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NNVC will still have to jump through the same hoops that every other pharmaceutical firm must jump through for each drug it creates. The investorshub NNVC reality distortion field notwithstanding.
NNVC will still have to do tox testing, phase I trials, phase II trials, and phase III trials on the nanoviricides that follow Flucide. So no, cranking out a new 'cide every two weeks is not going to happen.
It's funny. You're the one always making the excuses for the delays in Flucide, always coming up with new reasons why the process has to be long and complicated and still longer and still more complicated.
But suddenly, after Flucide, all those complications disappear! We'll have Denguecide, HIVCide, Rabiescide, etc. popping out every two weeks! Do you expect me to take you seriously?
We've been waiting over 8 years for Flucide. And we're still at least two years away from approval. So my timelines of 6 years or so from first cut at a possible drug candidate to approved drug is not at all out of line, although I could be accused of excessive optimism.
I don't think that a deviation of a year from a stated schedule would be any big deal. But NNVC has missed by many years. Frankly, older investors have to wonder whether they'll still be alive when this company finally achieves its goals.
If five years from now NNVC is still waiting to start clinical trials for Flucide you'll still be making excuses.
Too funny.
Note that that 2 year advantage is itself purely hypothetical. So far NNVC has shown no indication that it can get an approved drug out the door any faster than any other biotech startup. If big pharma is simply a little more on the ball in doing the meat and potatoes tox and clinical testing they could erase that 2 year advantage.
Let's just suppose it takes NNVC 2 weeks to get their first crude cut at a 'cide, and it takes Big Pharma 2 years to get a new drug of similar promise. That's not as big an advantage as it might seem when you consider that both are followed by 6 years or so of further development and testing before they are approved. It comes down to 6 years total vs. 8 years.
And that's just hypothetical since we have yet to see NNVC get any 'cide as far as completed tox testing.
Yes, like those posts that say NNVC can crank out a new 'cide every 2 weeks.
Complete nonsense. In two weeks NNVC can have a first cut at a new nanoviricide. Then it takes two or three years to fine tune it to the point they have something they'd like to get approved. Then it takes two years to get the damn tox tests done. Then it takes two years to get phase I trials done. Then we find some surprising new reason why phase II trials can't be done for the next two years. Etc., etc.
Nanoviricides has failed to meet any of their own timetables. It is many years behind their original schedules for Flucide, HIVcide, or any other nanoviricide. If NNVC was a racehorse it would die of old age before getting to the finish line.
I know Dr. Harris does not have any published papers on Denguecide (that nondisclosure thing again). Can you point me to any interviews where she is "ecstatic about the trials"?
Or is this just heresay from Dr. Seymour?
Somehow I never expected Nanoviricides to be equated with the fastest horse on the track.
So far not one outside scientist has come forth and said, "Yes, we tested them and those nanoviricides work". I know, they are subject to nondisclosure requirements. But that just means we don't know what they did or did not verify.
You are correct that I'm not a day trader. But if I was, I'd trade stocks that don't have a likelihood of dropping 50% in a day based on one piece of bad news.
I find it amazing how people can look at the random ups and downs of a stock chart and "know" just what caused it. Why, it's all the fault of a particular broker!
So Interactive Brokers is now "infamous" because of their conservative margin requirements? They don't want their traders blowing up. I think that's a good thing.
Frankly, anybody who buys NNVC on margin is insane.
Well, I keep "It's a scam" on my list of risk factors, although I don't give it more than a 10% probability. It is unlikely that a director of a a company would be so taken in by a scam done by others in that company that he'd put in $7M of his own money, but stranger things have happened. Certainly the average investor in Bernie Madoff's fund back in 2004 would have laughed off any claims that that was a scam, but it was.
Well, as I see it nanoviricides are radically different from other drugs. They are not likely to fail in the way that other, more conventional drugs have failed. But they may well fail in some brand new way that nobody anticipated. Pioneers are the ones with the arrows in their backs.
We don't even know if Flucide works in humans so my eyes glaze over concerning the things we are "virtually assured of".
I put getting "fast track" status in the same category as Echo's regular promise that some Chinese company will buy out NNVC at a rich price. It might happen, but not worth spending any time worrying about. It's like hoping some long lost but rich relative dies and leaves you a fortune. No one would bank on that.
Malaria is not a viral disease. It's not even a bacterial disease. It's caused by a protozoan of the genus Plasmodium. So how is a vaccine for malaria competition for NNVC?
It must be those evil naked short sellers. You'd think those villains would at least have the decency to put their pants on.
I don't regard the pre-tox tox studies with the great optimism that ZincFinger does but I'm not as negative on this as Nanotoday. As I see, as of last week we knew that NNVC had not met Dr. Seymour's timeline for the initiation of tox studies (the real ones, done by BASi). Now at least we know why, and I guess that counts for something. My question is, does anybody here have any notion of how long the non-GLP tox studies done by KARD Scientific are likely to take?
Clinical trials are still far in the future. I'd say 2015 at the earliest. There is nothing to have prevented NNVC from publishing a peer reviewed paper as soon as their patents were filed. Nobody says they have to wait for an NDA.
The old "naked short" bugbear. I think I'll see proof of bigfoot before anybody shows me a real live naked shorter who isn't a market maker.
Just as I think it is unreasonable to assume that anyone here who is critical of NNVC is shorting the stock, I don't think it's reasonable to assume that everyone who views NNVC with rose colored glasses is a paid shill for NNVC. I doubt very much that ZincFinger is a paid pumper. I just think he's one of the very many people here who thinks that NNVC is much more of a sure thing than I think it is.
Right. There is an approval process, requiring clinical testing. Precisely because the FDA doesn't know that a drug works in humans until it has been tested in humans. Which is my point.
The proof is that the FDA is requiring that we get Flucide through clincical trials before they approve it. They wouldn't do that if they already knew that Flucide works in humans.
You are right that they'd first ask what Flucide is and what the data is for it. And once they see it, they'd say something like, "Well, that looks promising. But we don't know if it works in humans."
Which is my point. Whether Flucide works in humans remains a big question mark. Most people here just assume that it will, and act as though all the testing and clinical trials are just some bothersome and legally required jumping through hoops but ultimately meaningless because we already know what the results will be. Me, I don't claim to know what the results will be.
I'm very confident that if you asked any of the people at the FDA whether Flucide works in people, he'd say, "I don't know."
If the FDA neither agrees nor disagrees that Flucide works in humans then that means that the FDA does not know if Flucide works in humans.
Which is exactly what I said.
I said that the FDA agrees with me that we do not know if Flucide works in humans. Do you really disagree with that? Because if I'm wrong then the FDA knows that Flucide works in humans. In which case one has to wonder why they're bothering to make us go through human trials.
The peer review would be on the mouse studies and would come years before any clinical studies. Right now the clinical studies are still sometime in the distant future.
Well, any trader who sold when NNVC first hit $2, bought again below 0.50, sold again at $2 ($7 post split) and bought again at 1.43 ($5 post split) has done a lot better than me.
I don't trade this stock because I suck at picking tops and bottoms. But I see no reason to disparage the people who are good at it.
You are missing (or just ignoring) the basic point.
That point is that theory and real experience are two different things. I don't maintain that there will be differences between how Flucide acts in mice and how it acts in humans, I maintain that there *might* be differences.
Fact: We do not know if Flucide works in humans. The FDA agrees with me.
Good question. Most strains of influenza don't infect cats or dogs, but they certainly infect birds. If vets reported that chickens were protected from flu infections by Flucide that would greatly increase the credibility of NNVC to investors and would provide real evidence that Flucide is agnostic about the host.
Yes, "we". Whether you admit it or not, you too are taking the efficacy of Flucide in mice on faith, unless you have some peer reviewed paper the rest of us haven't seen.
"Agnostic to the host" is a statement of faith, it has not been proven. After all, just what sort of animals have nanoviricides been tested on? Rodents and rabbits. No monkeys (they're very expensive). Not even dogs. The only way to be sure that nanoviricides work in humans is to test them in humans. I'm pretty sure the FDA will agree with me on that one.
Biotech is littered with "sure things" that worked in petri dishes, worked in mice, and failed to work in humans. Nanoviricides don't have to enter a cell before they can encounter differences between mice and humans.
I also point out that even the efficacy of Flucide in mice is something we have to take on faith -- there have been no peer reviewed published papers on it.
Yes, we are. I'll use it whenever I see another one of those posts about how we're almost done with getting Flucide to market.
Sheesh, you've just made the case that Drs. Diwan and Seymour should pay themselves one million dollars per year.
Given that schedules slip, slip, and slip again, it would be prudent for NNVC to conserve cash as much as it can. Indeed, Big K likes to tell us how frugal Dr. Seymour is. The salaries of Diwan and Seymour do not demonstrate much frugality.