Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
In their latest 10K NNVC's managers have themselves stated they they expect human trials no sooner than 2015, not mid-2014. Take this to the bank -- it is never a good idea to be more optimistic about NNVC's schedules than NNVC's own management is.
You say that NNVC is now on track, but the open ended schedule on initiating tox studies shows that they aren't. It seems we're never allowed to get to the point of achieving external validation of NNVC's nanoviricides -- either of their safety or their efficacy.
I'd be satisfied if NNVC met its own schedules say, one in every four times. You will apparently still be making excuses for NNVC five years from now if we're still waiting for tox at that time.
The only thing NNVC can be relied upon to do in a timely fashion is increase the salaries of its officers. I consider the latest round of salary increases to be inexcusable. Diwan and Seymour were already making enough to live a comfortable life before the increases. If they want to live high off the hog they should do so by making their company a financial success.
I have yet to see NNVC make a sufficiently conservative schedule that they could actually keep to it.
They need a common sense level of sterility but they don't have to be as hyper as they'd be for a human product. A product that causes an infection in 1 out of 10,000 humans is a liability disaster. If one out of 10,000 mice die of extraneous causes in the tox tests I doubt that it will have a significant effect on the results.
Just because you need special clean room facilities to create injectable Flucide for humans doesn't need you have to be so careful when making injectable Flucide for mice. After all, when they did the basic animal efficacy testing I'm sure they injected the stuff, using Flucide from the original lab.
I believe that is what was meant, so I interpreted it wrong the first time.
Still, it is clear that tox is taking a good deal longer than Dr. Seymour had originally estimated.
You may be right. I had assumed they were talking about equipment for the new manufacturing plant but it may be equipment used to scale up their lab production.
Well, there's also this quote:
While we have made significant progress in this scale up program at our current facility, certain key equipment pieces that we need are still on back order at present with certain vendors. After these equipment pieces arrive, we will need to set them up, validate them and then use them for the operations they are intended for. This continues to be an item causing delays in our goal of making sufficient quantities of FluCide for the tox package study and it is outside of the Company’s control.
You're incoherent. "Slows cause slows." Maybe that makes sense after a joint or two. You have utterly failed to explain how an economic slowdown will cause delays for NNVC, which claims to have sufficient money in the bank to do everything it plans to do for the next couple of years.
How can you even talk about "delays" without some idea of what wouldn't be a delay, i.e., meeting some previously specified schedule? So, if you talk about delays at all, you are implicitly talking about deadlines.
You have not explained how cutbacks in federal government actions would slow down NNVC. They aren't relying on any government grants and won't have to deal with the feds again until they have tox data in hand.
This is the first hint I've seen that NNVC intends to use the new manufacturing facility to create the Flucide used in the tox studies. It's nice for management to let us know, as this obviously has a major impact on the scheduling. (Instead of being done in parallel with the construction and testing of the manufacturing facility, tox must now be done after that.) This easily adds about 7 months to any previous estimate of when clinical trials can begin.
As for the delays not being under NNVC management's control, well duh. In any project like this you have to allow ample slack in the schedule for the inevitable delays that you can't control.
I've been expecting clinical trials in 2015 for some time. But I always get flamed for being such a pessimist, and accused of trying to destroy the company. As if anything I say on this board could do that.
At this point I give NNVC a 50% chance of starting tox by the end of this year. Missing a deadline by only 3 months will be a step up for NNVC.
WTF 3-4 more years and then only filing an IND!!!
How would a weaker economy slow the tox studies? You seem to be groping for excuses. Whatever reasons NNVC's management may have for missing another one of their own schedules, a "slow economy" is not among them.
You're joking, right?
This may be the first time a drug that hasn't even started tox studies, and is at least a year away from phase I trials, ever got called "well on its way to market".
Who knows? Maybe NNVC will go so low I decide to buy a few more shares, on the off chance that they do eventually get tox done.
When it comes to NNVC what I care about is that they achieve their milestones and eventually get Flucide approved. I don't see the federal shenanigans as of any relevance.
There may be a short term shutdown of "nonessential" government programs during the debt limit debate. But congress will raise the debt level as they always have. None of this is of any relevance to NNVC.
Congress will not pay down the debt for the simple reason that that is impossible. To pay down the debt you'd at least have to balance the budget, since if it's in deficit you by definition are increasing the debt, not decreasing it. To balance the budget with income tax increases the income taxes would have to double. That is politically infeasible. To balance it with spending cuts you'd have to cut about $800 billion per year of federal spending. Congress would consider cuts 5% that size to be drastic and draconian. And frankly, the public wouldn't stand for the sharp cuts in entitlement spending that would be necessary.
There is no "if" about it. Congress will raise the debt ceiling, as it always does. That's why I consider the whole debt ceiling debate to be a meaningless show put on by congress.
That doesn't mean I don't think the federal debt isn't a serious matter. But the federal debt, and the annual debt ceiling debate, are two very different things.
I noticed that some furniture I ordered got delivered. I also noticed that the days are getting shorter.
So, delivering furniture causes the days to get shorter.
I never said that the annual debt ceiling show put on by congress doesn't matter to the overall stock market. I said that logically it shouldn't matter to NNVC.
Well, rationally the nonsense about the debt ceiling shouldn't have any effect on NNVC. After all, the usual argument is that failing to raise the debt ceiling will cause nonessential government services* to be shut down, the reduction in deficit spending will weaken the economy and worsen profits, so stock prices go down. But NNVC doesn't make any profits anyway. What NNVC does over the next two years is going to be unaffected by what goes on in congress over the next few weeks. But then, since when has the stock market ever been rational? Especially when it comes to early stage, highly speculative biotech stocks, where it's impossible to say what the rational price is anyway?
* Somehow those creeps who stick their hands in your pants at airports are always listed as "essential". Which is why I can never take congressmen seriously when they say there's nothing left to cut.
What did he wear to the whorehouse?
There is not currently any option chain on NNVC stock. So blame the price of NNVC stock on whatever you want but don't say it's due to pinning on option strike prices.
Now that NNVC is on the NYSE, what could possibly be the reason for these huge declines we're seeing?
Well, the problem is that past experience has been that when NNVC misses its schedules it doesn't miss them by a week or a month. It misses them by years. I agree that being a month late in starting tox won't matter. I just wish I could be confident that it's only going to be a month.
Well I certainly agree with Dr. Seymour that getting all hot and bothered about the day to day fluctuations in the stock price is ridiculous. We have a big run up for a week and then people here start babbling about how the stock is going to go up 10% a day for the next month. Then we have a few days of correction and people gnash their teeth over evil market manipulators. The obvious explanation -- that some short term traders rode the momentum up and now are taking their profits -- is just too simple for some people.
What matters right now is proving that flucide works in people, not the current price of a share of NNVC.
When somebody gives himself a 6 month window for an event that is supposed to take place within the next year he's obviously giving himself plenty of slack. When he can't even meet the outside bounds of that window it is clear that, once again, a schedule has slipped. Now if we're lucky it won't slip by much and tox will start within a month or two. If we're unlucky I'll come back to this board a year from now and Puffer will be assuring me that the start of tox is just around the corner and will I please stop being such as ass for bringing the issue up.
A while back, but after the pre-NDA meeting with the FDA, Dr. Seymour said that tox testing would begin in June, -2 or +3 months. So the latest date within that broad range is September 30.
It tox testing starts within 4 days, I will agree -- things are different now.
Irrelevant to you, not to me. There are certainly competing products being developed for influenza, including antivirals better than Tamiflu and broad spectrum vaccines.
You are correct that it is normal for biotechs to have huge delays in development. It is also normal for biotechs to go tits up when they either run out of money or their clinical trials show that their "sure thing" wasn't so sure after all.
I've noticed that when people own a stock and it goes up they consider that to be a perfectly natural state of affairs, but if it goes down that can only be due to market manipulation.
We've had a big run up in this stock lately. A correction is the most natural thing in the world.
There is currently a short sale restriction on NNVC due to the recent sharp drops. Does anyone know if such a restriction also turns off the ability to use margin when buying the stock?
So evidently when you bought the (absolutely dead normal for biotech) slippage in the projections did not bother you.
I don't like to make stock price predictions, such as "$1 by the end of June." The stock market gods love to make fools of people who do such things. Would I feel okay if I never had a chance to buy NNVC again? Yes, as the speculative portion of my portfolio is already higher than prudence would recommend. OTOH, we have a whole year for the stock price to go lower than it is now, so if I want to round up my share count (its a mighty funny number after the split) the odds are pretty good that I'll have an opportunity to do so sometime later at better prices than I could do now.
On this board there seem to be only two views -- mine and everybody else's. Surely you value diversity of ideas? I do not trade this stock. It would be hard enough to guess the ups and downs of IBM correctly, never mind this crazy stock. I have held my shares for over two years, waiting for NNVC to do what they first said they'd have done by 2007 -- prove that their cides work in humans and get them to market. Until that happens, we can't really say they have a cure for the flu or anything else.
NNVC has been at this price before (a pre-split price of just under $2) and went way down after that. It could go down again, or it could stay about where it is for while and then go up on some good news. Either way, I see no reason to rush to buy more shares than I have now at current prices. The start of clinical trials is at least a year away, so in my view there's no reason to hurry to accumulate more shares.
I expect that there will be plenty of ups and downs on the AMEX just as there was before. After all, this is still a stock driven by emotion. It's not as though an analyst can sit down, put the past sales and profits into a spreadsheet, project them out 20 years, and come up with a valuation. I also expect that the institutional investors will bide their time about picking up shares. It's not as if results from phase I trials are imminent.
NNVC's schedules were slipping by one year per year before the 2009 crash. And while the crash might be credited with delaying everything by a couple of years, it's a bit of a stretch to credit if for the full six year delay in bring Flucide through clinical trials.
You have never said NNVC was a near sure 200 bagger but other people here have, assuring us that NNVC would get to $100 a share (pre-split price). Back when NNVC was at 0.50, that was a 200 bagger. Now I concede that NNVC *may* in fact get to that price, if all goes well and NNVC has a couple of large market anti-virals approved and in production, and the financial markets continue to put a high valuation on successful pharmaceutical companies. I will be delighted if that happens. Heck, I'll even be able to retire. But I sure don't see it as probable yet.
A pipeline with dates on it is certainly not set in stone but it should be a company's best guess as to roughly when things will happen. NNVC didn't even come close. It has yet to get to the first milestone of any of its pipelines, years after the dates it had hoped to see some of its drugs finish phase III trials.
OK so that's ONE missed deadline (not a whole string of them as one poster was painting it)