Is constantly trying to figure out what the h#ll he is doing.
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OK then,... Maybe it's a possibility then this time,...
The problem remains,... Does NNVC have Toxicity data in hand indicating that their drug candidates are safe for internal use in model animals?
Absent such data, the FDA is NOT going to permit a human clinical trial to proceed regardless of how promising the drug candidates might look in a model system.
Interesting information - thanks. I'll have to look in on that one.
IMO your friend's assessment is very correct. Antibiotic resistant bacteria are not going away, and almost nobody has discovered a new 'class' of antibiotics and made that work.
These lysins are probably going to be useful, and not a lot of companies are working on useful alternatives. Several years ago I had a small investment in a now-bankrupt company (AKAO) that had a new antibiotic in the aminoglycoside (think streptomycin-like) class that looked fairly promising in clinical trials as a treatment for hospitalized folks with antibiotic-resistant strains of bacteria.
They also had some pre-clinical 'unconventional' anti-bacterial compounds further down the pipeline, but obviously that work all ended when the company went belly-up. Small company even got it's drug approved, but didn't have the capital to get it to market effectively.
I make a small profit on that one, but not much. And lots of other folks lost a lot.
Similar problems - possibly even worse - are happening to renters. Rents are generally keeping pace, and in some parts of the country are exceeding, mortgage payments.
Have been lurking around here for a while now,....
Cheers!
Phase II testing is just that - Phase II testing. Until this company gets something completely past a Phase III and are preparing their BLA and data package to the FDA,... they are still a risky (risk is a two sided sword) bet.
Now - that having been said - CFRX has narrowed the range of that risk considerably by having what appear to be quite successful Phase II clinical results,...
That also having been said - I'll be looking to opportunistically add sets of shares here, and at a couple of other similarly positioned biotech companies through the winter. I don't really trade in and out much. I just find something that looks like it has some potential a year or so down the road, buy some of it cheap, and sit on it for a while.
Yeah,... it's not like they didn't have some idea months ago when they had a deadline to get this done,...
Alrighty then! A bit more than a month and we'll have some data on those first 127 (40%) of patients,... Here's hoping that enrollment is good and fast.
Again,.... Key word,.... POTENTIAL.
Dude - that's not how the stock market works.
Very unlikely. And definitely unsustainable.
What was/is in the attached document: Since I couldn't pull it up directly from the link in the 8K posted here:
https://www.sec.gov/Archives/edgar/data/1379006/000110465921117728/tm2128140d1_ex99-1.htm
Significantly Improved Safety Profile and Metabolism of Remdesivir Observed
Due to Encapsulation in NanoViricides Drug Candidate Enabling Potential
Highly Effective Pan-Coronavirus Antiviral Drug
Shelton, Connecticut -- September 21, 2021 -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today on the significant advantages gained by remdesivir encapsulation within its lead COVID-19 candidate NV-CoV-2 thereby producing a potential pan-coronavirus cure, NV-CoV-2-R to finally overcome the current global pandemic.
Pharmacokinetics of Remdesivir
Almost double the remdesivir remained intact in plasma when given as the encapsulated NV-CoV-2-R form, in comparison to the standard remdesivir formulation in SBECD, during the first day of dosing, in a rat study. Additionally, remdesivir accumulation was observed on repeated dosing of NV-CoV-2-R. After the fifth dose of NV-CoV-2-R (on day 7), and following the standard remdesivir dosing pattern (twice on day 1 followed by daily thereafter), the circulating level of remdesivir in plasma was 75% greater in the NV-Cov-2-R group as compared to the remdesivir group. The data were normalized to reflect the same amount of remdesivir given to the animals per kg body weight for uniform comparison. The studies were performed using the well established isotopic internal standard method of remdesivir estimation with LCMS detection.
This increased intact circulating level without any increase in toxicity is significant. It can be expected to result in improved antiviral effectiveness of the remdesivir component in human usage. This is important because remdesivir is a highly effective drug in cell culture and pre-clinical studies but does not show superior effectiveness matching the preclinical studies in humans because of its rapid metabolism. There is very little margin to increase remdesivir dosing in its standard form because of dose limiting toxicity.
These data demonstrate that the pan-coronavirus nanopviricide drug candidate NV-CoV-2-R minimizes the loss of remdesivir to bodily metabolism. The Company anticipates that this stabilizing effect should lead to a highly effective pan-coronavirus drug that could potentially cure most cases of COVID-19 infection.
Both remdesivir and NV-CoV-2 have demonstrated broad-spectrum activity against coronaviruses. Thus NV-CoV-2-R is expected to continue to be active in spite of evolution of novel variants of SARS-CoV-2. In contrast, antibody drugs and vaccines which induce antibodies lose effectiveness against variants. The more the variant drifts from the original strain, the less protection is offered by vaccines, and effectiveness of antibodies also diminishes significantly. This is now known to be occurring for current vaccines and antibodies during the global COVID-19 pandemic.
NV-CoV-2-R combines (1) the power of the nanoviricides® platform attacking the virus particle outside cells with (2) the power of remdesivir in attacking the virus reproduction inside cells. Additionally, we believe that (3) NV-CoV-2-R would be improving the effect of remdesivir by (i) enabling a higher effective concentration of remdesivir in the body and (ii) sustaining this higher concentration for a substantially longer period of time, both compared to the standard formulation of remdesivir.
NV-CoV-2-R combines two different mechanisms of attack against the virus and therefore is expected to be substantially more difficult for the virus to evade than either NV-CoV-2 or remdesivir alone. This is important because scientists believe it is only a matter of time before variants of SARS-CoV-2 that evade current vaccines and antibody drugs become commonplace.
Both NV-CoV-2 and remdesivir are expected to retain their effectiveness against variants of SARS-CoV-2. NV-CoV-2 has shown effectiveness against multiple unrelated coronavirus types. Remdesivir has been demonstrated to possess antiviral activity in cell culture against a large number of RNA viruses.
The clinical effectiveness of remdesivir is limited by bodily metabolism which turns a substantial portion of the injected drug into an inactive form. The protection from metabolism that is provided by e
Remdesivir, while effective in cell cultures, has not demonstrated a level of clinical effectiveness that such strong antiviral effect could muster. This has been related to the fact that remdesivir is rapidly metabolized in the bloodstream and its effective concentration at the site of action may therefore not reach the levels necessary. The standard Veklury® formulation of remdesivir in betadex sulfobutyl ether sodium (SBECD) helps with suspending remdesivir in solution, but does not appear to significantly improve upon the metabolic effects.
NanoViricides, Inc. has developed NV-CoV-2-R, a drug candidate that encapsulates remdesivir in the Company’s pan-coronavirus drug candidate NV-CoV-2 to solve this problem.
About NanoViricides
New 8K
Item 7.01. Regulation FD Disclosure.
On September 21, 2021, NanoViricides, Inc. (the “Registrant”) was advised that certain articles were published, prior to the opening of trading, by a third party based on certain information that the Registrant has not yet publicly released. The third party had received the information confidentially under embargo from our Public Relations provider. The Registrant had advised and confirmed with the third party to extend the embargo in order to provide the Registrant’s management additional time to review and redraft the document into a final press release. Unfortunately, due to a human error in moving the embargo date, the third party inadvertently published their articles based on the draft information. This information has not yet been released by the Registrant as of this date.
The Registrant believes that the statements contained in the Registrant’s information document (attached) are reasonably accurate, although they have not been fully vetted in their final form and do not contain typical safe harbor disclosures regarding forward-looking statements. The Registrant expects to fully vet the contents and publish the information on or before Tuesday, September 28, 2021, before 7:00 am EST, which may be substantially different than the attached draft.
The furnishing of the attached information is not an admission as to the materiality of any information therein. The information is summary information that is intended to be considered in the context of more complete information included in the Registrant’s filings with the U.S. Securities and Exchange Commission (the “Commission”) and other public announcements that the Registrant has made and may make from time to time by press release or otherwise. The Registrant undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K except to the extent required by applicable law, although the Registrant may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the Commission, through press releases or through other public disclosures. This information should be read in conjunction with the risk factors and other information contained in the Registrant’s filings with the Commission.
This Form 8-K and the Exhibit contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Registrant’s control. These statements are also based on many assumptions and estimates and are not guarantees of future performance. These statements may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Registrant. to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Registrant 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 Registrant’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.
Item 8.01 Other Events.
The disclosures set forth in Item 7.01 are hereby incorporated by reference into this Item 8.01.
Item. 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Draft Information Document
SIGNATURES
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES EXCHANGE ACT OF 1934, THE REGISTRANT HAS DULY CAUSED THIS REPORT TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED THEREUNTO DULY AUTHORIZED.
NANOVIRICIDES, INC.
Date: September 21, 2021 By: /s/ Anil Diwan
Name: Anil Diwan
Title: President, Chairman
Yep - good news indeed. And the 'good' think about these trials is that it's not going to take a long time to get the data they need in India. The course of respiratory distress for COVID is measured in days and weeks - rather than in months or years like some medical treatments.
Yep,... we appear to be halted at the moment. I wonder what's up?
Exactamundo!
Interesting information Q,...
A partnership of some kind would hardly be surprising to my thinking. There's less money up front from the partner than a buyout would be, but there's also considerably less risk to the partner than going all in on a buyout.
It might be good for CVM as well - the partner presumably would have more resources and experience in scaling up production, sales, marketing and distribution than would little CVM. And it would leave the company time and resources to focus in on what might be done using LEAPS.
Let's hope the September "news" is good, and actually happens.
What happened yesterday?
Pretty much nothing out of the ordinary actually. The market is waiting for actual news from CVM (positive or negative) and in the meantime trading is going to generally be inconsistent. Share prices had been on a general upswing on no news,... Now they went down on no news.
Expect this sort of thing until we get news about the BLA and meetings getting scheduled with the FDA.
At times a bit flippant, and other times a bit preachy,... but in general a fair take on the CVM situation.
Thanks for posting this. I've been adding small lots of shares again ever since the post-announcement 'crash'. I'll never hold anything near what the author claims he/she holds in any pre-FDA approval drug company as it's just too danged risky for my taste.
However - I think a lot of the risk is gone now for CVM. It's just a waiting game to see the BLA package that CVM puts together looks like,... and how the FDA responds,....
"NanoViricides is currently working on taking its two COVID-19 lead drug candidates, namely, NV-CoV-2- and NV-CoV-2-R, into human clinical trials. The Company believes that the essential preclinical work is substantially complete for taking these drugs into human evaluation."
I'll believe that when I see it happen,... starting a clinical trial that is,...
Have they ever actually completed toxicity testing for ANY version of their potential drugs that would permit them to test a candidate out either orally, or intravenously?
Not really any 'new' information from the article - but it does summarize (again) what we have already been told is happening and is going to be happening.
Thanks for sharing it Henkel.
That would make for a heck of a lot of millionaires - including myself and I'm not that big an escrow holder.
Admittedly - I think the likelihood is close to zero that we see that kind of return. It's kind of fun to speculate about though,...
There's always going to be lots of new viruses,... it's kind of how they make their evolutionary living.
Yep - I have added several small lots of shares in my regular trading account since the 'crash',.... all up nicely now. And they will be even nicer later.
Decided that I already had enough shares in my Roth,...
Cheers!
Very cool RobotDroid - a LEAPs derivative that appears to be quite effective in laboratory mice.
I've said for years that LEAPs could end up being more valuable than Mutlikine - more flexibility and the ability to aim the immune system at highly specific targets.
Multikine may get the door open - and potentially make us all fairly wealthy - but in the longer run,....
We got generally lucky in my bit of inland MD. We got about 6 inches of rain over about 10 hours, but almost half of that came down in a 2 hour period. Some localized flooding.
There was a near tragedy occurred involving a school bus getting stuck in floodwaters - but everybody safe and sound thanks to the local fire department. The county school executive who decided to close the schools early and send the kids home - during the worst of the rain - has already apologized unabashedly for her decision to close the schools,... But I am guessing her contract won't be renewed,...
I hope everybody has somewhere safe and warm to sleep and access to whatever necessities they can get.
Yep - I'm not much deeper in CVM as regards numbers of shares that I hold. I only do biotechs in a small way because they are inherently risky. Most of what money I invest goes into boring index funds and dividend producers.
That being said - with the Phase III done and at least one wing of the study looking pretty positive - I think most of the risk here is gone for CVM.
IF CVM goes to north of $100/share within the next year (assuming the BLA gets submitted by early-mid 2022), then we both get to decide what to do with our gambling winnings. I'll probably sell about a third of what I hold now and buy some other boring dividend producer with the money, make sure to save some for the long-term capital gains taxes, and let the rest ride for a while.
I didn't see - but then again I pay almost zero attention to Adam F and his drivel.
What was his implication here? I'm sure it was negative.
That definitely ain't no Mom & Pop investor action,...
Another good day with decent volume and a positive upswing. Warms my heart to see,... and makes the old trading accounts a bit more green,....
Hey G8 - Yes it has been posted before - but it's rarely bad to repost something useful like this.
And exactly right about "September" - we'll have a better idea of where we all stand.
Have a great weekend folks!
I don't think that I have been in Vegas since sometime in 1998 - unless you count changing planes in the airport being "in Vegas".
I also - here in MD - am enjoying the decent action. :D And I bought a few more shares today. I want to make one more similar sized purchase of shares, probably next week, to get me up to a specific nice round number of shares in my trading account,...
And then I'm just going to set these shares, and forget them, until the BLA documents get filed,...
Will go back to focusing on some other biotech stocks I have already been dabbling in the last year or so.
Anybody got a strong opinion on either CFRX or AMPE?
Interesting indeed. Small sample size of course (only 30 patients), but if the results are that good in a small population, and if the blood test does work well - they can target the therapy directly where it might do the most good.
It's only a Phase I/II study, so they are going to have to scale up and do a Phase III - but it's another possible application of the treatment.
And,... still a lot of nothing,...
Interesting development indeed.
https://trilliumtherapeutics.com/pipeline/
And keep in mind that Trillium Therapeutics hasn't got any of their potential cancer treatments past early stage (Phase II-ish) clinical testing as of yet.
I'm guessing that the price point for a CVM buyout would be quite a bit sweeter than Trillium's was,...
Good article,... detailed without getting too detailed or too chock full of jargon.
We're only talking about H&N cancer at this point because that's where the clinical trial actually has generated data.
It is quite likely (assuming that CVM does get FDA approval for H&N treatments) that other, similar types of cancer will start to get either treated off label, or even might get their own clinical trials. IMO - it's also likely that a similar improvement will be seen once that work is done.
By that time CVM will likely be generating a steady stream of revenue (again,... assuming H&N FDA approval) and can write their own (and our own) tickets for these studies, or license out making Multikine and focus the company on developing the LEAPS system further.
As the others have said - the price dropped off because the market was disappointed that the Phase III results were not uniformly great, but also because this stock has been heavily shorted for years, and because management has a history (justified or not) of overpromising and dragging things out.
If Multikine increases survivorship and positive outcomes by 14 or so percent at 5 years post treatment for H&N cancer patients who don't need chemo, just radiation, post surgery, then CVM still has a big potential market.
I suspect that we will see sentiment swing back much more positive once we see Geert's people get the FDA documents moving forward.
Most of my CVM shares have been sitting in my Roth account for 3+ years and I never had too many because I figured this was highly speculative. However, I have added significantly to my CVM holdings in my regular trading account during the last month and will plan to keep doing so while the share prices remain below $10 or so.
They ain't getting mine unless I like the prices,... And I ain't going to be selling in any sort of fire-sale myself.