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Thanks, while I felt there were examples of this happening in the past, I didn't have one to cite. There is no reason to believe it cannot happen here.
Most of the stocks I've invested in had investors critical of management, it's not something exclusive to NWBO. In most cases I could agree with at least some of the criticism, yet in the end the management did keep the company alive, and sometimes, that's the best thing they can do while developing a winning product. In some cases that product never comes to fruition and the company's left worthless, but it can go the other way as well. The CEO who months earlier was highly criticized becomes the toast of the town as investors make a fortune.
Our CEO may have done some bizarre things to keep the company alive, many may have done it differently, but in the end, if the DCVax family of vaccines prove to be successful, all who hold will be well rewarded. Certainly our CEO and other executives with the company who've gained many shares as bonuses will do very well, few investors will have done better. The point is, investors will have done very well, and that's all that matters to me.
Frankly the CEO's I'd put down are people like the leadership of the Big 3 automakers back in the 1960's, 70's, etc that permitted American named products to become clearly inferior to the foreign competition, even when the foreign cars were made here in the U.S.A. Many of those people made fortunes while their companies needed Govt. support to remain in business years later, they sewed the seeds of that failure.
I admire people like the founder of Federal Express who at one point couldn't make payroll. He took what assets he had to Vegas and got lucky enough to make payroll. I don't know what he played, but clearly he played it well, and kept the company alive. It had to stay alive before it could thrive. Our CEO has kept the company alive.
Gary
It's all relative, a company with a billion shares outstanding can still have a market cap going into the hundreds of billions or more. Apple has over 4 billion shares outstanding, they're certainly not a failure.
What if the DCVax family truly works with multiple cancers, if the company remained independent, can't you see it having a market cap that's over $100 billion some day. I don't know that it will remain completely independent, but I think a BP partner could emerge and keep it that way.
Let's get the unblinded results from DCVax-L and some more data from Direct and then maybe we can better access what we believe the company could be worth after 1 year, 5 years, and perhaps 10 years.
Of course few shares work as well, just look at Berkshire Hathaway, but personally I prefer something I can purchase by the hundreds or thousands of shares.
Gary
For all who believe the next two weeks are business as usual, I really believe you should consider that many companies close between Xmas and NY. I was told by a broker decades ago that while the markets are open, most senior management take vacations, and as he put it, the kids are allowed to play. Sometimes the kids do like to move certain stocks, you just never know for certain what they'll do.
I would suspect that if NWBO is in the process of unblinding and summarizing the data, many who would be involved in the effort will probably be taking off at least some of the time in the next two weeks beyond the two holidays themselves. Note the stock market closes early on the 24th, but not on December 31st. As I understand selling for losses or gain, you can do it right up to the 31st, it's when you declare it that will count, even though the transaction isn't necessarily recorded the day you initiate it.
Perhaps the company will surprise us, but I'm not counting on it. If some of the junior stockbrokers or market makers decide to play with NWBO, no telling whether they intend to move it up, or down, but without real news, they won't move it that far. I don't believe many investors will be selling for tax losses based on this years prices, but if you've owned it many years, and need a loss, you might do so, but remember to wait 31 days to buy back in, based on the wash rules. Whenever I do that with a stock I really wish to keep I purchase as much as I wish to sell before the end of November, then I can sell at the end of December at no risk of being out of the company should good news come in January. I wouldn't want to be out of this company in January.
Season's Greetings all,
Gary
I think if you check back far enough you'll see CVM has done reverse splits a few times, also that the drug in Phase 3 has been used in many Phase 3 Trials and failed many times before, I'll guess it will do it again.
CVM simply does a find and replace all the paperwork they issue and now they're testing their drug in a new disease rather than the old one they previously issued the paper for. The FDA is fine with them spending the money as they wish as long as their drug is safe, which was proven years ago. As for effective, sadly it's still a drug in search of a disease, maybe this time they found it, but I doubt it.
Gary
Please correct me if something I believe here is wrong. I believe that for each patient in the trial they already know what patient population they should be put in. I believe they know how long they lived before progression was noted, and for those where they could differentiate, was it pseudoprogression, then actual progression if it later occurred. If they passed on they know when. They also know if they did receive the vaccine by reaching the second round of treatment as a crossed over patient, or not.
What they don't know is who initially received the vaccine, and who didn't. When they unblind the trial they'll learn who received the vaccine from the initial treatment. They will also want to verify that all who were living the last time they checked still are, or if anyone has passed away, and if so when.
I believe at that time they'll have all they need to announce top line data, as well as to create the full documentation of the trial. I would think that it might take a few days to attempt to communicate with all who're still living in the trial, and perhaps one or two might initially be called LTFU in order to announce TLD, but they'll be found by the time the complete data is reported. In short, TLD is a few paragraphs which describes in summary what they see on unblinding the trial, it certainly can conclude that patients had a substantial benefit, but it won't tell people all they would like to know, that comes when all the data is presented for peer review at a conference, like ASCO, or in a major technical publication.
In short, after unblinding I believe it could be a week or two to announce top line data, but I cannot see a month or more, as some here seem to think.
The unblinding might be occurring right now, and if so, some of the clinician and patients alive in the trial may be on vacation, so that could add a little time, but if that's the case, they'll be back shortly after New Year's. I believe that before the end of January we could be much happier investors.
Happy Holiday's all,
Gary
I've got to admit that I'm taking a loss today. Why? Because many months ago, before the reverse split was discussed, I believed the company would reach $1 before the years end, I purchase options for a nickle. Today they will expire worthless, as the R/S changed them to $10, and each option only represented 10 shares. This gamble clearly didn't pay off, but I still believe my holdings in the stock will, and when I have the opportunity, I expect to purchase additional shares.
Gary
You're probably right, but I would hope it has a long way to go from there.
I can understand it being difficult to acquire funds at these share prices, yet other penny stocks still do it all the time, so it's not impossible. Now that they have a patent approved, what really remains for success is proving what's patented actually works.
It's probably been nearly 50 years since I heard the story of how the Trinitron picture tube was patented. In short a group of engineers looked at all the ways a color image could be generated in a picture tube. They found that what became the Trinitron tube wasn't patented, so they patented it. When the tube was actually built it produced a superior picture and the Sony Trinitron TV was created. I believe by the end of tubes being used for color TV's, most used the Trinitron tube, and those who patented it were very wealthy. I don't know the same thing will happen here, but if our cream is truly effective, I don't know that others won't be paying us to make a similar cream that essentially is utilizing out patent.
This company could make a tremendous move with virtually no notice, how, someone with adequate funds could partner either for the cream, or the entire company. While I don't expect that until at least some clinical results are seen from the cream, I cannot say that hasn't already occurred, without being reported. Why do I say this, because OWCP had agreements with some other companies, and I cannot say what some of them may have tried. An investor who visited the company some time ago had been permitted to smear on some cream, just to see how it felt, so clearly the cream was available. While no clinical trial has been run outside the Phase 1 trial done in healthy patients, who can say no cream found it's way into the hands of someone with psoriasis, acne, etc, and if it has, someone may have anecdotal knowledge of efficacy, and that might be all that's needed to gain a partner.
Right now the company is in a Catch 22 situation. If they had funds they could prove their patented product works, and if the product worked, they'd get funds.
Gary
Gary
I believe that if they knew they were taking in billions, they could buy back the warrants, etc to give them the flexibility of selling shares. The key to the partner having an equity interest would be the partner funding much, if not all the trials in the future. If much of the money they paid went to repurchasing shares, warrants, etc the company would still be in great shape if future development was essentially funded by the partner.
Worst case, the whole thing had to be voted and approved by the current shareholders. I cannot imagine any of us turning it down even if they either added to the authorized shares, or threw in a reverse split, as long as in the end your shares were worth a multiple of what they are today. While I certainly like the share count I currently hold, if it were halved, or even quartered, but my net worth was dramatically higher, I think I could live with it.
What I cannot tell you is whether the company controls sufficient shares to not even require the rest of us to vote. I've seen a few companies who dictated such things to investors as they simply held over 50% of all the shares. I don't believe that's the case here, but I don't know it.
Gary
Sorry for the multiple posts, I don't know what was wrong with I-H but it also wouldn't let me delete or edit them.
For those who may be leaving on Holiday after today, the Happiest of Season's Greeting.
As someone who'd Jewish, I like the timing of our holidays this year as if you give presents for 8 days, the last of them can be purchased at after Xmas prices. Perhaps they should do this every year. Frankly it's no longer something we do, but it's fun to put it out there.
I really don't care what people's faith is, I believe this is one of the best times of the year and believe it brings out some of our better angels. It's too bad we cannot keep the spirit going all year long.
Gary
Let's talk about timing of the TLD release. Let's say that it would be possible to release it on December 24th, before the open, when would the company choose to release it?
Releasing it immediately would certainly give shareholders a nice Xmas present, but let's look at the impact. I'm not certain, but I think that day may only be a half day of trading, probably not the best timing.
Then lets look at the entire Holiday period, from next Monday to the Friday after New Years many of the senior personnel at brokerages, institutions, MM's, and individual investors are on vacation. I suspect that many at the company may be in that status as well.
I'm not saying it cannot happen over this period, but perhaps for the greatest impact they wait till Wall St. is back to work on the second week in January. If that's the case, I'd be happy to take it as a belated holiday's present. That being said, they'll probably release it next Monday, but I hadn't included that in my scenario.
Gary
Doc,
Technically you know far more than I do, but I certainly agree with what you're saying. Merck may have the inside track, but top line results could bring in many others who'd like to be in this technology. A bidding war doesn't have to be for a buyout, a partnership could also go to the best bidder.
It's unclear to me if the company already has confidentiality agreements in place with one or more companies. If they do, those companies are actually able to look at the unblinded data as quickly as the company is, I.E. before we see top line results. Under confidentiality, these companies would actually be prev-vie to all the information that will ultimately be presented at ASCO or elsewhere. They could develop the presentation themselves from all they can see if they so chose, but while I doubt they'd do it, they would fully understand what will be there when it's done.
I believe it's a partnership for DCVax-L that will fund DCVax-Direct, the question may be, will the partner have an ownership position in the company, or just in L, that won't be answered until we have a partnership. I suspect they'll want a percentage ownership in the company, but they may have a greater percentage by owning an interest in L. I would hope that any shares a partner acquires come at a price that's dramatically higher than current prices, essentially moving the share price to that price. Some of those shares may come directly from the company, but ideally some would come from stockholders tindering their shares at the established price. Hopefully the price we're discussing puts the market cap at at least a few billion dollars, perhaps higher than that.
Gary
If you're speaking of $2 to $5 billion in a buyout, I believe it would be a bargain unless further testing proves that DCVax-L and Direct only work in GBM, and they still have a long way to go before approval.
I wish I were more technically knowledgeable about what we hold, but I'm not, but best I can tell, our vaccines have been tried, and anecdotally succeeded in cancers beyond GBM. Certainly it may not work in every cancer, but what if instead of just GBM it also works in one other, or two others, or three others. The point is, we don't know, but would you sell off the company without having any indication of what the vaccine may do beyond GBM.
I'd like to see a partnership, and I believe such a partnership could bring in hundreds of millions if they don't take an equity position, perhaps a billion or more if they do. Without taking an equity position in the company, they might have say a 35% interest in DCVax-L alone. In some cases I've seen a company partner where they took say a 30% interest in a specific drug, as well as a 30% interest in the company. If a billion dollars was earned from sales of the drug, 30% would go directly to them as they own 30% of it, in addition their net worth would reflect what happened to the stock with $700 million in earnings. In some cases I believe that such a partnership can actually be more lucrative than acquiring the company because the increase in share price of the independent biotech may very well be greater than all the earnings from product sales. I should note that if you do own 30% of a company you essentially have control of it as it's almost impossible to defeat you in a voting situation.
Gary
Doc,
I frankly don't know how high the top price could be if DCVax-Direct is proven in multiple cancers, just that alone could bring triple digit billions. What I don't know is how quickly a trial that proves that can be put in place. I don't think the FDA or other regulators would go for a trial that say had ten forms of cancer being targeted with only 30 patients in each cancer. I tend to think they'd want to see something closer to 100 patients, or more, in each targeted group, and such a trial would be very expensive, and take many years. I'm not sure we need that for a partnership that recognizes the potential of the drug, perhaps ten cancers with 5 patients each would convince them, but that would just be a tiny part of the entire trial the regulators would demand.
I'd love to see a trial that went after say 10 different cancers, I'm just not sure the regulators won't insist on one trial for each cancer. Anything is possible, but there is a cost in time and money, it will either take a partnership to afford it, or waiting until substantial revenue is coming in from sales of DCVax-L.
Gary
Doc,
While all you've said seems true, I believe much the same can be said of many tiny biotech's who've run trials in a manner similar to NWBO. As bizarre as some of the actions the company has taken may seem, it's nothing that hasn't been done in the past by others, and the key is keeping the company in business until they achieve the sort of success where they no longer need to resort to such actions. That doesn't necessarily mean once they have an approval, the initial success might very well come in the form of a partnership, or perhaps even a buyout.
I'm of the belief that Top Line Data for DCVax-L plus additional positive data from DCVax-Direct could potentially bring in a buyout offer worthy of consideration before either product is approved. It's been said that $20 billion has been thought to be roughly what the company wanted, such an offer won't come until the market cap is roughly half that, but really solid data from both products just might do that.
Gary
The deadline for ASCO is February 11th, so I believe we'll see TLD before then. I believe they can upgrade the Abstract for some additional period of time, but they need to send them something acceptable in the first place by the deadline.
Gary
Please correct me if I'm wrong, but I believe the top line data will be a summary that should impress all of us. I believe it will include things like how many from the trial are still alive, median survival, perhaps top 100 survival information, in short, it should be enough information to truly feel positive about the outcome, and the likelihood that it should be approved. I believe it will discuss targets established in the SAP, and how the data relates to meeting the targets. It may very well indicate that all targets haven't been met, but I believe it will be positive enough that investors believe that some, if not all regulators will approve it's use.
The details, such as the K-M curves, will be displayed at ASCO or a similar conference, or possibly in a technical publication. It's not impossible for them to roll out the trial in more than one presentation, but if you want to present at ASCO, there must be something new that's presented at ASCO.
Investors will learn of anything new that's presented at any of the technical conferences, or presentations. Between unblinding and ASCO Dr. Liau or others may very well speak elsewhere, in some cases their presentations may even be webcast, so some additional information should almost certainly come out, it just won't be as complete as what should be presented at ASCO if that's the conference they choose to present everything at.
For now, we don't know if they're already working on unblinding the trial as we write about it. We'd all love to see TLD by Xmas, or New Years, but if it's not till next year, so be it.
My old stock broker used to say that the next few weeks are when the junior people in most of the brokers and MM's offices are running the show. Why? Because most of the senior people are on vacation. As he would say, sometimes the kids decide to see what they can do with a stock with their new found power. We'll see is some of them would like to run up NWBO on no news, if that's the fact, nothing happens from the company between now and then. Things will probably get back to normal the week after New Year's.
Whether we're up, or down, have a very Happy Holiday's All.
Gary
ASCO is not where TLD is released, that's something the company will put out in a statement that all can see. At conferences like ASCO the complete data established in the trial will be reported. Because of the complexity of the trial, it will probably have at least a few scenarios with K-M plots for each, as well as an overall one. In short, it will be a very complex presentation, and the purpose for making it is peer review. Once such a presentation is made, the company is free to release all the information to investors.
Companies interested in a partnership or buyout can see all this information much sooner, but they do so under confidentiality agreements. After reviewing the data, they're free to offer a partnership, buyout, etc, but they cannot reveal what they've seen until it's presented for peer review. In reality, the TLD will be telling investors much of what they want to know, the full presentation fills in the details.
Gary
I think it's very possible that Duffy has come to us for a purely personal reason. At Merck he's one of many people building Merck, while successful, he's one of many having similar success. In NWBO he may be seeing the opportunity to be a big part of a tiny company that's about to explode and will truly be a key person in that growth.
I believe shares in NWBO have the potential to grow to ten to one hundred times or more what they are today over the next five years. Merck's growth would be considered excellent if it doubled over the next five years.
I can't say we won't be bought out over the next five years, I think the odds are better than even. What sort of gain do you think that Mr. Duffy may make by the time it is bought out by comparison to what he might make at Merck over the same period of time.
Sure, it's possible with his contacts that Merck has the inside track to a buyout, but I don't believe that NWBO's achievements will be unnoticed by the other BP's, so it's far from a guarantee that Merck will make the best offer.
Roche has a habit of buying into companies, they often then buy them out, then they turn around and spin them off again, always retaining at least 30% or greater ownership, so as they desire, they can do it all over again. Genentech is a great example of this, it's now wholly owned by Roche again, but if they wished to, it's positioned to spin off again, and bring in tens or hundreds of billions. I believe we'll see a partnership first, and if that partner takes an equity interest, they'll certainly have the inside track, but it's not a guarantee.
Gary
At this point I believe the SAP may very well have been accepted and they're gathering the data, if so it would mean they unblinded, but they're not going to say so. They'll release top line data and then we'll know.
I don't know this for certain, it's just something I've observed most of the time from biotechs. Investors always think every move should be announced, but that's not what the majority of these companies do. Top line data is by definition something that's announced. If they had a partner paying them for certain milestone events, if one milestone were unblinding the trial, then it would be a material event, so it would be announced, but we have no such partnership and no milestones, so I doubt if they'll be announcements until top line data is released.
And yes, I believe our lump of coal could end up to be a diamond.
Gary
I believe if the measures being voted on fail, and if Hirsch writes a letter to shareholders explaining how they intend to go forward with trials of the cream, and perhaps the status of other patents which he believes are close to approval, our share price could very well reach a nickle, or more.
If the price were a nickle, and communications continued with management, and if they reported the start of the Phase 2 Trial, then reported some early observations from the trial, if positive, a dime most certainly, and perhaps a quarter would come into play.
I'm not suggesting it will move back to all time highs, at least not for some time, but if the cream is truly effective, it won't take that long to prove it.
Gary
Jimmy Kimmel a couple years ago teamed up with a musical group on a Xmas song based on what they could do with a lump of coal. It was called Joel, Joel the Lump of Coal as I remember it, and is probably available on U-Tube. I thought the result delightful.
What do you imagine the lump of coal became?
Gary
Perhaps we've misidentified the goose, thinking it began as an ugly duckling, but it is becoming a magnificent swan that lays only jumbo sized gold eggs.
I loved your post.
Gary
I believe that cancer treatment has to consider much more than surrogate endpoints, quality of life needs to be a bigger part of the picture. Certainly survival cannot be ignored, and I can't blame drug developers from wanting trials to end before substantial survival data can be gathered for diseases where patients live years, or even decades, but such trials should continue as Phase 4's where patients prescribed the drugs are tracked to the point the FDA is totally satisfied there is a survival benefit, if that's the only justification for its approval.
I believe quality of life isn't given adequate consideration. When the SOC has negative side effects and the experimental treatment has lesser effects, shouldn't it be available even if it doesn't improve on PFS, etc. In fact, even if people will sacrifice some duration for higher quality, isn't that something that ought to be open for the patients and Doctors to consider.
I believe our vaccine provides a better quality of life, and while I believe it also has survival benefits, I think it should be approved on both considerations. Even if the survival benefit weren't great, a higher quality of life should be the basis of getting more drugs approved.
Gary
I realize that, but I don't believe back then you had an IR person essentially telling you how close we are to making it happen. I cannot say they have no more issues with the regulators, and I believe that's what has held things up, but I believe we're very close. In fact we may be beyond SAP submission issues and now be working on unblinding, we simply don't know. I suspect the first thing that becomes public will be, here is the Top Line Data for the trial.
In most trials that I've followed the companies never announced the end of the trial, they didn't say we'll be issuing TLD on a date specific, it just suddenly was there.
For anyone who follows IMGN, this morning they announced a quicker path to approval and held a conference call before the opening. Their was absolutely no indication this was happening, though the price was up yesterday, so someone may have known. My point is, companies do things, they don't pre-announce they're doing it, they just do it.
It's possible that NWBO will tell us more, but I suspect it won't be anything more than paying attention to what DI is telling investors, no formal announcement, just guidance.
Gary
I believe today's news opens the door to a ROW partnership IMGN has frequently spoken about, which would answer all financial concerns. I just hope they maintain their insistence on keeping at least the U.S. market to themselves.
Gary
It seems to me that NWBO has been working on this much longer. If that's the case, you have to wonder if others may be violating patents that NWBO has in place, even if the vaccine is for a different cancer.
I believe it's clear that our vaccines may work in many cancers, GBM was selected, I believe because it's so deadly and fast acting, but certainly not the only target they could try.
While it would be a Happy Holiday's gift if TLD were out this year, but what's important is that it gets out, ideally in time to submit an Abstract for ASCO. The deadline for that is February 11th, as I remember it.
Gary
I think investors need to recognize where we are, not just where we want to be. On the OTC markets, SEC regulations are often totally ignore until companies are looking to make a move up. In some cases I've seen years of quarterly and annual reports issued in a matter of weeks, and at that time their status was elevated as the company wished.
I'm not suggesting the company ignore regulations, but if the Annual Meeting would be far more beneficial to shareholders if it were conducted a few weeks late in order to openly discuss the trial, after it was unblinded, I don't think they should be concerned by such a delay. I also believe it's logical to hold the meeting at a time after the end of the fiscal year that's sufficient to discuss the prior years results. If something needs to be changed to support such actions, I believe it should be done. Other companies have their Annual Meetings scattered all over the calendar, I see no reason why ours needs to be before the calendar years end.
I would hope that by this time next year we're preparing to move up to the Nasdaq, or other major exchange. Once that's done compliance with rules becomes more important, but in almost every case these exchanges will approve requested delay that is reasonable. I believe the way the company is staffing up, they should be able to do things properly as we go into the future.
Gary
Something appears to be happening, some speculating it could be Oriental partnership. Perhaps news before the Holidays.
Gary
It seems to me that NWBO's fiscal year ends in December, to me it's logical they hold their Annual Meeting after they can speak about the entire fiscal year. February sounds reasonable, it also is when the ASCO deadline for Abstracts occurs, something nice to announce at the Annual Meeting.
I believe they get extra time for reporting annual results along with 4th quarter results. It may be March before the results are reported, but I'm not certain of that.
Gary
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