace in drug development that zero side effects is equivalent to zero efficacy.

Either the results are false, the dose administered was way too low or NV-387 is simply a placebo.

Did you see the pre-clinical PRs showing efficacy in animal models, better than existing antivirals? or Phase I PRs about safety?

Sounds like you are in the "It's fraud. They are lying, but I have no proof" camp.
Or maybe you meant something else by "the results are false?"
I guess anyone can say anything they want without evidence to back it up. See a lot of that here.

“ they did seem to show that NV-387 was safe in humans with their Phase I India trial, with NO dose limiting toxicity,”

Failure to establish an MTD (maximally tolerated dose) is not the flex NNVC thinks it is. Regulators want to know the MTD.

Additionally it’s a commonplace in drug development that zero side effects is equivalent to zero efficacy.

Either the results are false, the dose administered was way too low or NV-387 is simply a placebo.

There’s little doubt in my mind that NNVC is yet another penny stock would-be biotech that serves solely as a money making scheme for what passes as its “management”.

THE CONTINUING SAGA OF BIOSCAM NANOVIRICIDES (NNVC)

Last novel Phase 1 CT of the nanoparticle was made in INDIA, with ALL HEALTHY INDIVIDUALS and proved nothing (as SEC Letter says), THEY NEVER WERE INFECTED or got ILL with ANY VIRUS. So NANOVIRASCAM did not cure anyone from their Phase 1 CT indian participants in INDIA.

NANOVIRICIDES is under financial stress, CEO has acknowledged in fillings that they may reverse mortgage their company facility. It has only USD $6MM cash to fund survival operations all the while CEO Anyl Diwan and spouse CFO pay themselves (via latest 8-K) USD $44.133,33 monthly (obviousely financed through monthly shares issue dilution), and guess what….

DILUTION
Last April 5th there was an 8-K, with an additional $5MM in shares placed for sale in an “At the Market Offerings” (public primary offering) by Diwan and accomplices. Sales Agent is EF HUTTON who sells, purchase from the Company (or both) of this offering. This “At the Market Offering” could be spread in 12 calendar months, until a full allotment of $50MM is reached under the current Agreement. New 8-K file came out on 08/09/2024. With an additional $9,3MM in shares placed for sale in an “At the Market Offerings”. Totalling now nearly USD $60MM in SHARES DILUTION !! You cannot make this up !!!

NOTE //In January 2020 Diwan and accomplices diluted shares of the company by $8.65MM, in July 2020 Diwan again diluted the company by $11.5MM.

If you assume $2/share for the last placements, whereas, there is no extra-value expected generated from the company by the placement -and since the 2005 warrant convert placements no real value has been created-, then if fair value is the last run rate of shares before May 3rd (in reality is much less) at $1.1, then the dilution into the Market Cap amounts to $1/share, which puts the fair value of the Nanoviricides shares at $0.7 (or less) from fair value prices, after dilution.

A pumping NET then pumps the stock, YOU LOOSE your CASH for a: "false value-for-price stock", Diwan and accomplices gets the CASH FLOWING into his pocket, and pumpers & MOMO trading crowds get DILUTED forever. NANOVIRASCAM ETHERNAL DILUTION

Animal testing is used in pharmaceutical and industrial research to predict human toxicity, and yet analysis suggests that animal models are poor predictors of drug safety in humans. The cost of animal research is high—in dollars, delays in drug approval, and in the loss of potentially beneficial drugs for human use.

Human subjects have been harmed in the clinical testing of drugs that were deemed safe by animal studies. Increasingly, investigators are questioning the scientific merit of animal research. Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6978558/

Nanoviricides published a PR note indicating “protection” in an animal model for lung damage in mice infected with H3N2 avian flu, one of the the current flu strains that epidemiologists are monitoring.

What investors and MOMO retail traders do not grasp is that: The first thing to note is of those drugs which pass animal tests, 94% will fail during human clinical trials stages (Phases 1 – 3)* Source: https://www.animalresearch.info/en/medical-advances/articles-lectures/nine-out-of-ten-statistics-are-taken-out-of-context

What is overlooked is the spectrum of this new artificial technology that is ingested/injcted into body biologics. According to the research of the original team that developed the chemical polymeric structures (called nanoviricides, or 'cides) this structures (the nano viricides, a synthetic cell polymeric chemical structures) can cause NEUROTOXICITY or GENOTOXICITY.

Can you please tell us where to find this information, on your claim that the nanoviricides are toxic to neurons and to the genome? Appreciate you sharing, and your tales of caution.

What is overlooked is the spectrum of this new artificial technology that is ingested/injcted into body biologics. According to the research of the original team that developed the chemical polymeric structures (called nanoviricides, or 'cides) this structures (the nano viricides, a synthetic cell polymeric chemical structures) can cause NEUROTOXICITY or GENOTOXICITY.

There is a clear failure of the current protocols to measure the "effectivenes" of this nano structures in the time frame of Phase 1-2-3 Clinical Trial protocols rushed by IND's that mark effiency in reduced time periods. Anil Diwan and accomplices will micro manage the dose, so that these two kinds of toxicity do not register into YOUR BODY BIOLOGICS for some time (at least throughout the duration of the Clinical Trials), but later human life cicle effects could envision NEUROTOXICIRY, GENOTIXICITY and INTERGENERATIONAL GENOTIC DEGENERATIONS (Intergenerational transmission of genetic risk).

The situation in India is hence, UNCLEAR, since if we pay any respect to science, the time to measure NANOTIXICITY or GENOTOXICITY is only achieved with LONGITUDINAL STUDIES in great numbers of population after at least a DECADE (to say the least). Intergenerational genotic risk MUST be in the CONTROL VARIABLES.

The company may be playing with micro (nano) accumulation and sizes, introduced in body biologics, so that it doesen’t register toxicity for some years, as a caviat to current Phase 1-2-3 Clinical Trial Studies protocols, manipulating the legal framework and the FDA.

These are nano particles alien to body biologics that may develop neurotoxicity or genotoxicity. Only with broad (and long time -i.e decades long) longitudinal studies that are run for 10 years plus, one could really determine if these nano structures are safe for body biologics.

In order to determine if NNVC's NV-387 IND package is good enough for FDA, NNVC needs to actually submit it to them. It remains puzzling why NNVC goes so slowly with FDA and clinical trials, other than that Diwan is a cowardly and greedy control freak (loves the gravy train, afraid to try because that means the drugs might fail and the whole gig would be up), or maybe they are still working out some manufacturing issues, or there is some other unknown reason why it has taken them so long to apply for an IND and take one of their many 'cides into trials in the US after all these years. If I recall correctly, the last communication was that NNVC was going to have a pre-IND meeting, and think about submitting an IND for NV-387 by the end of 2025. They are hoping their NV-387 that targets HSPG binding viral antigens will be an oral, broad spectrum antiviral, good against multiple (respiratory) viruses like RSV, CoV, and IAV (fluA). It's WAY WAY overdue for them to plan and get into a human trial. They move SO SLOWLY that it is bewildering. That said, they did seem to show that NV-387 was safe in humans with their Phase I India trial, with NO dose limiting toxicity, and this data will surely be part of their IND submission to FDA, along with their planned Phase II trial against multiple respiratory viruses. People can and will continue to shout fraud here, without presenting any solid evidence of said fraud. Hard to know what to believe. The truth will come out some day. That day keeps getting closer and closer as NNVC finally does a trial to see if these nanomedicines work, or they run out of money, or something. It will be interesting to see if they can get a partner to fund and run the trial.

There is a reason why the indian CEO of NANOVIRASCAM, Anil Diwan, makes the Clinical Trials in INDIA. INDIA is one of the most CORRUPTED countries on earth. This makes it easy to "buy" results in Clinical Trials, and hide adverse cases and/or geno/neuro-toxicity from the nano particles (aka nanoviricides).

India’s CDSCO medicine regulator is criticised for quality checking only cough medicines destined for export
(Published 14 December 2023) News LINK: https://www.bmj.com/content/383/bmj.p2951


Kamala Thiagarajan

India’s system for regulating medicines has been questioned after an investigation found that more than 100 cough syrups made for the export market failed quality tests.

Specialists have said that the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for pharmaceuticals that conducted the investigation, lacks the necessary oversight to ensure that medicines manufactured in India are safe.

The comments follow a report from CDSCO shared with the media on 4 December on the results of tests conducted on more than 2000 cough syrups. Of these, 128 syrups manufactured by 54 companies, which were meant for the export market, were found to have problems with quality.

In June this year India’s director general of foreign trade mandated that cough syrups meant for export must undergo tests at a government laboratory and must be authorised with a certificate of analysis before they can leave the country. However, Dinesh Thakur, a public health activist and coauthor of a book about drug regulation in India, questioned why the policy was limited to just one type of medicine.

“Clearly, the outrage associated with the deaths of the children has resulted in this action, but this only applies to cough syrups,” he told The BMJ. “If this is the case with one class of medicinal product, what about the rest?” He added that it was not clear whether companies found to be in breach of standards would face any consequences.

"The very fact that a reputable regulatory body such as CDSCO allowed us to enter into a clinical trial is indicative that the drug candidate was deemed to be sufficiently safe and effective for humans."
Didn't the FDA say "If it's good enough for Central Drugs Standard Control Organization (“CDSCO”), a regulatory body in India, it's good enough for us?"

I didn't think so.

What do you mean we can't say our 'cides are "safe" and "effective" ?!?

Ummm, OK, you are the SEC I guess. We'll just talk about the "strong effectiveness parameters" of NV-387, then :).

https://finance.yahoo.com/news/nanoviricides-continues-march-towards-phase-103000857.html

"NanoViricides Continues Its March ..." a long, twisted, 20 year march, which may lead to a trial filing in the US in 2025.

Wouldn't that be amazing if these things really work as well in humans as they did in animals?

NNVC..................................https://stockcharts.com/h-sc/ui?s=NNVC&p=W&b=5&g=0&id=p86431144783