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If a BP offered stock, it wouldn't take cash to make the deal. Investors that want cash can sell at any time they wish, but the rest of us, and those buying their shares, end up with shares in a BP that should be worth a great deal because of owning NWBO, probably as a wholly owned subsidiary. Of course they could also offer cash and stock if they didn't wish to issue that many shares, I'd opt for the stock with the possibility of taking cash for what's in the Roth IRA's.
Gary
JFR,
We may not have access to the DTCC, but I suspect that if attention is drawn to illegal activity, the SEC should. I don't know if all this can add to what Posner already has going, but I suspect that if she's successful it may call attention to many things the SEC could take a crack at.
Gary
With us approaching day 120, and then only 30 more to 150 I've got to believe that patients following the approval deadline would await the deadline with their tumors properly preserved. If approved, they're ready to go, if delayed they can continue going for compassionate use.
As I see it, people who've very recently had surgery, or are about to, do have some time to get the vaccine. For the patients who're 3 to 6 months from surgery, they've probably applied for compassionate use if they've managed to raise the funds. I'm not suggesting that time is of no concern, but if you add the Poly-ICLC and/or Keytruda I suspect that getting the vaccine in 9 months or so after surgery gives the patient a very good chance of getting the benefit.
I think the bigger question may be patients who's tumor has been properly store, who're surviving, but where it's now a year or more from surgery, how does one establish the priority for making the vaccine.
Gary
I think the indication that such transactions would attract investigation by the regulators is an indication it's not all legal, but unless it's exposed nothing will be done about it.
Frankly things are far looser on the OTC than the major exchanges, and the SEC allows it to be, even more so on the Pinks.
If I were a short right now, I'd be bailing out of my position as quickly as I could without dramatically driving the price up. I know that attempting to learn what regulators are doing is common, but no telling if those with a major short position have any real indication of what the UK regulators are doing, or when they intend to announce it. Companies routinely don't provide information to investors using the excuse that they don't want to give the competition the information, meanwhile competitors have spies working within the trial and know exactly what the companies are trying to say is private.
If we truly have a massive short position, and gain approval, the short squeeze should be a thing of beauty. It needn't be 2 billion shares, if it's tens to hundreds of millions it still should generate huge margin calls and result in much higher peak prices, if there was ever a time to trade, this should be it.
Gary
There are many ways to do this, one would be considered a franchise, another a contract, the key is, no matter how it's done, NWBO will be paid for every patient who receives the vaccine.
I believe the vehicle that makes all this possible is the EDEN unit, and I very much doubt if the units will ever be sold. Rather they'll be leased and NWBO will be responsible for their maintenance and updates as deemed necessary. I believe every disposable cassette will be tracked from manufacture thru vaccine generation, and finally to its being recycled.
I know most here don't agree that the EDEN should be leased to places like research institutions, universities, hospitals, etc. but I still believe under the right conditions it may be. If I were the company, and if UCLA were continuing to make their own DCVax-L for use in trials that they're running to build DCVax-L's effectiveness, I'd provide them with EDEN's to get that job done which also would eliminate any argument as to any difference between manually made vaccine and what's made in the EDEN. Of course the other possibility would be NWBO making every batch of vaccine for them using the EDEN.
Gary
CO, by the time they're qualified to uplist, neither major exchange will care that while on the OTC they failed to have an Annual Meeting in 2023. Frankly at $4 or more they'll represent a company with a market cap of over $5 billion, far bigger than most companies at the time they apply to be on these exchanges. They will be a very different company than they are today.
As for a BP or other partner being necessary to grow, frankly with the right contracts for commercially manufacturing, storing, and distributing their vaccines, it's their contractors who could be doing the lions share of the work. I believe that Advent will be well positioned to do this for all of Europe, and CRL could potentially do it in most, if not all, the remainder of the world. It's up to the company how they want to go about this, but once the EDEN is available in mass the bulk of the business can be in the hands of these contractors. Tracking every disposable cassette from the time it's created until it's recycled will give them an audit trial for every batch of vaccine.
I'm not saying this is how they'll operate, they may grow dramatically and do it themselves. With a dramatically higher stock price and hundreds of millions of authorized shares still available to them, they could raise billions without asking shareholders to authorize more shares, so such explosive building growth is possible. Personally I believe they want to develop a huge market cap without becoming a huge company, with the EDEN approved and good contracts, they could do this with limited corporate growth.
I'm just suggesting that they have many choices. With approval, I believe they'll initiate both trials with DCVax-Direct to work it toward tumor agnostic approval, and on new trials for DCVax-L leading to a label change that's tumor agnostic. If they manage these trials, and allow contractors to handle the commercial manufacturing, storage, distribution and sales of DCVax-L they'll be well positioned for explosive growth. Of course they'll also be working for approval from all authorities, first the other three in the trial, but then expansion throughout the globe. Again, they'll use contractors in creating the changes needed to what's been created in approaching the UK.
Gary
I really don't know why age is brought up as an issue. This is especially true with our two major political parties selecting the oldest candidates in our history to run for President. There is no management position where the current holder of the position is irreplaceable if they either wished to retire, or if conditions demanded it.
LP deserves to take the company as far as she cares to, she's run the gauntlet and is closing in on tremendous success. If at some point she wished to retire, or diminish her duties, she certainly doesn't need to sell the company. A new CEO can be found, perhaps she'd want to be chairman of the board. The point is, she, and all other key people there, are replaceable without a buyout of the company.
With the UK approval, money will almost certainly not be an issue for those in management, or for many of us for that matter. A decision to retire or diminish their efforts won't be monetarily based, it will be based on their personal goals, and desires. As long as they enjoy doing what they're doing, and are in good health, they'll probably remain.
Many investors believe that with success NWBO needs to be substantially larger. They've gotten this far with contracting out much of what they've needed to get done, I believe they will grow, but they could also choose to contract out even more, possibly to a BP that partners with them.
Gary
You're right, it made little difference to the stock price. I do however believe it got a lot of attention from the thousands of oncologists, etc. who attend ASCO for information, few of them are investors. I would be surprised if more than a couple percent who looked at the webcast from the Experts Theater weren't already investors, or at least knowledgeable of NWBO before the conference.
If we have an approval before, the publicity about that may attract far more to attend the webcast, and probably attract many attending ASCO to attend live. Without approval, Newman may be right, they'd cancel, but I believe they would still pay and frankly I still think it's an opportunity to discuss where we are, and where we're going. If I'm right that they'd lose the funds committed to the presentation, I think they'll present.
ASCO Abstract Titles are scheduled to be released on April 24th so if anything has been submitted, we could learn about it then, the actual Abstracts are issued May 23rd. The ASCO Conference is from May 31st to June 4th.
Gary
Is it possible to build a 2 billion share short position in a stock with 1.2 billion shares outstanding. How is it done.
ChatGPT
Building a short position larger than the total number of shares outstanding for a stock is theoretically possible through various mechanisms. Here's how it could potentially be done:
Synthetic Shorting: Investors can create synthetic short positions through derivatives like options and futures. For instance, they could buy put options or sell call options on the stock. By doing so, they can effectively bet on the stock's decline without owning the actual shares. Theoretically, there's no limit to the number of options contracts that can be traded, so someone could accumulate a substantial short position this way.
Borrowing and Rehypothecation: Institutional investors or hedge funds with significant capital and borrowing power can borrow shares from multiple sources, including other institutions, brokerage firms, or even retail investors who lend out their shares through margin accounts. They can then sell these borrowed shares in the market, effectively shorting the stock. The process of re-lending borrowed shares to multiple parties, known as rehypothecation, can create situations where more shares are shorted than are actually outstanding.
Margin Trading: In margin trading, investors can borrow funds from their broker to buy or sell securities. If an investor has a large enough margin account, they can potentially short a significant amount of shares beyond what they actually possess.
Dark Pools and Over-the-Counter (OTC) Markets: Some trades, especially large ones, may occur in dark pools or over-the-counter markets, away from public exchanges. These markets often operate with less transparency and regulatory oversight, potentially allowing for the accumulation of very large short positions.
Synthetic Derivatives: Sophisticated investors can also use complex financial instruments to create synthetic short positions. For instance, they might enter into swap agreements or other derivatives contracts that effectively mimic the payoff of a short position without directly borrowing or selling the underlying shares.
It's worth noting that accumulating such a massive short position would likely attract significant attention from regulators and market participants. Additionally, executing such a strategy carries substantial risks, as short positions have unlimited potential losses if the stock price rises instead of falls.
____________________________________________________________________________________________
I don't believe we have the options or other derivatives available that Chat spoke of, but their answer does make it sound possible. I don't know if there are option markets that normal investors cannot invest in, but certain investors may, anyone have a feel for that.
Gary
Is this the calm before the storm?
We all seem to be set in our positions, waiting to see what the UK does, waiting to see the status of the EDEN unit, waiting to see when the company announces an Annual Meeting, etc.
Nothing we say can change any of this, but we all have our opinions of what's happening, but the facts must come from the regulators, and the company.
I'll restate my belief that the UK will approve on time, but I'll admit not knowing if on time to them now means 120 days, or if 150 days remains the target for this decision on their part. Early next week we're at the 120 day point, if nothing has been heard from the UK, I'll assume that they're looking at one month later. A decision can be made on any day, the company should be notified, then I believe they would have up to 4 days to notify investors based on SEC regulations. To me, if a positive decision cannot be announced by the open on Wednesday, I'd prefer it be held till at least the weekend, and rolled out in a way that maximizes attention to it. Other than an Annual Meeting or Expert Theater presentation at ASCO I cannot remember when the company has spoken to investors, or the general investment public. I have recently seen other companies get both good and bad trial news or regulatory decisions, in each case a webcast was announced at the same time the news was announced. I would hope that NWBO would have the same respect for investors and hold a webcast shortly after the news, good or bad. As a West Coast investor I prefer such webcasts during the market day, but I recognize that they're often held before the open. On more than one occasion the news was announced roughly one to two hours before the open and the webcast made a half hour to an hour after the announcement, I very much doubt that most investors were aware of it when it was live, but such webcasts should almost immediately be available for replay on the company website.
Speaking of the Experts Theater at ASCO, I would believe that once again the company will present there. What they have to say may largely depend on what does, or doesn't happen between now and then. I don't know if Abstracts were submitted for peer reviewed presentations of any of the other trials at UCLA, or elsewhere, but it's possible. Abstracts are due early February, new data may be added to the actual presentation, but submission must be timely. The Experts Theater isn't considered peer reviewed, but information that's right up to the minute can be presented there. If the company does what it's done in the past at ASCO, they'll have one of the larger exhibitors booth, and they'll have an hour to present at the Experts Theater, which has been webcast in the past.
Gary
I may be wrong, but I think that they will hold one meeting for the year. They may call it what they wish, but I doubt if we will have one meeting for 2023 and another for 2024.
Gary
If the strategy would work they could do it with even less and I'd be fine with it.
I believe the only ones who can build that sort of naked short position is MM's selling shares they don't own, so it would be the MM's holding the naked short and selling shares to customers who have no idea that's what they own. If in fact this is the case, Posner may have a much bigger case than spoofing against the MM's.
If even the tiniest dividend cleans up the naked situation it will cost the MM's dearly.
Gary
Thanks Mike, it seems that the UK really is publishing what happens about 10 days after the period they're reporting on, it covers a two week period, so it could be roughly 25 days after the actual approval. I would think we'd get a new update shortly, but it will not be current, it will be for the last half of March.
I think it's quite certain the company can disclose action from the regulator, and legally must do so withing a short period of time. I believe the FDA allows 4 days, I'm uncertain of UK requirements. Of course as we learned in the Martha Stewart case, anyone caught acting on the information prior to an official announcement could be charged with insider trading.
I would hope that the company has a well planned program for releasing the information once they know, but it could very well differ depending on when they learn of the decision. In a decision made early in a week, I'd hope they issue and act ASAP, on the other hand, if it's Thursday or later that they get an approval, if allowed an announcement before the bell on Monday, or even an announcement on Saturday or Sunday with a webcast to discuss what's happening would be great for a well organized release of the approval.
Let's see what happens with the next UK release, but I wouldn't expect anything before May given the delay in the data that's reported.
Gary
I think we all know that the different regulators do things in different way. In the case of the FDA for higher priority approval, a PDUFA date is established after the acceptance of a BLA or NDA 6 months after its acceptance. In the UK they're trying to do things faster, it was 150 days after the application is filed, now it's been reduced to 120. A pause is built in, where after an initial review, information could have been requested and the pause wouldn't end until that information was provided, people here who seem to know indicated no such request came from the UK regulators. None of us know this to be a certainty, however the company does, if they've been asked for nothing the total decision period should remain 150 days, or even be accelerated to 120 days based on the latest guidance.
I'm not saying that we're guaranteed an approval at 150, or even 120 days will happen, however, if it doesn't it will need to be explained by the regulator to NWBO, and the company will be responsible for telling us. Personally I like our chances, but if further delays result, I have no doubt that the company can deal with it.
The UK has a pretty good history of meeting or beating their approval guidance on products they approve, that stated I believe that it could happen any day, but something almost certainly by May 22nd. By that logic, April 22nd would be the key to a 120 day decision. Forget discussion of the EDEN being involved in the UK decision, they have already approved commercial production manually, so we can get started in the UK and transition when the EDEN is approved to do so.
Gary
Hank,
I had thought about that, but I wondered why if that was the case the leukapheresis couldn't be done at, or near the time of the surgery. My thinking was that if there was any change in the remaining cancerous mass what they're getting with the leukapheresis could reflect that change. I suppose there could be a problem with preservation of the product of the leukapheresis.
I know that in the case of my stem cells, because I was fighting colds, they cryogenically preserved them rather than rescheduling the donor until I was completely well. I know they had to add a preservative, I believe it was DMSO, and because it's a larger molecule than the stem cells themself, it required a Hickman catheter. If something similar would be required to preserve the product of the leukapheresis, it may not be possible to preserve it, or at least might complicate the process.
With the approval of the EDEN unit, if there is an advantage to early application of the vaccine, I would think they'd do the leukapheresis shortly before, or after the surgery so they can proceed with the vaccine production ASAP after the surgery. I don't know this to be the case.
I also wonder what the priority will be with patients whose tumors were preserved some time ago, but are still deemed to benefit from the vaccine once it's available. The question may be which patient has the greatest possibility of benefit, but there are certainly other possibilities until sufficient capacity exists to do it all immediately.
Gary
The MM's once again did a masterful job of closing at the low for the day. I guess we should admire their skill, or question if Posner can take note of such action and whether it could be added to her case.
Did the UK do a mid month update for approvals today. I lost the link and didn't find it in searching the UK. Anyone have the link handy?
Gary
I think that question is particularly relevant to patients with brain cancers who've already had their cancer properly preserved in anticipation of an approval of the vaccine. I've got to believe the company has some indication of the size of this group, but I'd suspect that some have been waiting for many months if they couldn't afford the compassionate use program. I don't know if the backlog is in the tens, hundreds, or thousands, but I suspect it's substantial. We'll probably never know, nor will we know how many people here, or elsewhere are in the same position, essentially praying for approval while the vaccine may still do them some good.
I believe that Sawston will be at maximum manual capacity essentially as soon as they have approval and patients are lined up for leukapheresis so the vaccine can be made. As I understand it, they want the leukapheresis to be fresh, while the tumor may have been cryogenically frozen a substantial period ago. The vaccine would essentially constitute what the patient is fighting right at the time the leukapheresis is done.
Next Monday will essentially be day 120, their new goal in the UK, I don't believe they report new approvals that day, but if notified of approval, I believe the company can announce it immediately. Whether it's then, or 30 days later, by day 150, it's getting closer and barring a delay we'll be a very different company when it happens.
Gary
When I awoke this morning, I hoped to be shocked by an early approval. When that didn't happen, I took the advice I've been giving others and bought another 20K shares. By next week it just might have gained as much as I'm putting out for taxes today, maybe more, and certainly much more in time.
Gary
Hank, I agree, that's why I don't think they should even consider different pricing depending on how the vaccine is made. They have approval to commercially manufacture manually in the UK. Once the EDEN is approved they'll seamlessly move to production with the EDEN in the UK. I believe the FDA, and perhaps other approvals will be based on the EDEN for commercial production from the beginning, but of course I may be wrong.
Gary
Is it possible that we're making far too much about the added cost of manual manufacturing. I suspect that the company could arrive at a price that they intend to sell DCVax-L for that's independent of how it's produced. It's my belief that many cancer drugs cost hundreds of thousands a year, I believe that NWBO is looking at a few hundred thousand as the total cost of treatment, but I don't know that's the case.
If we take a look at what I believe would be the worst case scenario, manually let's allow 200 hours to make it, that's every hour for over 8 days. Now lets say that every hour during this time a lab clinician has to be working on only that one batch of vaccine. I frankly don't know, but is $100 an hour a fair price for such people, if so we're saying it would take $20K in labor for the one batch. This would be over the cost of making it with the EDEN charging nothing for making it that way.
In reality I believe that one person can probably work with at least two different batches of vaccine, and perhaps several more, I'd like to hear others thought on this, but if we said two, it would bring the added cost to $10K per batch. I believe that NWBO would be in a position to negotiate for what will be charged for DCVax-L without consideration of how it's made. I would hope that the initial cost would be greater, to fully pay for manufacturing cost, and make a small profit, then so much more for each distributed vial of the vaccine.
Feel free to counter my argument, as well as my thinking on prices, but I think the company would be in a stronger position to say this is what we want to be paid, and how we want to be paid, regardless of how the vaccine was actually being manufactured. I also realize the cost of making and operating multiple tiny cleanrooms is far greater than one larger cleanroom, but understand that even in a small cleanroom, a few devices something like baby incubators with gloves that permit access to the media can be utilized so a single person should be able to work without the problems of going between cleanrooms, so productivity can be increased and cost reduced. Just think about it, I don't believe they'll push different prices for different manufacturing. The regulators will want the EDEN to meet capacity requirements, they don't need to be pushed for lower prices.
Gary
I really don't remember if the EMA and UK try for the same target days, but with priority review the UK is now shooting for 120 days after submission, it had been 150 days, If someone knows the EMA target please let us know but we know the FDA takes 6 months after they accept an application, they establish a PDUFA date. I believe the FDA often spends a month in approving an application, so their total process can be 7 months for priority review. The diseases we're discussing should get priority review from any of the regulators.
I don't know why Missling would choose the slowest to approve, if that's truly the case. I suppose if one wanted to submit to multiple regulators and have all approvals happen nearly simultaneously you'd submit that way, but I've never heard of such a thing. I don't believe anyone suggested he was employing such a strategy.
I believe the FDA is generally considered the gold standard and probably the toughest approval to get, but after them I don't know how they rank, or if Europe is considered to be the easiest. Any regulatory approval is a good start, but they won't stop after the first whoever it is.
Gary
I agree with you, but recognize that Cramer can send stocks soaring, so he can't be ignored. He also worked closely with AdamF in the past, I don't know if they have a relationship today.
Year's ago I routinely followed CNBC, but really never took advice from their Analysts.
I frankly hate the way good news often becomes bad to the market, and vice versa. In the long run, good news, like lower unemployment and reduced interest rates should be good new, and their opposites bad. Too often everything is based on what the FED will do with the news. I just wish we could ignore the FED and act on our own instincts, good is good, bad is bad.
Gary
I too have invested from the time I was a kid, but for the most part I haven't traded, I've bought and held, mostly cheaper stock, some went belly up, others made nice profits, and I'm still waiting for signs of life from many where I hold small positions, but would buy more if I like what's finally starting to happen.
NWBO is one of very few that I've bought into in a big way because I first heard about it from someone I trust very much. Once in I've added far more than I'd ever planned as the more I've learned about the company the more I'm convinced in what they're doing. If news isn't out before the bell tomorrow, I just may decide to add again. If I'm right, by end of this year we could easily have a ten banger from where we are today. I don't believe I'm wrong about ultimate approval, but if there is a delay even cheaper shares will be available before the ultimate approval. There is no way the regulators wouldn't approve with the protocols used at UCLA expanded into a small pivotal trial. I don't believe it will be necessary, but that's worst case as I see it.
Gary
It's not the FDA's choice, if the company applies to the EU, but not the FDA, the EU will be first.
NWBO choose to file in the UK first, I believe they had a few reasons, mostly tied to production there and substantial compassionate use there so they know more about their vaccine there.
I don't know what advantage the company may believe they have with the EU, but generally I believe they may be faster to act and more likely to approve without conditions. That might convince the FDA to do the same.
I appreciate the advice here and on other sites. The thing about reading all the official filings is that they say what's happened, but not that much about what's planned with the exception of the guidance they're willing to put out. I'll grant you that chat room information isn't necessarily reliable, but some people here often know what the company is considering, that they have good intuition, even if it's not backed by personal information. Certainly some people bash, others pump, I tend to like to ask questions and stir the pot, but I believe there is a lot of good information. In reality all that ultimately really matters is that the company is capable of gaining approvals in time. It may take much longer than people think, just as things like peer reviewed Journals take longer than anticipated for publication. What's important is things planned to happen eventually do. I just hope that after success the company isn't attracted to sell out before earnings build to the point that if sold it's at a price investors feel very good about. This wasn't the case in IMGN's buyout, they asked to soon, well before earnings for their recently approved product, Elahere, built, and they sold for ten times what ABBV, their buyer, thought the drug would be selling annually in the not to distant future. Virtually no value was given to products well into clinical trial that were producing approvable results to date.
If everything but Alzheimer's failed the value of this company would still be a substantial multiple of the current price. I don't expect that, but my point is that success doesn't need each product, or indication it's applied to, to succeed.
Gary
You have much more experience than me, but I certainly agree. I think that over 90% of their submission would be in what's submitted to the EU so it shouldn't take that much work to create the new filing, or for other places as well, for that matter. I'd think the UK would be nearly identical to the EU as before Brexit they were together.
I'm not familiar with AVXL's manufacturing capabilities, do they have sufficient capacity in place to handle worldwide distribution, or will new facilities need to be built, or contracted for.
Thanks,
Gary
I believe you're right if the goal is sustaining growth. However, if you're after massive growth, like I believe we can achieve with NWBO, just being concentrated in a few stocks that hit it big can give you the position you want where sustained growth is what you're after. Personally I now have mid six figures in my account. When the account reaches well into 7 figures I may put some into the sort of index funds you're suggesting, especially if I'm forced to move out of NWBO by a buyout. Otherwise my kids will inherit 7 figure accounts that they'll get a new tax basis for, and they'll get a lot of NWBO shares, probably more than anything else I own.
I think there are few stocks that come around in a lifetime that can make a tremendous difference, I believe NWBO could be one of them if they're not bought out. I actually thought IMGN could be another, until it was bought out. ABBV, who purchased it, may be a fine company, but the earnings growth I believe IMGN could have achieved would have taken the stock far higher, on a percentage basis, than ABBV will ever go.
To me, it's about percentage growth. I know many people who only purchase major companies stocks, if they see 10% or better annual growth they're happy, and they would never invest in a stock selling for under $5, at least not serious money. When we go from $.50 to $5 I'll have more growth than some of them will see in a lifetime, and frankly I believe $5 is just the beginning. Many of my friends tell me sell if you see $1, or $2. Why would I cell if I still believe NWBO is one of the best buys on the market. I don't care if it's $25, as long as I believe it's still a great stock to invest in, why sell any.
Certainly I've always said when we hit these sort of numbers I intend to generate some income, but doing it by writing out of the money covered calls each time I sense we've had a nice runup, and I believe we're due to retrench some before the next high. I have enough shares that selling say 200 calls for a couple dollars would buy a very nice vacation, and be a tiny fraction of my holding that are at risk. Do that a few times a year without ever costing a share of stock and you can travel first class much of the year and still pay the taxes on the gains. I'm at an age where I won't travel that much, but if I go, it will be first class all the way.
I've really not followed CNBC for years, so I'm really not familiar with the Analysts you're referring to, but I'll accept that some may do well. I used to like Jim McCamant's on biotech's, but he's been retired for many years. I could live a nice life with nothing from the market, so everything over that is icing on the cake.
Gary
They have been achieving more approval lately. There is no doubt, conjugates have improved dramatically over the decades. Forty years ago it sounded like an elegant idea, tie a poison to something that homes in on the tumor. It didn't sound nearly as complicated then as it's become as they've learned a great deal over those decades, but conjugates today are far superior because of all they've learned. I hated seeing IMGN bought out because I believed they had other blockbuster drugs moving forward in their pipeline.
CAR-T is of course a newer technology. While I didn't know of it when I first met my Dr. at City of Hope, he'd been working on it well before then, and that's over ten years ago. A patient I met about two months after my stem cell transplant had received his own stem cells the same day I did, then three days later his own T-cells modified with disable HIV. He initially hit a 107 fever, but they brought it down and he was at the point where he came in twice a month, while I was coming in twice a week. They don't need to be concerned with rejection when using your own cells, that wasn't the case for me. My Dr. said he hoped I'd never need T-cells, perhaps the biggest problem with them is the short period of time they're still active. The man I met had come out of remission and the T-cells were essentially his last chance to get another sustained remission as stem cells alone wouldn't do it. My original oncologist really didn't want to do stem cells once in remission, he felt they could do it if I came out, but after speaking with experts at both UCLA and City of Hope I learned a second remission often can't be achieved, better to do it when the first one is. Both UCLA and City of Hope were willing to do it at my advanced age, I liked the feeling I got at COH, but both are expert at cancer care. I did meet patients my age who'd been turned down at top flight Eastern hospitals for stem cells because of their age, even some of the best institutions protect their mortality figures and the risk for seniors is deemed to be greater. Before Covid COH would hold BMT reunions every year, I met some of their earliest marrow recipients who had over 40 years back then. At that time I don't believe they knew it was stem cells in the marrow that were actually doing the work. I'm not an expert, but I don't believe that marrow needs to be used in any transplant today, it's all about the stem cells.
Gary
You're right. Most days I don't even visit CNBC or other business channels, but that day I'll probably have a look.
I frankly find that most of the Analyst's they bring out have lost money on their prior recommendations, why should I believe they'll be right this time. Most Analysts, I believe, are working for brokerages and when interviewed will normally push whatever stock their brokerage is pushing that week. I don't believe Cramer will touch a stock under $4, so you won't hear anything from him until we're at that level. I'll be really interested to see what the snake, AdamF, has to say on UK approval, it will probably be something like, I called your attention to NWBO many years ago, while I wasn't hot on the stock, I wanted all to be aware of it, and make up your own minds, remember, I told you to watch it.
I'm hoping that once we have an approval many things change. The biggest would be regular quarterly webcasts where at least Analysts following the company can ask questions. Of course I expect an Annual Meeting will be called shortly thereafter, and I expect our CEO and perhaps others will be attending and speaking at many of the Institutional and Brokerage Conferences held pretty much year round. Of course the biggest change will be moving to a major exchange, that can't happen immediately, but I don't think it will be that long.
Gary
I was of the understanding that a filing for approval is forthcoming. That can potentially end with an approval, if not, we see where they go from there. If approved you've certainly got a reason for substantially higher prices. If the filing is made by the end of the second quarter, regardless of which regulator, an answer should come this year.
I believe the company has good data from a few trials, but perhaps nothing that screams approval without conditions. Gaining approval even if a confirming trial is required would still be a big positive, though it's certainly more positive if nothing more is required.
It's my belief that Anavex has several shots on goal, the likelihood is one will score, than others will follow behind, perhaps after some additional clinical trials. The key is gaining that first yes.
Gary
You may be very right. ADC's are getting hot now and most people don't realize it's been roughly 40 years since they got started with IMGN. I was invested practically from the day it went public, and I wish it hadn't been bought out a couple months ago, though I profited nicely.
Gary
I could be wrong, but I believe in the Phase 3 trial, and others, treatment has been with SOC plus DCVax-L. If that's correct we cannot say that cures are being achieved with DCVax-L as a monotherapy. In some cases I believe that at least some of the SOC could be eliminated, and DCVax-L would work as well, or even better, but that can only be proven with treatment. Trials follow the agreed on protocol, but I cannot say what's been done with the patients in the UK who were not in the trial. I would suspect that much could be learned if the way people treated under compassionate use were revealed, I don't know if that will ever happen.
Gary
The problem with a statement like the improvement is 3+ months, that's where the survivors hit the 50% point. What would the benefit be if you took all the patients at the current point in their lives. I suspect that there are people who were some of the first in the trial who're still alive, many with 10 years or more. I think that longevity is far more important than when we went below 50% surviving. If we took the average life span of all the patients it would still be growing as many of them just keep adding years.
Gary
Dstock, I certainly agree that our vaccine should fight any tumor it's manufactured from, but I'd add in most cases it needs the support of other therapeutics to cure them. DCVax-L alone may have a survival benefit, but without additional trials we really don't know if it's better than the current SOC alone. It's very possible that certain SOC products can effectively be removed from the treatment when using DCVax-L, but others, such as Poly-ICLC and/or Keytruda should be added. I would suspect that as DCVax-L is added to the treatment of other solid cancers there will be a great deal of experimentation with what can be added, or eliminated, to make the treatment most effective.
Many years ago at a pancreatic cancer event I was invited to attend I met a elderly gentleman of substantial means who'd lived for over 5 years with pancreatic cancer without the Whipple procedure. His success in staying alive came was simple, find an Oncologist who believes he can keep you alive, follow his guidance until such time as it's no longer working and he has nothing more to offer, then find another Oncologist who has something more to offer. I believe he went through several Oncologists, much of his treatment was completely unorthodox, but he was alive and if age hasn't gotten him may still be.
I don't believe that we'll ever find courses of treatment that cure all with a given form of cancer, I believe there will always be variations and people will need to have their treatment modified to stay alive, and hopefully reach a cure. In some cases, I believe that once a patient becomes refractory to SOC treatment another treatment that has limited success may be all that's needed to return to the SOC treatment and again have extended benefits before becoming refractory again. Nearly 40 years ago IMGN had their first generation ADC in a trial, it was an MAB linked to blocked ricin, it was not humanized, a large molecule, and almost instantly refractory patients became refractory to it, but they were no longer refractory to the SOC, so people lived longer. Could such a product gain approval for essentially resetting the cancer, perhaps, but certainly it wasn't deemed sufficient to continue commercial development with trials who's goal would have shown it to be something that could only be used once or a very few times. Frankly this is the sort of thing the pancreatic cancer's oncologist may have done to essentially reset the cancer so prior therapies would be effective again. No company is going to go for an approval of their product to be used in this way, yet it might extend the lives of many patients.
Gary
I'm certainly no expert and like to express things in a simple way that may not be technically correct, but I believe that BP's developing what they found in all patients, but most patients have 20 of them. A BP will design a vaccine that may contain say the 30 most common of these markers and develop a way to mass produce it, and it meets their definition of being a vaccine personalized for that form of cancer. A patient with enough of those 30 marker should see some benefits.
In our case, our vaccine is made from the patients cancers, if that cancer has 20 markers, the vaccine will have those 20 markers. If the patient has 10, it will have 10, or if it has 30, it will have 30.
What do you think will be more effective, a mass produced vaccine that might hit half the markers in the cancer, or a personalized vaccine that hits all markers found in the cancer. I believe the answer is obvious. Certainly, treatment with a mass produced vaccine may be cheaper, but the personalized vaccine should be so far more effective that the price difference should be more than offset by the effectiveness.
Gary
I do agree with you Cherry Tree, but I believe the approval in the UK will rapidly wrist any control the shorts attempt to have from them very quickly as I believe the demand for NWBO will be huge. I certainly could be wrong, it could be a longer struggle than just gaining our first approval, but I just don't see the shorts keeping the price below say $2 and I've got to believe that most of them would have margin calls that force them to take their losses in meeting their calls.
$5 or more, which should come in the future, is really a key as Institutional Ownership will greatly increase at that point. If the share price comes near $4 I believe the Institutions will begin buying in big time, some in the hope of driving the price over $5 before the end of the quarter, so they can hold, but even if they can't, they will increase the demand for the stock. Certainly there are Institutions that can invest below $5 and we'll be picking them up on a more permanent basis. I believe that once Institutional ownership grows the shorts will have little to no influence left at all.
Gary
I would agree with you that some here overstate the benefit of DCVax's as curing solid cancers. I believe that the majority will agree with me that our DCVax's provide one of the tools that are of benefit in extending life and eventually curing some of cancer, but it's only one of the tools, it won't do it by itself.
It's very possible that as we get into an in depth study of how DCVax's work with the various solid cancers we'll find that existing products from virtually all the major BP's work best in different solid cancers with the DCVax's. From the trials at UCLA we know that Poly-ICLC and/or Keytruda greatly improve GBM survival, but only when used with DCVax-L. Dr Liau won't stop with 50% or greater survival at 5 years, her goal will still be 100%. The point is DCVax-L won't do it alone, but with the right other products far better cure rates should become possible.
I believe that there has been anecdotal evidence of DCVax-L and Direct working in other solid cancers including pancreatic, which clearly is one of the worse. I don't know that there is any information on whether Poly-ICLC and/or Keytruda is of benefit there, or if other therapeutics may prove to be the key.
To me, if a BP acquired NWBO and attempted to limit the use of the DCVax's to combinations with products they make it would be a tremendous disservice to the goal of curing cancer overall. It's likely that a BP will eventually attempt to acquire NWBO, and certainly they'll try to maximize the use of their other products with it, but I don't believe they'll attempt to prevent its use with competitors products. There is nothing wrong with profiting while supplying something that also helps a competitor to profit as well. DCVax's may very well add to the profits of many BP's whose products may work with it, and even those that don't because people living longer will use their products for other conditions.
Gary
The problem with those like yourself is that you think everything should be done the way it's been done for a hundred years or more. For a trial to be effective you must have a control group. Once you begin a trial, no matter what you learn, don't change it, let it fail and just start a new one, no matter how much it costs in money, or time. Let the people in the control group event quickly, that proves the trial product is working, rather than allowing all the benefits to all in the trial, and comparison with hundreds of years of data and previous trials with the same diseases.
The trial for DCVax-L will succeed because the regulators are open to change, they've supported changes throughout the trial, and once they consider the evidence they'll clearly see it's a step forward. I don't know if anywhere in what's submitted there are any references to the Phase 1 trials at UCLA, but I've got to believe the regulators already know all about them, at least in the back of their minds.
Gary
I doubt if you'll see Missling's name under the authors. In the case of NWBO the article was written by the clinician for the trial and the only name from the company was their CTO who was also named as the source at the company for the trial. I'm really not familiar with Anavex's trials, but I believe that the lead author would also be the lead clinician of the trial being reported on. Of course other possibilities exist.
Gary
The Nature article I was talking about was on DCVax-L, I really have no idea what Journal the clinicians from Anavex, who would have developed the article, have submitted to.
Gary
Cherry Tree, while I agree with you in my primary account, and I don't have that many shares in the Roth's, I will consider selling at near the highs, and purchasing far more shares on retrenchment, if the price goes to what I consider an emotional high. $2, $3, even $5 wouldn't be an emotional high, depending on what's announced, but I believe $10 or more would be.
For those who can remember how an article in the NY Times on Judah Folkman sent stock in the company he worked for from $1 to over $100, that's what happens when emotion takes control and people want into a stock at any price. Once the dust settled and people realized that Dr. Folkman's advances were purely in mice, and while the Time's said that left alone he could cure cancer in two year, perhaps that would have been true in many different types of cancer and mice, but human trials would be decades. Sadly the technology didn't seem to work in people, but our technology would be a very different matter. GBM by itself would bring blockbuster results, all solid cancers would add at least a double digit multiplier, and probably triple digit or more. Give it time, it will be many years before DCVax-L can be approved in multiple solid cancers, but sales will grow in off label use before full approval is achieved.
Frankly if emotion goes crazy, something well in excess of $10, then I'll consider setting trailing stop losses in the primary account with the complete intent to buy back far more than I sell, and pay the taxes on my gains. Emotions can only last so long, eventually the price will probably retrench 50% or more. The higher we go, the greater retrenchment will be. Barring a miracle that achieves approval by all the regulators simultaneously, I don't see more than $5 to $7 being sustainable, and probably not that high.
Gary