Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
As long term holders of IMGN, patience goes a long way, but I'll agree with Druggie, much more info is needed here by ASCO. I in fact believe we'll get much more at SNO, though the trial may not be unblinded by then. I cannot say whether the company will present there, or only Dr. Liau or her team, but I think we'll learn for example how many remain alive in the trial, and I think the Top 100 will again be discussed, and the median survival will have moved over 60 months for that group.
I believe it is somewhat clear that some patients see little or no benefit from the vaccine, it's not harmful, but little or no added survival time seems to occur. Perhaps in the future they'll be able to pre-determine who's unlikely to benefit and target them with something else. Until that determination can be made, all should be given a chance with the vaccine.
Too many people view cancer as a disease that can be conquered, it's not. I have no idea of how many forms of cancer exist, but each is it's own disease. As a victim of Leukemia, before being diagnosed I had no idea how many variations of it occur, I still can't say what the number is, but I know it's substantial, and I know in many cases drugs tested on one form have benefits in others, but aren't included in the FDA approved label for the product.
I believe our vaccines may be a major advancement in many cancers, but it certainly won't be curative for a substantial percentage, at least it won't by itself. The good news is some substantial percentage may see benefits, and some will be cured, but in practically every case it will come with the vaccine combined with other therapies. To the person who's life is extended, it really doesn't matter which products used in achieving remission were effective, and which weren't, what matters is achieving the remission, and perhaps ultimately a cure.
I hope I'm surprised at SNO, and at least top line results are announced, but at this point I cannot say it will happen. I do think Dr. Liau can say 60, 70, or 80 some patients are still alive. If that number happens to still be in the 80's, it would indicate those alive are really quite stable, as it's been awhile since we got the number, and that's where it was at the time. On the other hand, if it's in the 60's that's still roughly 20% of those who started the trial, and many are alive well in excess of 5 years if the median of the top 100 is now over 5 years. We would certainly know that all were alive for over 4 years as it will have been over 4 years since the last patient was dosed at SNO.
I would also think that by SNO we'll get a commitment from the company on when they anticipate unblinding, and hopefully an explanation of what has delayed it. While most believe it's the SAP, it would be nice if that were confirmed by the company.
I believe we're getting close, a month from now we should know much more, I hope we can avoid sniping at one another while we're waiting.
Gary
The quarterly report makes it sound like the initial approval could come in South Korea, does anyone know why that's the case, or am I reading something into it that really isn't there.
Gary
Sorry to hear that Druggie, let's hope this time is the time.
My kids are in or approaching 40 often still live at home. Not our plan but they're basically good kids and we haven't pushed them into normal 40 hour jobs, they're both doing their own thing and making enough not to come to us for daily expenses.
Hopefully a near death experience will turn things around for your son.
Gary
Happy to hear of the progress. I hope your son accepts the warning he's been given and can break the vaping habit, but clearly like cigarettes it's an addiction.
I believe that cannabis does have medicinal benefits, but that any sort of smoke can't be good for the lungs. Personally I've been given products to try and never really felt anything, but they had low levels of THC, I cannot say how more of it might affect me, I really haven't pushed for it. Some of what I tried was in candy, other in drops, and I did try a little with a vape, I felt nothing, but my kids said they felt the effect of some of it. Thing is, I would support the idea of the Govt. at least approving it's development in drug trials, but achieving patents for products containing it has been problematical. Without a patent, a company would be foolish to spend the funds needed for clinical trials if nothing gave them rights to market an approved product exclusively, at least for a period of time.
Many years ago an person who worked as an Air Force medic told me they found hiccup's could be resolved with a spoonful of sugar under the tongue. Of course no research has ever been done on it as their is no commercial value to such a cure. There are so many cannabis based products legally available in State's where it's legal that almost nothing is being done to determine what really has benefits, and what doesn't. I hope your son can break the vaping habit, but find benefits from cannabis if needed in other ways.
Gary
Milo,
Products with THC are certainly available in legal cannabis stores in many States, but clearly they too are untested. On another board an investor prhas told us of a personal problem where his son vaped THC, he's in the hospital with his lungs coated with an oil that's related and they have yet to find a way to break it down. I have no idea if the devices he used were legal or not, it's been said that most of the vaping problems have come from illegal devices, but virtually no testing's been done with either tobacco or cannabis based devices. Frankly I don't think smoke of any kind is beneficial to your lungs. Clearly tobacco creates problems, and even chewing it has led to mouth cancers. I suspect if both tobacco and cannabis were studied for approval today, cannabis would be more likely to gain it, but we tried taking away alcohol at one point, that got us nowhere, so I doubt they'll try it again with tobacco, but if it wasn't around for centuries, it wouldn't be legal today.
I would hope our sublingual tablet would prove a safe way of administering all sorts of formulations of cannabis for a variety of uses. Likewise our cream for psoriasis and other skin diseases. I believe the Phase 1 Trial which was run with the cream demonstrated that the product being rubbed on didn't get into the bloodstream, so the THC in it wasn't getting people high. The sublingual tablets are an entirely different matter, they can get people high, which may, or may not have certain medicinal benefits.
Gary
Milo,
There are a ton of similar products using CBD in all sorts of ways, I frankly tried some of the pain cream but can't say my back pain which radiates down my leg improved at all. I believe the difference is that OWCP is also using THC and other components found in cannabis, and to gain acceptance they actually intend to run clinical trials.
I don't believe clinical trials exist for nearly all the products that can be found containing CBD practically everywhere. Check out Amazon, they have hundreds of products listed there.
I would hope that the inclusion of THC will make things like the psoriasis cream far more effective. I cannot say that no benefits can be seen from CBD alone, but I hope formulations actually tried in clinical trials can't really be shown to be more effective. If in fact OWCP's products were clinically tried and approved, I believe sales would greatly exceed that of anything else on the market, and it would be far more effective and prescribed or recommended by Doctors, and perhaps covered by insurance.
Gary
I heard briefly from Dave I, he promised more to follow. On a question I asked on right to try he indicated it's far more complex than they've made it sound publicly, right now it's possible to get DCVax-L in the UK.
I don't believe many companies are permitting right to try, just as in the past they didn't support compassionate use. It's sad that the FDA cannot arrive at a procedure for right to try that drug makers and insurance companies will go along with so that many who wish to try something that may be of benefit to them can get it.
Gary
Druggie, how is your son doing?
I've heard that most having problems are using black market products. Clearly more testing is needed. Here in California it's said that more sales are coming from illegal stores. I don't know that is a fact, but revenue isn't as high as anticipated.
Gary
I look at these things as long term and I still believe that NWBO will prove to be a great investment, especially for people like me that got in at an average price below $.25. I would hope that anyone who got in for double digit dollars have averaged down to close to, if not under $1. If not, it may take awhile to be positive, but it should happen in time.
Of course if you're among those who believe the trial will never end, if you're right, you could be right about the stock. I believe that what I've seen from Dr. Liau is reason to unblind, even if survival isn't the measure that's considered primary in determining approval. I don't believe the survival benefit can be ignored, regardless of the original approval criteria.
Gary
I'd like to chime in on this. I believe that investors have been waiting so long for the unblinding that no one is certain of when it will happen.
When I first invested over a year ago, many were certain that 36 months after the last patient enrolled it would happen. Some now believe that 48 months is the key. In a trial for a totally different product I saw that they keyed on 49 months, I have no idea what was behind that choice. The point is, investors don't know, and the company is providing little guidance.
Just today I wrote Dave Innis about errors in the website regarding the Phase 3 Trial. I suggested a change wasn't critical if something is happening near term, but if not it should be fixed.
I wouldn't be at all surprised if the company has confidentiality agreements with one, or more potential partners, and that might handcuff them wrt what they can tell investors at this point. Under confidentiality potential partners my be able to see the raw data as soon as the trial is unblinded, even before top line data is announced.
Gary
On another stock board I've heard from someone who's been in pharmaceuticals for many years who's son is hospitalized because of vaping a THC based product. They've found his lungs are thoroughly coated with an oil that's fairly impervious to current treatment. I certainly hope they find a way of treating this, but more importantly, it seems like vaping of any product may be hazardous as some of the deaths have been associated with tobacco products.
I really cannot say the act of vaping is satisfying, it may be to some, but I believe it's the THC that's satisfying, and our sublingual tablet may provide as much satisfaction, and hopefully has zero negative side effects. The only way of actually knowing is clinical trials, and perhaps if patent approvals are coming, they'll actually be done.
I suspect that the oil used in vaping is far more concentrated than what's in the cannabis if smoked, that may be why similar problems didn't seem to be the case with smoking cannabis. I suspect no form of smoke is good for the lungs, but Congress is hard pressed to make smoking of anything illegal. If there are benefits from tobacco, I wonder if it too could be handled with a sublingual tablet. I cannot say that whatever the benefit is from smoking will be equaled by a sublingual tablet, but if some feeling is achieved by it, perhaps the same feeling may come from using the tablet. Of course it's known that people who use chewing tobacco have cancer problems in their mouth, so it's impossible without testing to say that won't be the case with a sublingual tablet.
I wish I could say that all sorts of other products were safe, but clearly many of the nutriceuticals found in all sorts of stores have no proof of efficacy or safety. In reality, little that we eat and drink is proven safe, but some things have been used essentially forever.
Gary
My timing has been terrible, yesterday I sold stock in a position I've held for years in IMGN which is up 25% today including after hours to fill out my position in NWBO, which is down roughly 5% since I bought it. The good news I believe it that my position is now as great as I ever planned, and I still believe the future is bright, so having some of it in Roth IRA's will pay off well.
When it comes to a 25% gain, right now 6 cents essentially represents that. I believe the future will hold many gains of 6 cents or substantially more, in fact, once top line data is announced, I believe a double or more could easily occur in one day. I can't say when that day will occur, but each day, we're one day closer.
By the way, anyone heard how Druggie's son is doing. He should be in all our thoughts and prayers.
Gary
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