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What we need to realize is that we don't prevent people from doing what's clearly harmful to them. Roughly 60 years ago my father told me about a friend in Texas who he'd visit with a few times a year, he was a lung surgeon. He'd chosen lung surgery because he knew that cigarettes would give him a lot of business. He described how blackened the lungs of cigarette smokers were to my dad, clearly tobacco's harm was know then, and probably many years prior to then, yet the most we've done is putting a warning on the pack.
I was of the belief that some who've died from vaping were using tobacco based products, not cannabis, so I'd suspect that some similar type of oil may be associated with tobacco as well. I really wonder if practically any type of smoke may be hazardous to your lungs, whether it comes from tobacco, cannabis, or a burning forest or building, it all causes harm. We cannot stop fires by laws, but the law can be used to stop what's currently legal, but harmful. Don't get me wrong, I believe there are many benefits that may be derived from cannabis, and possibly even from tobacco, but there are other ways of administering it, some of which should be totally safe to use.
The problem is tobacco has been legal practically forever, even though it may be more harmful than cannabis, which is only legal in some stated. Perhaps the answer isn't making it illegal, but rather developing or determining ways to use it that are safe and effective, and removing the harmful ways of using it by making that illegal. I doubt that Congress will act, if they would, tobacco, or at least cigarettes would have been illegal half a century or more ago. Cannabis probably has greater benefits, and less health problems, but there too, Congress won't do what's needed to make it completely legal, but they've gone along with permitting states to do so.
Perhaps smoking marijuana isn't actually as dangerous as vaping it, in that no real clinical testing has been done, who can say. If Congress acted to permit clinical trials, perhaps more would be done to determine how to, and not to use it, not just CBD and THC, but all the compounds that can be extracted from cannabis.
I know nothing about the oil found in Druggies son's lungs, but suspect that it's highly concentrated in vaping, but perhaps hardly found in smoking. Perhaps a similar oil is used to vape tobacco, as some deaths have been attributed to it as well. The oil might actually be safe to use in many ways, as long as it wasn't converted to a smoke that could coat the lungs. I've been told that the lungs of cigarette smokers who quit do improve over time, hopefully that will be the case for Druggie's son as well provided he can beat the habit.
Gary
It seems to me that the patient treated under compassionate use had already been given a death sentence by the disease, the fact that the PLX treatment couldn't overcome it should have been expected. It would have been a spectacular outcome had the treatment worked, but it didn't.
Compassionate use shouldn't work against a company, nor should the right to try, which seems to be the current term for what was previously called compassionate use. One reason many companies don't permit their products to be used in this manner is that in the past bad outcomes have occasionally delayed trials. No one should be surprised when someone who's dying actually dies, yet some people make a big deal of it in spite of the fact that asking for the right to try only occurs when the Doctors know of nothing better to try.
I frankly wish the FDA would establish a way of pricing drugs under right to try that was a percentage of what the list price was expected to be, ideally 50% or less. I suspect that if the price were established, and if the insurance company had to pay, a lot more uses of right to try would be permitted. Essentially this would apply to drugs in, or beyond, Phase 3 Trials to be used while an approval decision was approaching consideration. In every case, the outcome should be reported, but only in a database where the patient isn't identified, but the disease being treated and the outcome is.
Gary
With SNO just a little over 2 weeks away I felt it was time to put some NWBO in both mine, and my wife's Roth IRA's. Essentially I wanted to fill out the position I wanted to hold and used other stocks to do it.
I cannot be certain our trial will be unblinded by SNO, but I believe we'll learn more about when it should be unblinded, it in fact it isn't. I would think we'll get a quarterly report before then, and perhaps that will provide some additional information about it as well.
I believe that much will be revealed by the end of the year and I certainly expect top line data by then. If I'm right about that, I suspect the company will submit a BLA before the end of the second quarter of next year. With a six month review by the FDA we'd be talking about approval potentially by the end of next year.
Many people are convinced the trial won't be approved because the original trial goals won't be met. In their mind in spite of a lot of patients living well over 5 years, many still alive, the FDA will want a trial properly structured to demonstrate what the vaccine can do. While I believe they're wrong, I must concede that they could be right. My point here is to point out, it will probably be a year of so before we'll know what the FDA or other authorities intend to do.
I believe in the mean time, we have a tremendous opportunity. To begin with, I believe the top line results will be impressive. Then at some technical conference we'll get the full data, also very impressive. At any time we could see a partnership, that could be huge. I can't say that these things will take the stock to double digit dollars, it's possible, but doubtful, but I do believe something over $1 is very probable, and it could easily be a 5 to 10 banger over current prices, and perhaps substantially more than that, depending on the terms of the partnership. If after something like a ten banger investors wanted protection going into the approval decision, selling a small part of the shares would bring in more than what's invested today.
The this is, right now, before top line data is released is an ideal time to invest, and if I'm right, you can hold for a year and still sell if you so choose before the FDA should act. I.E. shares added now would be held for over 12 months and be qualified as a long term gain. Of course if you already have shares at a higher price, if you sell you may want to designate the more expensive ones to lessen the gain, or perhaps even have a loss. The key is, you have plenty of time. Meanwhile, it's very possible that something more may come from trials of DCVax-Direct, that could also be very positive as long as it's showing positive results. If these things occur, it's not impossible for NWBO to receive a buyout offer at a price acceptable to management, which I believe would be into double digit billions based on what others have said. A ten banger from where we are today is essentially $2.50, a one hundred banger would be $25. I suspect an acceptable buyout will be something over a forty banger from today prices, perhaps substantially more.
Gary
Sorry to hear that Druggie, what you've told us is more than I've previously heard about the problems caused by vaping. Now that they know what's causing the problem, hopefully the solution will come rapidly.
My best to him and your family,
Gary
I'm certainly no expert on patents, but if they are, or soon will be granted, I believe the company is well positioned to take the next step. If the patents are for one of the products that already have passed Phase 1 safety trials, I believe the next step will be a legitimate Phase 2, it won't cost that much because of their relationships with Israeli hospitals, but if the results are positive, it could bring in the partnership that's really needed to do a Phase 3 that's multi-national and would put the company on the map.
Trials of this nature take time, but depending on which product, results may not take that long to gather. Unlike a cancer trial, where data on progression and/or survival can take years, a trial for something like psoriasis or PTSD might have patients evaluated in a couple months, perhaps even quicker. If effective, even the pivotal trial might be something that could be run in under a year if many research sites were working on it, not something OWCP could do itself, but if a major partner entered the picture, anything is possible.
Gary
Druggie,
It's nice to know you're not completely ignoring me. I do like to play Devil's advocate, but I believe if they gave it serious thought, the idea isn't that far out. Perhaps it shouldn't be the FDA, perhaps the NIH could be funded to do it, with the same sort of rules assuring that the drugs approved would keep the program self sustaining. I do believe the NIH funds a lot of development, actually running trials might give the FDA greater confidence that the drugmakers weren't trying to hide something negative.
I'm guessing that SNO should tell us something, I'm just not sure it will be the trial being unblinded. Something IMHO is better than nothing, but this cannot go on forever, I think we're getting close whether it's at SNO or not.
Gary
Thanks Doc,
During my treatment for leukemia I actually had a substantial benefit from a treatment delay. Originally I was scheduled for 8 courses of chemo, but after the fourth course my catheter became very infected and treatment was halted while they worked on the infection which took several weeks. I was put on Gleevec at that time, and during the time spoke to both UCLA and City of Hope about stem cells after the chemo. I chose City of Hope as cancer was all they treated there and it just felt right, but at both places they expressed the belief that all courses of chemo might not be necessary. By the time the infection cleared, COH indicated we'd continue purely on the oral chemo, Gleevec or other newed drugs, and watch the outcome.
Each of the chemos brought my counts down dramatically, and on some occasions no blasts could be see, but on the next check they could. My percentages were down to a small fraction of 1% but still sometimes they were there. They determined I was ready for transplant, but in that my counts bobbled before it, my Dr. doesn't feel confident about taking me off chemo, so I might be on it the remainder of my life. Perhaps at some time they'll come up with something with lesser side effects, but for now my most acceptable side effects have been with Sprycel. Occasionally my Dr. doesn't mind me taking a few days off for special occasions, and when I've had time in the hospital they frequently didn't have the drug, but if I was going to be there awhile, it was brought from home.
I've often thought that unplanned time off treatment may have benefits, sometimes it's just a matter of getting some extra home cooking that makes you feel better. I frankly did lose weight while in the hospital, but I seriously wonder if it was caused by the chemo, or how unappetizing the food was not only in taste, but also when attempting to eat it off a tray while in a hospital bed. I really wonder if people are permitted to walk and socialize with other patients if meals wouldn't be better if served to those who wished in something more like a cafeteria.
One suggestion I made that both Doctors and nurses loved was putting bidet toilet seats in all hospital bathrooms. I fortunately rarely needed that much help, but I know the staff often had to clean up after patients. A bidet toilet seat would have done the job as well or better and been more sanitary. At home I have an old fashioned bidet and I'll credit it with preventing problems, especially some that would be caused by the chemo I take. If I didn't have it, I'd be investing in the bidet toilet seat.
Gary
It's been awhile since I saw the statistics, but when I did, roughly 30% of Phase 1 drugs were reaching approval. I really wish that all trials were initially designated as Phase 1/2 and if efficacy was demonstrated in the Phase 2 portion the trial sponsor would have options that included FDA participation in the Pivotal trials.
Essentially the drug developer could turn the pivotal trial over to the FDA completely, and the FDA would get a substantial royalty stream on approval. The could also share the costs, and different royalty streams would apply. The point is, over time this would fund the FDA to at least the point of it's expenses, and potentially much more, but it would also permit tiny biotech to bring products to market without BP, so when BP did get involved, they'd pay more for what they were getting.
This certainly would require seed money from the Govt, but in a matter of years it should be self sustaining. More importantly, with the FDA participating in the trial, they would see what's happening, and they could approve a drug far earlier in the process as they could see the benefits for themselves. Companies would with their Phase 1/2 data show the FDA that the pivotal trial is worth pursuing, but once convinced, the FDA would have a hand in the pivotal development, the company could determine what degree the FDA would be involved financially, but as long as it had even the smallest position, the FDA would be involved in the pivotal trial. I realize this in some ways makes the FDA the fox guarding the hen house, but I believe the FDA staff approving the drug could be others than those working in the clinic, so it would be up to those in the clinic to convince the others that it was worthy of approval.
I cannot say that Dr. Padzur changed dramatically, but I believe his wife was struck with cancer and it has made a change in some of his thinking. I really believe everything would change dramatically if some reasonable price could be established for drugs in pivotal trials under the right to try provisions. If drug makers could profit even slightly by this program, I believe a lot more experimental drugs would be used. Every use of the drug should be recorded, but I also favor all newly approved drugs going into a Phase 4 where all use is reported. Off label use would certainly be permitted under right to use, or Phase 4, but the outcome would be clear in the database.
I know my ideas aren't likely to occur, but you never know who might agree to see them and actually is in a position to do something.
Gary
Back many months ago, well before our reverse split, I purchased some $1 options for December. That $1 became $10 with the R/S and while it's doubtful, I still believe I'm one really positive headline from being in the money. We still have few outstanding shares, with positive news the demand will be great, the supply tiny, I suspect that $10, $25 or more is very possible, depending on what's in the positive news.
The new patent could certainly be worth triple digit share prices based on the current O/S if clinical trials demonstrate the patent is right about the benefits. Hopefully the clinical trials won't be too far off as I know people I'd suggest them to.
We're at a period in medical treatment where advances are coming from many directions. I believe the work the PSTI is doing will achieve major benefits, but so will others, and in the end treatment that's most successful may take in at least a couple of the more recent advances.
Gary
I agree Poor Man, but I don't believe the figures BP has gotten Congress to accept, I.E. billions for each approved drugs. BP isn't creating most of the newest and greatest approved drugs, they're acquiring them from tiny biotechs and institutions who bring them most of the way through the approval process for hundreds of millions, or less. BP spends more money defending the patents on their established blockbusters by making improvements that extend patent coverage.
I attended a lunch with an executive from City of Hope and was amazed at the list of drugs that found their genesis at COH. In speaking with my Dr. I know he has been involved with CAR-T work they've been doing there for some time, certainly well before the first time I heard of CAR-T. The thing is, places like COH let BP take their drugs to approval in return they get small royalties that fund them for additional research. The BP's, and even the tiny biotechs rarely give full credit to people like Dr. Liau who's basic research led to the DCVax's. I have no idea what she and/or UCLA will gain on approval and earnings, but I suspect it will be tiny by comparison with what a BP would make if they did it themselves.
There is no doubt, it takes lots of money to commercialize a product, but you almost never see costs come down after product sales have paid back all costs associated with their development, and substantial profit. Recently just the opposite has occurred as drugs available cheaply as generics suddenly have the prices increase by hundreds of percentages because of no competition. People with insurance might not even see a difference, but for those lacking it, or with poor coverage, they suddenly see the cost of living go up very dramatically. I don't know the simple answer, but I do believe some sort of control is necessary. I would prefer the industry controlling itself, but if it fails to, and products can arbitrarily go up by hundreds of percent, the Govt. will eventually step in, and the industry will wish they'd taken some control of the situation.
Bayer provides a great example of how a company can profit from something that's been available for over a century, I believe. I'm sure their cost for aspirin is no higher than that provided by numerous genetic suppliers, yet many people are willing to pay far more for the name brand product. I have no problem with that. The thing is, people can choose. It's only when you're the only supplier of a product, like the epi-pen, that you can do the sort of thing that was done, and it's what puts the entire industry down because gread has overcome reason.
I suspect that after all manufacturing and developmental costs have been recovered, most drugs probably cost under $100 a dose, and often far less than that. I don't believe the industry wants Congress looking in depth at drug costs, as if they do they won't like the laws Congress comes up with. Over time I believe the only way they'll avoid that happening is by regulating themselves and bringing prices down somewhat. Our prices might be somewhat higher than found in Canada or Europe, but they shouldn't be a major multiple of those prices.
Gary
I could be wrong, but I believe we're getting very close to knowing the top line data for the trial. If I'm right about that, short term financial problems shouldn't be a concern as another bridge loan should be easy, given that it comes from our CEO. Once the data's out, I believe the share price will be dramatically higher, and a few million shares will bring in a healthy amount of funds and pay back any bridge loan that is necessary, plus.
I believe top line results will be a big positive, but it could be a year or more before the FDA or other regulators determine approvals. Why? To begin with, you don't rush the preparation of a BLA, in other companies I've seen them take over 6 months, so I have no reason to believe it will be dramatically faster here. Finally, the FDA, and I believe the other regulators look to have 6 months to evaluate the BLA. An approval before the end of next year is certainly possible, but much sooner than that is very doubtful.
I fully expect all financial considerations to be answered in the period between when top line data is released and when the regulators act by a partnership. While a buyout is possible, I don't believe the full value of the company can be assessed until more testing is done on DCVax-Direct, and I don't think management will accept a figure that doesn't put much value on Direct. Perhaps before the end of next year that value can be established if a trial for Direct is far enough along to access, but it's probably a stretch to expect a proper valuation of Direct to proceed an action by the regulators.
Any partnership could come with an equity interest, depending on how it's structured. If there is an equity interest, that partner would certainly have the inside track in a buyout, but that's not a guarantee they'll be the one. If the partner gains something over a 20% interest, they'd certainly have a major voice in how the company is run, and probably have one or more seats on the board. At 30% effectively they have control as in a voting situation, it's practically impossible to defeat them. The question is, what sort of partnership is the company willing to make.
Anyone following Genentech and Roche, you can see where Roche to a major interest, then bought out the company, then spun it off in part, and currently reacquired it in total. Nothing prevents them from spinning them off again, while maintaining enough of an interest to buy them back again. Investors in such scenarios have generally done well, but so has Roche as at no time did they lose control, and their actions provided finances for the companies when they wanted it.
Gary
I think there are a few things that need to be considered in your estimate. If $120,000 is the list price for treatment with the DCVax's, what does it cost to make it, and how much are they willing to discount that price when negotiating with insurance companies, govt. entities, etc. I hate to say it, but the prices in the medical industry remind me of the used car dealers, the list price is practically meaningless.
Don't get me wrong, I believe the vaccines will be blockbuster earners, but the actual earnings won't be anywhere close to the list price times the number of patients receiving the vaccines.
As a leukemia patient I really have no idea of what's actually been paid for my treatment, but cash out of pocket is insignificant, and I just can't believe the insurance plus medicare have paid anywhere close to the list price for all my treatment. That said, I do have more insurance than most, as I'm still covered by my own insurance from work, as well as my wife's, but I believe it made little difference. A hospital may bill $100 for administering an aspirin, but what they're paid isn't divulged. As I see it, the cost of the aspirin is insignificant, and the size of the staff providing it would remain the same, whether it was ordered, or not, but I'm sure they're paid, just nowhere near the $100 which might be shown for administering it.
I believe if Doctors were permitted to treat IAW their best judgement, not what accountants insisted on, the cost of the drugs administered might be higher, but the overall costs would come down dramatically based on more effective treatment resolving problems faster, and the lower costs of not employing so many accountants and attorneys in the practice of healthcare.
I believe there is plenty of money to be made in healthcare with substantially lower prices that are negotiated, and which all the insurance companies, etc. pay. The key is simplifying the manner in which healthcare is administered. It shouldn't take all sorts of paperwork for a Dr. to justify why one drug is being used vs. something else.
Many Doctor's are going to providing concierge services where they do accept medicare, and you're insurance, but you pay a fee for being treated by them, or for extra treatment from them. I don't know how much this would change if we went to some sort of Medicare for all, but something none of the candidates discussing it have addressed is that those of us on Medicare have it administered by an Insurance company or HMO. Is that the way they invision Medicare, or do those companies completely go away, and if so, what about all their facilities. During another time in my life my healthcare was by an HMO, Permanente, they have facilities all over California, and in other states, what happens to all of that if they're put out of business by Medicare.
I know Doctors who've retired from Permanente, I believe their pensions may be tied to the company remaining in business. What happens to all of this, and all the Doctor's working their now who I believe are considered owners of the company if the company goes away.
I do believe that all should have medical coverage, but I believe our politicians need to spend significant time in determining how this can be done equitably. In the end, I believe it's the accountants and attorneys that should have diminished income from healthcare, not the medical professionals. The drug makers may earn less from each product, but if their products are the best solution to a problem, they'll sell more of them as Doctors won't have to try something cheaper, and less effective, first.
Gary
I agree, but I don't see a partnership until you at least have top line data, and in that circumstance, the partner would have full access to all the data under cover of confidentiality.
I don't think top line is too far off, but we do need the SAP first. Dr. Liau is making a few presentations near term. Even she doesn't know with certainty what the unblinded data will show, but I think she could accurately guess and be about 99% right. What she can share is things like the current statistics for the top 100, she could also say how many are still alive in the trial. Nothing says how many in the top 100 are on the vaccine, likewise how many of those still alive are, but I think Dr. Liau could guess and be very close, if not right on the money. I suspect her guess in both cases would be nearly all received the vaccine.
From the time they unblind, I suspect it won't take more than a couple days to establish top line data, which normally only is a few paragraphs summarizing the trial. The full data presentation is substantially more, but with substantial efforts I believe it can be done in a matter of weeks. Preparing the BLA for presentation to the regulators will take substantially longer. If we unblinded today, I suspect that we'd be hard pressed to submit the BLA by the end of the first quarter next year. If we can do it during the first half of the year, we could have an approval by the end of the year given the six months our FDA takes. I don't know how quickly the other regulators may act. Frankly, I believe if the FDA has approved the manufacturing capability previously, when a trial is clearly positive they ought to be able to approve it in a matter of days or weeks, but the reality is, they'll take most if not all of 6 months, and that's for products with high priority, for others they take a year.
Frankly, if on submission of a BLA or NDA the products could be available say at half the suggested list price, I believe many patients could see benefits, and many lives lengthened, if not saved. I cannot tell you the amount of time that I've seen wasted by drugs that clearly should have been approved that were delayed by FDA's questions or additional demands. I believe that all approved drugs should go into Phase 4 Trials where all results were fed back into an FDA run database that was available to review for all.
Gary
November seems to be off to a great start with many biotech's I'm invested in, or follow. NWBO while far from my biggest gain today could prove to be a tremendous gainer this month, possibly even without the trial being unblinded, if substantial additional information comes out of presentations later this month.
Certainly I'm hoping we'll unblind, but that will mean the SAP's been submitted, I don't know that we'll be told of that happening. I would think we'll see top line data a matter of days after the SAP submission as after that event, things can happen in a big hurry. If in fact it's unblinded, but everything can't be presented at SNO, it could still be a major presentation, and the remainder of the details could be presented at ASCO. If I remember correctly, while ASCO's not until late May or early June, it's Abstracts are due in February. If the trial is presented in complete detail at SNO, we'd need to have something more to add if we're to get a presentation at ASCO.
Gary
I believe the 4 presentation they're making at ASH on IMGN632 will spur additional interest in the stock, and hopefully we'll end the year much closer to the high, rather than the lows where we're currently languishing.
As someone in remission after stem cells for ALL I'm happy to hear they're now working with it. I don't believe they're going after the specific form I have, but I know that much off label use is made, so no telling if it could be effective. I'm approaching 5 years post stem cells, but remain on chemo as it greatly diminishes the likelihood of coming out of remission. I hope not to ever need anything more, but it would still nice to know it exists if I do.
Gary
I think one problem is defining what early and late are, especially if the cancer rarely produces problems until it's well advanced. I suspect it's really rare to find the tumor when it's tiny, but I'd think your chances would be the best if that's when it's discovered. With such a tumor even if DCVax-L were applied late I'd suspect the result can be better than say a massive tumor that was removed with treatment with DCVax-L almost immediately.
Surely I believe that those who received DCVax-L initially, rather than after progressing on the SOC should do better when essentially the two are identical on discovery. The thing is, people are not identical. Some people might be cured even if the tumor were found late, whereas others won't be, even if it was discovered early.
I do think the Dr. doing the treatment can make a big difference, even though all the Doctors have access to all the same tools. I met people my age and older at City of Hope that excellent hospitals elsewhere would not treat with stem cells. Why? Because they knew the risk was greater, and they don't want to harm themselves statistically. Meanwhile COH gets excellent results with seniors because they do it frequently, and they know how to make it work. Dr. Liau certainly seems like someone you'd want on your team if confronted with GBM, and I'd trust her judgement in what course of action to take. I also suspect that under right to try, she'd have access to DCVax-L even if no trials were currently taking in patients.
In the future I suspect that many cancers will be identified very early because of blood tests that are in development. If a cancer can be detected in the blood before a mass can be found, perhaps DCVax-Direct can be created and given and the cancer treated far earlier than any symptoms would be seen to cause a search for it. I was found to have a mass in the kidneys after the removal of a skin cancer, sebaceous carcinoma, which was considered dangerous enough to do a scan of my body after it's removal by Mohs surgery. The mass was determine to be cancerous, but that was after four levels of experts checked it, alternating between benign and cancerous as it went higher through the chain. My point is that it might not have proved to be a problem for years, but when it was, it almost definitely would have cost me the kidney. As it was, because of where it was it was touch and go as to whether they could save the kidney, but in the end they were able to. I certainly can't say I was lucky, but I have had 3 potentially deadly cancer in my life that have been successfully treated to date that don't count less threatening skin cancers that were more easily dealt with.
I also suspect are bodies might routinely eliminate minor cancers before they become a problem. Early detection may find some of these, so we may end up treating cancers that would never be a problem without treatment. The problem is, it's impossible to know what will and what won't become a problem. I know in some cases where the seniors are found with prostate cancer it's monitored and only treated if it's deemed to be a threat as it may be so slow growing that old age will likely take the patient before the prostate cancer becomes a problem.
Gary
Thanks to all who answered. I think it is apparent that a benefit is achieved, but not a cure. Hopefully it can be built on with other agents to the point that eventually cures are achieved.
Gary
On the subject of pseudoprogression, has it been determined to exist in patients who never received the vaccine, or only after receiving it.
I think it's clear this trial is going to be judged primarily by survival, not progression. If you agree, we need to realize that the comparison in survival will be made primarily between just roughly 33 patients who never received the vaccine, and the roughly 300 who eventually did receive the vaccine, roughly 200 initially plus 100 crossing over.
If pseudoprogression was only seen in those who received the vaccine, the need for the vaccine in those crossing over would be clear. If pseudoprogression had occurred, but wasn't diagnosed in those who crossed over when what was thought to be progression occurred, the need to cross over all those patients could be questionable.
I believe it will be clear that survival is greatly improved with the vaccine. I just hope the FDA or other regulators are uncertain that the roughly 33 who didn't cross over provide an adequate control based on survival.
Perhaps this trial could have been done far quicker if pseudoprogression was known going in. If that had been the case, it's possible the trial could have ended after XXX many patients had been determined to truly have progressed. As is, the trial has been run to the point that even the last to enter the trial did so 4 years ago. Based on progression alone, the trial would probably have ended 3 or so years ago, and even less had their not been delays.
Gary
Doc,
If a cancer had metastasized prior to surgery, so when it was removed the basis for its occurrence could be found in several places. If a mass were found and injected with DCVax-Direct in one location, would it create any benefit elsewhere, or would each mass require injections when found.
As I gather it DCVax-L should be effective throughout the body.
Gary
When it comes to the subject of market cap, right now, with no real earnings our market cap is purely based on the potential investors believe the company has. Data from the trial that's positive will certainly increase what people think, perhaps to the point where our market cap is a much as a few billion dollars.
When people speak or double or triple digit billion dollar market caps for the company, I believe it should be based largely on earnings. For companies market caps based on earnings the P/E ratio usually ranges from a low of 10 to a high of 30.
If you believe as I do, the idea that the company can earn $10 billion a year if the vaccines prove to work in a few cancers, you should agree we could have a market cap somewhere between $100 and $300 billion. This doesn't happen instantaneously, but I'd have to believe that at some point between say 3 and 10 years post approval it should happen. The thing is, if more cancers are routinely added it won't stop at $10 billion in earnings. I can't say how high it could go, perhaps others would care to chime in, but if the company isn't bought out, I believe it has this sort of potential.
Gary
I was speaking with someone who indicated an improvement was seen in the knee after injections of what he described as his own blood plasma concentrated. I knew who he was speaking of, and knew he'd said he had an injection of stem cells. I do know that whatever was injected had improved his knee pain. All sorts of things are being done with what's described as stem cells, with no clinical proof of effectiveness.
I wonder if our products could provide the same, or even greater benefits, and they are being clinically tested.
Gary
You could be right, but I question what difference a month or two makes. I have no idea how many patients initiated treatment in the final month, but I think the number to be rather small, especially when compared to the over a decade since the trial began recruitment. We have no idea if the last to enter the trial are still alive, but if they are, what difference would it make in the K-M's if one or two patients were shown to be alive at 47 rather than 48 months. I don't know how many lived beyond 48 months, but from Dr. Liau's report on the Top 100 it sounds like over 50 are at roughly 60 months, or more as the number was close to 60 months several months ago, and those beyond, or approaching 60 months remain alive, at least many of them.
Of course when 48 months passes, if nothing happens some will think they're going for 60 months, by that time the median for the Top 100 may be well over 65 months, of course why stop there, go for 72 months. No, it's not necessary to go to such extremes to gain approval in a cancer that kills most of it's victims in little over a year. I believe they're ready to unblind the trial once the SAP is submitted, and it won't take long after unblinding to issue top line results. A comprehensive presentation for peer review will take longer, and will tie into a major presentation like SNO or ASCO, hopefully sooner than later.
Gary
I can't say for sure, but other companies I know do follow the boards, so I would suspect that at least some employees there would be checking in, even if it's not top management that's looking in.
I'm not big on putting down management either, but at times I do question what they're doing. I believe that if you don't trust them to do what's right for the company, you really shouldn't be an investor in the stock.
No investors like dilution, but survival and growth of a company have to be more important than how many shares are outstanding. I'd be perfectly happy with a billion or more shares outstanding if the market cap was double digit billions or more. I believe that's very possible here, provided the company is acquired, and if it is, it should be for double digit billions.
I wasn't around when the company asked some protocol to be taken down, but I wonder why. The protocol should be know by the time the trial is underway, so why the secret. I believe companies often think they're losing their competitive advantage when such things occur, but I suspect the competition knows all that's happening. It's investors who're usually in the dark, as we are today. Any company considering a partnership, or the acquisition of NWBO would be open to learn all about it provided they establish a confidentiality agreement. In short they learn if they're interested in the technology and the status of trials under confidentiality, if nothing results, they don't unlearn what they've seen. Hopefully the company doesn't have such agreements with companies not truly interested in the possibilities, but not every such agreement ends in a partnership or buyout. If two companies can't agree on price, an agreement won't come to fruition, at least not at that moment. Who knows, six months or a year later they might agree on an even higher price based on greater proof than existed when they first looked at the data.
Gary
I agree with you, they don't post, but I believe in many cases they do read the board, so they know what investors are thinking. Many years ago a CEO I'd met got in trouble with the SEC because he posted.
I'm not a big twitter fan, but I do know many companies do tweet. We live in a world where major announcements from our President come by way of twitter. I cannot say I like it, to me it's not that professional, but it seems to be the way of the world so I'll live with it.
I suppose the difference between message boards and twitter is that anyone interested can sign up for tweets. Message boards have few restrictions, but can be somewhat controlled by moderators. I don't believe twitter is controlled that way.
Gary
Actually it was sort of the opposite, the patient received stem cells first, then the modified T-cells 3 days later which caused his high fever. In my case, as I remember it, I did get certain chemos even after the new stem cells were administered. It took about 4 days before I was making new blood that was measurable, by day 19 the Dr. who was pinch hitting for my Dr. released me from the hospital. When I returned the following week my Dr. said he'd probably still have me there, but in that things were going well, I stayed out. As head of the Dept, my Dr. admitted being more conservative than his staff, I like that, but very much liked going home earlier. Had I not lived in a reasonable commute distance, they probably would have kept me in longer, than moved me into the village where I could be examined daily, or as needed. I did meet people from other states who lived in the village for months before they could return home.
Frankly I didn't try to learn that much about the various chemos I was given prior to the transplant. The week before I came in several days for chemo, then returned home. About 5 days before I checked in for chemo and remained there till 19 days after. I cannot say that I felt that sick from the chemo, but I was terribly weak and I did lose substantial weight. I believe that most people lose weight in hospitals, and I believe the food is a big part of the reason. Home cooking never tasted better.
Gary
I think your worst and best are right, but I do believe there is a middle ground that if DCVax-L fails to be approved is more likely. I suspect if it isn't approved it won't be because the data isn't impressive, it will be because the regulators insist on more. Because so many in the trial can be put into subgroups, the regulators may say, no single subgroup is suitable for approval.
The good news in this scenario is that the data would still almost certainly be worthy of a partnership, and the partner would provide all the needed funding to do the trials on both DCVax-L and Direct, even if the partner had no interest in Direct.
I'm not saying this will occur, but if it should, the partnership will take the stock to a new trading range, and it will do so well before any action by the regulators. I expect enthusiasm to be high after top line data is reported, and typically it's a year or more between top line data being reported and filing a BLA and regulator actions. Remember, the FDA gets 6 months to evaluate a BLA, so nothing happens that quickly regardless of how good the data looks. From the FDA standpoint, they feel great if they act in 5 months when they have 6, so nothing simply happens in weeks, it takes several months, and sometimes years when they have questions, even more if additional trials are required.
Gary
Thanks Doc,
I certainly look forward to seeing more data, and especially data on cancers which either currently have not been tried, or only tried anecdotally by people who've apparently been permitted to use them under right to try, or similar provisions.
It's been a quarter century since my wife was treated for breast cancer. While she was undergoing chemo she met a man who was only given months to live, but who's Doctors had agreed to him taking a two week trip to South America, as I remember it. On returning they could find no cancer in his body. No one can explain miracles, but clearly it's more than chance when someone does something and suddenly dramatically improves. I cannot say if food, water, etc was curative, or if his body just started fighting the cancer, but clearly he had a miracle, and from the sound of it, our vaccines have produced miracles for some who've tried them.
Gary
Thanks,
You make a good point with the money the warrants will bring in handling the immediate funds needed by the company. Once the trial is unblinded, we ought to see share prices that will make the warrants quite profitable.
I believe we're getting close to things coming to a head, I don't know it will be at SNO, but still believe it's quite possible.
Gary
On the subject of the SAP, I would think the company is trying to develop a single document acceptable to all four regulatory agencies, but I wonder if people think they may need separate documents for each regulator. I would suspect that getting all to agree on the same document may be what's taking so much time.
I believe it's not a case of gaining regulatory approval of a draft, but rather having changes suggested. If language is changed to something suggested by say Germany, it's possible another regulator won't like it if they passed on the language that previously existed.
There may be a point where they just submit what they have, even if it hasn't been fully concurred with by all four regulators. Whether it is, or isn't, it's the data that should establish approval. If the data clearly demonstrates that the vaccine should be approved, even if it fails to meet all provisions of the SAP it has a good potential to be approved. Of course it's very possible that one regulator will want more, while others approve. It's not unusual for products to be available in one part of the world, and not in others. Frequently it's the U.S. that's the odd man out, and patients with means travel elsewhere to gain access to drugs not available in the U.S.
60 Minutes did a great story some time ago on top flight hospitals largely establish by American Doctors in foreign nations so the Doctors would have access to drugs not yet available in the U.S. For those who choose treatment in these hospitals, they not only had great medical care, they also got great food, and they recovered in world class resorts prior to release.
I hope the new fires in the L.A. area don't have anyone at risk. I have friends living near where some of these are occurring, but don't believe any are in immediate risk. Serious winds are supposed to be hitting here from Tuesday to Thursday are supposed to be worse, so it's far from being over.
Gary
Hopester,
I agree that T/A can't do those things, but someone using it is also free to include what's known to all, when corporate presentations are scheduled, major conferences that have an influence, and even the rough time period trials are expected to hit key events. I'm simply saying I'd follow someone practicing T/A that includes all the other upcoming events that are expected over someone who believes that all answers can be found in T/A alone.
In the case of PSTI, we have no idea when the DOD will act, but we still expect something and are aware of upcoming presentation. Trial results may be more predictable, but not to a date certainI for events to occur. I'm of the belief that events may move the share price of PSTI far more than T/A analysis could show as we have such a tiny O/S that major positive news could create such a demand that T/A alone couldn't predict.
I have no idea the size of a DOD order could be, a small order could be under a million, but tens to hundreds of millions are certainly also possible. If the nations of the world adopt our product for protection against radiation and other threats, billions certainly will be purchased. We also need to recognize it also has medical applications that aren't threat related, just good medicine.
Gary
I respect the way technicians can forecast what a stock will do, but I won't invest based on it if I believe some of the following are possible.
1. New trial data will be released.
2. A new partnership is anticipated.
3. A substantial order could come at any time.
4. A major news outlet could release a story on one or more products from the company.
If a technician is telling me he's looking at all these things, and even anticipating certain moves due to them, that's a technician I'd pay attention to.
Gary
I know it's not mandatory, but I believe that one way a company can successfully communicate with it's investors, as well as potential patients for a trial is by utilizing the clinical trials database and keeping it up to date. It's one thing I can fault the company for not doing. Don't get me wrong, I've seen many other companies do the same, but we'd not be debating when we thought the trial should end if clinical trials were up to date and telling us the month and year it was supposed to happen.
In some cases, I've actually seen other companies update clinical trials twice in the same month, it's not common, but some companies telegraph even minor changes in a trial by showing it on the database virtually when it occurs.
In the end, none of this matters if the product is approved, and if it isn't, all the information in the world from the company won't make up for the failure.
Gary
I'll agree with you that the company communicates little, but the company has permitted it's lead clinician to communicate lots. I've seen few companies that permitted or encouraged such open communication from the lead clinician for their trials.
I believe many companies believe their lead clinician to be very important. I've often seen trials delayed by several months because it would be months before the person they wanted to be their lead clinician was available. Certainly others could have started the trial sooner, but for whatever the reason, they wanted on particular Dr. and they were willing to wait.
As I understand it, Dr. Liau and UCLA were involved with the genesis of these vaccines, it's only natural for them to lead the development. I don't believe it's that uncommon to have that sort of situation where a research institution is involved in the development of the product.
I originally had the choice of going to UCLA or City of Hope, I'm sure I'd have had excellent care at UCLA, but I liked the feel I got when meeting the people at City of Hope. Both are top flight cancer institutions.
Gary
Sukus,
Clearly I'm no expert, but don't the dendritic cells vary depending on the cancer being fought. If they don't, it would seem like a person could go through the procedure once in their life, and have a vaccine that could be used on any cancer provided what they did was properly preserved.
I was of the belief that the vaccine is so personal that it was specific to the cancer being fought, that's why I reasoned that if in fact the cancer morphed over time, so would the dendritic cells.
I believe the more we learn about cancer the more we realize how complex it really is. I believe over time that drugs that are individualized to not just cancer, but many diseases will prove much more effective than drugs made in mass. Automation will bring down the cost of making such drugs, and because of their effectiveness, they'll prove to be cheaper in the long run, but not necessarily in the drug cost itself. What I'm suggesting should be included is the cost of down time of the people being treated. If a personalized drug achieved a sufficient cure for a person to return to work in a week, whereas conventional meds would take a month, the productive time of the individual should be considered as part of the costs. Today, accountants often tell Doctors what drugs they must use initially due to price, if those drugs fail, they permit the more expensive product to be used. No consideration is given to the time lost if the treatment time with the cheaper product takes longer to achieve it's goal. Certainly not all time is lost, but I don't believe people working while suffering can be as productive as when healthy. I'm a believer that Doctors, not accountants and attorneys, are who should suggest the course of treatment and insurance should pay for what the Doctors suggest is best. I believe if you took the bulk of the accountants and attorneys out of healthcare, costs would go down dramatically.
Gary
The question might be, is their any promise. OWCP had a myriad of products that were cannabis based. Given the size of the company, if even one of them gained patent approval and demonstrated efficacy in clinical trial, the company could become successful. I'm not saying this will happen, but at these prices I'll not sell all I hold on the possibility that it does happen. I certainly will sell some by year's end for a tax loss, but not nearly everything.
Gary
Thanks very much Doc,
It sounds like future improvements will be made in the technology NWBO has developed. The question might then be, can others piggyback on the technology without paying NWBO, or will their patents assure they pay for the rights to create vaccines built upon what NWBO has created.
Hopefully our patents will have others paying for the rights to develop vaccines using techniques similar to what NWBO is doing.
Gary
My thought had been that if in fact the tumor had morphed, or the new tumor was in some way different from the original, wouldn't what's extracted from the blood be somewhat different. I have no expertise, but it was my thought that the vaccine established resistance to the tumor from the specifics it got from the blood.
Many years ago IMGN had drugs called Oncolysin's, they were conjugated with blocked ricin which was a rather large molecule. The trial gave the drug to patients refractory to the SOC. The result was that while some benefit was seen, after a few doses patients became refractory to the drug. In reality there was a benefit which wasn't pursued, in becoming resistant to the Oncolysin, the cancer was found to no longer be refractory to the SOC and treatment was resumed. I don't know if this cycle could have been repeated many times, but no attempt was made to try it that way. Perhaps part of the thinking was that it wouldn't be a profitable product in this way, and the cost of such an approval would be very high.
Generally the FDA wants drugs that are better than the SOC. The idea that by attacking a cancer briefly with something different would extend the duration of successfully treating with the SOC is something that would require a totally different mindset from the FDA as well as drug developers. I'm no expert, but I suspect that alternating treatment for cancer to prevent the cancer from becoming refractory to a drug might permit treatment to be extended indefinitely. The question might be, do you wait for an indication of the cancer becoming refractory, or change the treatment on some schedule that's intended to prevent it. I don't know the answers, but like to ask such questions.
Frankly, if the FDA only approves drugs which are an improvement on the SOC, wouldn't it seem logical to remove the approval from the older product, making the new product the SOC. I'm not advocating that, I believe there are good uses for all these products, but if you agree with that, why not also approve drugs that show benefits, but don't surpass the SOC. I'd contend that these drugs too would give Doctors more tools to work with, and in some cases could prove to be the answer for certain patients. The big thing would be if cancers could be prevented from becoming refractory to one product by alternating with others, might that not become the SOC even if one product could be used substantially longer than the other.
Years ago I met a gentleman at a pancreatic cancer conference I attended because of a drug being discussed there. This man had pancreatic cancer for over 5 years without the Whipple procedure. His longevity was attributed to his Oncologist. Each time his Oncologist said he'd tried everything he could think of and couldn't stop the cancer from advancing he found a new Oncologist. He certainly didn't limit his treatment to the SOC, he'd try anything, and it was keeping him alive.
I believe that people treated for all sorts of cancers is improved because Doctors have learned to experiment more when cancers are no longer responding to the SOC. I seriously doubt that any approved product is purely used in the manner in which it was approved, I.E. with only the protocol specified in the clinical trial. If the FDA changed to approve drugs based on the idea of not doing harm, but approving drugs that achieved some benefit, I suspect patients would live much longer even if the benefit wasn't as great as the SOC.
Gary
Speaking of fungus, I did meet another leukemia patient who could have been killed by a fungus. At another institute she was diagnosed with it, but also they believed something they were seeing in a vital organ was caused by the leukemia. She came to City of Hope where my Dr. didn't agree, they sampled what was in that organ, found it to be a fungus. They cured the fungus before giving the chemo that would have knocked out her immune system prior to a stem cell transplant. Had that not been done, with the immune system eliminated, the fungus would have gone wild and killed the patient. I really like City of Hope because they're so through. I've met several people given up for dead years or decades ago there.
I'm sure there are many other places that offer great cancer care, but I doubt that many will go as far for patients as they do, including personalized drugs. I suspect that in the future, more treatment will be personalized, it still may require chemo, but they too may be personalized to be more effective, and have lesser side effects. I don't know that cancer will ever be totally cured, but treatment will be greatly improved.
Gary
Thanks Marzan,
I did have an interesting discussion about fungus toenails the other day. A retired doctor friend was telling us that none of the currently marketed cures were that effective. I told him one cure I didn't recommend, but it worked, leukemia. I don't know which of the chemos cured the fungus, but I had one nail for years that now looks just like all the others.
Frankly I cannot say the nail was cured by one specific chemo, it was quite gradual, and I don't think it was completely cured before the stem cell transplant, but the nail seems to be completely cured.
Gary
Thanks,
My Doctor was working on CAR-T developed at City of Hope and told me he hoped I'd never need them. I happened to meet a man who had stem cells the same day I did, then CAR-T 3 days later. His cells were his own, so he was only coming in every other week at a time when I was still coming in twice a week. He'd come out of remission from a prior stem cell transplant after several years, putting him back into remission and doing stem cells, and CAR-T all using his own cells will hopefully give him a permanent remission. During the administration of the CAR-T's his temperature at one point hit 107, that was the biggest risk, and something my Dr. hoped to never put me through.
It's now roughly 4.5 years since I got the stem cells, I don't know if what they're doing with CAR-T's have advanced that much, but at that time my Dr. indicated the shortcomings were both the high temperature, and the fact that their effect was over a limited period of time. If the disease was eliminated while in the effective period it's great, but if not the disease could recur. I believe they're making strides, but it still has a long way to go.
I could be wrong, but as I gather it, they still need to bring a patient into remission before stem cells and CAR-T can be applied. That remission is often a big part of the problem, especially if you come out of a prior remission. My original oncologist wasn't pushing stem cells, but he had me go for other opinions, I learned that my chances of staying in remission were only about 30% at 3 years without stem cells. He thought if I came out they could put me into remission and do it, but one of the Drs. I spoke with told me a second remission was often much harder, and sometimes impossible to achieve. He told me of a much younger patient than me who'd chosen that course, and he really didn't know if they could save her. I will probably stay on chemo the rest of my life, not because I absolutely have to, but it lessens the likelihood that I come out of remission. Perhaps at some point a new chemo that has lesser side effect will replace what I'm on, but what I've got is an acceptable quality of life with it.
Gary