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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
Mav,
While I can agree with what you're saying, I don't see how it's possible to do a critical re-evaluation prior to at least getting an update from the company on the status of many of their efforts. In the time I've been an investor, the Annual Meeting is the one time roughly yearly that we get such an update.
I don't believe this will occur until at least the UK has accepted the submission which hopefully will be made by the UK's deadline of December 25th. While I doubt any person there will handle anything submitted after tomorrow because of the holiday, it will still be determined to be on time if it's transmitted to them on or before XMAS. I suspect the company will wait for UK acceptance, announce it, and roughly simultaneously announce when they're planning on doing an Annual Meeting.
I believe the company is allowed to go a week or so into March before issuing their Annual Report, they might tie the Annual Meeting into the Annual Report, further delaying it.
Of course I could be wrong, perhaps when they announce the filing of the MAA they'll produce guidance on other things that are ongoing, anything is possible, but it hasn't been done in the past, so it's doubtful in the future.
I'm certainly no expert on the differences in what's to be filed with each country. That stated, I would think that in 1.7 million pages, only a few hundred, if that, must be substantially changed to file with different regulators. If this is the case, and if the company has told it's contractors to work on these changes, we might be very surprised to learn how quickly they intend to file with others. Of course we'll really only know this when they provide some guidance, probably at the Annual Meeting.
Gary
It has been decades since my wife had chemo for breast cancer. When her counts were too low to administer it, she would get a drug to boost her count, and a day or two later, they could give the chemo. I wonder if something similar could be given before leukapheresis to make it easier to get larger counts.
The question may be, do such drugs affect the quality of the white cells.
Gary
Flipper, is the leukapheresis more critical to the number of doses than the size of the tumor? If that's the case, what would prevent doing the leukapheresis more than once. I know that when they harvest stem cells from the blood, patients first get a drug that stimulates stem cell production, then a process like leukapheresis is done. I believe they'll do as much as 6 hours a day, but do occasionally require 2 or even 3 days. Of course donors do have the option of removing the stem cells from the marrow, it's more painful, but it doesn't take nearly as long.
I certainly don't know, but it would seem to me that some initial price be placed on initially making the vaccine that's greater than $30K, then $30K each time it's given seems very fair. I don't know how high the initial cost of making the vaccine should be, but I'd think something in the $50K to $100K range would seem fair. We do need to recognize that not all patients will live extensively longer, some patients might only receive a very few doses.
I'm a big believer in what Dr. Liau and the people at UCLA are doing, in time I believe she'll get 5 year survival to perhaps 70% or more, and I believe that DCVax-L will be part of the treatment regimens for all of them. When that occurs, perhaps the cost of DCVax-L can be further reduced, likewise if it's being used in many cancers, not just GBM. Honestly I believe that if NWBO wished, they could charge far more, the figures I've heard are significantly lower than prices for certain chemos which generally aren't nearly as effective and have negative side effects. I believe that cures do require more than DCVax-L, but hopefully combinations will be found that aren't nearly as negative as the side effects of certain chemos. Quality of life is certainly one of the biggest advantages of our vaccine. I have no idea the effects of Poly-ICLC, Keytruda, or other products that complement DCVax-L.
Gary
Out of curiosity, does anyone know if in the UK a submission can be made 24/7 or if it must be done during certain business hours and days. If it's limited to certain working hours, then I'd think it could be filed for hours before our market opens, but by the time the market closes their business day should be over. While I'd think this is an electronic transfer of information that could be done at any time, it's very possible that the time in which submissions can be limited.
If anyone knows for certain, let us all know.
Gary
Marty,
I think at times we place perfection above everything else, so any perceived flaw results in delay. I say perceived because many may not think of it as a flaw, but someone does, and until it's resolved it sits. I like the expression that in every project there comes a time in which you must shoot the engineer, and proceed. I believe we're approaching the same position.
I remember a discussion of music in which it was asked if the music stopped, could you name the next note. People agreed that they could, but the notes would be different. That was the point, perfection is different for all of us. Hopefully we're at the point where the company is willing to say the submission is good enough. It will never be perfect to multiple people reviewing it as we all view perfection differently.
If the FDA or other regulator wishes to nit pic anything submitted to them, they can find something to base it on. On the other hand if they're looking at what's best for patients with the diseases being fought, they should avoid the nit picking and approve products. They can always do post approval Phase 4's, or insist on confirmatory trials for full approval if there are any real doubts on their minds.
In our case, with or without the regulators wanting more trials, I believe we'll have them. I believe we'll be going for the tumor agnostic label and we and others will want to co-sponsor trials to demonstrate other products which make DCVax-L far more effective, but where the other products don't work well without DCVax-L.
Gary
I agree, very few longs will trade substantial portions of their holdings, but many traders who believe they can sense reaching new peaks, then retrenching before advancing again may trade in attempting to add shares at no further cost to them. Of course if they're wrong and want back in, they may have fewer shares than they started with.
Personally I believe our growth, under the right circumstances, may be explosive, I wouldn't want to be out at all. Once we've reached a major exchange I expect options will be made in NWBO, at that point when I sense a peak I'm planning on selling out of the money calls on a small percent of my total holdings, but until that time I'll just hold, and perhaps add on weakness.
Gary
Don't you think that with substantial news, our volume will rise by a substantial multiple of the current daily volume. With all the shares that we have outstanding, I think a 100 million share day is possible.
Gary
Doc,
I didn't say it earlier, but if our oldest survivor received the DCVax-L 25 years ago, this is almost more like a crime than a clinical trial. Can you imagine it's taken a quarter century to bring a life saving product to near approval. Why in the world haven't the medical experts all over the world recognizing what's been happening here and done something to expedite it by a decade, or more.
I can't believe all these people living went unnoticed, I'd be willing to bet that at the time of the halt the Germans, who insisted that all patients get the vaccine from the get-go would have preferred to end the trial right then and there, and make the vaccine available to all. This is speculation on my part, but it's clear that the four regulators all agreed to the changes, even if the company didn't formally document them until shortly before the trial was formally ended. They actually were caught off-guard when the UK and Germans upgraded their versions of clinical trials, so it's really quite clear the FDA agreed to essentially the same changes, but they, or the NIH don't change the record, it's up to the company.
Of course we'll never know for certain, such tales are never told. I would think that the DSMB could have called this to the regulators attention, as well as the fact that PFS wouldn't work as a goal, but again, they rarely stop a trial early for efficacy, though occasionally it's done. One of the chemo's I was on, Gleevec, is one of the rare cases when a trial was stopped early because just the form of leukemia I was being treated for was miraculously saving people, as long as they stayed on it. At the time it was approved I noticed it and indicated I thought it to be a perfect drug for the developer as it worked, but only as long as you took it.
Gary
Thanks Doc,
I have no idea how many of the surviving patients have been tracked for many years after they completed the trials, but it would be great to see what data they had, and perhaps hear from some of the longest living survivors.
Gary
Doc, I don't know if it's possible, but it sure would be neat to see a K-M plot that incorporated all usage of DCVax-L and extended out as far as the longest living patient. I suspect that might be 20 or more years. It would also be great to see every type of cancer it was tried in from the information they have from compassionate use in the UK.
Year's ago in the ASCO Experts Theater I believe they had a panel of survivors speaking about the treatment. At the appropriate time it could be great to see another presentation like that with the patients several years later. That's the kind of thing that could be done in a brokerage or Institutional conference, we just need to be invited to such an opportunity to speak.
Gary
If Griffin can give Harvard half a billion and get the medical testimony he wants, he can pay someone enough to build a chatbot that lies, but it will be exclusively for their use. Frankly what he's said for the record is all that should be needed to get a major judgement against him. I'm amazed that a person in his position would make such a statement, wonder if he already owns several Supreme Court judges.
I frankly can't believe what many of our wealthiest and politically savvy people say, or fail to on hearing what others say. If it were up to me, politicians would be reminded daily that they take an oath to the Constitution, to serve the people they represent, not the political party.
Gary
I would think that if there really are hedge funds, etc. paying bashers to do so, with all the billions they're making they'd eliminate the people and develop there own version of Chat that just did the bashing automatically with all sorts of identities. Our bashers could all be replaced by a computer.
Gary
While I agree with much of what you're saying, I believe that none of us would be happy with $1 on a permanent basis, I really don't believe we'll be significantly below $1 once we've filed with the UK, but it will take some further action from the company. I believe that once they have acceptance from the UK they'll schedule the Annual Meeting, and I believe that will be a substantial positive as it will be the first real update since the last Annual Meeting. I know we've had quarterlies, but they've provided almost no long term guidance.
I'm not a strong believer in penalty provisions as I've seen how contractors find ways of adding costs and delay, and in the end you almost always pay more. I also knew Govt. buyers who'd drive prices well below what estimators said something could be built for, everyone knew what they were doing, but they'd bid well below their costs, then change orders would bring the overall cost way above what the estimates were. I believe that if you have knowledgeable estimators, any submission that's more than 10% below that estimate should be thrown out to avoid low ball estimates that clearly can't be delivered. Change orders are the mothers milk of contracts, often even asking the contractor to do less results in higher, not lower costs.
There was an old Mark's Brothers routine, as I remember it, where you paid $XXX for their band to play at your event. You paid more if they were paid to practice, but not to play, and if you paid them not to either play or practice you couldn't possibly afford it. Some contractors try to operate in that way.
Gary
AE K, I believe the numbers you're using are possible, but very optimistic. I'd be very happy if we actually achieved approval in roughly 5 months of when we submit, and even that would beat their guidance. I do believe that the UK has a great deal of experience with DCVax-L, so it's possible that they'll get everything done faster than any of us think, but I wouldn't want to bet on it.
Gary
Barnstormer, I'm of the belief that if we file with the UK, our share price will reach $1. If I'm right about that, while it doesn't seem like a great year, I believe we'll be up somewhere around 25 to 35%. Most stock investors would be thrilled with that sort of percentage in the year.
We all think NWBO should be trading in dollars, not pennies, but when it comes to percentages, a penny stock that moves up 25% in a year has a greater gain than a $1000 stock that goes to $1200, yet people with $1000 stocks are generally happy with $1100 for the year. People don't buy $100 stocks expecting $500 in a year, they're very happy with $125, yet we all want to see $5, and almost certainly will in time, very possibly next year. For many of us, myself included, that's nearly a ten banger.
I suppose if there is no news in the next couple weeks we could be down slightly for the year. I still believe we'll be up, but it's not in my hands, and I'm not sure if the company really has any control over the contractor either. I frankly never liked contracting something out if I could do it myself, but more than once was told to do it as we want to keep our contractors working. In the case of NWBO, they've kept their size minimized by contracting out most tasks, but at times I'm sure they wished they could do certain things themselves. Regardless, it is what it is and in time they'll be proceeding, let's hope it's tomorrow.
Gary
There was a time I'd have said you were right, but that was long ago. I've seen how low IMGN got only to come back, but the best example I can think of is CVM, I really can't say how many times their one drug has failed, without improvements in that sole product they keep finding new targets, and find new investors to support their trials. Who knows, this time they may have actually found a disease that works with their drug.
I don't believe it will be necessary, but in the past I've seen such bizarre action from the FDA that nothing is impossible. I think we'll get UK approval, and that alone could support additional requirements the FDA or others might impose. It's sad, but the regulators all too often don't think of the sick people who lose access to promising products when they insist on added trials, but that's clearly the case.
I've probably anticipated approval of a dozen or more drugs that I had no doubt of approval. I would guess that at least a third of them had delays, some over three years, but all were eventually approved by the FDA. Confirming trials could have been done post approval, and perhaps the FDA is doing that more frequently now, but years of delays, and hundreds of millions in additional developmental costs doesn't seem to bother the FDA at all. Meanwhile, certain products which their advisory committees advise them against approval get approved. Go figure.
I frankly believe that all trials should be shorter, but all approved products should be tracked in Phase 4 cataloguing of all uses which are reviewed to determine whether any additional cautions or labeling changes should be required, or worst case if they should be taken off the market.
Gary
Companies, especially biotech's, have failures all the time. There is no way that I can see DCVax-L as a failure, but the worst case would require additional trials, and that would create a scramble for the funds needed to do so. We know that with Poly-ICLC, Keytruda, and other therapeutics the survival can go to ten times or better than what's achieved by the SOC. How long would such trials take, if well funded it could be done in a couple years. You wouldn't need to take survival to 5 years, the difference is so great that 2 or 3 years at most should be sufficient, but you do need to get a lot of people enrolled. That's where if well funded, it could be done quickly with virtually hundreds of clinical sites. The answer would probably be a partnership, but not at the $20, or even the $10 share price investors would want, even $5 could be tough sledding because of the delay conducting such trials will take. The other choice, going it alone, would sadly involve a lot more dilution, and I really don't know that wealthy investors who've supported the company wouldn't bail out.
I don't believe this sort of action will be needed. I believe the regulators can see that by itself, DCVax-L proved itself worthy of approval, but if you have to look at worse case, it's what I'm saying above.
Gary