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Rufus,
I believe anything is possible, but we need clinical confirmation, or at least anecdotal confirmation. One beauty of treating psoriasis is that photos can speak for themselves. A picture of someone suffering with the disease before treatment is initiated, and a few weeks or a month or so later showing dramatic improvement would probably sell a lot of cream, even if it didn't have FDA approval. There may be laws preventing such photos from being used with few people tested, but if done under the control of a clinical trial, they could be convincing.
The thing is, what should the share price be knowing we have the patent, as well as plans to try the cream in a clinical trial. I really can't say how high it should be, but I believe over $.05 is very possible, perhaps a dime, or even a quarter is possible near term. Long term, what would it be worth if clinical trials proved the cream worked on a variety of skin diseases. To me, I believe blockbuster sales would be possible, i.e. over a billion annually. Right now our market cap is under $7 million, I certainly believe that ten times that is warranted if anecdotal proof of efficacy is seen with the cream. If we had clinical proof of efficacy, one hundred times that would be fair, and by clinical proof, I'm speaking of promising Phase 2 results, not what the regulators would insist on for approval. Approval would almost certainly take the market cap to billions.
Market cap, not share price, is the way companies should be measured. Look at practically any biotech where approval is anticipated in a year or so and the market cap is likely to be near a billion or more. Post approval it normally reaches into billions. Certainly by the time OWCP has an approved drug more shares will be issued, perhaps even double or more what's currently outstanding.
We currently have over 250 million shares outstanding, if the share price rose to $.25, and if management wished to do a small reverse split, one for five or less, I could understand that, but nothing like the one for up to seven hundred that they proposed. I frankly see no reason the existing shares need to be brought significantly below roughly 100 million shares so one for two or three really works for me.
The point is, if the cream works, even without a R/S we should be trading above a dollar once we have proof it works. That's really all that's needed to eventually move it to the Nasdaq as trials move it to actual regulatory approval. At some point a BP or other company who can distribute and sell product worldwide, or regionally, will partner with OWCP and fund the additionally needed trials.
Gary
I believe you're right, getting in before TLD is a great investment opportunity. The funny thing is that while small investors make the greatest percentage rewards getting in this way, history also shows that Institutions make the biggest dollar gains, and most of the time they won't invest until the share price is $5 or more.
For an individual investor who gets in say at a quarter, and sells to an Institution at $5, they've earned twenty times their original investment, but think of the dollars an Institution makes taking it from $5 to $25, it's far more dollars, though it's only five times their original investment. I'm certainly not saying don't sell, but I'm suggesting don't sell everything just because Institutions want to buy it. Of course if their is a buyout, it's out of everyone's control, we'll be well rewarded, but the only choice will be either taking the cash, or stock in the company acquiring it if that's an option. Personally I'd rather have my money in small biotech's capable of explosive growth than a BP, but with enough money, it probably is smart to have some of both.
Gary
I certainly could be wrong, but I don't believe the company will announce unblinding, nor do I believe that they'll say when they anticipate top line data will be announced. Perhaps some may know, and volume and perhaps price may do something before it happens, but I suspect that it will suddenly just happen.
Here on the West Coast I generally don't get up until roughly an hour or more after the open. I'll know somethings happened when I look at my stock quotes, and without looking I'll know they released TLD. I normally check quotes on my phone, once I see them, I'll probably head to the computer to learn more, though I can do it on the phone as well. I simply prefer to post using the computer when I can.
I cannot say that DI won't give people a hint at what may be happening, I just don't believe the company will issue a PR before TLD. I doubt it will happen before January 6th, when brokerages, MM's, and Institutions are all essentially back to being fully staffed. I would expect the news to drop before the market open. I don't know if such an announcement might garner an invitation to the JP Morgan Healthcare Conference, should it happen before it, but that conference essentially kicks off the year in the healthcare area, others follow, and once results are announced I suspect the company will be speaking at many of them.
Gary
Please don't use me as an expert, I'm just trying to apply logic, and to me it's logical to want to present the complete data on the Phase 3 Trial at ASCO. I've only been invested a little over a year, I've just read about all the things many of you have experienced that clearly frustrate most investors, at least in this company, but I've witnessed much the same in other companies. I certainly believe that LP is feathering her own nest well, but with success it will benefit all who stay with her. From what I've gathered, she was very well off without NWBO, so with all she's done, while ultimately having great financial benefit to her, without it the company might very well have folded, or needed someone else to go to similar measures, so I'll not put her down for keeping the company in business.
I believe that Dave is being sincere in telling us what he can, and is careful not to commit to something which may not happen on schedule. I believe all the company is saying should happen will happen in time, but clearly not everything happens as quickly as they, or investors, think it should. I do believe the SAP is done, so at this point the company, not others, should be in control of when they can release top line data, and when they can present it for peer review.
January could be a great month for investors if I'm right about ASCO as I believe at some point in January they will release top line data. It may already be unblinded, that's something most companies don't generally announce, and I suspect that's the case here as well. Summarizing all that's happened in over a decade in trial into a matter of a few paragraphs is something that needs some time to get it right. In reality, most such releases, even for drugs which have no trouble gaining approval, may not seem as optimistic as the results really are because the regulators, both SEC and FDA, abhor what they consider hype. I would certainly hope they tell us how many patients remain alive, and that they update the prior figures given for the top 100 by Dr. Liau. I would also hope they draw comparisons between historical data and what occurred in the trial. Because of the cross overs, I really doubt that they can accurately say what would have occurred had the entire control been run without cross overs. In reality this trial permitted most in it to gain advantage of the vaccine, and I suspect that those who didn't choose to may have passed on before they had the opportunity. I wouldn't be at all surprised if every patient still alive received the vaccine either up front, or on crossing over. That's the sort of information I hope we'll hear in top line data. When the company presents at ASCO or other peer review opportunities you'll see a variety of better technical information, probably several different K-M plots, etc, but it won't be in the top line data.
Gary
You're correct, but how much cream would be sold if it's sold as a drug by prescription, rather than OTC. Plus, if approved, it should be able to be sold everywhere, while in that it contains THC it would only be able to be sold where cannabis is legalized in cannabis stores.
The point is that, without clinical trials it could probably be on the shelves where it's legal today, with zero proof of efficacy. The company want's to be a cannabis based biotech, and biotech's don't sell unproven products. If in fact they have FDA approval, I suspect they'll also be much better positioned to go after other look alike products for patent violation, even if they're not exactly the same.
Gary
I certainly hope you're right. While I still fully intend to sell a few of the shares I've purchased to establish a tax loss, I've moved up my limit price twice in the last few days, and won't hesitate to move it up again before I sell for sure on Tuesday. At this point I'm keeping far more share than I originally planned, and who knows, perhaps before the end of next year they'll be very profitable.
While I certainly don't believe an FDA approval for the cream is possible next year, I do believe that we'll get information demonstrating that it's worthy of approval then, and we'll have a path forward to approval by the end of the year. If in addition we get other patent approvals no telling how high the stock could go in the coming year.
Season's Greetings,
Gary
I've been involved with several biotech's over the years and I cannot remember a single one where investors felt they were getting all the information they should. I'm not saying NWBO is perfect, but it's not that different from most in biotech, and a lot of other industries for that matter. About the only company I've seen that provides an excess of information to investors is on the Pinks, and routinely is pumping up the price, and selling more stock. I know some here believe in CVM, but I find them to be one of that type of company and will be very surprised if their Phase 3 Trial leads to an approved product. Frankly I believe it's been 20 years or more since I made a small investment in it, at the time it's symbol was HIV and the very same drug they're testing today was being touted as the solution to AIDS, they changed the symbol when that failed.
I read a lot of technical information here, much that goes over my head, but what I believe is undeniable is all the people who're alive in the trial. The FDA may not see it that way, but I believe people living with diseases considered a death sentence is the biggest reason a drug should be approved.
Gary
I believe that much may depend on who's treating you, and how much they fight for what they want. As a patient at City of Hope, I don't know of any test, scan, drug, etc that was denied after COH worked with whoever was necessary to get it authorized. On a few occasions it took a couple days for an authorization, but I got what the Doctor wanted.
My internist is offering concierge services, if you pay for it, he'll include fighting the drug company, and other things for what he'd like for the patient at no added charge. If you don't go for it, if he prescribes a drug, and the insurance turns it down, he'll fight for it at an additional fee, or he'll prescribe something else that they may go along with without a fight. I was recently prescribed something new, but he indicated a genetic was acceptable, and as fate had it, a generic just became available, no fight. The druggist questioned whether the prescription would be authorized until she found the generic, then it was no problem.
I mention this because I think it illustrates what's wrong. To begin with, the company originally supplying the drugs could price them lower if they knew they'd maintain patent rights longer. Secondly after all costs and a reasonable profit was achieved they would lower prices somewhat for even longer patent protection. In short, if prices came down sufficiently, many drugs wouldn't be challenged by generics which in the long term would benefit the original developer. Overall cost would go down, but companies would be as or more profitable than ever before.
Gary
There really isn't any reason for management not to play it straight from here, all of them hold substantial portfolios in the stock, what could be better than legitimately hitting a ten to one hundred banger with the news that should be upcoming in the not that distant future.
I certainly agree that management has done some bizarre things to keep the company viable, but sometimes such action is needed to do it. Could others have done it differently, certainly, but it's hard to say whether they'd have done it better or worse. If the trial news is as positive as most here believe, we'll all be well rewarded, and that naturally includes those in corporate management, and perhaps employees if they've invested in the company.
It's easy to criticize management, it's somewhat different when you're the one making the decisions.
Happy Holiday's,
Gary
You certainly could be right, I'm no expert about such things, but if true over 4 years after the treatment was initiated, it may predict that it's still working. I would suspect that many patient 4 years or more after initial treatment are in reasonably good health, but we all know that while cancers may be considered cured after 5 years, they frequently return. It's sad but the word cure is probably less frequently used, in remission is probably a better way of referring to a cancer.
Happy Holiday's,
Gary
While you may be right, I wonder what sort of surrogate endpoint would be necessary when all patients still alive in the trial have survived for at least 4 years, many much longer.
I would think that all current survivors would be evaluated either by the clinicians or their current doctors to classify their current status. I think they could be put into a few broad categories. One would certainly be those who appear to be a no current risk as no cancer can currently be found. Another would still have discernible cancer, but no progression observable. Others would be progressing, and some may be in hospital or hospice care and considered critical.
Perhaps if you had all this information you might be able to predict, for instance, where the median for the Top 100 would end up, but then you could probably look at the Top 50, and that would keep advancing. We really have little or no knowledge about the living, if most of them essentially are in complete remission, that median for the Top 100 could exceed a decade by a decade from now. I don't know that they'll look back at the trial after that much time, but it would be interesting to learn what they'd see if they did.
Other than the current status of all those still living, I don't know that they have much they can estimate. I wouldn't be surprised if many of the Top 100 lived to the point that it wasn't GBM that ended their lives.
I certainly don't know, but for discussion let's say that 50 of the top 100 are in complete remission, no cancer can be found. If that were the case, how would the anticipated life span of these people be figured. I don't believe the K-M plots have a provision for noting that certain patients seen on the plot are in complete remission and potentially could live decades longer. In reality, these people could be spread over the entire curve beyond 49 months from its origin.
Happy Holiday's all,
Gary
A very Happy Birthday Captain,
I'll be 11 years your senior toward the end of January, I believe by that time we'll have the top line data so they can include them in an Abstract for ASCO due by February 11th.
I believe by the time you turn 67 you will be thrilled with your investment in NWBO.
Gary
I'm not praising dilution, but if that's what keeps companies alive, and sometimes flourishing, it's acceptable to me.
I've been involved in IMGN essentially since it came public, and have watched SGEN from the time it came public. SGEN freely diluted while IMGN was much more restrained on using shares. I still believe IMGN's technology to be equal to, or better than SGEN's, yet look at the share price and market cap difference. SGEN clearly built on the capital it raised, while IMGN failed to do so, monetizing what assets it had. I still believe in the future it will do better, but it was a big mistake not investing in SGEN.
Perhaps it could have been done differently, but if in the end NWBO has a multi-billion dollar market cap, investors should do very well. Without the dilution it's doubtful they wouldn't have gone belly up, I'll accept the dilution.
Gary
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