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I generally support capitalism, but I don't support the sort of greed that has crept in at the top. Decades ago I was in Japan when CEO's there were complaining about American CEO's making too much. In Japan they made roughly ten times what senior workers made. It's gone crazy since then, and it often hardly matters is a company is losing money, or highly profitable, the CEO's and other executives take home big salaries, but often much bigger bonuses, often in stock.
I suspect that if the highest level execs couldn't gain greater percentages than the worker, the workers pay would rise much faster. When tax rates were exceptionally high for the higher income, people weren't that greedy as most went to the govt. As rates came down, and you could keep more of what you earned, people became more greedy. In Japan the workers were looked at as assets, and it was the management who was responsible for employing those assets by developing products or services for them to make. Here in the U.S. some of our most successful executives are famous for cutting employees, rather than developing new products that keep them productive. I hate seeing CEO's rewarded for reducing the work force.
I agreed with reducing corporate tax rates, but believed that it needed to be accompanied with the elimination of tax loopholes, that didn't happen. Too many very profitable companies pay little or no taxes, and they do so completely legally, but I believe they should pay by removing the loopholes. I'm for greatly simplifying tax code, as well as Congressional legislation. If pork barrel spending were eliminated by not permitting it to be hidden in major bills I suspect we could see much greater infrastructure work, rather than some building in a Congressman's District to get his vote on a certain bill.
As far as wasted money goes, I can see no greater waste than what's spent in politics. Take the money out of politics and perhaps the politicians can work for the people again. It's not going to happen, but I really believe election campaigns shouldn't begin until a matter of a few months before an election. Our politicians often spend far more time raising money than they do in doing the people's work. I have at times given times, tried giving ideas to politicians, but I've given little or no money for years.
In short, I agree with capitalism, but believe some limits are needed as well. Stockholders are all too frequently treated like mushrooms, kept in the dark and covered with s-it, sometimes it does work, but it could be much better.
Gary
I have no problem with that, but I do object to drugs that have been made for decades having dramatic price increases, especially after generic competition is eliminated. If it were up to me, patents would be longer if the drug developer agreed to reducing prices as sales volumes hit certain targets.
Greed has resulted in several companies being brought down, if a company doesn't do something that attracts attention they can make a substantial profit. When companies try to hide flaws in their products or do other unethical things, like buying their competitors and raising prices by multiple of current prices they're likely to be punished for their actions.
I cannot tell you if Bayer Aspirin is better than others, but I can say that some people will pay more for it, and that's fine, it's their choice, but if Bayer bought up all the other producers, than raised the prices dramatically, I think they'd be punished for doing so. Personally I trust the Kirkland brands created by Costco.
Gary
I have no problem with that, but I do object to drugs that have been made for decades having dramatic price increases, especially after generic competition is eliminated. If it were up to me, patents would be longer if the drug developer agreed to reducing prices as sales volumes hit certain targets.
I'd love it if you were right, but it seems to me there would be shelf life issues that would need to be addressed, and what do they do with what they've made if the order doesn't come in, and no regulator approves its use.
I frankly believe there may be many uses of this drug that have yet to be tested. As a stem cell recipient, I watched the board daily as my nurses posted the latest blood tests, the counts were nothing for a couple days, then began to rise. I suspect that used at the right time, hospital time could be lessened if the drug were used. I went home after day 19 because my Dr. was out, an associate released me. When I saw my Dr. the following week he indicated he'd have probably kept me longer, in case of complications, but by that point I was fine being out. I had plenty of complications, like shingles and catheter infections, but they came later, fortunately...
I don't know whether variations on the current drugs in trial are necessary, or if without change they can be used in many applications where blood counts are low to boost the patients recovery. I suspect that it's more about giving the proper dose than different formulas, but I'm certainly no expert.
Gary
The question about the pricing of drugs came up awhile ago and I thought I'd mention my thoughts. I can accept the idea that we pay more to provide for the research, as the wealthiest nation in the world. What I don't accept is how much more. 5%, even 10% would be reasonable, double or worse seems really extreme.
The real question in my mind isn't the list price, it's the real price that's paid by insurance companies, patients, etc, and I suspect that price varies tremendously. I believe that if we really want to tackle healthcare, we need to establish some realistic prices and do something to equalize what's paid. I'm not suggesting that every individual pay precisely the same price, and certainly if you have options on insurances, they make for options on what you, and your insurance company pays, but the net price ought to be nearly the same for all. The net being the price you pay plus what's paid by insurance, medicare, etc.
I believe the problem is no one wants to admit what's paid. My treatment for leukemia probably has a list price that runs well into six or seven figures. I wouldn't be surprised if the actual price paid was in five figures, I really don't have any idea what it actually is. That's the point, healthcare costs shouldn't be hidden. I suspect that one of the biggest cost of healthcare is accounting, it shouldn't be. Doctors should say what the best care for patients is, not the accountants.
I just spent nearly two months with back pains that seem to have been fixed with a shot, the wait time was for an insurance approval of the procedure. I could have gone to a Dr. who wouldn't have waited, but I'd have to drive much further, and I thought the approval would only take days. My point is, accountants shouldn't be who make the decision. I'll guarantee that the Dr. who'd do it without prior approval would get paid, he'd be fighting with the insurance as necessary after providing the relief, but he'd win. The point is, they shouldn't need to fight to get what's right.
I don't know what range of price NWBO will agree to for it's products, or how many may gain free access to the vaccines as they can't afford to pay at all. I suspect whatever the list price is, few will actually pay it. It's rather like buying a car, no one pays the sticker price, but some really rare cars will sell for over the sticker price. Selling healthcare shouldn't be like selling used cars.
Gary
No company pays anything close to ten times the current price of the stock in a buyout, you're very lucky to get double the current price. For NWBO to be bought out for $20 a share, it needs to achieve a share price of at least $10. That is very doable, but it won't happen overnight.
I believe it's possible in the next year, but a lot of positive things need to come together. One could certainly be a partnership, that should bring the price to a substantially higher trading range. If trials of DCVax-Direct are reported to demonstrate efficacy against a variety of cancers, that could certainly add to the potential of the company. Finally the approval of DCVax-L could be possible before next year's end, but things will have to happen soon to make it happen. It's possible the FDA and other regulators can make a decision in under 6 months after a BLA is submitted, but it's not something you can bank on. It's better to take the time needed to do a BLA right, rather than in a hurry, so six months is about as quick as possible to do it.
My point is that if all goes well, by the end of next year a sustained double digit price is not out of the question, and that's the sort of price that could get a $20 buyout offer. Could it reach that high sooner, certainly, on shear emotion anything is possible. A front page article on a paper, like the New York Times might drive the price up dramatically, like it did many years ago when Judah Folkman was featured and a single digit company was driven to triple digits, that was on mouse data, but the price didn't hold, and I believe the company failed completely, but it's possible they were bought out.
The point is, if investors see a headline, look at the share price, think it's cheap, they often purchase before doing their homework, namely determining how many shares are outstanding. Unless some of the warrants, etc are repurchased by the company, there will be nearly a billion shares outstanding. If the share price were driven to double digits on the strength of publicity from the Phase 3 Trial, and perhaps even a partnership, at that time I think you need to ask, should it be worth a market cap of over $10 billion at that time. Barring some new information we don't have at this point my answer would be no, I'd consider it a trading opportunity. I cannot say how far the price may retract before it starts to advance again, but I'd certainly look to sell some shares, and buy back even more at lower prices. On the other hand if it slowly advances to $10 or more it just might be bought out for $20 or more, but that should take a year and probably longer to happen.
Ask yourself something else. How much would the company be worth if both DCVax-L and Direct were approved for multiple forms of cancer. I think the answer to that would make $20 billion or substantially more than that sound cheap. I don't know how long the company will wait before accepting some offer.
Gary
Thanks Doc,
I don't try to understand all that's happening here, it's way above my medical knowledge. It does sound to me like with approval, our most effective vaccine should be what's available to patients, and in any additional trials the company wishes to run to broaden the label.
I don't know if the regulators are open to trials for a multitude of cancers, or if each must be independent. It sounds like both DCVax-L and Direct may work in a wide variety of cancers. I don't know that either is curative by itself, but it certainly is extending life and potentially leading to cures in combination with other therapies.
I'm curious if anyone believes that a Direct made in a person who didn't knowingly have cancer would help to prevent cancer in the future even though it wasn't being injected into a tumor, just into the bloodstream. I'm certainly not saying this is the case, but if it were, such a vaccine could help prevent a great deal of pain and suffering.
The potential of this company is extremely difficult to judge as if it truly works against a variety of cancers, it could be a trillion dollar company if it remained independent. While I don't expect that, I do hope they can take trials far enough to get some idea of just how effective it may be in at least a few other cancers.
Gary
When you say it's approved, or even that it will be, what does it mean if a stockpile of it doesn't exist. What's needed is a rather large order from the DOD to set up deployment of it as needed, you can't start manufacturing the product after a nuclear event and have it deployed in a timely way.
Gary
I would suggest coming up with the questions and transmitting them to the company before the meeting. In another company I routinely did that even for quarterlies and often found they covered what I asked. I think it's more tactful than trying to trip them up with questions they've not considered.
Gary
Thanks,
I would hope that the pilot study would be all that's needed to attract a partnership, and that's really the end game for the company. If that study fails to gain a sufficient benefit, the patent will have little worth.
I don't know if they were prevented by regulators from using patients with psoriasis in the Phase 1 they previously ran in healthy patients, but it's clear that it failed to do what most Phase 1 Trials would do, I.E. establish the dosing protocol for running a Phase 2 without further experimentation. Hopefully the pilot study is underway, or will be shortly, and they'll be able to discuss results with it, before initiating the Phase 2 portion, which will be blinded, and have a control group.
I believe the company would be doing shareholders a great service if these trials were documented in the clinical trials database. I know the trials won't be done in the U.S. but many trials not done here are documented there. Updating the database is a good way to keep investors informed.
Gary
Thanks Lykiri,
I'm glad it's incorporated, and while I suspect it makes evaluating the data somewhat more difficult, the net effect is certainly very positive, and would be even more so if the entire trial had been run with the improved version of L. In the past I've seen the FDA require more for all sorts of reasons, I just hope this isn't one of them.
If they hadn't used the improved vaccine, I suspect the FDA would insist on a new trial with it before approving it, though they may have approved the lesser version. Hopefully it's the data that wins out, not the confusion that may have been caused by both better vaccine and the initiation of improved surgical techniques.
It sounds like we've had greater support from certain regulators, and that could also be reflected in the time to approval. The FDA might be last, but hopefully won't insist on another trial, but if they did, it could be supported by sales in the other countries. Of course a BP partnership before any of this happens will ease the process, but it may not avoid all delays.
Gary
I think it is a presumptive. approval if no concern is brought up in a specific number of days. This is the way IND's are approved as well.
Gary
The question in my mind is whether the improved L has been incorporated into the trial. If not, will the FDA and other regulators allow its use without further testing.
Normally improved drugs come in just before patents run out.
Gary
Frankly I cannot blame the authorities for pushing the drug makers to lower the price. I've heard that in many third world countries the drugs are available at substantial reductions of the list price. Some adjustments need to be made, especially after drugs have been on the market for substantial periods of time. People today are paying more for insulin than in the past, it makes little sense, but the drug maker can do it and no one seems to care, even if some people don't take what they should be to save money.
Gary
I would agree that our FDA is really the Gold Standards for approval, so few companies go for others first, but failing our FDA due to comments or questions that must be addressed, drugs are often approved elsewhere.
Where it really hurts is if our FDA insists on additional trials, while the other regulators are willing to approve on the strength of current trials. Drugs in that category are often delayed by several years, and it's one of the reasons some Doctor's practice medicine in other countries where they can get additional drugs. 60 Minutes did a great show on 5 Star hospitals and resorts that specialize in such treatment. I'm uncertain if any insurance exists that cover this, but in some cases it could clearly save money in addition to providing excellent medical treatment.
Gary
Thanks,
If I understand the program, if sufficient vaccine exists, even now patients in the trial may be receiving it. Please correct me if I'm wrong about that. In most drug trials I'm aware of, even when the trial ends unsuccessfully, if a patient is getting a benefit, and drug exists, the patient continues to receive it.
I may be wrong, but I believe the clinician that originally dosed the patient would attempt to contact, and examine if necessary, any living patient. That's not to say that the clinician may be doing this through the patients personal oncologist. I would hope that no patient is forced to travel substantially to be evaluated.
Personally I still see my Dr. at City of Hope quarterly, I would suspect that if I were in a trial which was completing, I might be asked to make an additional visit, or they might just confirm my status on completion, and confirm my health on my first routine visit, I don't know. The primary thing is confirming a patient is still alive, beyond that, I would think the precise status could wait, or be confirmed by a local Dr. rather than requiring a trip. In my case, COH is less than an hour away, but I've met people who've come there from all over the U.S. My Dr. in particular takes many elderly patients which even some of the finest hospitals in the country won't when it comes to stem cell transplants. It's not that the patients won't be treated, but they know their's a greater risk with stem cells, and while it also has a greater reward, some choose not to take the risk. I was happy to have done it.
I'm actually looking forward to visiting COH on December 26th for my next appointment as it's beautiful how they decorate for the Holiday's. Last year I came in during January and missed it. It's really an amazing place.
Gary
It's not about the people at this point, it's about the cream. Does the cream really improve psoriasis over a few weeks, does it help people with acne in a few days, or less, how about other skin diseases. If the cream truly produces benefits, there will be success, whether it comes from within the company, or they partner or sell the product. On the other hand, if the cream doesn't work, the finest management team in the world couldn't turn it into a profit.
At this point they're set up with Israeli Hospitals who'll run the Phase 2 Trial, should they take on a partner, they might want to open more trial sights, perhaps Internationally, even the U.S. might get involved, but the THC component still creates Federal problems, though it's legal in many States.
I suspect that if 10 psoriasis patients are enrolled in the trial, if after 2 months the greater majority see major improvement, and it's reported, it won't be long before one or more major partnerships will occur. I indicated major as opposed to the partnerships they've had to date to differentiate those who'll come in with substantial payments to OWCP. I frankly don't know if prior partnerships remain in place, but even if they do, a BP partner could buy out any pre-existing partnership that would prevent them from taking over something they want. First lets get some results, then we'll know what we have.
Gary
Was anyone here involved with the company way back at the time GBM was chosen as the target for the Phase 2 Trial. I ask because I suspect that back then they looked at a variety of cancers, and I suspect the GBM was the deadliest one they felt they could be effective with.
Anecdotally we know it works in others, but had they done it in say breast cancer, the life expectancy and survival opportunity is far better, and it would have taken dramatically longer to demonstrate a benefit.
I've seen other drugs targeting pancreatic cancer, not because it was the best target, but because it's so deadly. The trial failed and lack of funds prevented it from being tried where other evidence indicated it would be more effective.
I frankly wish drug developers had a choice as to how trials would be done. In all cases I'd want them to be responsible for Phase 1/2's that indicated they had something worth further investigation. At that point a decision could be made to go it alone to approval, or moving the drug to the FDA for further testing. The FDA testing option would be one in which the FDA would receive substantial royalties from any drug with that option which was approved, that revenue after some initial seed money should make the program self funding and replace the seed money in time. This option would be open to everyone from the tiniest of biotech's to BP, you make more money if you can fund your own trial, but pay far less if the FDA is permitted to do it. A huge difference is, the FDA wouldn't give up simply due to a lack of funds, and would be likely to modify the trial in mid course to make it more effective. Because they made such decisions, not the drug maker, there would be less suspicion of cheating by the drug developer Remember, the FDA would need to be convinced something was worth funding by what was done in the Phase 1/2 Trial, they could accept, or reject a product applying to be in the program.
Gary
My feelings were that once a patient passed on, all the pertinent information about them would be gathered, remember, in some cases these people passed on nearly a decade ago. I don't believe that they learn if the patient was on the vaccine from the beginning until the trial is unblinded, but they would know they crossed over if a second course of treatment were undertaken, as I understand that would always be done with the vaccine. As I understand it, only roughly 30 patients weren't crossed over, and I would suspect they either expired, or were too sick to dose by the time it could be done, at least that's what I gathered from others.
I may be wrong, but once someone is dead I believe the cause of death is ascertained, and all vital information should be gathered at that time. The only unknown is what they received on entering the trial, and they know how many courses were delivered thereafter, and when they were delivered.
As I see it, there may be several different K-M plots, but a patient who passes on will represent exactly the same thing on each one in which ,they're included. If a patient passes on at precisely XX days, there will be a small tick down at that point, unless more than one died at that precise time. Of course if they've also tracked TTP, which the probably would, that to would be built into other K-M plots, but again, it's not a figure that would change after the patient has passed on.
In the case of those still alive, some may have determined to progress, others not, what's important is that they're alive, and it's possible that some viewed to have progressed may still live for years, and perhaps even go back into a complete remission. In treating cancers there are miracles that no one can explain.
It's been a few decades since my wife was treated for breast cancer. On a few occasions she underwent chemo with a patient who was given a couple months to live. He got approval to go on a vacation to South America, as I remember it, for a few weeks, provided he take treatment just before departing, and on returning. On return, they could no longer find any indication of the cancer. No one could explain it, and I have no idea if his remission was maintained, but clearly he had a miracle. I do not believe he sought out treatment where he went on vacation, but who knows, it may have been something in the water or food he ate, or it might have just been fulfilling a lifelong wish to do something.
Gary
I believe I'm no different from many others here, I could sell for tax loss purposes, but probably won't unless I really need them. Why? In the hope that something could actually happen that could drive the stock up. I'm not saying it will, but if nothing else there is a corporate shell here that may be worth more than anything the company has is being valued at.
It's rare, but on occasion these stocks do come back from being dead, lets hope that becomes the case here.
Gary
One of the investors conferences that companies like to be invited to annually is the JP Morgan Healthcare Conference held in early January. I really don't know that if NWBO issued top line results were announced before the end of the year it wouldn't garner enough attention to get them a late presentation to prevent there. Of course we realize such conferences don't provide in depth data, but they do give the company an opportunity to discuss their plans for bringing new products to market.
There is no reason for the likes of JP Morgan to invite them until TLD has been announced, but once it has, there are other similar conferences where they might present, and organizations like BIO where I believe members pay to present, but once they have something to say, it's worth doing so.
I believe the company will be more eager to present at investors conferences once they have more that they can talk about.
Gary
The discussion of 82 trial sites should be somewhat simplified by the fact than it's very doubtful of a living patient at each of the 82 sites. I would suspect that Dr. Liau at UCLA has many more than one, but it's impossible to know precisely how many sites have no more patients alive. I would be surprised if over half of them still have living patients.
I certainly don't know, but I would thing that the only information they should need on patients who passed on would be, did they receive the vaccine, and if so, was it administered initially, or on cross over. That information shouldn't even require a visit to the trial site IMHO.
I'm not trying to diminish the scope of the work to be done, and of course I hope many are still alive, but I believe in most cases the trial sites will only have one or a few patients to contact and verify their status. I would think that all those living would be medically assessed so not only do we know they're alive, but also how healthy they are. I would hope that many of the living are in complete remission, as that would suggest they'll be living substantially longer and perhaps be considered cured in time.
My point is that, with the exception of patients who're traveling in places where they cannot be reached, much of this work should be able to be done in a matter of a few weeks, or less. Top line data is far from the final report, if a few patient can't be reached, LTFU for now is better than delaying for weeks or months while they're found. By ASCO they certainly should be found and reported in the full data presentation.
Gary
I think you've hit on half of what they need to do, the other half is beginning the Phase 2 Trial for the cream. If that trial is not blinded, it shouldn't take more than a couple months to demonstrate some degree of efficacy. Imagine before and after photo's of patients who used the cream for a month or two, or perhaps even less, if it's that effective.
Certainly the regulators will want far more than a few such patients before an approval can even be considered, but it's possible to expand a Phase 2 Trial to provide all the regulators want. Of course each of the regulators may take a different approach, and the FDA in particular still has a problem with THC, but perhaps that will be overcome by having the approved patent.
The company will have a choice to make at some point. If efficacy is demonstrated, I don't believe anything would prevent them from selling the product where cannabis can legally be sold. That said, not doing so and waiting for drug approval would better position them to dominate the market when it could be purchased in any drug store by prescription, and covered by insurance. I know that products available over the counter can also be purchased by prescription, and covered by insurance, but that occurs normally when first approved only by prescription. It might be more difficult to do the reverse of that.
I believe the answer is a partner, ideally a BP or a few of them, who'll handle distribution and sales internationally, and provide the funding to complete pivotal trials, as well as needed funding for other products. This would immediately move our stock price to a very different trading range, but I don't believe it can happen before at least an example exists that proves the cream to be effective.
Gary
I know it's important, but as a cancer patient I really wonder how much an expanded label is worth if anecdotal evidence shows a drug is effective in cancers not specified on the label. My experience at City of Hope has indicated that the Doctor's there will try almost anything to keep patients alive, they do make personalized drugs there, and I believe they practically ignore the label if they believe an approved drug can benefit a patient that isn't responding to therapies approved for the specific for of cancer. I don't believe they have a problem gaining insurance coverage for what they wish to do, but sometimes it does require a few days as they fight with insurance.
Yesterday I had a spinal injection that took nearly 2 months to gain authorization for. I accepted that by choosing not to go a greater distance for a Dr. who would have done it, then fought the insurance for coverage. My mistake, I never dreamed it would take so long. Hopefully these shots will prevent the need for further surgery, the Dr. who did the procedure believes it will be the case. I didn't feel, or remember a thing as I was put on Propofol, I don't even remember falling asleep, but woke up in roughly a half hour feeling no pain. I understand that such procedures are not cheap, but what savings do the insurance companies achieve when their actions simply delay, but don't deny coverage. Want to cut healthcare costs, cut the staff of accountants that say when and where you can receive treatment. Let the Doctors decide what's needed.
Gary
If we start with the deadline for submission for Abstracts at ASCO we may get some insight on when the trial needs to be unblinded, that's February 11, 2020.
I'm no expert, but I believe at least a couple weeks will be needed after unblinding to have sufficient information to generate an Abstract worthy of submission to ASCO, if I'm right about that, laute January is roughly the latest it should happen. I do believe ASCO permits an update to Abstracts that's a month or so later, but establishing that placeholder is necessary, and you need to give them something not previously seen to gain acceptance.
Of course I still believe it can come earlier, but I believe it's becoming clear that ASCO should be where the data will be presented in detail for the first time.
With four regulators dealing with approval, does anyone know if a common BLA will be what's needed, or does each regulator have their own unique way in which they must be approached. I agree with the idea that they all must agree to a single SAP, but as complex as the BLA must be, I have no idea if all four accept the same submission.
It's still my belief that a partnership is likely before the BLA submission, which could come about the time they're presenting at ASCO or later, if the BLA is submitted by third quarter, an approval of one or more next year is possible, but it's more likely it will come in 2021 if it's submission is after the second quarter.
I suspect that the initiation of additional trials for either DCVax-L or Direct will probably require additional funds. A partnership would be ideal, but if not, dilution after share price move up once top line data is released would certainly be a possibility. I would hope that substantial dilution is avoided until the price is dramatically higher.
The price achieved after top line data should bring the stock price to a market cap that at least approaches $1 billion, but could be substantially more depending on how it's received. If it receive a lot of media coverage, no telling how high it may go. Of course a partnership may set a fair price for the shares if the partner is purchasing stock at an established price, I would hope that represents a market cap of a couple billion, or more. As always, JMHO, I welcome the thoughts of others.
Gary
The broker will give you the best price even if you're wanting to pay more to raise the price at the close.
Gary
If that is the case, I wonder why Dr. Bosch didn't establish 2019 data to date in his presentation. I suspect they like the impact the data should have and don't want to preview what it will say.
Hopefully it won't be that long until we know.
Gary
In that Dr. Bosch essentially repeated Dr. Liau's data, I'm wondering if I'm wrong about what the lead clinician knows, and what they may discuss with the company. I was of the belief that Dr. Liau could determine routinely how many people in the trial remain alive, and that number could be reported to the company. I know that in another blinded trial the company would provide such numbers, but certainly they knew nothing about who was on the drug, or who was on the control.
Please let me know if I'm wrong about this, I can understand not expending a substantial effort monthly to make such a determination, but I would think it would be done at least a few times a year. Perhaps it's not been done for awhile as the company simply wants to wait until they unblind, and while they may have anticipated that months ago, they know it won't be that much longer.
By the way, does anyone believe the SAP will be different for the 4 different regulators. I was of the opinion that they were attempting to develop a single document that all four agreed on.
Gary
Flipper, I'm well aware of that, but I don't see much of a change in his actions. As an IMGN investors, I believe he could have accepted a limited approval for IMGN853 which clearly benefits those with high platinum resistance, but instead he insists on another Phase 3 trial which certainly will have greater proof, but how many will die for lack of the drug, and how many millions and years will this cost.
I certainly hope we can gain approval on first approach to the FDA, but I believe before that ever happens we'll have a partnership and our partner will fight the battle whether it requires an additional trial or not. If I'm wrong about the partnership, I'll be more concerned about approaching the four regulators, not just the FDA.
Our FDA has resulted in American Doctors practicing in foreign 5 star hospitals because they can get so many additional drugs there, 60 Minutes ran a great story about this a few years ago. People with the means are traveling for non emergency treatment in hospitals with recovery in 5 star resorts for less money than it would cost here, but more importantly with drugs the Drs. want to use, but which still aren't available in the U.S. but are approved in much of the world. We may still be considered the Gold Standard, but it's sad when Drs. know something works well, but know it cannot be purchased in the U.S., but is available elsewhere.
Gary
Not necessarily, an attempt could be made to have investors sell sufficient shares at a fixed price to do such a deal without more share being authorized. Essentially they could pay the company a price for establishing the partnership, and that money would be used to buy back sufficient shares to permit the partner to take an equity position.
The question may be, how large a position is the company willing to give a partner. Typically anything above about 20% would give the partner a great deal of control as it's hard to defeat an action the partner wants when they begin with 20% of the voting rights, they'd also probably get one or more seats on the board.
I'm uncertain if say a 20% position was being established by the partner where half was in new shares, and half was in shares tindered by shareholders whether they'd exceed what's authorGized and require an increase to be voted on.
Gary
Frankly before the announcement of the patent approval it was my intent to sell half my shares for a tax loss. Now that it's been announced, I will still sell some, but far fewer, and perhaps sell something different if I need a greater loss.
Gary
I certainly hope you're right about Dr. Padzur. He certainly had no flexibility years ago when he refused to even read Genentech's BLA for approval out of the Phase 2 Trial for Kadcyla. It was believed that his staff had agreed to the protocol being registrational, but he disagreed and wouldn't even review it. No telling how much money and time was spent before approval came in Phase 3.
I believe a new SAP is justified if much new is learned in the performance of a trial. I'm not certain it couldn't have been done a couple years ago, but clearly much has been learned since the trial was initiated.
I can't help but wonder if IMGN might have gained approval of IMGN853 had they taken such steps. I suspect if they had, additional patients may have been added lengthening the trial, but approval might have resulted for at least a limited grouping of patients.
Gary
Good point, I hadn't thought about a delay to get the right FDA head. The question might be, just how much influence does he have over people like Dr. Padzur. In the past I've seen him speak about supporting the initiatives of the head, but can't say that much changed. Hopefully it will this time.
Gary
I believe that Dr. Barach should get his day in court if it comes to that, the company seems to be leaving it to the justice system and I'm fine with that. If he's guilty, I don't see him remaining with the company, but I understand he has a story as well, and perhaps he won't be guilty.
As to the dilution required by the company, it will continue unless we partner the cream, but if the trials of the cream are successful, the earnings should justify a much higher share price. I do believe that with the patent approval and initiation of a Phase 2 Trial for the cream, we should see well over a penny again. If I'm correct about that, a much smaller, perhaps under 1 for 10 would be worthy of consideration to work toward getting on the Nasdaq. I'm not suggesting something that establishes a $4 price, they would be far better off to reach $1 and work to move it to $4 or more. Patent approvals, trials, and partnerships could most certainly get the job done without any reverse splits, but it will take time.
I would hope that before the Holiday's we receive an update from Dr. Hirsch, it's long overdue, and now he has a reason for writing us again.
Gary
I wonder if Hahn will do anything to make right to try more acceptable to he drug makers. I believe if the drug maker wants to be paid for the drug under right to try, they have to make their cost of making the drug available, something BP and even tiny biotechs don't want to do. It forces them to either give the drug away, or not participate, and many choose not to participate.
I would propose that early in drug development the either the post approval price be established, or at least a right to try price established. If the post approval price were established, I'd suggest that under right to try they permit a percentage of that price, perhaps 50%. Drug makers could still choose to make it available for less, or free for people who couldn't possibly afford it, but for those who could, or if insurance were to pay, the price would be established.
Drug makers might spend tens of millions or more to create just the production facility needed to make the drug, but once you have the facility, the drug may relatively cost pennies to make. That's the sort of information the drug companies don't want to discuss, and it's a major reason for not participating in right to try.
As I understand it, NWBO isn't participating in the U.S. but I believe they are in one country, I believe it's Germany, but I'm not certain. I believe it will be late 2020 or 2021 before DCVax-L is approved. I think it's terrible that people diagnosed with the disease will either be told no, or told that they can get it outside the U.S. At a reasonable price, I'm sure the company would be willing to have the drug made under right to try provisions. Now the ball is in Hahn's court.
Gary
Merck is certainly a possibility, but if you look at BP, there are many others and if the results of the trial, and of the additional trials using both L and Direct truly show this technology works in many cancers, few of the BP's won't be interested in buying, or partnering with NWBO.
I've frequently said that more information is needed to properly value the company at the $20 billion or more that the company has apparently said it would take to interest them in a buyout. I'll stand by what I said, but believe there is one exception that could change that, a bidding war between two or more companies attempting to acquire the company. Frankly that could be very possible.
Think about it, we don't have a lot of data on a variety of cancers, but what little data we have, we know some people who received one of the products either under trial, or right to try, have seen benefits, some of them that are really amazing. If two, three, or more BP's are watching this, if they see really positive Phase 3 results and add it to what they know from anecdotal evidence, it's very possible that a move can be made on the company. While I believe a $20 billion offer based on earnings etc could be a couple years away, it could happen in a matter of days if two or more BP's got into a bidding war on the company.
Gary
For ages you've been saying they couldn't get a patent. Now they did, so you're telling us it's worthless. You could be right if in fact the cream has no benefit in psoriasis or other skin diseases. Frankly you don't know, we don't know, the only way to know is with some clinical trials.
I believe that the company has the cooperation of some Israeli hospitals in performing one or more trial. I can't say for certain, but think the hospitals have the potential of earning some royalties on sales in exchange for doing the trial at little, or no direct cost to OWCP with perhaps the exception of the cost of providing the cream to them. I believe they already have an arrangement for making the cream where once again, the maker will share royalty income from it's sale and can supply the cream at little, or no cost to the company.
Let's get the trial done, depending on the results, we'll see if the company is viable, or not based on the results.
Gary
Bruce,
I'll agree that I called for building the price up before any action, like a reverse split. I said that before the patent approval, and it's certainly works toward that goal. At this point I wonder if even that would be necessary if a quick trial were done which proved the cream worked on psoriasis.
Certainly a trial of say 50 psoriasis patients observed for perhaps 3 months or more wouldn't be worthy of drug approval, but if such a trial were done, and if it demonstrated efficacy, I suspect that we'd all agree that the company's value would be dramatically higher. I don't know if it would make an all time high, or even exceed one dollar, but clearly it would be higher. If on the other hand it showed no efficacy, it could hardly go much lower.
As I see it, the company has the agreement of some Israeli hospitals to do a Phase 2 Trial, perhaps it should be redefined to be small, and quick, but now that we have ownership of the intellectual property, it should get underway ASAP. It may be tougher for the company to operate without the R/S, but it's what they need to do. If a short trial proves the cream effective, the share price after it will give us a reason to reconsider what should be a much smaller R/S if it's to our advantage to do so. I frankly believe that if the cream is effective, something under 1 for 5 should bring the share price above $4 where a Nasdaq listing would become possible. If at the same time other patent approvals are granted, the $4 requirement might be met without any R/S.
My point is that we now have something to build on, we have intellectual property rights for one of our potentially biggest products. Let's build on that, not by a bizarre R/S that kills investors, but permits dilutive actions at substantially higher stock prices. Dilution may be necessary, but the price can be built substantially based on what's happening, perhaps just to a few cents for now, but how high should it be if psoriasis patients see relief from using the cream.
Gary
I believe LP is doing what she is because of anticipating a partnership at some point after the trial is unblinded. It's impossible to say how much negotiations have already occurred under confidentiality agreements, but such agreements would permit one or more potential partner to know anything the company knows. I.E. once the trial unblinded, under confidentiality a potential partner, or buyer, would have access to everything as quickly as the company did. Who knows, the terms of such a partnership may have already been established based on what comes out of the trial as long as it's sufficiently positive to consummate the partnership.
I'm not saying this has happened, I have no idea, but I'm suggesting that it's possible. No potential partner, or buyer, would put billions into a company with a few hundred million market cap, even if they agreed to pay billions. Their strategy would be for sufficient information to be released to raise the market cap to the point that what they paid would seem reasonable to their investors.
If a hostile takeover was attempted at this point, it's likely that more than one company would be interested, and we'd get into a bidding war that drove the price to the point that the company would agree to be purchased at a price agreeable to them, and investors. I think there are at least a few interested companies, and that prevents a hostile takeover effort.
The first step is unblinding and learning what we actually have, but it's clear to me that even without that, companies know that many patients in the trial are still alive, so they know results will be very positive, even if they fail to comply with the regulator judgement criteria.
I think yesterdays presentation was a clear statement that the company is playing their cards close to the vest. They could have asked the clinicians to gather the latest data, and added 2019 to the information in the presentation, but they didn't. They want to present it all in summary in Top Line Data, and then in detail at a technical conference for peer review. The deadline for ASCO Abstracts is February 11, 2020, I believe they'll have an Abstract based on the unblinded data by then.
Gary
I rather like the strategy Roche has used on numerous occasions. I'm familiar with what they did with Genentech, so I'll work from that. Initially the partnered, taking a substantial position, I believe it was roughly 30% of the company. With a 30% position they effectively had control, as it's practically impossible to defeat them in a voting situation. They then bought out the company, investors either cashing in, or getting Roche stock. They maintained a degree of independence for Genentech, and chose to spin it off again, maintaining sufficient ownership to effectively control it. Currently they've again bought it out and it's wholly owned by them, but operating somewhat autonomously. In short, if they wish to bring in lots of money, they can spin it off again, and still remain in control.
Shareholders made money with these actions, and Roche was able to bring in substantial funds with the way they managed their holding. I wouldn't be surprised if Roche did this again with Genentech, or others of the companies they hold that each operate in a similar manner.
I don't know that Roche has any interest, but anyone who does could follow a similar scenario, partner while taking an equity interest first, then thing proceed from there.
Gary