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That's not correct ILT, at first they were distributed and given under an EUA, but full approval followed.
As far as I'm concerned, far more products should be made available sooner under EUA's, then followed with full approval. Had this been done with DCVax-L I suspect an EUA could have been issued back when the trial was halted and the goals were being changed to OS. Everyone who receives the vaccine under an EUA should have results reported in a Phase 4. Had that been done, I believe the Phase 4 data would have led to a tumor agnostic label, and approval some time ago if the company, manufacturing manually, could keep up with demand. Under an EUA they'd be entitled to be paid by insurance, I would suspect that the price could be higher after full approval, but the company would have had real earnings, especially if the EUA was internationally accepted.
Happy New Year's,
Gary
I certainly don't know for a fact, but I believe that NWBO has been working closely with the UK authorities for years. I believe that they have spent an immense amount of time on the filing, and the regulators know what they are getting in advance of seeing the final document. If I am right about this, I believe that it will fly through the regulators and be approved in under 4 months, possibly even under 3 months.
Of course, it is also possible that they will have delays. Nothing is certain, but I don't think that we should assume the worst case.
I hope that shortly after they announce acceptance that they announce the Annual Meeting, then we should get the information on where we are, and where we are going.
Gary
I think we could be surprised in the near future. I have slightly increased my position.
Gary
Personally I've only done single leg options based on my own opinion of where I expect the stock to go. When I needed substantial funds to do the solar and heat pump system, I sold calls in IMGN that were well above the current price, but years away. I've rolled them to higher levels, even further away and now with IMGN in a buyout, I have repurchased some of them to get the full price in the buyout. I've also be buying substantial options that are over the price of the buyout for nickels and dimes in the belief that the price will go up, if I'm right I'll make far more money, if I'm wrong, it's cost me a couple thousand in a gain of hundreds of thousands.
Gary
I would actually hope that in the future I can make money without selling share, but not until we're trading for about ten times or more what we're trading for now. By that time I expect that Options will be made in NWBO and ideally after a run-up I'd sell out of the money calls at premium prices. If I'm right about the stock retrenching after the run-up, I'll buy them back at a substantial discount, and keep the difference. Worst case, I'll either let the stock be bought out at higher prices than when I sold the calls, or buy them back, possibly at a loss, but overall with a big gain as I'd never do it with over 10% of my stock, and more likely less than 5%, but even that could make $10,000 or so if completely successful in the transaction.
Gary
As the year draws to it end, let me wish all a Happy New Year's with the thought that I believe 2024 will be a great one for NWBO Longs.
Gary
Here's a question for the longs. If at the end of the year the share price is lower than at the end of last year, did you lose money?
The obvious answer of yes might very well not be true. If like me you purchased more shares when the price was lower, it's very possible that you have a gain. In reality, the answer for each of us may be different. Some here who chose to purchase at higher prices might even be behind if the stock closes up for the year, especially if they didn't purchase when the stock was lower.
We'll know in just over 3 trading days, but I would suspect that regardless of the exact price at the end of the year, nearly all of us who've added at low points during the year will actually have gains. As for the shorts, depending on how they've played things during the year, they too could have losses or gains, but if they're still holding stock short, the potential for big losses is greater then gains IMHO.
I don't think we'll hear anything from the company this week, but who knows, perhaps they'll surprise us. I suspect that we'll know about the UK acceptance in the not too distant future.
Gary
Thanks Dstock,
During a colonoscopy if they find polyps they remove them and biopsy them, as I understand it. I'm wondering if cancerous, could the polyps provide sufficient cancer to make DCVax-L which perhaps would help to prevent future cancerous polyps. The few people I've known that had more severe colon cancer had to have substantial portions of their colon removed, but did recover and live for years.
Reading the statistics that were shown here, the cancer is much deadlier than I had thought it to be. I'm uncertain when they say 1.4 million are found to have colon cancer if this includes all those with cancerous polyps removed, or if it's grown beyond that point to be considered as part of the 1.4 million. 700K dying annually certainly would make it a fitting target for DCVax-L if it proves to have benefits. It reminds me, I'm due for a colonoscopy, I've not had even a single polyp in previous ones, but you never know, that's why you do them.
With the New Year's I really should get caught up with some of the Drs. I guess I've been avoiding, not intentionally, just things you don't get around to doing. I do hope we rally a bit going into the New Year, if not it seems that we'll essentially end the year where we began it.
Gary
Dstock, I sure hope you're right. I know that many BP's won't even discuss their Phase 1 and 2 trials, if they don't see success, they simply fall by the way.
I did try going to the school website, but I certainly couldn't find a link to clinical trials they're doing there. I really can't say if a call there might be able to learn something. I would be best if done in German by someone living there, though I'm sure many of those who're listed with phone numbers very probably do speak English.
If as you say all clinical trials become public in 2024, if the trial is still running it should be in the database. I would think it would be the responsibility of the school to do it, but that's not something I know to be a fact.
Once again, Happiest of Holiday's,
Gary
As I understand it, colon cancer is a slower growing and less deadly form of cancer than many which are more aggressive. Is it possible that this trial is still ongoing and gathering data. Do we have anyone in Germany who may be able to check into it.
I know nothing about German designations, but it's possible that if a Phase 2 is generating excellent data it could lead to an approval without doing a Phase 3. In the US it would have to be considered a registration Phase 2 trial, done with Pivotal quality material, but it's possible to do.
If it is an ongoing trial, it's unusual that by this time not even a peek at the data being gathered in the trial was ever announced, but NWBO has never been very open about what's happening, and I have no ideas what German regulations permit to be done. Perhaps we could be in for a pleasant surprise sometime in the future.
Gary
As I understand it, colon cancer is a slower growing and less deadly form of cancer than many which are more aggressive. Is it possible that this trial is still ongoing and gathering data. Do we have anyone in Germany who may be able to check into it.
I know nothing about German designations, but it's possible that if a Phase 2 is generating excellent data it could lead to an approval without doing a Phase 3. In the US it would have to be considered a registration Phase 2 trial, done with Pivotal quality material, but it's possible to do.
If it is an ongoing trial, it's unusual that by this time not even a peek at the data being gathered in the trial was ever announced, but NWBO has never been very open about what's happening, and I have no ideas what German regulations permit to be done. Perhaps we could be in for a pleasant surprise sometime in the future.
Gary
Biosect,
I didn't mean to imply that City of Hope had attempted to make DCVax-L, but rather that I'd not be at all surprised if COH had over the past many decades experimented with tumor lysate and white cells to make therapeutics that may have benefitted their patients. How close they may have been to DCVax-L I have no idea, and I doubt they do either. COH has been a world leader in many therapies, including CAR-T.
I've mentioned meeting a patient who received his own stem cells the day I received mine, three days later he received his own T-cells modified by adding a disabled HIV molecule, as I remember it. My Dr. was involved in the development of the technology, and that was nearly ten years ago. It was nothing he ever wanted to use on me, the patient had a peek fever of 107, but clearly survived, but it's not an ordeal he'd like to put me through. I believe the treatment worked for this patient, though I've never run into him again. The problem with it was the modified T-cells were only effective for a matter of days, if the disease isn't eliminated in that time additional treatment is required.
Our DCVax-L isn't modifying your own T-cells, but greatly increasing the population of them, and as I gather it that greater population of the T-cells is sustained so your body is continuously fighting its cancer. I believe this is the key reason that our vaccine should be effective in all sorts of solid cancers. I'm a believer that curing cancer is an additive process, IE the more tools the physicians have to use, the greater the likelihood of a cure. DCVax-L will be one of those powerful tools, Poly-ICLC and others will be others, it won't achieve a cure every time, just many more of the times, and Drs. like Dr. Liau will continue to work on use of other therapeutics that will make it even more effective. I certainly don't know, but I suspect that if Dr. Liau's hands weren't tied by a trial protocol, she could achieve 5 year survival for something between 60% and 80% of the GBM patient population.
As I gather it, Dr. Liau and the other Drs. working with her at UCLA are the experts at brain cancers there. If UCLA is to continue to be a leader in treatment of other cancers with DCVax-L, I would assume that Drs. from other depts. would lead such trials at UCLA, not Dr. Liau in spite of her being one of the developers of DCVax-L. I've got to believe she'd be monitoring what they're doing, but I'd be surprised to see her being the lead clinician, or even being officially involved with the trial.
Gary
I was never part of the bet either, but frankly I don't mind some ignoring they lost. Why? Because I rather enjoy the way we're challenged by the more intelligent shorts, but besides that, I know that anyone who wishes can establish a new ID and even if we know who they are, they're not violating what they said they'd do. If the moderators could eliminate such posters it might be meaningful, but frankly I don't want to see them become the police of such things.
I'd rather people just keep their ID, but if we have to guess, I suspect that most who said they'd drop out will be back with other names in less than a month.
Gary
Again, I never said to give the EDEN units to anyone, I suggested that they could be leased with NWBO maintaining full control and having each machine operating in a network under NWBO's control.
I'm sure that you're right about being able to rip off either the machine, or the vaccine for that matter, but anyone doing it would be violating patents. I would suspect that not that many glass companies are able to make the disposable cassettes, and a major company doing so knowing they're infringing on patents is doubtful, but not impossible, especially if they're in China or other countries where stealing technology is common.
I believe that NWBO would be smarter to work, as IMGN did with Elahere, and license DCVax-L to one of the major Chinese pharmas.
I don't believe that City of Hope has manually made DCVax-L intentionally, but I wouldn't be at all surprised if they'd have the capability to do so in their cleanrooms and have probably created something quite similar over the years. I know patients who are alive today because COH created personalized products for them decades ago. At COH patients generally return at least once a year for check-ups even after decades, I've happened to speak to a few who've had hematological cancers decades ago and still come to see my Dr. who's head of the department. You hear some very interesting stories when chatting with such people.
You could be right about eventually selling FlaskWork, but I'd rather see them become a wholly owned subsidiary of NWBO, and if NWBO wished, they could spin them off, in the way Roche spun of Genentech, while retaining majority control, permitting them to reacquire them as they so choose, which Roche did as well.
To me, the key to the EDEN unit is the precision pumps which operate in the same manner as IV pumps. What you've said about stealing technology may be true, but I've spent a fair amount of time in Drs. offices and and it seems to me that all the IV units I've seen seem to be from the same company. I don't know if these units are sold, or leased, and perhaps other companies make them, but I've not seen them. My point is if they're making them and selling or leasing them at a fair price, people will use the tried and proven units. If the EDEN unit is accepted in the same way I wouldn't be that concerned about it being duplicated, at least as long as patents are still in place.
Gary
This is one of the posts I was referring to WRT achieving an approval that's tissue agnostic, though I called it tumor agnostic. I believe that Drugrunner, who I've affectionally called Druggie for years, has a great deal of knowledge of the industry. If he believes they're going for the tissue agnostic label I certainly believe it's a possibility.
Happy Holiday's all,
Gary
Druggie clearly suggested it in earlier posts, and I do believe others have suggested it. I don't know that the submission couldn't justify a tumor agnostic finding while asking for GBM approval. I certainly don't know what's in the submission, I really don't believe any of us do, but it's clear that the company's not being shy about calling the DCVax's tumor agnostic.
I believe that if additional trials are needed for a tumor agnostic label it won't be done with DCVax-L alone. I think that other combinations including Poly-ICLC and/or Keytruda will be included in the trials, and these trials may be sponsored by more than one company. If this is the case, the trials could involve many trial sites with the intent of being fully enrolled in a matter of months and initially evaluated after just one or two years after being fully enrolled. The complete trials might be run in under 5 years.
If more anecdotal evidence of efficacy in other cancers build, I believe that off label acceptance of DCVax-L will become acceptable to many insurance companies and the approval may not be that impactful as DCVax-L has already become part of the SOC.
Gary
More evidence that IMGN is undervalued:
https://finance.yahoo.com/news/investors-undervaluing-immunogen-inc-nasdaq-192108949.html
I'm hoping the Annual Report is out before investors must vote, I believe it will support the price needing to be higher. I'm hoping that ABBV is convinced to raise their offer prior to a vote. To me, $40 a share is roughly the lowest figure that I'd vote positively for.
Happy Holiday's all,
Gary
Druggie, and I believe others, have suggested that NWBO is going for a tumor agnostic label in the UK submission. I'm wondering if anyone thinks that the documentation for that will come out of only the data developed in the Phase 3 trial, or if they can incorporate data that's never been previously revealed on patients with other cancers who were treated under compassionate use in the UK. I know we've heard about a few of them, but I gather that there are many more that could be cited.
If it's true that NWBO is shooting for a tumor agnostic label, and gets it, even if confirmatory trials are required, the demand for DCVax-L in the UK alone could be well beyond what Sawston can deliver without the EDEN device. It might be questioned if NWBO is simultaneously going for EDEN approval in the UK.
There is no doubt that NWBO is pushing tumor agnostic, just the pictures of their booth at SNO made that clear, and I'd bet that ASCO or any other conferences that they exhibit at from here on will be very similar. I believe that other products tried in pancreatic cancer alone that were approved were essentially given tumor agnostic labels, if that's the case, I don't know why an equal case shouldn't be accepted for GBM.
Gary
Best of luck with your treatment Smokey, make sure your Drs. know about DCVax-L and cryopreserve your tumor. I could be years before you need it if there are problems, but DCVax-L could be made, and utilized then if needed, or DCVax-Direct could be available then as well.
Gary
Happy Birthday CO,
In a little over a decade you'll reach where I am today, I suspect that you'll be wealthier than you could ever imagine by then. Stay healthy.
Gary
LTR,
I had the fortune of being treated at City of Hope, in their labs they've created many drugs which they've licensed to BP's, like Herceptin. I didn't mean that every hospital could produce DCVax-L, but there are a number of such research institutions who could do so, and do it very successfully if the company wished to have spread out distribution.
I'm sure you're right about the average hospital, but in L.A. alone I suspect that three or four other major hospitals and research institutions would be capable as well. We know UCLA is doing it, but I also believe that USC and Cedars have similar capabilities as well. If I'm right about a centralized computer tied to NWBO would be controlling the EDEN unit, I believe the chance of errors could be greatly reduced. Again I'm not saying it could be done everywhere, but I don't believe distributed processing is impossible.
Not every pharmacy is a compounding pharmacy, but those that are do a good job of making certain drugs. I believe certain hospitals or laboratories that already have cryogenic capacity as well as distribution would be capable of doing the job. I'm not saying this is what the company should do, I just believe that it may be one possibility. It's very possible that such capability is completely unnecessary. I believe CRL is probably capable of supplying most of the world if that's NWBO's choice, along with Sawston serving the UK and perhaps most of Europe. Of course with sufficient funding NWBO could do it themselves, as Biotech believes, or a BP could partner with NWBO and take over the task. Personally I believe it's very different from what BP's are used to doing, so I really don't know that they'd want to take on such a task.
Gary
We'll have to agree to disagree, unless there is a partnership prior, I just don't see where NWBO can afford the costs of building the facilities you describe. It's not that the EDEN units are that expensive, but all the rest, especially the cryogenics and facilities needed to distribute the vaccine that's needed, potentially for a number of years for each patient, will be a very expensive proposition that already exists with the likes of CRL and Advent, but they'd have to build from scratch themselves.
I believe agreements, which will use the EDEN's, already exist, but must be dated, signed and sealed. Of course I could be wrong about that. I believe that their patent protections are strong, as is their agreement with St. Gobain's to make the disposable cassettes. I won't say they couldn't be ripped off, but it would clearly violate their patents and could cost more than purchasing from NWBO.
I previously said that FlaskWorks could become a profit center for NWBO. I believe it can build devices similar to the EDEN for other personalized products that have other companies paying NWBO for this equipment. NWBO would be paid by those using FlaskWork equipment rather than attempting to duplicate it without violating their patents.
Gary
Dedugan,
I can't say such an arrangement isn't possible, I've never seen that great a disparity between the current price and what's being paid, but if it clearly came with other benefits, it's possible. I believe such action would elevate our share price dramatically, but I don't know that we'd move close to $10, but even $5 would be a huge move, and that would be justified by the partnership.
While I'm not betting it will happen, I'd certainly love to see it.
I believe that LP has been quoted as wanting more than $10, but I believe that this is the sort of arrangement that she could take without totally compromising what she's after. I'm not sure if she'd go along with 10% of the OS at that price, perhaps 5% would have a better feel to her.
I'm still of the belief that no such deal will be made until we're above $1, but perhaps we don't need $5 or more to get the sort of number that I believe would satisfy LP. I still think over $1 will come with UK acceptance of our filing which could come rather quickly.
Gary
Dstock, I certainly don't know, but I believe the cost of making cancer fighting products has little to do with the price that will be charged for it. If a mass produced vaccine is just slightly less effective than DCVax-L it's price will very probably be just slightly less than DCVax-L.
It's been a long time since I took college chemistry, back then many people used tooth powder, rather than paste. When we analyzed what went into the powder, it became very clear that the cost of making the container was far greater than the cost of the powder inside. The point is, once you've paid back the research costs and costs of the equipment making the product, the cost of the product itself is often pennies.
DCVax-L is a very different animal. Whereas the cost of manufacturing a mass produced vaccine may well go into the hundreds of millions in equipment, what's in the vial is cheap. Assuming the approval of the EDEN unit, others have said that when mass produced each unit should cost tens of thousands, essentially less than will be charged for the first batch, making the EDEN a profitable unit on selling the first batch produced in it. Sure, it take a lot of other equipment, but it's already available in many places that could make DCVax-L if they had the EDEN unit.
All I'm suggesting is that DCVax-L can be more effective than mass produced products and sell at prices that are competitive.
I see our close is down $.07, so as of now we're only $.025 higher on filing with the UK, a sad commentary on how much control the MM's have on our price.
Gary
I'm still of the belief that our price should be above $1 now, on the news we filed with the UK. It's clear that it's not because of the actions of the MM's supporting the shorts in manipulating the stock price. Eventually the news will overtake this effort.
I'm uncertain precisely how long the UK will take to accept the filing, but I believe it will be sometime early in January. Have no doubt, it's good news. Of course the really meaningful news will be approval, and that's at least a few months away. I don't believe that the price can be held down to the point where a UK decision comes in, I expect that we'll be trading in the $1 to $3 range until then, depending on the other information that comes out when we hold the Annual Meeting, or other positive news.
The short term power of the MM's can be seen in today's trading, but in the long term, as demand increases as more is learned about NWBO by ever increasing numbers of investors, the MM's will be losing their tight control of the stock. I gather that any day we may get the judge's action on the MTD in the spoofing trial, I expect that to be a positive, and perhaps send a message to the MM's that their current actions may undergo scrutiny as well. Frankly, I'll admit the ability of the MM's to manipulate the share price is stronger than I've given credit to them in the past, I agreed with others that today should be an up day.
Gary
Are all these shares private placements, they don't show in the volume of the day.
Thanks and Happiest of Holidays,
Gary
What sort of partnership are you speaking of. At current prices I don't believe that LP would partner with anyone who was taking stock ownership as a part of the partnership. A partner might pay double, even triple the current stock price, but nowhere near the double digit prices she's suggested in the past that it would take.
Of course other partnerships are possible. NWBO could partner to run trials with other drugs, both companies could provide support for running the trials, but no equity would be involved. I still believe a partnership, or contract, may be forthcoming with CRL for commercial manufacturing of DCVax-L, again the terms wouldn't have to involve stock in either company.
I believe most people are talking about a BP buying into NWBO, that certainly could happen in the future, but if LP sticks to her guns, it won't happen before the stock is at a price that the double digit price she'd want for NWBO stock in the partnership is within striking distance. Personally I believe double the current price is very achievable, perhaps even triple the current price is possible, but 10, 20, or 30 times the current stock price is not something any company will do, and that's what would be needed at current stock prices to meet LP's demand. I wouldn't want to see such a partnership at less than she's demanding.
Gary
Smitty, are you sure of what you're saying. Are you certain that the tumor agnostic label will not eventually be applied to both of the DCVax's. If it were applied, wouldn't it become a part of the SOC in fighting many cancers. I won't deny that at least one, perhaps more BP's will have probably partnered with NWBO before this happens, but if it's not bought out, I don't see why it cannot be compared with Apple in the Biotech world.
As a guess, it will take a decade or longer to know, and odds of a buyout over this decade may be probable, but if that doesn't happen and NWBO exists in 2033, how big might it be if in fact if many cancers were being treated with DCVax's.
Gary
Barnstormer, I've never see a company forecast anything less than the regulators allow for themselves, but I've seen many FDA approvals come in before the PDUFA date. On the other hand, if they're going to delay or deny approval, it normally happens on the last day. I was impressed by a post that said how quickly the UK had acted on a number of drugs, I know that they're shooting for 4 months, 120 days vs. the 150 in their guidance. There are people trying to make a problem about NICE adoption of the cost of DCVax-L, I don't believe it will be a problem at all, I don't know what the price will be, but nothing works like DCVax-L and if they add Poly-ICLC and/or Keytruda the results will be spectacular, and I believe they know it.
Gary
Thanks, now it's all about how long they wait for the meeting. I would hope that they wait for the Annual Report at least, that way we'll at least see the Elahere sales growth for the last quarter. They seem to be in a rush, so I don't know that they'll give us that long. I believe the more investors know the less likely they are to vote for the proposal.
Gary
I really think that it's possible that a BLA will be forthcoming even before we have UK approval, but I believe it depends on how we can accomplish commercial production. The BLA normally gets a PDUFA date that's six months after it's accepted. If the EDEN unit has not been completely accepted before the BLA submittal, NWBO needs to feel certain that it can be within say 4 months of its submission so that the FDA can inspect a production facility and fix minor problems before the PDUFA date. This would be a tight schedule, but if they know a few more month of testing will get the EDEN unit approved, they might go for it.
Of course this is based on my contention that the EDEN is needed to meet anticipated demand. Some believe Sawston with manual production could meet FDA requirements. I feel it's possible that Sawston equipped with the EDEN could do it, but I really believe that CRL will be their contract manufacturer and distributor out of the Memphis facility, and news on that will be forthcoming when the timing is right. I certainly don't know that this is possible before we have UK approval, let's hear what they have to say when they hold the Annual Meeting.
Gary
It's silly to fight over what day is day one, in another post a number of approvals were cited where just over 60 days was needed for them to make a decision. I believe the UK regulators know a great deal about DCVax-L already and this will be one of their faster approvals. That said, the 60+ day window will open in late February making a first quarter approval a possibility.
I think we'll get the official acceptance the first two weeks of next year. Approval by March is very possible, if we don't have it by June we may hear of complications that must be resolved.
The manipulators seem to be trying to keep us under a dime gain, let's see what happens in the last 15 minutes.
Gary
Biosect,
Let me be clear, I've not suggested selling the EDEN, I've suggested it be leased. I'm of the belief that the EDEN units will be computer controlled and NWBO would have complete access to what each of the units were doing. I also believe they'd totally control how the disposable cassettes are distributed and disposed of. In short, they could track every batch of vaccine regardless of who was making and distributing it as it would all be done by companies leasing the EDEN units from NWBO. The company would also be responsible for maintaining and upgrading all the leased equipment.
As to whether they'd be leased to one or two major CDMO's, or distributed to many by lease, would be up to the company. The key is that they wouldn't be responsible for the construction and maintenance of major cleanrooms, cryogenics, etc. They would be paid by all who're doing the work, and of course those companies would also profit from each batch they made and distributed as well.
Most companies who use CDMO's to produce their product don't provide the equipment it's produced on, but they're producing massive quantities of the product. We on the other hand have developed the means for producing each unique batch and are well positioned to lease the equipment to those we license to produce it. Barring that we'll need hundreds of millions or more to build the needed facilities ourself. I rather like the idea of doing this with other peoples money.
Gary
I believe that any prediction for the price at the end of next year has to be based on assumptions about what happens next year. I believe the worst case is only achieving UK approval next year. The best case would include acceptance of the EDEN unit for commercial production and approval by the other three regulators in addition to new trials some of which are funded by others, and perhaps new partnerships. The point is, there are so many possibilities that could occur during the year that at the end of the year the share price could fall into a range as low as $4 to perhaps $25 or more if all that could happen during the year did happen. I would expect it to fall someplace in the middle, but anything is possible, including a buyout or partnership at substantially more if trials are indicating that DCVax-Direct is headed for approval and DCVax-L for a tumor agnostic label that quickly.
As we head into the power hour it's hard to tell which way we'll go, I would hope for a close that's up $.15 or more.
Gary
Your right, today's filing should be the first of many.
The shorts aren't going down without a fight, so we need to realize just how much pressure they can apply even with great news. I still believe we should end the year above $1, but it's hard to say that we will. When I first woke up this morning I saw it up over a dime, without checking I knew they'd filed, but sadly they brought it down to under $.80, though it's back above it again. Hopefully as the news spreads it will go higher.
I frankly don't know if this news is too late to get us an invitation to speak at the JP Morgan Healthcare Conference, or any of the others that follow it in close order, that would really say that we're coming out of hiding and are ready to tell the world what we have.
I would expect the next news from the company to be acceptance by the UK and the scheduling of the Annual Meeting shortly thereafter.
I think we all realize that Holiday Weeks aren't the best time for good news, but delaying great news would be foolish, so it is what it is, great news, not the greatest timing. Depending on what the company has to share at the Annual Meeting, that could be far greater news and much better timing. As for today, I hope we rally further into the afternoon and close at or near $.90 or higher.
Congrats to all who've waited so long, and again Happiest of Holiday's,
Gary
Mav, I have to disagree. I believe that there are other ways in which they could bring in substantial money that don't involve a buy-in from BP's, but they may include some trials with other companies, and most certainly could bring in money for rights to utilize the EDEN units in commercial production, presumedly from both CRL and Advent.
When we move to the $3 to $5 range nothing will prevent an offering that is designed to bring in $100 million or more which may be needed to support new trials and preparation for additional approvals. I really don't believe that LP wants a partnership with a BP until they are willing to pay double digit share prices, while that may be possible in 2024, if it doesn't happen I don't think she'll take less for a significant percentage of the company.
Gary
You're right about my faith, but frankly I love the holiday's and the XMAS music. I'm honestly not very religious and think it's terrible that so many wars have been fought in the name of religion. As I'm writing this I'm enjoying the Grand Old Opry's XMAS show.
I really believe that we could all learn a lot from one another, and the hatred that exists between so many people would end if we got to know one another better.
Let's hope that NWBO gives us a little gift for the Holiday's and again Happy Holiday's all,
Gary
Doc,
I forget what class I first heard of the insignificant many, and the vital few. I would suspect that if we looked at the 1.7 million page filing with the regulators, 1.699 million of those pages, or more could be classed as the insignificant many. I really doubt that over 1000 pages in the filing really belong in the vital few, and if you're reviewing what's being submitted, it's these pages that need to be scrutinized.
Hopefully all these critical pages have been reviewed extensively, including by the regulators as part of a rolling review. If that's the case, we should learn of the filing being made by XMAS, the deadline, though it's possible we won't be told of the filing until the 26th, after the Holiday. While it would be nice to get the notice before, like a small XMAS present, I'll be happy with it at any time this year.
By the way, Happy Holiday's all,
Gary
Anyone know why the I-H quote is higher than what's shown in Fidelity, CNBC, etc?
By the way, I believe that what's making DCVax-L work so well is the increase in T-cells at the tumor site. The question that hasn't yet been answered is whether this phenomena is only occurring in GBM, or if it's known to be the case in the patients with other cancers who've received DCVax-L under compassionate use. I don't know if any data exists, or if it was determined so late in the GBM trial that no attempt has been made to get that data, but if it's known to be the case, it's a solid reason for a tumor agnostic label.
Aspirin has been marketed for over a century and they keep finding new benefits from using it. I believe that DCVax-L could be much the same. I can't say it benefits Alzheimer's patients, but if it did, getting cancer to cure it is hardly a desirable way to treat it. The question might be, can DCVax-Direct be made and of benefit even if there isn't a solid tumor to inject it into. I certainly don't know, but I believe if T-cell production is somehow spurred by both of the DCVax's, that by itself may make them miracle drugs against all sorts of diseases, not just cancer. I certainly don't know that this is the case, but I don't know that T-cells were even being looked into in patients until Dr. Bosch did so, apparently well after the trial ended because if it had been earlier, I believe his findings could have been included in the Journal. As I remember it, he was one of the authors.
As I said when I saw his presentation is that the Journal explained how well DCVax-L worked, but it was Dr. Bosch's presentation that explained at least in part why it was working. Increased T-cells may not be the only reason, but they are certainly one of the reasons, and they may be of benefit in far more than GBM, or even cancer in general. Perhaps even blood borne cancers, like leukemia, could benefit from DCVax-Direct administered into the bloodstream.
Hopefully everyone knows I'm not a medical expert, but I do like to stir the pot and see what the experts think.
Gary
I don't believe that where things currently stand with Advent, or CRL for that matter, is that great a concern. I do believe that both companies may play a major role when it comes to commercial production unless NWBO makes the determination to go it alone once they have the EDEN unit approved. I don't believe they'll go it alone, in fact I think just the opposite will be the case and both Advent and CRL may pay NWBO for leasing the EDEN units and the money they're paying will largely pay for them to be built. Clearly they'll make their money back, plus a lot more, by making, storing and distributing the vaccine as it's needed by patients all over the world in time.
I certainly don't know, but I suspect that these companies have agreements ready to be signed once the necessary paperwork is either filed with the regulators, or approve by them. As I see it, NWBO must make sufficient commercial production facilities to be available for inspection by the regulators before approval by any regulator. The UK is already approved, as you can't file the MAA until that's been done. The others, I believe, inspect and approve the facility as a part of the overall product approval package.
It's very possible that with EDEN the company chooses to do some of the commercial production themselves, and have some of it done by contract manufacturers, probably both Advent and CRL. It will be up to the company which way to go, but initially I believe they'll need existing capability at both Sawston and the CRL facility in Memphis.
Gary