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I believe that NWBO is well positioned to advance while wholly owning DCVax-L where many tiny biotech's couldn't possibly do it. Why, because if you've got to have a facility that produces massive quantities of one particular product it requires a massive investment, either by you, or a contractor on terms they can dictate. NWBO needs no such facility. The EDEN unit permits them to grow on an as needed basis and if many here are even close, the first dose created by the new EDEN will more than pay for its manufacture.
While I'm sure the price of the EDEN can be reduced as demand increases, it should still become highly profitable as soon as it's approved for commercial use. Certainly NWBO will either build, or contact for places that can handle numerous EDEN units, but that's not near the expense of having machines that turn out massive doses of one specific product.
Gary
Doc, we're in agreement. I believe that there is a misconception about research sites such as UCLA, City of Hope, etc becoming drugmakers, I don't believe that will ever happen. These research sites develop a tremendous number of great products, but they don't attempt to fund them through pivotal trials, which often go into hundreds of millions, or billions of dollars. Rather they license to biotech's or BP's for nice royalty streams. I'm hoping that the existing relationship between NWBO and UCLA results in such actions. That doesn't prevent the BP's from coming along later to partner, or attempt to acquire the technology, but at a dramatically higher price.
I believe that NWBO has taken the vaccine so far that it is too late for a BP to acquire it, NWBO is positioned to become a giant among the Biotech's, as AMGN did decades ago. It's not that the BP's are out in the cold, they're positioned to partner with NWBO, taking a substantial equity position, and providing the funding needed for NWBO's growth. One or more BP will make big profits by being NWBO's partner as the value of their stock position grows dramatically, it's also very possible they perform certain tasks for the company which they'll be paid for.
As for us stockholders, we'll be well rewarded by partnerships as they'll always be made at a substantial premium to the current stock price, the stock will then trade at, or near the price being paid in the partnership.
Gary
Biosect, is there any way the regulators can look at what's obvious to everyone else and approve the use of Poly-ICLC along with DCVax-L. I've always felt that regulators should be able to make such moves, even though it violates their regulations. When it's obvious that a major stride has been achieved, why insist on years of additional trials plus the time needed to apply and evaluate to approve something that's obvious years before.
Don't get me wrong, I really don't believe patients will have no trouble getting Poly-ICLC and having insurance cover it, but why not approve it and end all the debate.
Gary
Let's cool down the rhetoric. No one product is going to cure cancer. DCVAX-L, in combination with other products, may prove to cure many people with a variety of cancers that wouldn't be cured without it.
Cancer isn't one disease. It won't be cured by any single silver bullet. If it is just part of the solution in some of the solid cancers, it will be a tremendous success.
Gary
When added to other therapeutics, DCVAX-L may lead to cures in patients that otherwise would not have been cured. It could play a major role in the treatment of cancer.
Gary
Why should the courts be different from the other regulators we're dealing with? Just say, it's for NWBO, and 150 days becomes 250 days or more. The good news is, in time it will all be resolved.
Gary
Thanks Kab. I'd hope that in making DCVax-L from that specific cancer you'll have the vaccine, but if not, hopefully what's needed to make it can be adapted to the process, and made in the EDEN unit, and eventually be licensed to NWBO. If there is any organization that should be authorized to utilize an EDEN unit for new product development it ought to be UCLA.
Gary
I agree Jimmy. If permitted I would hope that UCLA is actually making the vaccine in a prototype of the EDEN unit so there is no doubt about it's ability to make the vaccine in commercial production. I believe the same should be true of any new trial that's initiated before full approval of the EDEN unit. It should be noted that in early phase trials the product being made need not be considered commercial quality material. In time I believe the output of the EDEN will be proven to be of commercial quality, but regardless, the EDEN's should be utilized in any new trials.
The question may be, are the EDEN's provided to the clinical sites, or is everything shipped to a NWBO site, Sawston or otherwise, for use in every clinical trial. As I understand it, they have limited capacity right at FlaskWorks, that may be sufficient to supply clinical trials, at least those being done in US based sites.
Gary
I'm certainly no expert, but with the vaccine they're zeroing in on a specific form of cancer. Is it possible that it's DCVax-L made with that specific cancer gives them what they're after?
Gary
We certainly don't know that you're right about this, UCLA won't say DCVax-L when that's what they're making, but remember they were making it there. If they have made an improvement for a Phase 1 trial it will probably be 10 years or more before it could reach approval, and it's reasonably likely that it will be licensed to NWBO in time given their relationship and the fact that the EDEN would probably be the best way to commercially produce it.
Gary
Admittedly, I know nothing about the other systems. I would think if they could already be making vaccine that was acceptable to the regulators with another system, they wouldn't be making it manually. Clearly the costs associated with individual cleanrooms are very high by comparison to having multiple closed systems in the same cleanroom. I don't know if the units you say could have been doing the job have existed long, but if they have, and if they could make DCVax-L, I believe they'd have purchased those systems rather than building the tiny clean rooms.
Of the other systems you're saying exist, how many are approved by the regulators and making approved products?
Gary
Once they establish a dominant position with both DCVax's, I see no reason that FlaskWorks couldn't either be used by others in making non-competitive personalized products, or be spun off as a separate company with all NWBO shareholders receiving shares.
Gary
I believe that it could have, but you need to understand that DNDN's drug didn't have nearly the potential of DCVAX-L. The question may have been that if DNDN earned enough to stay in business, could they have developed a product similar to DCVAX-L.
Gary
I believe in the FlaskWorks patents. Attempting to copy it, without violating the patents should be a more difficult task than paying NWBO to have FlaskWorks develop a product that is intended to make their specific product. Again, I see NWBO profiting from others by using FlaskWorks to make personal products that don't compete with NWBO's products.
I believe the basic technology behind what FlaskWorks has developed can be utilized in personalized products that go well beyond dendritic cells. The question isn't so much are their other ways of doing it, but whether it wouldn't be faster and easier to allow FlaskWorks to do it for them and avoid patent infringement suits.
Gary
I'm not saying that at all, remember, the EDEN unit by itself cannot be used to make anything, it needs the disposable cassette. I believe that every cassette can be tracked and can be used for only one thing, to make DCVax-L. Whether it's all made in one or two places, or all over the world, NWBO would know every batch of the vaccine that was made, and they'd be paid for each one. I don't see them ever selling an EDEN unit, I can see them leasing them and being responsible for all maintenance and upgrading for the units. I believe each unit would be linked to the company over the net and every use of it would be monitored for proper operation.
Don't get me wrong, if NWBO can develop the entire production facility for themselves, I'm fine with that. Right now I don't see where the funds to do so will come from, but of course that's subject to change with many possibilities.
I'm not against the FlaskWorks division of NWBO developing other products for other companies and becoming a major profit center themselves, but again, NWBO would share in the success of any other product that's developing personalized products.
Gary
I'm sure that you're right. If you look throughout the world I suspect that there are thousands, perhaps tens of thousands of places that have both the required cleanrooms and cryogenic capability. Many believe that NWBO will greatly limit the number of companies that could be contracted to make the vaccine to just a very few. On the other hand, with leasing, training, licensing, etc. it would be possible to use the EDEN and it's disposable cassettes to send our technology all over the world.
I've seen a little of City of Hope's labs and I'm sure they'd have no trouble in making and storing DCVax-L there. I'm sure it's equally true for a few other facilities right here in Los Angeles. We know at UCLA they do it without the EDEN, it would just be far easier with it.
My point is the EDEN gives NWBO tremendous flexibility in how they may wish to build the company. I don't know that any of us outside the company know for certain what direction they'll take.
Gary
When I initially invested in NWBO, as I remember it, CRL had already purchased Cognate, namely the Memphis facility. I really don't know precisely what they got. Was the facility built with many tiny cleanrooms. or hadn't it been taken that far when CRL took it over. If it had been built with tiny cleanrooms, has CRL retained them. In short, what capabilities did they have, and what do they have today.
I don't believe that today CRL has significant capability to manually produce our vaccine, or that much else manually, but of course I may be wrong. I do believe they have substantial large cleanroom capabilities in Memphis and many other of their facilities. I believe in many of them they have cryogenic capability as well. In short, once the EDEN is available I believe that CRL could produce DCVax-L for NWBO as a CDMO with facilities located in much of the world.
Gary
All you say is true, but as my neurologist stated when I asked her about another drug in Alzheimer's, it's far easier to get FDA approval if you have approval elsewhere and many exhibiting improvement where it's approved. She indicated that many companies are employing this tact, why butt your head on the FDA first, especially when you don't have production capability to deliver the product here.
I'm hoping the delay will be less than a year as the EDEN is that close, but if I'm wrong I still think that an FDA submission won't occur until there is at least some indication of efficacy from the patients receiving the vaccine in Britain. Approval by the US and others at roughly a year after UK approval could be nearly perfect if the EDEN is ready by then, which I believe it will be. I suspect that little resistance will be seen in the various regulators once some data is available from the UK.
Gary
I believe the inspections will largely be at clinical sites. Dr. Liau was the lead clinician for the trial, I believe it's clear that inspectors would want to see her and many other clinical sites in the US. Also, the company is still headquartered here, I really can't say it they'd also be looking at corporate sites as well.
Gary
What's the good of FDA approval if you can't manufacture the product. It's all about the EDEN, until it's available there is no facility the company has, or contracts for, that can be inspected for commercial production, and that's part of the FDA approval process. The UK has permitted the manual facility at Sawston to meet their minimal requirements, that doesn't apply to the US and I believe the company knows that.
During the course of the trials, and beyond, the company has communicated with all the regulators, I believe they know what they must do prior to approval and they're in the process of doing it. If you cannot make the product commercially you cannot apply for it's approval.
Once again, it should be noted that Sawston is not adding tiny cleanrooms to expand manual production, they are adding large cleanrooms intended for EDEN production, I would think that should be telling investors how soon they expect the EDEN to be available to them.
Gary
I don't doubt that's true, while they can maintain control. Right now, they can. I would suggest that they're helping the shorts, who they've been supporting for years, to unwind their positions. The naked short position is huge, the volume isn't that great, but with each day at these prices smart shorts are reducing their positions without putting upward pressure on the stock.
Today our volume was under 3 million shares. I certainly don't know, but with computerized trading buying and selling at fractions of a cent in share price I'd not be surprised if a billion shares traded on the day UK approval is announced. Certainly I may be wrong, perhaps it won't get that much attention, 100 million would be a huge day, but regardless of the numbers, shorts who've failed to eliminate their positions will be hard pressed to do so without taking huge losses unless they established their positions when the stock was selling for many dollars. The shorts may be hoping some retrenchment occurs before brokers demands have to be met, but if media attention is strong, if the general public learns of a new paradigm in the treatment of cancer, it will be some time before the stock retrenches from new 52 week highs. The short squeeze should be something beautiful for us longs.
Gary
I'll certainly admit I'm not knowledgeable on the cost of building tiny cleanrooms, but if either NWBO or Advent actually believed that the EDEN wouldn't be available for a year or more, don't you think they'd be building more of them in anticipation of UK approval. Let's say it would cost $25 million to build 10 tiny cleanrooms, each capable of 50 vials of vaccine in a year, don't you believe that those 500 patients being provided with the vaccine would make those additional 10 cleanrooms very profitable. I certainly do.
This leaves me with the belief that the EDEN unit is much closer to approval than many here believe. Advent isn't building any tiny cleanrooms, they're building larger cleanrooms intended for the EDEN. NWBO has said nothing about building tiny cleanrooms themselves. It's know that companies like CRL have large cleanrooms that could handle multiple EDEN units. My point is, all indications are that in the UK they'll need more capacity than they have, and yet they're building large cleanrooms for the EDEN, it should be telling us something, it won't be that long.
Gary
I really wish the SEC would take a closer look at the way all MM's function. They were created to maintain fair markes, but I believe that if they were put under close scrutiny it would be found that they're not performing their primary function and in fact the MM's are manipulating the market in a way that never had been intended.
Gary
The MM's may be guilty of manipulation, spoofing, etc. but they're not responsible for not going to all the regulators simultaneously. The EDEN unit isn't ready for commercial production and Sawston producing manually doesn't have the capacity to handle all the UK, let alone other venues. NWBO will seek approvals everywhere when it can meet production demands, or at least have approval of the EDEN so it can build that capability.
I'd suspect that without the actions of the MM's and the bashers we'd be trading in the $1 to $3 area near where we were when Dr. Liau was supposed to present at NYAS. As I remember it, we reached $2 in anticipation, but fell back to earth with a heavy dose of AdamF and the bashers. I would suspect that substantially fewer shares would have been sold by the company if our price was dramatically higher.
Gary
Here's a video on CATL's condensed battery. They're roughly doubling the battery capacity. The question is, how would our technology compare, and could it build on the CATL technology. They're getting 500 watt-hrs/Kg.
If I understand what others have been saying, the company could take up to four days to announce what has happened. I'm not saying that is what they will do, only they know at this point.
Gary
Meirluc, I think that we fell off the cliff back when Dr. Liau had Covid, and the shorts played on her absence and misinterpreted the data. We've really just been trying to get back to where we should have been.
I agree. A quick settlement may get some attention, and I expect it will happen before the MM's are forced to open their books. Now, we need the judge to tell them that no further delays will be tolerated.
I really don't know if approval or judicial action will be first, but expect both in the next few months.
Gary
Meirluc,
I believe that much depends on how the news is handled. If these events occur and no one in the investment public knows about it, you could be right. I don't believe that will happen, but anything is possible. I believe the news of approval will get substantial notice and once the price takes off, the MM's won't be able to hold it down. I do also believe the company has other news to release once we have an approval and that will keep the share price moving up.
Companies with approved potentially blockbuster drugs don't have market caps below a billion, not when at least a few billion are justified. I just don't believe the MM's, bashers, AdamF, etc. can keep this down once an approval is out. As for the court case, it's the frosting on the cake, but approval is the key to success and it will get us there. If there is any equity partnership, it will be under terms the LP agrees with, and I don't see that happening at below double digit share prices, but of course I could be wrong about that.
Gary
Just let the UK decision come out. No R-S will be needed once it's out.
Gary
Thanks, that's interesting. What sold me on CNT's was their strength and very low resistance. I was told that computer chips and circuitry utilizing them would be faster and consume far less power. Electric transmission could be done with much thinner cables, or far more could be supplied at the current diameter, and either way, they will be much stronger.
Gary
I was at my neurologist's today and happened to ask her if she was familiar with AVXL's Alzheimer's drug, she hadn't. I told her it slowed brain shrinkage in the trial, that interested her, but she indicated it must be approved. I told her they were going for it in Europe first and she told me that's what companies are doing because it's easier, and the FDA will approve easier when use has been shown in a thousand or so patients.
This, in part, may be NWBO's strategy as well, though I still believe we're waiting for the EDEN as well. UK approval and many hundreds treated by the time the FDA must make a decision may make that decision much easier. Most of the patients will have under a year on the vaccine, but even then improved survival should be apparent.
Gary
You're right, investors comments won't move the regulators in approving a stock. There is another consideration in which bashers, stock manipulators, the MM's with their spoofing, etc. might effect the time to approval. If they're successful in keeping the share price down, the company may choose to not dilute as much at the lower prices, and slow their own progress in preparing to file with regulators. I can't say that this is the case, but I suspect if they had more money things would have happened faster.
Certainly it's a choice, the company could have sold even more shares and sold them quicker and had more money to work with, but I don't believe that was their choice. This ought to be reflected in Posner's case as well.
Gary
Carbon nanotubes, if we're ever able to work with that technology, will be a huge step over anything silicon. The energy used in computing could be cut dramatically, and the machines would be dramatically faster if much of the computer, including the screen, was made with C-N-T technology.
Gary
The problem is that mankind's accelerating natural events, so things like wildfires are getting worse. We're looking to buy a home in the redwoods in Gualala, CA. You can't believe the price California is quoting for fire coverage. Here in LA I have friends with homes in the foothills and they're being forced onto such plans too. I believe that we really need to find ways of helping nature, I believe that bringing colder nutrient laden water to the surface of oceans that are largely void of life could work in several ways to do it. I have an idea of how it could be done, but can't do it myself.
Meanwhile in NV, where I'm selling homes in Tahoe they too are raising insurance dramatically. It seems to me that every time we have a disastrous fire, flood, etc. the Federal Govt. brings in a great deal of money, and I suspect that the insurance companies get some relief for their losses, but I'd bet that's not considered when the elevate rates, and the Govt. blesses their actions. If I didn't have money in stock to back up my expenses I'd probably just not buy, but my daughter will inherit the rental house and rent it in part while I'm still here, so it's something I want to do. I frankly don't know if I'll be ahead or behind in Coretec, it'a a smaller investment for me, but if my biotech's hit I'll be set for life, and so will they. Don't get me wrong, I think Coretec has tremendous possibilities, it just must fulfill them.
Gary
It is not ficticious. It is not that natural changes don't occur, but man made pollution is greatly accelerating them.
Gary
Were the presentations this weekend considered to be peer reviewed? If so, I'd have to believe that they either have the okay to present from the Journal, or there was an agreement that if the Journal wasn't published by a certain date, they could present the material.
Gary
His video's look great, is he playing professionally? He moves with ease the way the elderly gentlemen did, except they wouldn't go beyond the first step.
The Olympics has really fit in well as my wife just had shoulder surgery and I had the heart issues, 2 weeks of TV watching sports is about as good as it could get, at least for me. My wife who doesn't normally like sports that much does enjoy the Olympics.
Hopefully before it's over we'll hear some good news, at least in terms of a quarterly delivered on time, and hopefully some positive information delivered therein.
Gary
Our current market cap is only $570 million. With a submission to Europe in the fourth quarter of this year, by this time next year we should have an approval or be very close to it. I believe that with approval the very least our market cap should be is around $2 billion, but it could very well be $5 billion or more depending on how other things are advancing. To put it another way we should at least be four times our current price, and perhaps ten times or more. I certainly believe that if by the time we get European approval we've already also applied to the FDA and others we'll be at the higher range of what I've suggested, and perhaps substantially higher if other news is positive on other indications and perhaps even additional filings to gain approval for them.
Do others here agree with my assessment. If you do, I believe we have a great deal of upside potential before we actually file, and as we approach a decision by the regulator. I'd expect the share price will be dramatically higher than it is today. With each month or quarter, we should be moving toward that price.
Gary
That's an after-hours price, the close was at $6.74. The high for the day was $7.24 so as I understand it, if we trade below that on Monday we don't have a gap, but I'm not a technician. I've never believed that every gap must fill, but most do in time.
Gary
Dstock, it's always been clear that we're represented by some of the best in the industry. I'm sure if we examined the MM's defender's they're also very talented. The key is the judge. I believe the decision will be not to dismiss the case, but I'd be very surprised to see these highly talented attorneys go against one another in court. It certainly would be interesting to see it happen, but I just don't see the MM's opening up their books and permitting an examination of what they've been doing. I don't know if they'll ever divulge who paid what, but they cannot prevent the overall amount showing up in the financial report from NWBO, and of course Posner's firm will report a substantial gain.
It would be nice if the SEC questioned why the MM's would pay so much, but I doubt if they'll dig into it. They might if NWBO were on a major exchange, but they pretty much look at the OTC's like it's the Wild Wild West. Only the Pink's get less scrutiny from the SEC.
Gary