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Somehow flooding the body with fake cells to trick the virus into binding those seems like a bad idea. Certainly not a Tesla worthy invention.
It's a very long and expensive process. Lucky Diwan has been working on it since 1980.
Why don't the SEC filings mention pre-IND?
I wonder.
I also wonder why the filings continue to say 18 months to IND, even though several 10-Qs in a row have said this. Aren't they making progress??
What a scam artist.
If he was any good he would be managing money for himself and clients instead of writing silly promotional penny stock newsletters.
I don't normally use internet forums. Two of my other investments are Amgen and Becton Dickinson. For some reason people care more about what Patrick Cox thinks about NNVC while Becton Dickinson is owned by Warren Buffett and that information is free... go figure.
Why anyone would waste their time listening to someone who hasn't made a fortune in the market is beyond me. In fact, betting against them usually works. I am going to enjoy taking Cox's subscribers' hard-earned money.
I just got authorization to short an additional 50,000 shares, thank god. These prices are great for me. Dream come true would be 2. It would be a nightmare at 3 or 4 though!!!
Only 15%ish annual cost to borrow these shares.
Hehe you have no idea. ask me about any healthcare stock.
My short is more of an ongoing joke than it is a real investment. I have 200 different investments. None define me.
I assure you, at $200 million value, with no clinical candidates, Nanoviricides' stock is far from cheap. Few, if any, other companies can boast this value with such little progress.
You are being suckered.
Hepatic metabolism
Basic ADME dictates "nanoviricides", as described in the AllExcel IP, would be quickly metabolized through hepatic phagocytes.
Without T1/2, cmin, cmax, tmin, tmax data it is unlikely nanoviricides would work in humans. Has any of that data been published or revealed?
I'm more alluding to Seymour's past as CEO of StatSure (SSUR), which was very poorly ran and terribly unsuccessful. Why give this guy another chance? Why not get a CEO with biotech experience?
So basically, PRVs will never matter for NNVC.
Why would anyone trust this management after SSUR?
Their track record is not so good. Seymour did a terrible job at SSUR and everything else he has done in his corporate life. Diwan is no better--one can find messages on this very board noting he has been trying and failing to raise money and develop this technology for 20 years.
There will be dengue vaccines and/or dengue direct antivirals (SIGA is more advanced than NNVC and is a real company doing real R&D, publishing data, etc) well within the next 6 years.
They don't know what the FDA wants since they haven't contacted them yet. Remember, a pre-IND meeting is just a phone call, and toxicology packages are very routine and standard. Many pre-IND meetings occur after basic toxicology is done as that is a prerequisite for every company (rats, for instance - second species may be a topic for a pre-IND call).
Poor NNVC. Really no idea what they're doing.
Yes, it is sad that there are folks who willfully mislead investors for their own profit. It seems like Cox is easily buyable. He recently has been making outlandish claims about CIGX, which I have recently shorted.
NNVC is difficult to short - we keep getting rejected from prime brokers who have no supply for shorts. So the share price is probably not too accurate. As soon as short sellers are able to short, it will likely be knocked down again.
A Pre-IND is a telephone call. Do you really think a call with the FDA clarifying 'next steps' is that important?
You're making a catalyst out of nothing.
The FDA will tell them 'do toxicology studies'. 'Get to cGMP standards'. 'File an IND'.
There is no substantial news for over a year.
More interesting than the stock price is the borrow market. We were denied access to short any stock today. The indicative rate in the lending market is 27%. That is a very high annual rate to borrow shares of NNVC, indicating extreme demand from short sellers.
You will have to wait at least one more year as the company seems to have difficulty even meeting with the FDA to clarify toxicology requirements which are typically straightforward.
cGMP setup and toxicology normally take at least one year. So maybe the company will be in phase 1 late next year? At that point it will likely need more capital. It's hard to see the shares being worth $200 million when management has proven unable to meet timelines and operate effectively.
What happened?
There's an endless supply of pills for HIV. Sorry, Feelgood. Modern medicine has defeated HIV. If you become resistant to Atripla you can take Isentress. If you become resistant to that you can try Combivir. Resistant to that? Take your pills on time, already, but try Prezista. It doesn't stop. There are easy choices for this. Talk to a HIV physician and stop Googling. Google does not replace real research unfortunately. We all know resistance occurs. But there are plenty of articles which detail that HIV patients have a normal lifespan. Guess you're not searching for those.
Accurately Measuring Recombination between Closely Related HIV-1 Genomes
http://www.ploscompbiol.org/article/info:doi%2F10.1371%2Fjournal.pcbi.1000766
This link doesn't work.
Of course all medicine have side effects. On a relative basis it will be very, very difficult to come up with an even safer version of Atripla. Gilead is hard at work on that, however. And in a few years, Atripla, Viread, Truvada, etc will all be generic and cost pennies. Certainly these drugs with over a decade of experience in millions of patients with a tremendous safety track record cannot be usurped by a preclinical 'idea'.
http://darwin.uvigo.es/download/papers/56.recModelHIV07.pdf
This paper recapitulates what everyone knows and does nothing to refute the idea that Atripla is the standard of care with a tremendous therapeutic profile.
http://www.ncbi.nlm.nih.gov/pubmed/19842973
Here is a 2-year study which shows how uncommon it is to fail HIV therapy. You really have to be irresponsible and not take your medicine. Only 4% of patients in 2 years failed. No one got AIDS in this study. Side effects are what you would normally see in any patient of 45 years. Placebo controlled studies are no longer done so telling which side affect is drug related has become impossible.
Ignore all ideas contrary to your own! Surefire way to make money in the markets.
Having a meeting with the FDA means nothing. The FDA will give some advice on what toxicology to do. That will take a year at best. With these clowns running the company, never is a more likely time frame. So, in a perfect world, IND/Phase 1 in 2012. Tamiflu has a year to go generic and HIV drugs are still one pill once a day with no side effects.
$200m for this? No thanks. I short.
There is no opposition to this technology. Well-heeled investors like myself are dreaming of great opportunities to fund. Nanoviricides hasn't been successful because management has no experience in pharmaceuticals and has no clue how to develop the product candidates, and the product candidates are not very good. Don't dream up of a conspiracy theory as an excuse to a poor investment decision. Kleiner Perkins wants to invest in great new ideas regardless of the 'powers that be'.
Immunogenicity always occurs in foreign administration of native proteins (eg EPO HGH etc). Don't forget there is sparse data on degradation of 'nanoviricides'. Proteases/polymerases are ubiquitous and destroy polymer molecules like these quickly.
Tried to short 100,000 shares of NNVC today.
No borrow available! 0 shares approved for shorting.
Oh well, tomorrow is another day.
PEG is one of the safest things known to man.
PEG-irinotecan would be one example of a not so safe PEG drug. You can add PEG to anything. PEG-interferon is the most commonly used drug. It is quite toxic. PEG does reduce peak blood levels of drug which lowers toxicity. It's a great invention for biotech based drugs and increasingly Nektar and Enzon (the PEG companies) have been able to attach them to small molecules. It's just a delivery tool. PEG by itself does nothing--it's inert pharmacologically.
Good luck. Great job on MSFT but I think you are way off base on NNVC. While I am somewhat tongue-in-cheek when I use the words "scam" and "fraud", I think you should consider that in medicine there are few ways to break the mold. ADME-Tox, preclinical, etc are inviolable tenets of making drugs. This is what destroyed antisense and RNAi as therapeutic modalities and it will probably do the same here. I wish someone would sit and explain "nanoviricide" (feels dumb just saying it) ADME. Simple stuff. Unfortunately there hasn't been any patents that describe ADME, any papers, any presentations etc. I've never seen a half-life for these things. Why not?
I found this message posted on another board and thought I'd show it here for the benefit of everyone. I would like to know the answers.
Mr. Feelgood, I'm neither short nor long in this co. but wanted to ask you a few questions.
I couldn't help but notice that the various message boards around the internet for NNVC are populated by you and a handful of others who seem to have been around since the inception. Not only that, but many of the early investors have also defended/touted Seymour's prior venture of Saliva Diagnostics which traded under a variety of symbols before it finally found itself flushed down into the cesspool where things can get quite brown if you know what I mean.
It's very possible you've disclosed this in the past, but I'm just wondering why the vigor for you to defend Dr. Seymour so much? It seems like he may be a nice guy but he's also the head of a company that has made many unfilled promises in the past. What, exactly, is your own personal genesis with Seymour's ventures, and why defend/promote them to the extent that you do? Is it possible you could give a synopsis of your investment history? Did you just buy in on the open market and got involved that way?
I realize my questions are rude and forward on some level, but hey, it's the wild internet after all.
Any info you can give on your early and enthusiastic promotion of Saliva/Nanoviricides would be appreciated. I realize I'm behind the eight-ball when suddenly popping up to ask such a Q.
Atripla is pretty darn safe as far as drugs go.
It's been on the market for a long time.
It's not appropriate to say that nanoviricides are safe without safety data in humans. There is a difference between speculation and fact.
HIVCide: It is unlikely will be a useful drug as Gilead's Atripla is satisfying the market. www.atripla.com contains the Atripla prescribing information which will be useful for determining whether or not Nanoviricides is fulfilling a market need. Note that a patient who takes Atripla as a once daily pill will have undetectable levels of virus with very few side effects.
I don't see the point of HIVCide given this data. Nanoviricides will most likely require injection/infusion, for instance.
Their parents should have gotten them vaccinated or taken them to the hospital sooner. Both would have saved the kids life. Most people die from flu from a lack of fluids, not getting vaccinated, going to the hospital too late, etc. Not really flu related but stupidity related.
Not my problem.
Those people would die from anything. It's just how it works. Don't shoot the messenger. Flu drugs are not useful. There would be dozens of companies working on them if there were. If you don't get vaccinated that's your fault.
Shorted a little bit. I would cover if they did IND enabling work.
No, there is no way to make this drug in a pill form. It is peptide based so it would not work that way.
You fail to understand that influenza affects millions - the small percentage who die are not worth saving. They're dying for other reasons (they're very old). It's not the influenza that kills them. Influenza can't kill... A flu drug is a drug of convenience. Flu goes away. Patients who become severely ill from flu waited too long to get antivirals. They need fluids. Nanoviricides have to be formulated as an IV which makes them very inconvenient, if they even work. There is a good array of flu drugs that stop the disease. Flu does not progress and can be left untreated in most patients. It's other things that kill the patient.
HIV needs no new treatments WHATSOEVER. That is common knowledge. Patients who are not compliant with their medications have caused their own problems and there are solutions for them as well. There are more than 10 HIV drugs approved, maybe even 20.
You have to start at the basics.
ADME.
How long does this drug stay in the bloodstream?
UNKNOWN
How far in the body does the drug penetrate?
UNKNOWN
Does the drug get broken down? How? How quickly?
UNKNOWN
How does the drug get excreted?
UNKNOWN but probably not too important...
Then we have therapeutic index and toxicity to talk about...
In vitro success is one thing. Getting a drug into the clinic that works is another. The in vivo success is hard to believe because none of the above details have been divulged. No publications. No presentations at peer-reviewed medical meetings like ICAAC. Etc.
I wish I could say 'I hope it works' for society's sake, but influenza is extremely easy to treat and there is no desperate need for a new drug. There are bad diseases out there where drugs are needed. Flu and HIV aren't them. Hepatitis C is still a while open field.
Because it's a scam. You'll never get an IND.
Sort of. There is a big difference between the stalwarts and the stonegates... There are banks who you are proud to have represent you and then there is the stonegates...
I think so. $41 billion market value.
Never heard of Stonegate.