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Yup, and then the phase III tests are completed 6 months later.
Apparently you don't.
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. A year after that, phase II trials. A year after that, phase III trials. And then finally FDA approval. So figure on 6 or 7 years before NNVC has a drug to sell that can cure MERS-CoV. I hope they do that. It will be a good thing to have in the pipeline. Of course it is irrelevant to the near term survival and success of NNVC, which is tied to Flucide.
The problem is that NNVC is acting more like the hare. It has the hot, snazzy technology that's "obviously" better than another vaccine or conventional drug, but it's been snoozing under a tree for too many years while the various tortoises crawl steadily to market.
I agree that the recent stock price movement, both up and down, is best seen as random noise. But it is other people here who see a quick short pop in the stock price as grand vindication for their views on NNVC. The only real vindication we will see, one way or the other, is if and when NNVC actually completes clinical trials for efficacy of Flucide. That won't happen this year. There's a chance it will happen in 2014, but on my own timeline I expect to see phase IIa trials in the first half of 2015. After all, NNVC has never surprised us by being early.
So far the only evidence we've had for market manipulation are the touts from the penny stock pumpers, who apparently achieved their goal of temporarily getting NNVC back into the .70s. Are the penny stock pumpers anarchists? I doubt we can determine their politics from the questionable way they have chosen to make a living. (Except to say they'd meet the qualifications for high level positions in both of our major parties, namely, an ability to make money with little concern for the ethics of how it is done.)
Companies appoint new board members all the time. This is not third tier news. It is fourth tier news. There is no reason for the market to react to that news at all.
The issues have all been covered before on this board. First, no human testing can be done until sufficient quantities of Flucide can be produced. It turns out that no conventional drug manufacturing plant can produce Flucide. So NNVC has had no option but to build their own manufacturing facility. This they are currently doing in Connecticut. It will probably be at least the end of this year, and maybe well into 2014, before they are manufacturing sufficient Flucide in the new plant for clinical trials. Second, they still have to do toxicity testing on Flucide. This is essential for any tests done in the U.S. Dr Feelgood/Synaptic Pruner/Whoever He Is Now claims that these tests are not required for doing clinical trials overseas. That may be correct, although I certainly wouldn't volunteer to take any experimental drug where they hadn't done the standard toxicity tests. The pre-IND meeting was completed in April 2012. Why, 13 months later, the tox tests haven't even been started is something I really don't understand. Anyhow, management claims they'll start in June +/- 3 months. So they might start as late as September. Or as soon as next week.
If you know anything about the history of this company you know that development has been glacially slow and they've missed many of their own deadlines. And that is why NNVC, whose product if it works could change the face of medicine, has a share price in the 0.60s.
Sanofi's technology is quite different from NNVC's. They use nanotechnology to induce antibodies against a wide variety of flu strains, while Flucide attacks the viruses directly.
But yes, this is more competition for NNVC. There are several promising approaches to curing influenza now in development, some of them further along than Flucide. I have said before that one of the greatest risks for NNVC is that by the time Flucide has been approved there may be more effective treatments out there. These may make Flucide irrelevant or, more likely, will provide competition that will force NNVC to charge much lower prices than the "$100 a share" crowd have been assuming.
The stock has seen high volume trading like this before. On 3/16/2010 2.235M shares were traded in a day that spiked the price from 1.12 to 1.50. This kicked off a rally that peaked at 2.70 about 7 weeks later. So maybe Dr. Feelgood/Synaptic Pruner/Whoever He Is Today will see his $1 a share well before the end of June.
Of course every rally ended with declines back down into the $1 range or less.
NNVC is in day four on www.pumpsanddumps.com's list, with 10 touts from Blue Wave Advisors Affiliates, and one tout each from StockProfessor.com, PennyStockShark.com, and LuckyStockPicks.com.
With such titans of the investment world on our side, what could possibly go wrong?
So humans in G.B. or Australia are dumb enough to volunteer to use a drug that hasn't been through the standard toxicity studies? I sure wouldn't do that.
Note that on the very site you reference NNVC is listed as one of the stocks subjected to pump and dump campaigns. It has a total of 13 touts from known pump & dumpers and was involved in two pump & dump campaigns. That doesn't mean that NNVC isn't a legitimate speculation, and I'm certainly not saying that management had anything to do with this. But it does mean that NNVC is subject to illicit attempts to pump up the price about as often as it is subject to take downs by evil shorters, although the latter are the only sort of manipulators complained about here.
If our fluicide works with this years human trials...
A classic pump does not require new shares to be issued to promoters and their friends or payments from the hyped company. It simply requires that the pumper quietly buy a large block of shares while the stock is cheap and then hype it to the moon while selling into the enthusiasm. This is illegal, but that doesn't stop people from trying. And a pump doesn't require telling actual lies about a company either, it suffices to emphasize the positive and ignore any negatives, such as lengthy timelines, a lack of customers, or a financially precarious balance sheet.
Yup, and note how oriented towards short term trading that article was -- resistance at 0.626. In other words, it was recommending buying at around 0.55 and selling in the low to mid 60s. Anybody buying on that bit of trading advice is already out of the trade by now.
If the information went to people who had never heard of NNVC before it could have had the same effect as real news to people who already had. NNVC is still hardly a household name.
200 newsletter readers or tweet followers each buying 5,000 shares (about $3000 worth of stock apiece) results in one million shares of volume. Easy to do.
I wouldn't call that a "pump". But it is the sort of newsletter recommendation that's usually good for popping the stock price up a few nickels. Then it drifts back down after the newbies stop buying.
You are right -- May 2014 was a typo, I meant May 2013.
I know this much about the future of all biotech development -- it always takes longer than you think. Usually, much longer than you think. Even after taking into account that it takes longer than you think.
The FDA is under no obligation to approve a drug just because its approved in another country. And decent phase IIa trials are not by themselves likely to get the drug approved in Australia. The phase IIa trials will be scaled down phase II trials. So at best we can expect evidence for efficacy, not proof of efficacy. I doubt Australia will approve Flucide on that basis. I don't see the odds of Australia approving Flucide as being much better than 20% either.
Most drugs that get through phase I trials never get approved. And Flucide is still a long way from even getting to phase I trials. But I know this means nothing to the NNVC Exceptionalists.
Yes, the fact remains that if phase I or any other human trials are to be done in the USA the FDA has to approve it. I stand by that statement. If they are done in Australia the FDA doesn't have to approve it, but given that NNVC isn't likely to be ready to do phase I testing until early 2015 I don't think it matters very much where they do the tests.
Sometime in 2014 (hopefully 1st quarter 2014 but maybe later) we should have the results of the tox testing. Sometime in 2014 the manufacturing facility should be working. I have no idea how long it will take to get the bugs out. Scaling up from tiny lab batches to production level batches of Flucide is bound to present problems. What I do know is that once production is working well there will be more months of "unexpected" delays before phase I begins, because there always are such delays. After all, how many people here thought, after NNVC had their pre-IND meeting with the FDA last year, that in May 2014 we would still be waiting for tox testing to start?
I still consider the odds of NNVC getting Flucide approved by the FDA to be about 20%. I'll increase the odds a bit if NNVC starts toxicity testing and their manufacturing facility completion on schedule.
My understanding is that Dr. Seymour says they have enough cash to get through phase I/IIa trials, but hasn't said anything about having the money for phase III trials. The hope is that the phase IIa trials will show enough evidence of efficacy that big pharma gets interested and offers to put up money for the remaining clinical trials and provide distribution in return for a cut of the profits. Or, failing that, NNVC should be able to raise money on far more reasonable terms than it can now.
The qualitative, not the quantitative facts of dilution apply to NNVC. Had I thought that phase III trails for Flucide would cost $100 million, I would have said "phase III costs for Flucide will cost $100 million." But I never did. Puffer can claim otherwise all he wants but it isn't so.
I'm sorry Puffer, if you are incapable of understanding the nuances of debate. Speaking about the ability of start up biotechs generally to raise large sums of money by diluting their shares and pointing out that NNVC could also raise money by diluting its shares (but not specifying any share count for NNVC) does not mean that I said that NNVC had to triple its share count to pay for phase III trials.
A pre-phase I deal is certainly possible but is a highly unlikely event. It's like winning the lottery -- very nice if it happens but don't count on it in your retirement plan.
Me, I'm confident that we'll have to get through the planned phase I/IIa trials first before we see either much action in the stock price or real interest and deals offered from big pharma.
Bingo --
Quote:The only other supplier of cash is stockholders. By tripling its share count a drug developer can raise the cash to do its own phase 3 trials.
Quote:I never said that FDA approval was required for doing trials in Australia.
You have a short memory. You deleted your post after I corrected you.
Sure, the stock price *could* go wild, but how likely is that?
Haven't you ever heard the expression, "Once burned, twice shy."?
People know that on third tier news like "Oral flucide works in rats", or "insider buys 100,000 shares" this stock pops up a bit and then comes right back down. It is unlikely that anyone is going to be dumb enough to pay over $3 a share solely on news that tox has started.
I agree with all of this. The risk factor that seems to get the least attention from the usual cheerleaders is the likelihood that there will be one or more good competing influenza drugs (not Tamiflu) by the time Flucide gets past all the regulatory hurdles. Flucide will still be marketable but at prices far below those assumed in the "$100 a share" predictions. The additional competition is a direct consequence of the multi-year delays.
In fact if some competing drug "X" gets to market too soon that might add to the costs of getting Flucide approved, because the requirement might become, "Show that it works better than X", not "Show that it works better than Tamiflu". This could require larger and thus more expensive trials to get statistical significance.
I expect a modest pop on the stock price when the start of toxicity testing is announced. Maybe into the mid 0.70s or so. Then there will be the usual gradual downward drift back to where we are now.
Remember that the first news that really matters will be the completion of the toxicity tests, with the results, not the start.
I did not say that NNNVC would have to triple their share count to pay for phase III trials, although I am skeptical of the extreme low ball estimates that you and Dr. Feelgood promote.
It was not me who counted insider buys as insider sells.
I never said that FDA approval was required for doing trials in Australia. Right now I'm not holding my breath for trials to be done anywhere. I'll believe it only when I see it.
When you watch a team that keeps striking out and fumbling the ball you're bound to get critical. And it seems to me that most of the criticism goes to me. Anything other than permanent boosterism is heavily frowned upon in this forum.
And what have you, or anyone else here, actually done to get any nanoviricide to the status of approved drug? We're all spectators here. Some cheering on the team in the field, and the rest of us scratching our heads and wondering when the game is actually going to start.
It is not the cheerleader who counts, not the man who makes excuses for why the weak man is late again, or where the non doer of deeds could have done even worse.
I said no such thing. Especially since your latest prediction of $1 by the end of June took place on April 2, a day after the wonder trade.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=86362283
Only somebody desperate to win his "$1 by end of June" bet would want to count a trade like that one on April 1.
Actually there were two posts. One said "by summer solstice" (June 21) and the other said "end of June".
So let's cut Dr. Feelgood a bit of slack and stick with "end of June".
Me, I will be very surprised to see 1.00 in two months. I'm excluding 5-minute-wonder likely misprints like the one on April Fool's day, where a whopping 100 shares were sold at the alleged price of 1.10, when all other shares that day traded below 0.70.
So are you seriously saying that you consider NNVC to be a scam, but are holding on because you think some bigger fool might buy it from you at a higher price? That looks like a losing strategy, given the price action of this stock. What worked for pets.com during the height of the 90s tech boom isn't going to work for NNVC.
I have been quite critical of NNVC and certainly don't view it with rose colored glasses. But I don't think Diwan and Seymour are deliberately scamming us. I think they genuinely believe they have a cure for flu and some other viral diseases. But they've been mighty slow about getting it through the approval process.
Given that NNVC wants to market Flucide as a broad spectrum drug, effective against many strains of influenza, it makes sense for the FDA to insist that they actually test it against a number of different flu strains. In any case, the rat tests are not what's holding up the toxicity tests, which aren't dependent upon how many strains of flu Flucide works on.