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I can't say I love LG's appearances on the Big Biz Show, but I suppose it's better than no exposure at all. I'm uncertain if the BIO organization permits OTC companies, especially those trading below $1, to appear at their conference presentations, but I know over the years when IMGN wasn't being invited to many conferences, they appeared there. I believe they'd pay to be part of the organization, then routinely present when they had their conferences every few months. I don't know the cost, it may be far higher than the Big Biz Show, but it's a far more professional presentation, and normally the presentation was made by the CEO.
If the BIO organization is available to NWBO, I believe it's a better investment. Hopefully with the approval of DCVax-L in the UK we'll actually be receiving invitation to the major brokerage conferences, and we won't need to pay to play.
Annually we've paid for one of the biggest display booths at ASCO, including many years when nothing was being presented and perhaps nothing at the Experts Theater either. I'd rather see a smaller booth, and more webcasts at professional organizations like BIO.
A friend once attended the BIO Conference to see the IMGN presentation. Few people were in the audience for many of the presentations, but that wasn't clear to all the people who sign in to get the webcast as the audience wasn't shown. The conference did what it was intended to, it permitted many companies to pay to speak to their investors without being considered as hype by the regulators. I suspect the Big Biz Show is more likely to be considered hype.
Gary
Good article from over on the I-V board.
https://infomeddnews.com/anavex-tackles-cognitive-aging-and-related-disease-pathologies/
Gary
With Core Optics now holding 80% of the shares, I have no idea of how those shares are distributed. I don't believe it's one single shareholder, but is it held by tens, hundreds, thousands, or millions of different people.
Perhaps someone knows, I don't.
Gary
We have numerous posters who tell us things like, no inspections have been made yet. To the best of my knowledge the company has said they won't say what has, or hasn't, yet happened. Are investors somehow finding what's happening either from the company, or their own spy network, or is it purely speculation.
I don't doubt that a few here may know people at various trial sites, etc. I don't believe anyone here can really say, I know the UK will inspect any specific facility, or any facility at all, for that matter. While places like UCLA might be obvious, it's also possible that the regulators have already either spent time there, or time with Dr. Liau and others and have no further reason to visit the site.
We're approaching 8 months into a 5 months decision process, even allowing 2 months for requests for further information we're well beyond when a decision should have been made if the UK was nearly on schedule. I can't say why, but I feel certain if the regulators wanted certain facilities inspected, they'd be inspected by now unless the inspectors were told they had more time to do so.
I cannot speak to what the UK might be waiting for. Could it be that actions they expect from the FDA are slowing them down. It's clear the FDA in their journal article said that things are changing as to how they intend to do trials on deadly diseases in the future, but their regulations haven't changed yet. Could the UK want that out to back up their actions? I certainly don't know.
I believe in the trial there was an extraordinary degree of cooperation between the regulators and the company in agreeing to the changes that occurred during the trial because of what was learned in the trial. There was agreement to accept certain things that previously would not have been accepted, but little of this has been formally documented in the various regulators official documentation. The FDA written journal article is probably the closest thing to the direction the future should be taking.
Gary
I don't know about approval on Tuesday, but I do know that Labor Day marks the end of the Summer Doldrums in Biotech, so things should start to happen across the board, not just in NWBO.
Essentially Labor Day is the end of the vacation period when many of the key people needed to make things happen are on vacation. In the past I've seen partnerships held up for many months when key people were either on vacations or traveling on business.
Gary
Flipper, I have no doubt that LP wants to deliver DCVax-L at a price acceptable to NICE and others, by the same token she would want as high a price as possible to recover all the company has invested from its genesis.
I don't see the price as being what's preventing patients from getting the vaccine. Once we have regulatory approval patients covered by some form of insurance should get the vaccine.
I don't know that anyone can say what price the various countries, or insurance companies will actually pay. I believe that each entity can negotiate for themselves as to what they'll pay.
In some cases, a lower price may be agreed upon if the insurer guarantees they'll purchase XX many batches of the vaccine. Another company may purely only pay as they purchase with no quantity guaranteed. There will be a list price, but I doubt many will pay it.
As to the uninsured, the company may very well offer price relief that's anywhere from free to a substantial discount for the uninsured, or those choosing not to use insurance.
Why would anyone choose not to use insurance? Perhaps because approvals don't take in the form of cancer they have, but they wish to use the vaccine anyway, and their Drs. agree to such use off label.
Gary
When we speak of BP partnerships most people are speaking of the BP taking a stock position in NWBO, I believe. I don't think this can occur until the share price is dramatically higher establishing a price high enough for the company to agree to such a sale.
There is another partnership that I believe could occur at any time, a BP paying all, or part of the cost of doing a trial that combined a product they make with DCVax-L. I believe the key to this is running the trial with the EDEN, and if there is something preventing the initiation of such trials it's not yet being able to utilize the EDEN.
I don't believe full approval of the EDEN is necessary, but some degree of its acceptance for use in clinical trials probably is. Once again, I don't know if it's a must that all regulators say yes, or if a single regulator could do so, permitting the trial to start in the country where that regulator approved, then expansion to other jurisdictions as clinical effectiveness is observed.
Gary
What you're saying is true for essentially all companies. Every quarter there are things they must report, to make it a legitimate quarterly, but there is much that's optional. Perhaps the biggest option is a webcast at the quarterly and the most open they can be is having a call in number where even investors can ask questions. Normally the questions are limited to Analysts, but it's doubtful it serious Analysts are following the company, so questions from investors would bring out a lot of information.
I doubt if they'll do such a webcast, but hopefully in the future, when the price is dramatically higher and they do have Analysts, they will.
Gary
If based on it's label it is covered by insurance for most applications it's sales will be far more based on its price after insurance coverage. I'm on a number of products who's list price is well into 3 and even 4 digits. I have insurance from 2 companies plus Medicare and in many cases these meds are free.
I don't believe the companies pay near the list price for the drugs, but I'm sure they're not cheap. My wife doesn't have the double insurance but rarely pays over $25, and frequently much less. and often for a 3 months supply.
Far more will depend on the label, if the insurance company must provide the product if prescribed the list price may mean little, to nothing.
Many of the products I'm on are ones my Dr. advised me they would have to fight for, and they charge for such action. To their surprise the prescriptions weren't challenged at all, and in some cases they were free to me. The only way the Drs. really know is by trying.
At City of Hope they prescribed some drugs that had to be justified, it took a few days, but invariably they won. They were mostly for preventing rejection immediately after receiving stem cells for ALL. They had no approved drugs for precisely what I had, but these drugs were being used in people with similar diseases. Worst case it took about a week to get what my Drs. wanted.
Gary
I believe that Ford is using a Chinese battery and the lower range Mustang Mach E had the better battery already, but the higher range version was to get it in 2025. They didn't get it in 2024 because they purchased so many of the older type battery and wanted to use all of them before converting. I heard this from a Ford representative at the last LA Auto Show.
Gary
I believe that there are misconceptions about what price a product will sell for when it's cheaper, or more expensive to make. Even if the product costs pennies, if the cost of developing it was in the billions, it's not going to be cheap. Much may have to do with the anticipated sales of the product.
Gary
For patients treated and cured with chemo and radiation it is better than the alternative. But what about the others who might only get added weeks or months, it's a sad way to spend your last time on earth.
All can do better with better forms of treatment.
Gary
I hope you're right as long as they can differentiate between pseudoprogression and tumor growth. Pseudoprogression should be looked at as tumor shrinkage, even though scans make the tumor appear much larger. it's largely dead matter. As long as a means has been found to differentiate pseudoprogression from progression it certainly should say what's working, and what isn't.
Gary
Doc, if that proves to be true, I would expect the DSMB to contact the regulators to terminate the trial early and get Direct approved. I know results in the Phase 1 looked impressive, but it sound like you expect them to be even better. Are you figuring the trial will be done with other therapeutics making it far more effective than in Phase 1.
Gary
When I hear people say, let's get the party started with UK approval, I'll agree, but ask when does the party end.
In my view, it doesn't, at least not for quite awhile. If in fact the current form of the DCVax's, or improved versions, are still expanding their role in improving the treatment of cancer, the party doesn't end. It could be a decade or more before we know just how effective the DCVax's are against a variety of cancers.
If our DCVax's have become a part of the SOC in treating many forms of solid cancer, can you imagine how big NWBO could be?
Gary
For all who're loving the idea of a buy out, think about if it's really what you want. It's no problem if in part or all you can opt for stock in the purchasing company, but if as I had in IMGN, if it's purely a cash out, it leaves you with a huge gain you must take, no choice.
I for one would like the choices I have while the share price is moving up, or if there is a buyout, I have the opportunity of taking stock. Without that, you may be dealing with millions, but Uncle Sam is going to be getting a substantial part of it.
I much prefer the company partner, remaining independent and the share price grow routinely as revenue substantially increases. Partnerships often bring gains that are nearly as great as buyouts, but the company remains, substantially stronger from the cash infusion brought in by the partner as well as technical support. Such a partnership might bring a price that's half to 3/4 of what a buyout may bring, but the company is positioned for tremendous growth in the future. Most importantly, as an investor you can choose if and when to take some, or all of the gains you've made. If you're like me, you might just bring in pocket change by selling out of the money calls and let the stock price grow, and others to inherit it with a new tax basis.
Gary
Whether you have a gas generator yourself, or plug into power, potentially you may be getting power from something that pollutes. It's very possible it doesn't pollute nearly as much as the ICE in many cars.
I put in solar at my house before purchasing my electric car. Unless I'm going somewhere on a trip I have no problem charging the car from the power I'm generating with the solar.
I'm finding that charging from 120 volt is no problem, a couple days a week is normally more than enough. I intend to put in four way 220 volt charging, that will make the batteries in the car the emergency supply that runs my house if power is lost. It was supposed to be available, but it's delayed until next year. Most of the electric car owners I know don't routinely use half their battery capacity, I suspect they'd be just fine with their car batteries being their reserve batteries in putting in solar. Most cars have substantially more battery capacity than the stationary batteries people are installing to back up their homes power system.
Gary
It's clear that whatever was anticipated today failed to happen, but that doesn't mean it won't in the not too distant future. There is a great deal to come, LP told us so at the Annual Meeting, but she said it was coming over the next 18 months, now we're essentially down to 16 months, but it will be coming.
As for BP's having a plan for doing something similar, I don't believe it. They sell products by the thousands to millions, we're selling a vaccine that's only good for one person which is made one time, held cryogenically, and distributed over a period of years. If they do want to get into such a business, they'll build, or purchase, a separate division and keep it completely divorced from their mass production drug operation.
I'm not suggesting that BP's aren't interested in NWBO, I believe they are, but if they partnered, they'd help manage the company and support it's growth, but not bring anything into their facilities. If they buyout the company they'll keep it operating as a wholly owned subsidiary.
The last thing you'd want is one organization responsible for shipping a million pills to distributors all over the world, and one dose of a personalized vaccine in a cryogenic container to one place. It's very true that one of their mass produced products may be used with the vaccine, but don't keep them together.
Gary
Frankly the regulators don't act in the way I suggest. I wish they did, then the company could ask them to do so.
Instead, products which anyone clearly can see as superior to anything on the market early in a Phase 3 trial normally must finish the trial and take the years necessary to put together what's often over a million pages to apply for approval.
What I'm suggesting could cut years off the process, but it's simply not something the regulators are willing to do. They can't really look into a trial, they need those millions of sheets of paper, plus other proofs.
Gary
It's probably been over 40 years since I took charge of a project that no other supervisor wanted to do, a small conference room was set up to do it. We needed computer support and that required running cable in from below. The first thing was putting a substantial sized hole in the floor. Once it was done various executives would come into the room and check out the hole. After awhile, as each person came in I'd go to a chalkboard in the room and add a mark, all that worked for me knew what I was doing, none of the executives did. I think the numbers went up into the thirties before we got some cable, and substantially longer until we had working computer support.
I mention this because perhaps we ought to do some sort of scoreboard for the bashers. Start the day with a blank form, with just their names. Each time they post someone should credit them for their work. If we wanted to get sophisticated we could separate those done during market hours, and those that aren't.
Once we have an approval it will be interesting if any of them double down for the shorts, or just fade away like MacArthur's famous quote about old soldiers.
Gary
I was in IMGN essentially from the time it first became public. It's the first company that developed ADC's. Sadly they sold out just at the point of really becoming successful after all those years. I profited nicely, but still believe they could have done far better if they remained independent, or waited a few years before selling.
Gary
Have any of the other products tried on Alzheimer's been found to slow the shrinkage of the brain? If not, with no significant negative side effects why not an EUA based on that fact alone while awaiting further proof for full approval.
Gary
If you're a biotech investor for any period of time, I believe you'll admit that practically everything takes longer than you'd ever think it would. Perhaps what takes the longest is successfully concluding a trial, being thrilled with the results, than observing how long it takes to apply to one or more regulators for approval, finally how much time they take in review.
I believe that if the regulators were able to open their eyes, look at the gains being made right in the clinic, then issue EUA's allowing the product to be sold, many lives would be saved and perhaps they'd simplify the red tape in achieving approval because they'd know the product is working. They did it for Covid, why not other deadly and debilitating diseases.
Gary
While I agree with you completely, I also think that NICE often works to lower the price they pay and their initial ploy is to say no, it's too expensive. They will not delay deployment of a potentially life saving product very long, but they certainly could negotiate and not pay list price.
I frankly don't believe that many people, or insurance companies, or Govt. healthcare agencies actually pay list price, but you need to establish a price you negotiate from.
Just yesterday I had an interesting discussion with an economist friend regarding insurance on real estate and autos. He assured me that those in this business are losing serious money and while none of us like the increases they're getting, they're still in a world of hurt. I can't say the same about healthcare insurers, but I really don't know who knows what they actually pay for anything.
One thing is certain, if you're known to have a quality product. People will pay for it. I trust Kirkland products at Costco, but just looking at peoples carts I suspect as much or more Bayer aspirin is sold there than the Kirkland version and Bayer's probably been selling it for over a century. I'm not saying a century from now people will be demanding NWBO's DCVax-L, but we'll have made major profits far sooner than that. I suspect that no one can make aspirin for less than Bayer, yet people will still pay a premium for it. The same may never be the case with insurance paying for DCVax-L, but by the time we need to be concerned about that, it won't be of concern to us.
Gary
I think we all need to realize what the regulators will permit in the pricing of a product.
Once the EDEN unit is approved it's very possible that the cost of actually making a batch of the vaccine is well under a six figure number. Charging $100K for the entire vial, multiple years of treatment could be profitable.
In spite of that, the regulators will permit perhaps over $100K for each dose making the entire vial worth perhaps a million or more.
Why? Because of the money that was spent in developing the vaccine and the equipment to commercially produce it. Often this figure goes well into the billions.
If it were up to me, after the initial costs and a substantial profit was recovered the price of products would come down to reflect a fair profit for the foreseeable future. That's generally not the case, in fact all too often the price rises over time.
I have no concern about what will be charged for DCVax-L, it will be more than sufficient for NWBO to be very profitable.
Gary
Is your theory the same as some politicians, tell a lie enough time and it becomes the truth, at least in the minds of some.
Gary
SL, I'd agree with all you're saying with one exception, I believe that 1 and 2 must happen before 3 will. I say this because I don't think LP will partner until some minimal share price is seen, and I don't believe that possible until they have an approval and a way of commercially making the vaccine in volume.
I do believe that many are interested in partnering with NWBO, they know what's LP's minimum and they'll make their move when they believe they can justify paying that price with their shareholders.
Gary
What happens tomorrow really doesn't matter if we never learn why Friday's gain occurred. On the other hand if Friday's move is somehow explained by what's learned tomorrow, we may have reason to believe someone acted on news that was not yet public. If it was purely manipulation based on nothing, I suspect we'll give up some, if not all that quick gain.
On the other hand if there is news, a further move will depend on what the news is. Certainly it had to be something positive, that could be anything from a decision by the Judge to UK approval. Of course other things are possible as well. I suspect if the news is major, like UK approval, we'll gap up, and we may very well have trade halted on an imbalance of orders. If it's nothing that significant, but positive nonetheless, it should keep the price moving up.
This is the last week in August, many believe our UK approval comes in September, or October, I still feel there is a chance this week. Frankly the day makes little difference, it's approval that makes all the difference, what day is insignificant. I'll predict that we gap up that day regardless of what day it is, and I believe it will be a gap that never fills.
I still believe that we have a substantial short position and part of it may be naked shorts perhaps held by the MM's, who can legally do it. I don't know that all the brokers react identically in terms of how quickly shorts must cover their positions, if I'm right about that, with a very large short position, the upside could continue up for several days as shorts are forced to close their positions. The MM's never report their gains, or losses, based on their actions, it just comes down to trading gains or losses from all the stocks they handle, nor are they subject to margin calls while maintaining a naked short position.
Gary
Who do you think prepared the article, I believe Bosch was the only person at the company given some credit, all the others were the clinicians that did the trial lead by Dr. Liau. Much the same has been true of other presentations, if anyone from the company gets credit, it's Dr. Bosch, but he hasn't been primarily responsible for what's presented.
Gary
I hope this site doesn't turn political. I have friends on both sides of the aisle and enjoy a good political discussion, but not in an exchange of messages where the tendency is to put down others ideas. Let's leave the discussion here about NWBO.
As for NWBO not creating the technology themselves, it's sort of like the difference between physicists and engineers. The physicists may create the tools, it's the engineers that take them and create all sorts of things. Both are needed, but don't put down those who take ideas that have not yet been applied to anything practical and turn them into many practical applications.
I don't know if when Dr. Liau first learned about DCVax-L if she was purely only looking as far as brain cancer, or if from the beginning she saw the potential could be far greater. It really doesn't matter what she was thinking in the beginning, she may have played a huge part in benefitting people with all sorts of solid cancers. It will take time to tell.
Gary
I would hope that new information and guidance will be forthcoming in the next week or so. One thing is certain, the newly merged company's first quarterly report should be on the quarter ending in September, with the report due by early November. Hopefully much will be revealed before then, but at that point there should be very little we don't know about what's happening at the company, and what's planned.
Gary
LC, I think you hit the nail on the head, especially your last sentence. Our vaccine by itself may not be curative, but the reaction it illicit, especially in terms of dramatically higher T-cell counts, makes it possible for for other therapeutics to be far more effective.
Gary
I think that the company will negotiate the price regardless of the production process. It may not be quite as profitable if made manually, but have no doubt, it will be quite profitable.
Why? Because developmental cost is strongly considered when establishing the price. The BP'S have done an amazing job at keeping the prices up after recouping their initial investment many times over. Many products sell for far more than when they were initially approved, and the politicians don't seem to care as long as their campaign contributions keep coming in.
Gary
Someone posted that NWBO needed to start training Drs. in the use of DCVax-L. Certainly they need to get the word out to them, but I have a feeling the Drs. will have little to do with the actual administration of the vaccine.
As a leukemia patient I knew that the stem cell transplant was a big thing in my future, but when the time came to do it, there wasn't a Dr. in sight. Since my cells were cryogenically preserved a nurse simply brought them in along with a water bath to defrost them. They were simply attached to my IV and if you looked carefully you could see the cells move in with the preservative. The preservative gave me a temporary warm feeling that shortly went away. After that it was just a matter of waiting as each day blood counts were taken, at first they showed nothing, but after a few days they grew, and each succeeding day they grew more.
I suspect the same thing will happen here. Once the surgery and leukapheresis is done the vaccine will be made. A schedule for administering it will be established, appointments established, and very probably a nurse will administer the vaccine. The Dr. of course will be evaluating the patient, but the involvement of the Dr. to the vaccine will be minimal, if anything at all. The key is what the vaccine is doing for the patient, not the Drs. involvement in getting it there.
Gary
I can only tell you I believe the EDEN will be approved in 2025 or before. I believe it's the key to other regulatory approvals, but it's possible to file for approval before the EDEN is actually approved.
If new lower level trials are initiated with the EDEN and appear successful, I would think that would have some influence, though I know that's not normally how it's done.
Gary
Meirluc, I believe that we will be a very different company by the end of the year. I think we'll have that UK approval and at least some additional guidance on the EDEN and filing with other regulators.
Perhaps no actual actions completed, but guidance on when we can expect it to happen. LP said that much would be happening in the next 18 months. The end of the year will be one third of the way there, just UK approval should bring prices that are a multiple of today's price, but I believe we'll get more guidance before then.
If we concentrate on the full 18 months that LP discussed, I've got to believe by then we'll have EDEN approval and at least some regulatory submissions in process. I believe we should be at least a ten banger from where we are today by then, much less than we anticipated years ago, but nonetheless a healthy profit for longs who've averaged down over the years.
Gary
While there is a lot of truth in what you're saying, we do need to realize that even if they filed today, 2025 sometime would be the earliest we'd get an answer.
That stated, if we have the peer reviewed Journal article published and it's clearly complementary of the science, some of the gap between now and then will be filled by the information that can be discussed after peer review.
As many here probably know, I'm a big investor in NWBO. One thing has become clear there, a filing with the UK believed initially to be acted on in 150 days is now well over 200 days, and many are believing it's still 60 or more days off. While I'd like to be more optimistic than that, the point is, with the filing of an application for approval, it's a long, long time to a decision.
We know the Journal submission was made, once again the lesson from NWBO is that it takes much longer than people thought. In the end they got the publication in JAMA Oncology while most were guessing on NEJM or Lancet. I don't know where the submission was made, perhaps we'll all be surprised to learn where it's published. The key is being published in a respected peer reviewed Journal, which one isn't a major concern. Our article has been submitted, accepted for review, and there is little doubt some requested revisions have been made, or are in the process of being made. When all are happy it will be published.
Gary
I'm getting sick and tired of seeing posts from bashers saying, even with approval, it simply won't earn much. Show me any other product that has the potential of benefitting so many people that isn't selling, or approaching, blockbuster levels.
On approval the market cap of this company will be in the billions. As approvals come in for the EDEN unit and other regulators the market cap will grow toward double digit billions. With the realization that DCVax-L can benefit patients with many forms of solid cancers the market cap will approach triple digit billions. Finally, and yes with the determination that DCVax-Direct can treat many with inoperable cancers the trillion dollar market cap should be approached.
Naturally what I'm suggesting is based on NWBO remaining independent. They may very possibly have one or more BP or other partners, but remain independently trading. This won't happen in a year, it could easily take over a decade. With a trillion dollar market cap, what would one share be worth? That question can only be answered if you know how many shares are outstanding, I would guess that will be somewhere in the 3 to 10 billion share range.
Every shareholder has their own decision on what they hold on to, for how long, etc. Right now I don't intend to sell, I intend my kids to inherit the stock and I intend some of that inheritance to go to charity. Perhaps some of the charitable contributions will be made before I depart, but not until I'm looking at an 8 digit stock portfolio. I can't say when that will happen, but it's certainly possible in the current decade.
Let me repeat my challenge to the bashers, show me any other stock with limited approvals, but blockbuster potential, that doesn't have a market cap of at least a coupld billion.
Gary
I had the pleasure of spending several days being taught by Dr. Deming many years ago. The Japanese took his teaching of constantly improving to heart after WW2 and it resulted in the tremendous improvements in their products after WW2. We could still learn a lot from him though he's been gone for many years.
Gary
Sukus,
I really don't know what NWBO's plans regarding commercial production is. If they're purely going to license the EDEN's, once approved, to CDMO's, they might actually bring money in, instead of spending it.
I don't believe that they'll ever sell EDEN units, they'll be leased and NWBO will track and maintain the use of each of them.
I believe the company has all sorts of choices to make, and some may be dependent on others. If partners come in with billions, they may take on substantial expansion and taking on a great deal of work in house, otherwise there can be a variety of contracts to do many of the things that must be done.
I don't know if a billion would get the EDEN unit accepted any quicker. You cannot make a baby by getting 9 women pregnant for one month, certain things just take time.
Gary