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While the FDA has often acted as an anchor on drug development, it can't be blamed for the glacial pace of Flucide development.
It is silly paranoia to say that the FDA regards drugs that attack a virus as "crazy talk", given that it has approved numerous antivirals that, in one way or another, interfere with a virus' ability to infect a cell and reproduce. It is not the FDA's fault that NNVC has yet to begin toxicity testing of Flucide.
From the big, pretty picture:
"Reality Check: A drug entering phase I study only has a 1 in 10 chance of getting through all the regulatory hurdles to approval."
Yet most of the permabulls here insist that Flucide has at least a 50% chance of success.
You say you have done due diligence. Well, I say that my ability to do due diligence on this stock is very much limited by the dearth of published results. I basically have to take an awful lot on faith. That's why I call this a faith based stock.
Pointless hypothetical.
If Kevetrin trials got funded with tax payers' money on the basis of nothing more than a couple of poster sessions I'd call that another in a long list of wastes of tax payers' money. That's not justification to waste still more.
But they're funded with the pharmaceutical company's own money.
This is silly beyond words.
Actually, I don't. You didn't find out about Dr. Harris' results by reading her paper, because there isn't one. You apparently didn't hear about the results from Dr. Harris herself, either. So where did you hear about it?
This hypothetical request for funds isn't for pie in the sky basic research. It's to fund clinical trials for a drug that supposedly is already known to work in rats. It is perfectly reasonable under those circumstances to ask to see the peer reviewed paper that shows it does work in rats.
Again, none of those outside researchers ever published a paper, or to my knowledge even gave a poster session, showing that some nanoviricide works.
If NNVC were to go to congress asking for money, joining thousands of other tax eating businesses doing the same, the first thing the congressmen would ask (in private, of course) is, "How much did you contribute to my campaign?" If I were a congressman (no chance of that, I wouldn't get elected) my first question would be, "Where is the peer reviewed paper showing that this stuff works?"
Did Dr. Harris report it to you?
Show me the paper where Dr. Harris reports that.
The company would certainly gain credibility if they published peer reviewed papers demonstrating efficacy of nanoviricides in laboratory animals. Right now they can only get faith based investors.
Yup, a confidentiality agreement that ensures we can't know if there is a nanoviricide that really works against dengue. That certainly inspires investors' confidence.
My point remains. Talk all you like about outside collaborations, the fact remains there are no peer reviewed papers supporting the claims made by Nanoviricides.
Where are the published, peer reviewed results of all those collaborations? Going to her web site, or to PubMed, I can see, for example, that Dr. Eva Harris has indeed published many papers on dengue. But none of them are about the tests with nanoviricides.
As has already been pointed out, presenting a poster session at a conference isn't the same thing has publishing a peer reviewed paper.
They might have fooled themselves. We really won't know until clinical trials take place. We would certainly have more confidence at this point if peer reviewed papers had been published.
And people are voting with their wallet. That's why this stock stays in the 50s and 60s.
Puffer, you seem to misunderstand why publishing peer reviewed results is necessary. It's not solely to increase the credibility of NNVC to outside investors (although that's certainly a very good reason in itself). Humans have an enormous capacity not only to fool each other but more importantly themselves. If you have a strong reason to want to believe something is true you focus upon the evidence that supports it and ignore the evidence that contradicts it. The scientific method is largely about how not to fool yourself and others. Under peer review people who don't have a vested interest in seeing NNVC succeed will be looking for flaws in the experiments or the analysis. If they don't find them, that's great. If they do, maybe the experiments can be done better. Or maybe Flucide isn't as effective as hoped. In any case, we're more likely to get at the truth, whatever it is, if peer review is used.
May Weedie should volunteer to work one of the shifts.
I'm not the one splitting hairs over members of the academy, researchers, and business and medical professionals.
What progress? Okay, last year they came out with oral Flucide. Which, like other NNVC products, apparently works in rats but is not known to work in humans. Other than that, we have:
1. No phase III trials.
2. No phase II trials.
3. No phase I trials.
4. No IND approval.
5. No toxicity tests completed.
6. No toxicity tests started.
Exactly where NNVC was 3 years ago.
Yes, you do love to split hairs.
They are not "academics" as in "professors", after all, they don't have classes to teach, but they are researchers and researchers like to talk about their research projects. There's no great harm in that, but it isn't getting Flucide any closer to approval.
Why do you think Dr Seymour and Diwan go to presentations and speak on FLUCIDE and NNVC?
This fantasy of yours assumes that all this interest of and bidding for NNVC will occur before any toxicity testing is done, and before there is any evidence for efficacy in humans. Dream on.
OTOH, if the toxicity testing gets done and Flucide is shown to be effective in humans, there will be plenty of interest in NNVC without any nasty new flu strain in China.
Your referenced post fails to explain *how* development of Flucide approval would be "greatly accelerated". Will it make the construction workers work faster? Will it make the tox testing go faster?
So H7N9 is now an "immediate problem". That would be relevant had NNVC met its original time tables, because right now it would have a treatment to sell. There are real human consequences of NNVC's long sad history of missed deadlines. But how does H7N9 make the construction of the manufacturing facility go faster? How does it speed up the tox testing? No human trials are going to be done until both of those items are completed, no matter how "immediate" the problem of H7N9 might be.
Yes, the hype about the current flu-strain-of-the-month might cause the stock price to pop up a bit, before it drifts back down. None of that is relevant to what matters -- actually proving that Flucide is safe and effective in people and getting it to market. H7N9 isn't going to speed that up.
I'm not saying that NNVC shouldn't do in vivo tests of H7N9. It can never hurt to have more evidence that Flucide is effective against a wide variety of influenza strains. But that won't get us any closer to phase I trials.
If the Canadians test FLUCIDE on H7N9 and it works the whole FLUCIDE PROGRAM could take off.
Yup, I presume that at the pre-IND meeting NNVC was told, among other things, exactly what was expected for the toxicity testing. But here we are, at the end of April in 2013, still months away from the start of toxicity testing, and that's if you believe that NNVC will, contrary to custom, actually meet their own time table. The pace is glacial.
Nope it's not news. It looks like an attempt to pump the stock by saying, "We think Flucide will work on the latest flu-strain-of-the-month." When in fact Flucide has not yet been shown to work on any flu strains in humans. If NNVC's management really wants to move the stock price up they should start toxicity testing. Any press release they put out before that event I will file under "Irrelevant".
If I decide I want more shares in this rabid speculation I'll wait until the price hits 0.50. I think we'll see that price before we see $1.
Doctor Feelgood, on March 14, 2013:
If the CEO loaded at .69, what makes you think that he will allow it to break that bottom? Dr. Seymour likes to preserve every cent he can. In fact, I heard he still has his lunch money from the 3rd grade.
If someone came up to you and asked if you knew of any promising technology that might be a good investment for FLU and SUPER FLU, what would you say?
I agree with you on this. Unfortunately our government still believes that government knows best, and pharmaceutical companies that want to sell in the United States have to deal with this reality.
Second, I haven't seen any evidence of "hoping" for the worst. A pandemic is going to happen. There's no way around that. It could be the current bird flu, or it could be some other strain. Periodic pandemics are a fact of life until a universal vaccine or treatment is found. There is nothing ghoulish in hoping FluCide will be a treatment when that pandemic finally occurs.
If I were dying of flu someone trying to give me the freedom to work with scientists to save my life would be seen as a friend.
China is not likely to allow testing the cure before toxicity tests are completed. Frankly, it's a bit ghoulish the way some people here are hoping that this or that nasty strain of flu will allow NNVC to do an end around run of the approval process.
No, why do you ask?
I figure that if and when Flucide is approved and available for sale China will buy it just as a lot of other countries do. I'm sure these future sales are already taken into account when people project $100 a share for NNVC. We could expect these sales to occur whether or not China happens to have an outbreak of flu this year. So again, the current flu outbreak in China has nothing to do with NNVC. It won't make the testing happen any faster, and it gives speculators no more reason than before to buy NNVC stock.
So, a Chinese company once wanted to buy NNVC. Big deal. If they had, they would still have had to do toxicity testing before they could to trials with humans.
You keep grasping at straws. NNVC will have to do toxicity tests and complete its manufacturing facility before any human trials are done. It will have to complete phase IIa trials (at least) before there is any general recognition that it has a likely cure for the flu. This is a speculation for patient people. If you want something that will fly to the moon by fall find some other stock.
"Right now and in the foreseeable future no such emergency exists or will exist."
Correct. Which is why no investor is going to buy the stock on speculation that such a fringe event is going to occur.