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My best guess for the start of human testing is also 2015. (Early in 2015, for me.) I too would love to be proven wrong but so far NNVC has never surprised us by being early.
I note that Dr. Seymour loves to say human clinical trials will only take a few weeks, and he can whip up a new 'cide in 2 weeks. The former estimate ignores the many months (or years) of preparation before NNVC can even start the human trials, and the months of review afterwards by the FDA. The latter estimate is for the first crude version of the 'cide to test on rats, and ignores the years of tweaking before there is a drug to submit to human testing. In other words, they are estimates that are meaningless in the overall scheme of things.
NNVC seems to have its own growth and generation and so does not seem to be directly connected to the DOW.
The old "naked shorters" complaint. Find me somebody, other than a market maker, who is shorting NNVC shares without borrowing them. Tell me who he is. There's more evidence for bigfoot.
Is anybody besides the market makers doing any shorting? So far as I can see, that isn't possible. If you tell your broker you want to short NNVC stock he'll tell you it can't be done because no shares are available to borrow. That's actually the usual case for OTC stocks. I checked the stock borrow/loan panel of my broker's app. I can short all sorts of exchange listed stocks, but not NNVC.
$20 billion market for Hepatitis C treatment.
Given its use in an aqueous environment, I assume that the micelle is filled with water.
Ah yes, the paranoia excuse. Big pharma isn't slowing NNVC down. (Just how would they be able to do that?) Neither right now is the FDA. It is NNVC slowing NNVC down.
Visualizing desires is the easy part. Doing tox studies is, apparently, much, much harder.
If you have a realistic dream and are willing to work very hard and don't get bowled over by one of life's many "gotchas" then you can realize your dream. Plenty of people have unrealistic dreams, or aren't willing to put in the work needed to achieve them, or just get run over by a truck at the wrong time.
We do not know yet whether NNVC's dream of cranking out cures for viral diseases is realistic because we don't know if any of them are safe for humans to take and we don't know if any of them work in humans. That's why what NNVC needs are tox studies and clinical trials, not more pumps from the speculators.
I wasn't claiming that quote came from you. I was saying that you have an attitude in agreement with that quote. Your precise words were, "If you can dream it, you can do it," which amounts to pretty much the same thing.
Now I'm really worried about my long position. People with Forzanano's attitude ("Dream it, and it will come!") usually get taken to the cleaners in the stock market. Wall Street loves people like that. But that means I'll get taken to the cleaners.
As a software developer you know it always takes twice as long as you think it will, even after you already took into account that it will take twice as long as you thought it should.
So why do you knock my time estimates when I apply the same rules to biotech, where they apply even more strongly?
I didn't expect tox studies to be completed before the first quarter of 2014 but mid 2014 is even later than I expected.
Well, NNVC never surprises us by being early.
I didn't say it was. I just said I hope he has a Plan B.
Well, naturally I would prefer to see NNVC get on a major exchange the old fashioned way. By proving out Flucide well enough that NNVC can get some revenue, and see its stock price go up above $2. I hope that will happen, but I don't expect it within the next year. My point was simply that if for some reason management sees it desirable to get on a major exchange soon, they can meet the per share price requirement with a reverse stock split. I own shares in another biotech that did just that. I own a third as many shares as I did last week, and they're each worth three times as much.
If NNVC wants to get listed on a major exchange they will have to do a reverse stock split. That's not a big deal.
That is not an answer. It is hand waving.
In fairness, most start up business owners pay themselves more than $1 a year. They pay themselves enough to live on, comfortably but not richly. There's little benefit to a company to have a boss who is starving to death or unable to pay his heating bills.
The cases where you hear about a CEO getting $1 a year are where the CEO is already rich and will get amply rewarded through gains in his shares or options, such as when Steve Jobs was brought back to Apple.
You haven't answered my question. So far as I can see NNVC needs scientific and clinical results more than it needs financial wizardry. So I don't see that which CFO NNVC has makes a whole lot of difference, except to Dr Diwan's household income.
Nonsense. All sorts of people dream about all sorts of things that they will never, ever be able to accomplish. That's reality. NNVC doesn't need motivational speakers. It needs to start the damn tox tests.
Dr. Seymour seems to be pinning his hopes on the FDA giving Flucide breakthrough drug designation. That might happen, but the FDA is known for the capriciousness of its rulings. So I hope Dr. Seymour has a plan B.
Yes, and I think that's great because she has the ability to earn every cent of it.
It's not a straw man. If a company has been dragging slowly along for years it is unreasonable to assume that "next year" will be different. The time for the FDA to review the phase I results, the phase II results, and the phase III results is pretty much certain to exceed a year in itself, and that doesn't count the time for all the stuff NNVC has to do.
Yes it was my original point. Here is the relevant initial post:
Certainly it will be a good thing for NNVC to develop a 'cide effective against MERS-CoV. If they start now they might have something that works on rats in a couple of years. A year later, if they are more on the ball then than they are now, they may have toxicity tests completed on it. A year after that, they may have completed phase I trials...
No its not. Having a version of the drug you intend to put into clinical trials is precisely the point of the lab work.
It has already taken 8 years for Flucide, and it's not even in clinical trials yet. So far there's no evidence whatsoever for NNVC exceptionalism.
And the truth is, we have no idea how effective Flucide will be in humans. That's why we have to do the trials.
We could compare the costs of testing Flucide to the costs of testing another antiflu drug -- Tamiflu. But Big Kahuna won't let us do that because the costs and time for clinical trials of Tamiflu were so outrageous.
A two year estimate for having the drug they expect to put into clinical trials is reasonable. I stand by it.
Okay, you admit to being an NNVC exceptionalist.
Me, I think that neither the laws of physics, nor the laws of man, nor the ordinary facts of drug development, have been suspended for NNVC.
What started the current slew of flames was my assumption that going from the initial discovery of a 'cide that cures some new viral disease to FDA approval will probably take about 6 years. So yes, the the total development, testing, and approval time is what is relevant here. The NNVC exceptionalists are shocked at my high estimate, despite the fact that the same cycle for Flucide will be at least 50% longer than that.
The "exceptionalism" we object to is not the assumption that nanoviricides will prove to be exceptionally effective and flexible anti-virals. Indeed, we all hope they will.
The "exceptionalism" we object to is the assumption that all the rules of drug development that apply to other companies, including the costs and times involved, the amount of testing required, and regulatory hurdles that must be overcome, somehow don't apply to NNVC.
I think that getting a 'cide that works at all on a new virus, then tweaking and optimizing it to get the drug you actually want to submit to testing and approval, will take much, much, longer than two weeks. A year is not an unreasonable estimate, and I won't be surprised if it takes two.
The NNVC exceptionalists live in a fantasy world where a dangerous new virus is spotted in the wild, NNVC comes up with a 'cide that can cure it in two weeks, and the FDA approves it one year later.
Any biotech investor who has ever watched other drugs go through the long, laborious process of development, testing, and approval must have his jaw agape at such assumptions.
One key point that was mentioned... Phase I/II/III clinical trials for Flucide can "easily" be completed in 6 to 9 months and less than $15M. That's for everything, all three clinical phases.
I guess that's why you can't get Tamiflu in the U.S. Oh, wait...
But in fact if we look at total time development and trials have not been notably faster than for other drugs. Recall that even assuming that phase I, phase II, phase III, and FDA approval all happen in one year, 2014, the time from Flucide as lab experiment to Flucide as approved drug is over 9 years. And that one year testing and approval schedule is whirlwind fast compared both to other drug development and anything NNVC has done in the past.
Do you really think that the current version of Flucide was developed in two weeks? I'm sure they were dicking about in the lab for a lot longer than that.
I already explained why approval is relevant, particularly if you assume NNVC can charge the monopoly prices that lead to your $100 a share projection.
Part of NNVC exceptionalism is the assumption that FDA approval is irrelevant to NNVC's success. While the FDA has no legal jurisdiction outside of the U.S., the fact is that many countries look to the U.S. FDA to see if they should approve a drug.
We should also consider the reality that drug profits are much higher in the U.S. than in many other countries. Many on patent drugs are much cheaper in Canada than they are in the U.S., because Canada's one payer system uses the governments' monopsony power to drive the prices down. And the same is true in many other countries. Those "$100 a share" projections assume U.S. levels of prices and profits.
It is perfectly normal for phase I - III trials plus FDA approval to take 3 years. That length of time occurs for drug after drug after drug. I remind you that NNVC had Flucide working in lab rats back in 2005. If the cheerleaders are right phase I/IIa trials (not necessarily phase III trials) will take place in 2014. But lets assume that phase III trials *and* FDA approval all happen by the end of 2014. That's over 9 years of development, testing, and approval time. So I'm assuming a 3 year speed up.