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Several years ago I purchased CTKH because of what was supposed to be it's superior processes for making all sorts of thin film displays, etc. I was especially enthralled with the work they were supposed to be doing with Carbon Nanotubes. Since that time the company has totally stopped reporting and while I still see Carbon Nanotubes as the future of many things, it frankly is not moving nearly as quickly as people thought years ago.
There is no doubt LED/LCD panel displays are far more efficient than anything else on the market, but CNT would use a fraction of the power they do. Furthermore CNT based circuits, processors, etc were also supposed to be far faster, as well as using far less power. In fact, even transmission lines made with CNT instead of copper or other cores would be able to transmit far more with lower line losses. While all this is for the most part theory, development seems to have slowed to a crawl.
A few years ago MIT announced batteries that could be charged in 5 minutes. Properly designed cars could travel about as far as they could on a full tank of gas, and recharge in about the time it takes to fill a gas tank, has anyone seen or heard of one of these cars.
I believe it's the petroleum industry that's holding down development that will dramatically reduce our need for all sorts of energy. Everything piggybacks on one another, if you can trim electrical use dramatically by building all sorts of devices that use less energy and also dramatically cut line losses, you can actually cut back on the required generating capacity required, and ultimately much can be done with solar, wind, etc. With less electricity required for all sorts of services, less fuel is required, be it natural gas, petroleum based, etc, less is required and more, plentiful electricity is available. Add cars that can go hundreds of miles on a charge, and with MIT Technology be recharged in 5 minutes and you have a formula for the demise of the Petroleum Industry as it currently exists. Why do you think these technologies aren't advancing as quickly as they're forecast to. Could it be the petroleum industry is slowing or preventing the development of these technologies while openly advertising how they're investing in green technologies to make the world a better place.
Gary
Like many here my shares are worth so little that I'll not sell, but I do agree the potential may still be there. I frankly doubt it will happen while FH remains in charge, and possibly not as long as he's alive. I believe he's burned so many bridges that even though he could make a fortune on restoring the stock to trading in compliance with security regulations.
There is hope, I had another stock, APPI which was down dramatically as well and hadn't filed financials for years. Suddenly the name and emphasis of the company changed to WHEN and years of missing financials were submitted over a few days. The stock is still sub pennies, and I paid pennies, but at least there is now hope.
I understand FH is 70 and not in the best of health, I wish him no ill, so I'd rather he hand down the business to his sons rather than passing away, but I suspect that one or the other is required to straighten this out. With FH in control, he simply isn't suddenly going to wake up and change what he's done for years.
Gary
On the face of it, this doesn't sound like a great deal. Under a million in total milestones, nothing stated up front, mid single digit royalties. There is only one thing that could make this good, perhaps even great in time, Merial.
There is little doubt that Merial is the World Leader in FMD Vaccine. GNVC could have fought them, gotten more from someone who'd be willing to challenge them, but you know Merial would have found a way to compete, and they own the inroads in the market place.
It's my belief that GNVC's science is a game changer wrt this disease. Today the market is roughly a half billion dollars annually, but vaccinated animals cannot be exported and often are slaughtered because there is always a question about whether the animal is protected, or infected. All this changes with GNVC's technology in the vaccine. Once global agreements are changed to permit, even encourage vaccinations with vaccines which can be differentiated from infected animals, a half billion market might change dramatically, perhaps by a factor of ten or even more. Today I doubt if anywhere close to 1% of all potential carriers of the disease are vaccinated, in fact it's probably under .1%. If someone can find specific details, I'd love to see them.
The extreme would be laws saying that all animals must be vaccinated, that's a number to high to imagine, even with 5% royalties. If the market simply doubled and Merial had half the market, with 5% royalties it would mean $25 million in earnings annually for GNVC, say $.20 a share. Any reasonable P/E puts the stock price somewhere between $2 and $6 on the strength of FMD Vaccine earnings alone, and we all should know that FMD Vaccine is perhaps GNVC's least lucrative product.
Today's announcement certainly wasn't worth what I'd have hoped it would be, but 3 to 10 years from now it might be recognized to be a truly great decision on GNVC's part.
Gary
If you read my entire post you'd note the last item was a partnership for TNFerade with the partner taking over advancement of the trials.
$10 of course is a stretch, but I've seen much stranger things happen when someone chooses to act on a stock. It's probably been well over a decade since the New York Times wrote a major article on Dr. Judah Folkman and how his technology was curing mice. They gave the impression that ENMD, the company employing his technology, could have the cure to cancer in years. On the strength of that article ENMD went from the dollar range to over $100 before falling back to earth. ENMD still exists, it would be a low penny stock had they not done a reverse split.
Let me ask you a question. What would happen to TNFerade without a partner if a year or two from now the Trial which will be run by the NIH was shown to produce excellent results in Prostate Cancer. What if sooner than that it was shown effective in Pancreatic Cancer when used with the other experimental drug that's currently in trials. I'm not saying these things will happen, the company certainly is downplaying the current trial, it's in a very tough indication, pancreatic cancer with limited mets, but what if efficacy is seen from the experimental treatment, and greater efficacy is seen in the group also getting TNFerade.
My point is not to create hope where there is no hope, it's only to say we don't know what may be shown in trials and we cannot know until they're run. TNFerade has certainly shown that further trials should be run, and if you listened to some of the clinicians who participated in the PACT Trials, I believe they'd recommend other protocols for the use of TNFerade in Pancreatic Cancer, rather than abandoning that indication. I believe the reality is, clinicians would love to do more trials on all sort of drugs that are abandoned, and if money weren't a consideration, they'd be done. It's hard to say how many blockbuster drugs have been shelved forever for the lack of funds to do one more trial.
On the other hand, there are companies like CVM and GNTA who've developed drugs that have been in trials for decades. These companies exist on the strength of issuing very positive statements about these products, announcing new pivotal trials either for different indications or with different protocols for indications previously tested, pumping up the stock price, and most importantly, issuing lots of new shares. In GNTA's case reverse splits are a big part of the plan, if I remember correctly 100,000 shares a few years ago would be 10 shares today, and I believe they're about to do it again. It's hard to sell millions of dollars worth of a 3 cent stock, but with a 1 for 100 reverse split, the right sort of hype, they can sell several millions of shares before the stock again falls below $1.
I've often said that CVM and GNTA were both stocks that had cures in search of a disease. In CVM's case it's almost like clockwork. If some new disease is headlined as the next pandemic, etc within days you'll see a major PR effort announcing how their Multikine is the answer, and trials to prove it will be initiated shortly.
GNVC isn't such a company, they have real drugs, real partnerships and they produce the data, good or bad, and they act to maintain viability of the company. A partnership for TNFerade is certainly needed to advance it, but even in its current status it continues to creep forward. I say creep because those who enrolled in trials continue to be dosed or monitored if still alive, there still is the planed trial for prostate cancer which could start at any time, and yes still the small pancreatic cancer trial which could surprise.
$10 may happen next year, or it could be 3 to 5 years if results continue to accumulate slowly that lead to approvals of FMD vaccine, other vaccines and TNFerade. The good news is once this happens, it won't stop at $10.
Gary
I believe there are a number of upcoming events that should take the stock well over $1. I cannot say the specific order that will be followed, especially wrt partnerships. I will list them below.
1. Initiation of FMD Vaccine trials for safety, should be a 7 week trial if literature on the subject is correct.
2. Evaluation of the safety and other data by the appropriate U.S.D.A. panel and Approval if satisfied. It's my belief they act far faster then FDA, but allow a couple months.
3. Homeland Security initiating procurement action for FMD Vaccine. GNVC should be sole source for the technology, but production of the vaccine may be competitively bid. Probably a 2-4 month procurement.
4. Partnership for FMD Vaccine for all except Homeland Security's use. H.S. has the rights to make the vaccine with its own contract which may, or may not be the same supplier.
5. Initiation of Prostate Cancer trials using TNFerade with NIH paying for the trial.
6. Partnership for TNFerade with the partner taking over all developmental actions for TNFerade.
Of course there are other news possibilities from a number of other vaccines and drugs in earlier stage clinical and preclinical work, but the above are the sort of positives that individually could move the stock to $1 or more and together could bring $3 to perhaps $10 depending on the details, especially of the partnerships. It's all about money and it's partnerships and an order from H.S. that should come with cash, and it's cash that could dramatically move the stock.
Gary
With year end tax loss selling it's uncertain where the bottom may be, but it's also completely uncertain when positive news may come. Homeland Security's target to acquire FMD vaccine for the Strategic Reserve is 2nd Fiscal Quarter, which is by March for them, but it's been slipped before, we can't totally count on that happening, but if it should, we should get action soon to make it happen. I tend to think they'd like U.S.D.A. to act on Approval first, again it's hard to tell how quickly they'll act. H.S. does not have to wait, like the DOD, they can acquire drugs for internal use.
Partnerships for both TNFerade and FMD Vaccines could certainly come at any time. FMD Vaccine may be greater priority with approval potentially just months away, but the company's been seeking a partnership for TNFerade for an extensive period of time, the company hasn't hinted how close they may be, but sooner or later it should happen.
Gary
I don't know when the drug will be partnered, but it will happen. Read, or is that beyond your capability, how well it's worked to date in Esophageal, Head and Neck, and other cancers. After reading results in the other cancers, if you can still say it doesn't work, we'll see if all the potential partners agree with you. I say we'll get a partnership, I don't know when, but it will happen.
You're welcome to spout off as much as you wish about the drug not working. I believe the PACT Results will be shown at the ASCO GI conference in January, unless the Abstract isn't chosen for presentation. Perhaps then we'll better understand why the people on the SOC suddenly started living dramatically longer. I doubt if they'll really discuss the major flaw in the trial, i.e. patients in such trials want to live, when they aren't selected to get the experimental drug that's extending lives, they do other things outside the trial protocol. They are not prisoners to the trial, they're outpatients who's lives are short and who take an interest in what's available, if they didn't they wouldn't be in the trial in the first place. Other drugs already approved for other cancers are producing results that extend lives, they're not part of the SOC as they're not yet approved for Pancreatic, but that doesn't mean that Oncologists trying to prolong their patients cannot provide them. It's the trial protocol that the problem, not the drug. If TNFerade was added to the other experimental drug, patients would probably live even longer.
The problem really lies with the FDA. If this trial were properly run, the FDA has sufficient data on the SOC to establish a median, one year survival, 18 month survival, and more that needed to be met or exceeded based on current experience with the SOC. All patients in the trial should have received TNFerade, if they had, I believe they would easily have exceeded the established median, 12 month survival, 18 month survival, etc that the FDA established. The only other way to run the trial with some participants not receiving the experimental drug would have been to put all patients through expensive and probably painful dosing protocols so that those not receiving the experimental drug don't know it. I believe the FDA should do the same for most trials, those volunteering for trials should all see the benefits, but in most trials, those not seeing them don't know it, they get something, either placebo or other approved drug in place of the experimental drug. In this trial, all patients received SOC drugs, 2/3rds received TNFerade injected directly into the tumor with endoscopic or other methods, those not on the drug clearly knew it, no attempt was made to fake them out.
Of course there is another way to do it, essentially you hospitalize the patients, or imprison them until death, or a cure is achieved. As outpatients, dying people try to lengthen their lives and in the PACT Trial, clearly some were successful.
Gary
First you need to understand that the PACT failure probably is more related to a flawed protocol then a complete failure of the drug, and that the drug should work with numerous solid cancers, not just Pancreatic. Numerous drugs approved for other cancers have failed in Pancreatic. The company's choice of not enrolling patients until they have a partner has created all sorts of doubts about the drug, but it was purely economics based. Look at any other trials and data and decide for yourself if you don't think the drug's worthy of approval, they can be found on the company website.
If GNVC had proceeded with trials, added a Pivotal Trial for Esophageal Cancer, most likely the next to advance to that stage, they'd be elevating the burn rate to the point where they probably wouldn't have a year's funding. Instead they've assured years of operations, but they need that partnership.
They could gain a partnership and funds from their efforts with Homeland Security on FMD Vaccines in the next quarter along with approval from the U.S.D.A. The FDA's not involved with veterinary vaccines, though they are with other drugs. The current market for such vaccines is nearly a half billion worldwide, but because existing vaccines cannot be differentiated from the disease once given to the animals, vaccinated animals or products from them cannot be exported and many are destroyed. GNVC's vaccines, and others being developed, are a new paradigm as they can be differentiated from the disease. I've not seen any estimate, but clearly the market for these vaccines is likely to expand once they are approved. GNVC needs a partner to produce, gain worldwide acceptance, distribute and sell these vaccines. Homeland Security intends to purchase substantial quantities of the vaccines for the Strategic Reserve, as I understand it, they may produce it under their own contract, but only for self use, and GNVC should be paid.
GNVC also has many other vaccines for human use in development, included are HIV, Malaria, and influenza. All these vaccines have other sponsors paying most, if not all, developmental costs. In addition, GNVC has Novartis partnering on it's drug for hearing and balance disorders.
In short, the failure of TNFerade in Pancreatic Cancer clearly killed the stock price, but pancreatic cancer really represents a very small part of all the company's doing. Unfortunately, it was the lead trial for TNFerade, once a partnership is established, another Pivotal Trial could be established, probably in less than a year, and the trial could be completed a few years later. It will be up to the partner to determine the course of action, GNVC will surrender control of development of the drug.
Gary
Does anyone here follow WHEN, formerly APPI? I mention it because for years it was doing nothing, including not filing any quarterly reports. All of a sudden the company was renamed, and all the back reports were filed in a matter of days, and the stock price grew dramatically from where I last remember seeing it quoted. While it's still under a penny, now there's hope it will regain that number, and more.
I bring this up, naturally, because who knows, some day it might happen here. If it does, I suspect it would either mark a change in management, or a decision on their part that opening up on what they're doing after years of silence will make them very wealthy. As I understand it, the family and friends control a majority interest in the stock. If they make themselves a fortune, those of us who wouldn't sell, even if we could do so at $.0002, 3, 4, or 5 might will make a fortune right along side of them.
I'm not suggesting this stock would ever be a $1 stock, but I believe many of us own it for well under a penny, if we're ever trading above a penny, we have a profit.
Gary
I'm unfamiliar with requirements of Nasdaq BB vs Pinks, what must WHEN do to achieve this goal beyond having all required reports filed.
I know the Nasdaq requires trading at $1 for some period of time, and perhaps over $4 to initially qualify, while I'd love to see the day WHEN was on the full Nasdaq, I wouldn't want even the smallest reverse split to achieve such a goal. It's rare that R/S's achieve their intended goal, and often a month or two after a 1 for 100 R/S a penny or sub penny stock will be right back to trading for pennies or less. Don't believe me, take the time to look at GNTA, I once had a fair share count there, now I have 5.
Gary
Frankly I've never seen anything like this before, but APPI was another sub penny company I had some stock in. They recently changed their name and symbol, which now is WHEN and look at how they caught up with unfilled data.
http://www.otcmarkets.com/stock/WHEN/financials
Perhaps some day we'll see the same from CTKH, or whatever they care to call themselves on suddenly catching up for years of ignoring regulations. If I didn't see it, I wouldn't have believe it possible.
Gary
I haven't been actively watching, though I still own millions of shares. The company simply hasn't been willing to keep investors informed in any way for years, I'm amazed it's allowed to trade, even on the Pinks.
That said, it seems to me that others have reported things happening at each of the plants they own, so I have hope that when owning the stock will provide something meaningful to management, they'll come out of their shell and tell investors what they're doing.
I frankly haven't kept up with what's happening with Carbon Nanotubes, but I do believe it's a technology that eventually will replace all sorts of things that are done with other materials today. Is CTKH working to play a major role with this technology, I certainly don't know, but believe it's possible.
Honestly I've been amazed with the speed of the transition from Plasma and LCD TV's to LED lit LCD TV's that are far thinner and energy efficient. Roughly a year ago Samsung was about the only company making them, and only at the high end, today they're being marketed with practically every brand name, and at some really amazing prices even for the 120 HZ model. 3D appears to need 240HZ to be fully effective, but I'm really waiting to see 3D without glasses, which is now available in a dual lens camera. I heard about it some time ago from someone attending the CES show last year, it sounds amazing. Again, Samsung apparently has the lead here.
I have no idea if CTKH has anything whatsoever to do with any of these development, but hope springs eternal. Perhaps a few years from now everything from TV's to lighting to computer chips and circuits will have material from CTKH inside, and the company will be a fully complying stock on the Nasdaq.
Gary
I haven't been actively watching, though I still own millions of shares. The company simply hasn't been willing to keep investors informed in any way for years, I'm amazed it's allowed to trade, even on the Pinks.
That said, it seems to me that others have reported things happening at each of the plants they own, so I have hope that when owning the stock will provide something meaningful to management, they'll come out of their shell and tell investors what they're doing.
I frankly haven't kept up with what's happening with Carbon Nanotubes, but I do believe it's a technology that eventually will replace all sorts of things that are done with other materials today. Is CTKH working to play a major role with this technology, I certainly don't know, but believe it's possible.
Honestly I've been amazed with the speed of the transition from Plasma and LCD TV's to LED lit LCD TV's that are far thinner and energy efficient. Roughly a year ago Samsung was about the only company making them, and only at the high end, today they're being marketed with practically every brand name, and at some really amazing prices even for the 120 HZ model. 3D appears to need 240HZ to be fully effective, but I'm really waiting to see 3D without glasses, which is now available in a dual lens camera. I heard about it some time ago from someone attending the CES show last year, it sounds amazing. Again, Samsung apparently has the lead here.
I have no idea if CTKH has anything whatsoever to do with any of these development, but hope springs eternal. Perhaps a few years from now everything from TV's to lighting to computer chips and circuits will have material from CTKH inside, and the company will be a fully complying stock on the Nasdaq.
Gary
I think both Democrats and Republican's are looking, and stating things in extreme ways. Govt shouldn't run the economy, but we can see what happens when industry operates unregulated, it's what led to the economy falling on its face under regulators Bush appointed who failed to regulate.
Deregulation's largely been a failure, is there anyone who believes the airlines, phones, energy, etc costs are lower now, do they offer better services today.
Obama continued to give TARP money to keep Wall Street in business on coming into office, but unlike Bush's people, it wasn't a gift, their were terms attached. The result is most of the TARP money is being repaid that Obama provided as until it's repaid, the recipient can't simply do what they wish, their are constraints, especially on bonuses. Still, Wall Street paid record salaries and bonuses.
I'm sick of CEO's earning record bonuses while laying off American workers, often in companies that aren't that profitable from the import of foreign products. American workers it's said cannot compete, the question is, is the competition fair. The decision is often made to totally automate the process in moving production offshore. What would the result be if the process were totally automated here.
In the auto industry most of the Japanese, German and other car makers have moved much of their production here, they still get quality cars at fair prices. True, they don't have the legacy costs, but while wages may be lower, in some cases benefits are even better, at least when it comes to opportunities for advancements.
American policy in much of the last half century encouraged foreign investment, it's only in the last decade or so that people started to see we need work for American's. Of course there always is another possibility, like the titans of Industry, all American citizens could simply label themselves all CEO's, pick a bunch of other CEO's to regulate their pay, and vote everyone all the money they'd like. No one would make anything but money. While this is said in geest, it's no funnier then the way CEO's lay off tens of thousands to pad their bonuses, or cook the books to do the same, they live for this year, if the company falls apart in five years, or less, they could care less, they have a Golden Parachute already.
It's time for some degree of sanity on both executive pay, and how much our people are worth.
Gary
Herceptin's selling about $5 billion and T-DM1 should replace Herceptin almost completely in a matter of a few years after the initial approval. I also believe that Takeda may make more then you're figuring from your analysis of SGN-35, so IMGN should make more over time.
As to the argument about who's technology's best, I've yet to see positive data from SGEN in solid tumors. I also believe that IMGN has many more drugs in trials and coming into trials. Compare the pipelines. SGEN has by far led the PR war, but IMGN has numerous linkers, numerous effector molecules, and moderate success to date with its roughly 15 year old technology in N901-DM1, essentially its earliest version of TAP Technology.
To date it's latest generation linkers and effector molecules have yet to be discussed even in preclinical drugs. It may be years before we really know what their technology can do. I suspect that one reason drug trials have been delayed is to permit partners to try the latest and greatest with their MAB's as all partners have access to the linkers, but only SNY has access to effector molecules other than the DMx family.
Gary
J&J has cut back dramatically on research in the past. IMGN now owns a drug they originally developed for J&J's CNTO unit because of the funding cut. Results for IMGN388 should be reported soon. CNTO does have Opt In rights.
I believe this is a weakness in J&J, not a strength.
Gary
Aren't you forgetting that many of the major Pharma's homes are in the very countries you're calling irrelevant. Certainly new markets are opening that can grow faster than Europe, and even the U.S., but with headquarters in these countries, I don't think you can ever consider them unimportant.
Gary
If people here wish to see further indications that TNFerade works in other cancers, follow this thread to what's recently been reported in Esophageal Cancer.
http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_G/threadview?m=te&bn=7976&tid=123206&mid=123206&tof=6&frt=1#123206
There is almost no doubt that approval of TNFerade is delayed because of the failed PACT Trial, but anyone convinced it will be denied over time will miss the boat. Like DNDN, Provenge approval was delayed, but not denied. How many here followed D.D.'s recommendations and didn't invest when it was well below $10. Some really wise investors on that one now have ten bangers, I admit, I wasn't one, but then I failed to make the right decision, I didn't let someone tell me what to decide.
Gary
I believe Dr. Thornton is well aware that TNFerade works, he also knows of Dr. Vincent Picozzi's criticism of the PACT Protocol, and about the protocol that Dr. Picozzi wanted to run. In short, when I met Dr. Picozzi he wouldn't give me specifics about his protocol, but assured me that management was well aware of it, and his misgivings on PACT, I should have taken his warning more seriously, but he did indicate a possibility that PACT taken to conclusion potentially could gain approval.
Unfortunately, I don't believe anyone took into account the advantage of adding drugs like Abraxane to the SOC, but clearly it should be approved for Pancreatic Cancer. The question is, would TNFerade further enhance what it's capable of.
By the way, TNFerade is currently not out of the Pancreatic venue completely, we should know a some point this year if the small trial being conducted with another trial with limited mets in combination with another experimental drug produces results superior to the other drug alone. If it does, and if together the results are better than the SOC, we could be back in business in Pancreatic Cancer quicker then anyone thinks.
For now, Dr. Thornton may be the scapegoat for the failure, but listening to Dr. Picozzi, he may have been responsible for a trial protocol that was destined to fail, perhaps letting him go was the right thing to do.
Gary
No, at the Pancreatic Cancer Symposium's I've attended Doctor's who were working the PACT Trial were enthusiastic about the numbers of resections in TNFerade patients, I believe that should show when we get all the data. Unfortunately, that's a secondary endpoint that cannot of itself gain approval, even if some patients ultimately are deemed to be cured. I'm sure this is the case with our landscaper.
Years ago I learned of patients thought to be cured by drugs which were abandoned, it happens more frequently than anyone probably wants to admit.
I'm not sure if a trial couldn't be sold to the FDA where resections were the goal in Pancreatic Cancer. We know most who are resected still die, but the few cures that do occur happen in patients who's cancer is resected.
While there is no telling if the trial using TNFerade with another experimental drug could lead to approvals of both until we see data, to me that still makes it possible.
Gary
If I understood correctly, a partner will be for TNFerade and advance it in all indications it selects to, i.e. the partner will take control, as Novartis has with our hearing drug. Any partner that has the financial and technical support needed to advance the drug should be greeted warmly by shareholders. We'll probably never know the size of the partnerships previously turned down by GNVC, but any reasonable offer should dramatically advance the stock.
I believe there is one Joker still remaining, this trial:
http://clinicaltrials.gov/ct2/show/NCT00868114?term=TNFerade&rank=8
If by chance substantially more efficacy is seen in the group taking TNFerade with another experimental drug then in the experimental drug alone, together they may move into a Pivotal or Registrational Trial. You'll note this trial is not being run by GNVC and currently is being done just in the one site. The trial should complete sometime this year, it was originally scheduled for last year. If positive, this trial could be a real game changer, especially if positive data is seen in Pancreatic Cancer with limited Mets.
Gary
The company has previously indicated a plan to partner, if they've now indicated otherwise I question whether they either couldn't find anyone interested that was willing to pay their price, or they intend to dilute dramatically to afford the effort. If they don't partner or contract for assistance, they'll be undertaking a job that they'll find overwhelming. I'm talking about dealing with the foreign equivalents of the FDA to gain approvals. Certainly many countries may approve based on FDA actions, but others won't. They will also be burdened with the logistics of distribution and sales worldwide which have extra burdens because of personalizing the drug for every patient.
I'm not a DNDN investor, but if you're correct, I believe much of the price growth that could have been expected from U.S. sales and partnering will be burned in gaining approvals elsewhere, and setting up a worldwide organization. Long term the profit may be greater, but will investors want to wait.
I may be wrong in terms of what they're doing, but then I wasn't wrong about the drugs ability to be approved. I urged caution in 2007 and was correct about that, but then I indicated I thought it would be approved on the new data, but admittedly thought it might be delayed. I'm happy the FDA didn't further delay it with some silly question, as they've been known to do, but then they did delay roughly 3 years. Perhaps some Change has come to the FDA, far more is needed IMHO.
Gary
No I believe that DNDN does have a platform to build on, Neuvenge may be several years from potential approval, others I really don't know about. I also believe they'll partner Provenge for licensing, distribution and sales outside the U.S., that should be worth a pretty substantial gain. I'm not involved because while I believe the gains will be substantial in dollars, on a percentage basis, I don't believe a 3 banger is possible for perhaps a decade. Wish I'd gotten involved when it was under $5, but didn't back then, now working with others I believe can be 10 to 100 bangers in next 5 years.
I know the Dew put down both DNDN and GNVC, another stock I'm interested in, I'm uncertain of his position on IMGN, which I also believe has 10 banger potential once a second drug becomes Pivotal in addition to T-DM1 which should be approved this year or next which should be worth a double or more. I believe that if will be shown that the protocol was flawed in the PACT Trial by GNVC and the stock will shortly be back over $1. Where it goes from there will depend on the companies actions, but they do have many other clinical drugs working for them.
Most of the risk is now out of DNDN, but much of the reward has now been reaped. I don't know when that partnership may hit, but depending on the terms, $70 to $100 is certainly possible. On the other hand, if no partnership emerges, I don't know that the price hasn't gotten a little ahead of itself, and it might retrench a bit until sales of the drug start to build.
As always, JMHO.
Gary
Dew,
There are many other companies and drugs that you've put down over the years, as I understand it, you were death on DNDN and Provenge, how do you feel about that decision today.
Unfortunately, I never bought into more then a few options, and my timing was wrong there, but I never doubted that in time they would gain approval. I wasn't certain this would be the time, but I'm happy the FDA is finally not obstructing drugs from companies that aren't yet paying them. It won't be long before DNDN will be.
What do you say to those who honestly follow you and who were talked out of their investments in DNDN by your wisdom.
I may be wrong about my choices, but I always recommend that others look and judge for themselves. I don't care if a stock is 70 cents or $70 when I look at it, but I do ask if both have 10 banger potential, how about 100 banger. Today I don't place DNDN at the point where it will be more than a 2 banger from where it is today, and lucky if it does that, but does it have the potential to do so, most certainly.
Whether you like it or not, I'll be saying more about it later.
Gary
I would suggest you review GNVC once again, a stock I know you've put down in the past. At current prices it's a bargain as without a doubt it will move up nicely on the news of resumption of recruiting patients into cancer trials other then the PACT. They have a broad pipeline, vaccines under development funded by other for Malaria, Foot and Mouth Disease, AIDS, and others. They have a Partnership with Novartis that could bring in over $200M for hearing and balance disorders.
The PACT Trial was a failure, but not because the drug didn't work for Pancreatic Cancer, it does. Patients in the trial who were offered no hope because of not receiving TNFerade remained in the database though they searched out other effective treatment. Abraxane does help pancreatic victim prolong life, but isn't approved yet for that indication, but is approved, so patients looking for benefit turned to it, lengthening the lifespan of many in the SOC group. I know this is speculation as data's not been reported, but it's been clear that the numbers lost to follow up have been high, and these patients are again considered on death. My point is, the trial protocol which permitted this to happen and also clearly permits those receiving the drugs, or not, to clearly know it is flawed, the problem isn't the drug, it's the protocol.
In short, if you didn't like GNVC because of questions about the PACT trial at $3, take a look at it now, at $.70 cents and without the PACT trial. I believe you'll see a reason to make it a long term hold.
Gary
If the HR value at the end of the trial remains at .75 or better, won't the P value fall right in line with what's required.
While I believe the HR value will improve, it already put TNFerade in a position that's better than many other recently approved drugs and all that have been approved for Pancreatic Cancer.
I believe there's a Secondary Endpoint that hasn't been addressed that by itself could lead to approval. I'm talking about the percentage of resections in the TNFerade group when compared with the SOC. I've attended a couple Pancreatic Cancer Symposiums where speakers were investigators for the PACT Trial, they were clearly enthusiastic about how many patients on TNFerade were being resected. In one case, Dr. Farrell reported that 5 of 11 had been resected, and others had shrinkage of their tumors which would have permitted it, but mets were found eliminating the possibility.
It's clear that handling Mets is the key to curing substantial numbers of pancreatic cancer patients, there is another trial with another experimental drug in combination with TNFerade that's being tried in patients with mets, it will be interesting to see if they're making any headway.
Gary
Druggie won't agree with me, but I certainly agree with him, TNFerade showed itself to be very effective with the 92 event data. I believe the effect of nearly all added patients getting endoscopic dosing of TNFerade will show a marked improvement in the 184 event data as roughly 250 of the nearly 300 in the trials who received TNFerade will have gotten it endoscopically.
I doubt Stat Sig will be reached at the penalized level required at 184 events, but it should be at roughly the level required at the end of the trial, though improvement can certainly be expected then as the longest living patients will end up in that data.
http://investorshub.advfn.com/uimage/uploads/2010/1/29/frndgpiratefinalnew.jpg
Gary
There is a huge difference, GNVC has drugs that are working first time out in the clinic. CVM has drugs that have been in numerous trials, each time they fail one they start another. CVM routinely issues PR's hyping their drugs use with whatever disease is hot at the time. They raised cash at $1.50 a share on news that they were confident their drug would cure H1N1. They know that the trial will take years, by the time the drug fails, or succeeds, the threat will be long gone.
I've watched CVM for years after making a small investment years ago, they were talking about the same drugs back then. I'm not saying their drugs won't work, but they've failed in all they've been tested in thus far. In short, they're a drug in search of a disease.
GNVC on the other hand has drugs that have worked from the initiation of trials. They just got a major partnership with Novartis, and yes, like CVM they did do an offering at a level that was close to the top. The difference is in the way they operate. I still receive all the PR's from CVM, they've become very predictable. If tomorrow the threat of Doggie Flu is a highlight of the newspapers or TV, within a few days they'll announce that their drug could be the answer, they'll announce a new Phase II or even Phase III Trial against the disease. Who knows, maybe this time they're right, but it's not like GNVC who really is developing new drugs that work.
Gary
I think it's all about a partnership and the anticipation of approval. If we have both by the time the data's revealed for 184 events, it's a possibility. As I see that, it's ASCO 2010, roughly the first week in June.
On the other hand, if the data's good, but still is subject to questions about approval at trial completion, it could be some time.
IMHO, unless numbers in the trial increase, I believe we'd be lucky to reach 276 events in 2011. It's good when people live longer, but a lot of people living longer will stall the completion of the trial unless the company, and the FDA determine to call the trial complete when say a combination of 276 people have died, or are living for over XX months. If XX were 18 months, perhaps the trial would end by mid 2011 as by that time, roughly 300 patients in the trial will have been there 18 months. I believe that some patients in the trial, like Richard Jordan, will eventually be officially labeled Cured, but it won't happen during the trial as such a finding requires at least 5 years cancer free without further treatment as I understand it.
I believe a blind man could see this drug is worthy of approval, however the FDA at times cannot see as much as a blind man.
Gary
It's been many months since I last posted on IH, or viewed what's happening here, for that matter. Good to see so much activity.
GNVC's finally moved in the manner I'd been expecting for some time, but I believe it's still easy to make a case that it's still very under valued.
Look at where we were before ASCO in 2007. The stock was approaching $5, excitement about what was to be presented had nearly everyone saying we'd easily blast through $5, but the presentation at ASCO left places where questions could be asked, and not well answered. I believe today we realize those questions, answered or not were meaningless, people are clearly living longer on the drug, and perhaps even being cured because of its use, in conjunction with successful resectioning of the tumor, if you listen to those who know Richard Jordan. You can't say cure for at least 5 years cancer free, but we appear to have some people who are at least half way there who couldn't have done it without TNFerade.
We're now approaching 3 years since that ASCO, I believe we're that much closer to Approval, yet the price though moving up dramatically, still lags the price then.
Now let's add a tremendous new partnership for a preclinical drug with Novartis. Over $200 million in Milestone Payments and royalties that escalate with sales, when is the last time you heard these sort of numbers for a drug partnered while in preclinical development.
Finally lets add the fact that we have other trials going for Malaria, FMD, and AIDS Vaccines that are all funded by others and in the time since ASCO 2007, all trials continue, funding has either been sustained or increased. To put it another way, none of our products have yet failed to perform. It's virtually unheard of that all drugs developed by anyone are all approved, and I'm not suggesting that will happen here, but to date, things are certainly working well enough to have development continue.
Where could GNVC go this year. I know people who'll say a ten bagger from where we are is possible, while I'll agree it is, I'll say it can only happen if two things happen. The first thing is a partnership that answers the question on how quickly an FDA approved commercial manufacturing plant for TNFerade can be built, as well as impressing investors by it's payment and royalty structure to GNVC. The second thing is a clear understanding of the game plan for approval. I'm not saying it must happen on 184 data, but it must be clear that it will be achieved in a timely way. If the data shows values that are clearly within the criteria for approval at 276 events, even if they don't quite make approval at 184 events, I think approval is clearly in the cards, a question in my mind is, does the DSMB say, because of the other data for Secondary Endpoints, GNVC and it's partner should go for approval while the trials continues, or do they say the trial simply should continue. If early approval is to be sought, $30 or more becomes very achievable, if not, it's doable just as it has been for DNDN and HGSI, it's just not guaranteed by any means.
Personally I'd be thrilled with anything in double digits and as an Optimist, I certainly believe that's not only possible, but probable. In fact, depending on the terms of the partnership for TNFerade, that could be all that's necessary to reach that level.
One other thing, another poster identified the fact that in conjunction with Homeland Security, Novartis is developing a new, state of the art facility for making vaccines. I really know little about what they're doing, but if nothing else, this sounds like a natural for producing the FMD Vaccines that GNVC has developed in conjunction with H.S.
Could Novartis ultimately partner with GNVC for many vaccines, certainly possible. I hope they aren't looking to acquire them, but wouldn't mind if they continue to add to their position if they also do additional partnerships. I frankly believe that a company like Novartis would actually make more money owning say 20% of GNVC and a partnership share of most drugs then they'd make if they did acquire the company.
Just one other thing, the investors and Institutions who'll make the most money in GNVC won't invest until the stock is near or approaching $5 as they operate under rules or self regulation that prevents it. They'll make the most money, but we that don't sell to them will by far make the biggest percentage gains. Don't let these Institutions buy your shares cheap. You may wish to trade some as $5 or more is achieved, but don't get out and give them the really big dollar increases. In the time I've been in GNVC, the 60 cent gain yesterday was the biggest I've seen. In the future, days where the stock goes up ten times that much are possible. I plan to be here when they happen, will you.
Gary
Something which could be positive about the Chinese is a tendency to execute plans over years, even decades. Unlike most American companies who cook the books to maximize bonuses this year. The emphasis on instant gratification for executives is what's behind the decline of our economy.
Gary
I was of the opinion that was required for Approval, but that H.S. could act on their own, which they infer in their releases.
I wonder how such a safety trial is run. I would believe the researchers working on the development of the vaccine on Plum Island would have already done safety and efficacy trials to the extent it can be tested. I don't know if they actually give the vaccine then attempt to infect the animals, or not. I know one of the reasons for isolating the research is to prevent disease spread, but not they're giving up keeping it offshore on an Island. I hope they know what they're doing. If I'm not mistaken, outbreaks in England can be directly attributed to Merial (sp) mistakes.
One question it would be interesting to hear peoples answer on is, if H.S. does order for a strategic reserve, how much would they be expected to order for each strain of FMD. I really have no idea if the intent would be to have millions of doses, so that massive innoculations can be given in the event of an outbreak, or mearly tens or hundreds of thousands to try to prevent the spread and protect the area around where a case is found.
I believe we'll learn more by November, whether there's a buy or not.
I do know that DOD has internal approval for drugs that our soldiers get. If the Navy contract for the Malaria Vaccines is determined to be effective, the DOD can order vaccine and either use it, or stockpile it for use if soldiers are going into places where those specific types of malaria are found.
Hopefully further trials, previously announced, will result in FDA approval, but that could take years longer than a DOD decision to order the Vaccines.
I once worked with a Navy Commander who was having some medical problems. He was totally being stonewalled in trying to find out what experimental drugs he was given just after being recruited. His Drs. were concerned that his problems 20 years later may have been caused by one or more of these drugs, but they couldn't get the records. We frankly shouldn't treat our soldiers this way, while this incident occurred over 10 years ago, I don't know that anything's changed, or if he ever got the information.
Gary
Gary
I don't think you interpreted the CC comments on FMD Vaccine correctly. I believe it was clear the Vaccine was not Approved for general use in the U.S., nor would it be by November when Homeland Security intends to add to the Strategic Reserve. I believe it's clear that GNVC's vaccine is what's being added to the Strategic Reserve, and that H.S. may add a vaccine that's not yet fully approved in the same way that the D.O.D. may use drugs that aren't FDA Approved.
As for a Partnership, in that GNVC doesn't have the manufacturing capability, when H.S. acts to add to the Strategic Reserve, someone will need to have the rights to do so, they will either be a partner of GNVC or have some sort of license from them, and yes, GNVC will be paid.
It would be desirable for a major partnership, i.e. someone with the rights to pursue gaining approval for the vaccines worldwide, and full manufacturing, distribution and sales rights. Certainly a partner who acquires all these rights from GNVC will pay GNVC far more than someone who's only licensed to provide vaccines to H.S. for this one order. Those are the extremes, we could get something in the middle, perhaps someone with U.S. rights, leaving the rest of the world still available.
What's important is however it comes down, GNVC will be paid, and the payment should be substantial enough to see GNVC through to TNFerade approval, at least if it comes by 2011.
It's just over 2 months till November, that's not too long to wait. While I believe the partnership could come at any time, it's also possible that a license has already been agreed on as part of GNVC's original agreement with H.S. I.E. when H.S. contracts with a manufacturer for the vaccine, GNVC would be paid according to something that's already established in the H.S. agreement. It would be up to GNVC and the manufacturer to determine if they wanted to take that agreement any further.
Gary
Actually I did, but it was over on Yahoo. I'm certainly not sure, but so little being said about FMD Vaccines could mean a number of things, one being that they're deep in partnership negotiations, but I want to hear what's said this morning.
I think that the dollar situation with Nasdaq if far from a problem yet, though there are people who will throw it up as long as it's there. If FMD is partnered and on order by November, as H.S. seems to indicate, $1 will never be a problem again. Of course there are no guarantees.
Let's hear what they have to say in 30 minutes, then I'll say more.
Gary
Penny,
You may be right about his reasoning, however if he can develop the cash flow that would justify higher stock prices, as I gather it, he and his family would have the most to gain as they control so much stock.
I certainly don't know, but if Fayiz has developed something that could make big profits, his greatest opportunity would be in bringing the stock back to being a fully reporting company, and eventually moving to a major exchange.
Personally I don't sell because it's just not worth doing, a few hundred dollars won't make a difference for me. If there's something here, I'll be interested, if not, I won't lose any sleep over it.
Gary
Lucky,
Let's hope someone knows something. It did just trade at .0002 again and I have a feeling someone may be trying to make the last trade of the day at that level.
I frankly have no idea what can be done to make the company legitimate again. To my knowledge they've not filed an Annual Report in years, done no quarterlies, held no Annual Meetings, i.e. done any of the things expected of a publicly trading stock, but I suppose you can operate in this way on the Pinks forever.
At one time I had hope that Fayiz really had something when it came to high quality thin ceramic films, and I really believe he was working with the next generation of materials that should totally change how all sorts of electronics is built, carbon nanotubes. I suppose it's still possible, I've heard people are still seen coming and going from his factory, but no one seems to have any idea what they're doing there. Maybe we're all in for the biggest surprise of our lives.
Gary
I'd be very careful with DNDN, personally I'm not invested in it but I believe that it will gradually drift lower until it's closer to an approval decision. It is of course this decision that will make, or break the stock price.
While I believe TNFerade is a slam dunk once the company has sufficient data to approach the FDA, provided the future data equals that of the past. I cannot say the same of Provenge, don't get me wrong, I believe it's good, but I don't know that it's so good that the FDA won't ask further questions, or ask for more. I've seen the FDA turn down drugs that were thought to be worthy of approval by all who had an opinion, including several Analysts who uncharacteristically stuck out their neck, the drug was always later approved, but the company tanked on the news.
Of course this could be true of TNFerade, in spite of my feeling it's a slam dunk, but when you're dealing with the FDA, delays are practically a part of the game they play.
I believe that well before we're seeking FDA Approval we'll have had two partnerships and an order for FMD Vaccine, this will put the stock at levels that haven't been seen in years, and perhaps that have never been seen. At that point, an FDA delay could bring the stock down 30 to 50%, on the other hand, an approval just might double the price or more. Much of this will be determined by the terms of the partnerships that are revealed. It's also very possible that a partner taking over the TNFerade trial funding may choose to fund additional trials even before approval has been obtained. This to could spur the stock to far higher prices as suddenly we'd be looking at markets far bigger than Pancreatic Cancer, even if they're a few years downstream. What's important is, does the early data reveal efficacy, if it does, the drug will be used off label until the approval is finally obtained.
Gary
In after hours trading GNVC trading continued at levels that would have been moderate to high during a normal day. It ended at $1.17 having reached a high of $1.20. Here's a link:
http//www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?selected=GNVC&mkttype=after
I don't know what spurred the interest in the last half hour and after hours, but I suspect that either there is news pending, or one or more premium advisory stock letters signaled a buy on GNVC a half hour before the close. I've also read that Hedge Funds which BAM is one could push it up, short it, bring it down take their profits, buy more, and repeat it over and over. Anything is possible, perhaps tomorrow we'll learn. Meanwhile it's very possible we'll gap up at the open.
Gary
I've always said I wasn't a medical expert and I really don't understand the technology completely. I'm sure you're far more correct then my simple understanding of what's happening. What's important is that it's working.
Gary
There are some misconceptions about TNFerade's use here. I'm certainly no expert, but I understand that TNFerade's function is to fire up the body's production of TNFalpha, a natural response from our body that fights cancer. That being the case, I believe the drug will work with far more then the limited form of Pancreatic Cancer in the trials.
We've already seen excellent results with Head and Neck as well as Esophageal Cancers. There is no reason to believe it won't work with many others. If I'm not mistaken, another drugmaker is already using it in with their experimental drug in Pancreatic Cancer with mets.
Secondly, because TNFerade works with other drugs, it's doubtful that other drugmakers will fight it's entering the market where they own the current SOC drugs. TNFerade as a drug is much like the company that doesn't make anything we use, but makes all sorts of products we use better. In most cases TNFerade could increase the sales of other drug as patients live longer, and therefore are treated with the SOC drugs longer.
We really don't know all the cancers that TNFerade may work with, but it certainly could be bigger than Provenge, and it's possible it may work with many, or most solid cancers.
I believe it's also currently the case that TNFerade is only given in one course of treatments in the PACT Trial. I do not know whether there are any benefits from retreatment with TNFerade. The PACT Trial doesn't offer that possibility even years after the initial dosing, but in practice post approval I would not be surprised to hear of Drs. giving booster amounts of the drug at some point after the initial treatment.
Gary