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It seems to me that push has finally come to shove. We now have a patent approval for the cream, now it's up to the company to prove it works. We know it's safe, the Phase 1 Trial told us so, but that was done with healthy patients. Phase 2 is where we can demonstrate efficacy, perhaps in multiple indications. We know they did preclinical work with psoriasis, but it's been expressed that it could also work on acne, eczema, etc.. I know they have Israeli hospitals line up to do this trial, but with patent approval, and perhaps a partner in time, this trial could be expanded to other nations, perhaps even the U.S.
Many drugs do work preclinically, sadly they fail in the clinic. Let's hope that's not the case here. I don't know that it's never been tried with someone who had psoriasis, but they'd never admit if it was, or wasn't, that's not the proper way of doing it.
It would be my contention that a few months after initiating a trial on psoriasis, the results should become apparent. Other skin diseases might clearly show benefits even faster. I believe that if benefits are clear, even if the trial is intended to run for a year or more, a potential partner will be able to make up their mind after a few months time. Such a partnership would assure OWCP of all the funding they'd need to not only put the cream through Phase 3, but also continue development of other products. They've at least proven they can gain a patent, now it's time to see what the patented product can do, as well as securing additional patents.
Gary
I've been away most of the day and just getting caught up, it appears to me that Dr. Bosch made a solid presentation, and it makes me believe top line data ought to be seen by the holiday's, or sooner, but he didn't bring it up to 2019, the data's essentially what Dr. Liau previously presented. Please correct me if something specific was revealed that hadn't previously been.
That said, I'm speculating that the company would rather surprise the world with just how many people are still alive, how high the median has gone for the Top 100 etc by putting out where things stand for 2019 with the full unblinding of the trial. Clearly Dr. Bosch's presentation didn't excite the market at the end of the day, but perhaps it will spur it as it's digested overnight.
If the company is currently speaking with potential partners, or buyers, we may be in the period where they're privy to what the clinicians are seeing and saying as the trial is unblinded. Under confidentiality agreements they should be free to speak with and see everything that the company is gaining access to. I don't know that anything would happen as, or before they announce top line data, but it could be possible.
There are no guarantees, but this could be a very Happy Holiday's.
Gary
The problem is the SAP is how the trial will be judged, the criteria must be established before the trial is unblinded. I know the regulators can play games, and perhaps if it's accepted by a majority the company should just do it, but only if one regulator is clearly just playing games.
I believe we're well into the home stretch, it would be a shame to stumble just before the finish. I think we should let the company do what they believe is right, if it takes a little longer, so be it. We know a lot of people in the trial are still alive, I don't believe it's possible to ignore this fact, and even if the trial had some problems, it's impossible not to conclude the vaccine saved lives and that should warrant approvals.
Gary
I would suspect that the regulators have until a date certain to comment on the SAP, as long as they don't request a change, that date will be when they can unblind. The problem is, if they do comment, the whole review starts over when a revised SAP is submitted. It's a presumptive approval after XX number of days, but they must be given all those days and it's not uncommon for them to wait to the last day to request something more.
Perhaps tomorrow something will be said by Dr. Bosch, and the company will issue a PR to let all of us know, but I'm not relying on that to happen.
Gary
Thanks, I went on to the next video which was one of my favorite sports moments, Kirk Gibson's World Series home run. Truly a wonderful memory, especially for an L.A. native.
Barring some release by the company, I don't think Dr. Bosch has been given the tools necessary for a home run tomorrow. Sure, he can be enthusiastic and tell a strong story, but without unblinding he can't really conclude it. I believe if he were able to tell the full story, the company would find a way to webcast his presentation.
Gary
Out of curiosity, does anyone know what happened with this clinical trial.
https://clinicaltrials.gov/ct2/show/NCT03638765?term=DCVax-Direct&draw=2&rank=2
Gary
Flipper,
I certainly hope you're right, but sustaining a $5 billion market cap, so as to attract an even bigger buyout price, isn't something I've previously observed prior to FDA approval in other companies. A few billion, yes, even more with a partnership, but I believe $5 billion or more with neither partnership or FDA approval is certainly a reasonable high, but I find it hard to believe it will be sustained. It could easily be exceeded with either a partnership, or regulatory approval anywhere, as both would begin to initiate substantial funding and earnings.
I really cannot say if regulators other than the FDA can act dramatically faster, but I'd be very surprised to see FDA action before the end of next year, at the earliest, if a BLA is filed by mid year.
I don't believe a buyout can be a large multiple of an emotional high, but it can be at a sustained high. If a price of $5 is sustained, a $15 buyout could be reasonable, just a little more than that and you have $20, but that's the extreme. Most buyouts aren't more than double the current price, and many are less than 50% above the current price.
It's my belief that a company looking to acquire another company where the price is agreed on will help boost the stock price toward that price to not be viewed as overpaying for what they purchased. A BP would be chastised by its shareholders if it bid 5 times what a company was selling for, but if that company rose to half the offering price in a matter of days or weeks before the offer, it would be no problem. I still believe more about Direct is needed to bring numbers like $20 billion, but that could be possible in a year or so.
Gary
Marzan,
The THOR buyout is impressive, but remember, it's just over $2 billion and they have 30+ million shares outstanding. We have over half a billion shares outstanding, and with the conversions of warrants, etc. we are near a billion. A $2 billion buyout would bring us $2+ in share price, if we're looking for $20, it will take a $20 billion offer unless the company reduces the number of shares.
I certainly don't want a reverse split, but if a partner came in with substantial funds, a share buyback might bring the numbers down somewhat, but we're still probably going to have half a billion or more. If we had the O/S at half a billion, we'd need a $10 billion offer for a $20 share price. It's certainly possible in a couple years, but I don't see it happening next year.
Of course I've left out something that could be very important, emotion. If some major press exposure was given to DCVax-L, major national news, a front page story in the likes of the Wall St. Journal or NY Times, etc no telling how high the stock could go as people see the cheap share prices, and fail to recognize how large the O/S is. If emotion did drive the price to $5, $10, or more, while I typically am not a swing trader, I would change my way of thinking and probably consider establishing a trailing stop loss position in all my shares. I'd raise them as the stock was moving up, and look to buy back in when the market cap was back to the couple billion area, where I believe it belongs after solid news from Phase 3. There is no telling how high emotion can take a stock, years ago a NY Times article on Judah Folkman curing mice took a single digit stock to over $100, it wasn't long before it came back down to earth.
Most here know I've been involved with IMGN essentially since it became public. It's risen to over $40 and fallen to below $1 over all these years. I still believe in it's potential, but today its market cap is back under $1 billion in the belief that a new approved drugs is still years off. The previously approved drug, Kadcyla, has been totally monetized, so no further financial benefits will be seen from it. My point is that success in the clinic can only bring stock success when it brings in substantial and routinely growing revenue. In IMGN's case, the needs for funds now resulted in forfeiting all future fund growth. As much as I dislike dilution, IMGN would have been better off maintaining it's milestone and royalty income through dilution and/or partnerships. NWBO certainly has diluted, but in doing so, it's not given away its intellectual property.
Gary
I had stated that about Direct before, but failed to mention it in my earlier post, but I believe it can occur quicker than you believe, depending on how the Phase 2 Trial is structured. If the trial were not blinded, you could routinely be updated, I don't know that it must be blinded, but if that's the case, peeks at the data can be engineered into the trial. I believe many Phase 2 Trials permit interim discussions, and see no reason this trial cannot be developed in that way, and if it is, and if it began say in January, by Summer at least anecdotal evidence of efficacy could be seen and discussed. If the vaccine is as effective as we believe, I believe it's all a potential partner or buyer would need to know to properly value the company.
That said, does the value of the company increase as Direct closes in on approval, certainly, but that may not be the case until years later even if the FDA is willing to consider approval out of a Phase 2. At the earliest I think it would be a 2023 approval, by that time DCVax-L should be developing a substantial revenue stream, with DCVax-Direct coming on line, well over $20 billion could be the asking price. Of course it may not be nearly that early, the FDA may insist on a Phase 3 which probably couldn't complete for at least 5 years, say 2008 at the earliest. The question by then would be, how high might the stock price be by then. I believe that earnings at that time could easily be into double digit billions, especially if off label benefits of use of the drug were clear. A P/E of 30 would certainly be reasonable if Direct was anticipating approval near term. That would give a market cap near or in excess of $100 billion. I don't believe that BP will permit NWBO to grow to this point without consummating a buyout.
Gary
I've been saying this all along, if the company sticks to $20 billion to buy it out, they need to get the market cap to $10 billion, or more. I believe this is very possible, but it will require either a partnership first, or the approval of DCVax-L, perhaps both of these things.
It's all possible, but not in a day, week, or month, it should take at least a year, perhaps years.
Gary
I've been saying this all along, if the company sticks to $20 billion to buy it out, they need to get the market cap to $10 billion, or more. I believe this is very possible, but it will require either a partnership first, or the approval of DCVax-L, perhaps both of these things.
It's all possible, but not in a day, week, or month, it should take at least a year, perhaps years.
Gary
Milo,
I think you're selling them short on the weak science. From what I could tell Israel is taking a leadership position in the development of cannabis based products, and they had the leader of the Israeli program. I believe the weakness was in finding a way to patent something where key components can be extracted from something still considered illegal in much of the world.
I don't know that OWCP will figure it out, but I still have hope. I believe they need to tell the world what they're working on, and before anything like a stock split they build value in the company. I'm not suggesting they can get the price back to $3, or even $1, but even a dime would give it a $1 price with a 1 for 10, something I might consider, but way less than up to 1 for 700 they're proposing.
Gary
I certainly agree with you, but the question in my mind is will the FDA want more statistics showing the vaccine truly enhances treatment, not just the actions of the SOC + surgery with 5-ALA. I believe that we had an improvement on the SOC before 5-ALA, so hopefully that's sufficient, but I never trust the FDA to move in the right direction if there is any question in their minds.
Gary
P.S. Go Ram's
I have no problem with what you're saying, I feel embarrassed by a Govt. that does disagree with the scientists working for it.
I suggest we include NWBO into the discussion, so I believe it fits in this way. NWBO has developed technologies that will force BP to either buy in, or get out of the way. I don't believe it's what BP wants, they'd rather mass produce drugs they can sell at a high price, but when it's clear that personalized treatment works better, they'd be foolish not to get in.
That said, the one thing to fear is their getting in only to quash such development, like I'm convinced the petroleum industry has done on energy saving devices. We could make a lot of money in a buyout, and that could be the last time you heard of DCVax-L or Direct.
Gary
The problem is, a U.N. report won't scare our leadership which believe it knows more than all the rest of the world. The Paris Accord was certainly nothing more than a weak start about what's needed, but at least it was a start. We've not only stopped, we're going backwards when we promote the use of coal and petroleum, and lower vehicle efficiency requirements slated for the future which vehicle makers believed could be reached.
I believe that environmental improvement should create the genesis of a tremendous new industry, it will create many new jobs and improve our standard of living. I suspect that if we do it right, nearly every exterior surface of our homes could collect energy. I'm not saying we could be 100% solar powered, but we could reduce power consumption significantly. I don't know of efforts to use hydrogen in jet engines, but it certainly should work, and aircraft would only be putting water vapor into the atmosphere.
I know work is being done with carbon nano-tube's, but it's not moving that fast. It could replace so many technologies and be stronger, lighter, and far more energy efficient in all sorts of applications. My cousin, who's gone a long time, was working on crystalline structures like a wire that was only 4 atoms across, the strength was amazing, and it could cut through practically anything. I have no idea what's
happened with his work.
It's fun discussing such things on a weekend, but it has little or nothing to do with NWBO. I'm uncertain that the discussion belongs here.
Gary
I don't doubt what's shown in the films at all, I'm just not certain it wasn't invented here. I believe our and other govts. have developed things that weren't supposed to see the light of day, but occasionally are.
When I was a kid, someone I knew was up near Lake Arrowhead and swore they saw what looked like a flying saucer being towed on a truck, it had USAF symbols on it. I had no reason not to believe them. My next door neighbors son had a close friend, who I knew, who took delivery of an Oldsmobile in Detroit, you could save enough to more than pay the cost of the trips across country by doing so. He reached Denver before they caught up to him, he never needed fuel to that point. I can only guess that it was carrying liquid hydrogen, I don't know what else could move him that far without refueling.
I cannot say that during the creation of our solar system life didn't exist somewhere else within it, and while those planets may no longer be inhabitable, some life forms could be among us. I have a problem with something coming from many light years away. Of course if Warp Drives can really exceed the speed of light, anything becomes possible.
Gary
When I was in engineering school in the 1960's a few things were thought of as certain by the year 2000, one was cancer would be defeated, another was that we'd all be getting the advantage of cheap and plentiful fusion power. We're really not very good at knowing what we can be certain of.
I still believe fusion energy possible, but suspect it will be pulsed, rather than sustained. As long as we're getting more power out than we're putting in, it still could be cheap and plentiful. As for cancer, I doubt it will be totally conquered by the end of this century, but we are making strides at it and the more we learn about it, the more complex we recognize it is.
In the last 50 years we've gone from having no proof that other solar systems existing elsewhere to determining we're far from the only one. No telling how many have intelligent life. While I don't believe we're alone, I also can't say a much more advanced life form has actually been able to travel between galaxies or constellations. I believe our life on earth is up to us, we'll neither be saved or destroyed by aliens from elsewhere, but it makes for fun movies and TV shows.
Gary
Thanks Meirluc,
I was thinking of the last 31 to enter the trial after the halt, but what you're suggesting makes even greater sense. The question may be, was anything at all done to make the vaccine better, or is this a matter of surgery being improved by the product that better discriminates between cancerous and normal tissue during surgery. Perhaps it's a product of both.
Frankly I believe the treatment of all sorts of cancers is improving, so people are living longer with all sorts of cancers, but few are totally being cured. I for one can probably live a normal lifespan, but barring some new development, if I want to eliminate the likelihood of coming out of remission, I'll stay on chemo the rest of my life. The leukemia is certainly under control, but I can't say it's a cure as long as I'm on chemo. I suspect that many different cancers may be handled in this way in the future, and DCVax's may prove to be a part of this treatment. The question may be, can DCVax-Direct have a role if no tumor is seen to inject it into, but rather to deal with cancers which may be occurring but are undetectable because of their size.
Personalized medicine I believe will play a big role in our future, and that's certainly what we have here. I don't know that it will ever reach the point where diseases like colds and the flu are treated with something personalized, but I do believe that many terminal or very serious crippling diseases will be addressed with personalized therapies.
Surgery is an area where things are changing dramatically, but not in every case. I had a kidney tumor removed robotic-ally, but much simpler disk and hernia surgery was done with a much bigger incision. I suspect that a few years from now the robots will be used for nearly everything because they involve much less disturbance of organs, especially our skin. Humans will still control the robots, with computer assistance, but my point is that recovery will be much quicker as everything will be done through tiny openings rather than large slices that your hand can reach into. Of course all this will probably be replaced with nano-bots that can actually travel to where the surgical works needs to be done and do it on a microscopic level, but I suspect that's more than a decade away.
I suspect that anti-aging technology will make it so people can live productively for centuries, but we as a society need to deal with how to deal with that. I doubt that retirement at age 65 will still be the case if people are routinely living to 150 or more. I won't be around to see it, but perhaps my kids will.
Gary
It's been some time since I took a flyer and purchased PSTI options. At the time they were for $1 as I thought the price could regain that point by the end of the year. With the reverse split they will be lost if PSTI fails to go over $10 by two weeks from yesterday, doubtful, but not impossible should something really major be announced.
Without such an announcement, I suspect it may be down a bit on tax loss selling this month, but I still believe the potential is as great as ever. When the time is right for me I intend to purchase additional shares.
As a survivor of a stem cell transplant for leukemia I suspect that our drug for radiation, which boosts all blood cell reproduction, could also be used during the transplant period, when the new stem cells are added after the existing immune system has been eliminated with chemo. This is pure speculation, but my Dr. who heads hematology at City of Hope was interested and hopefully will meet with the company at some point. They run a lot of clinical trials at COH.
Gary
Unless you're somewhere on the inside, you cannot be certain when the next announcement from the company will come, or what it will say. It could say our SAP has now been accepted by all 4 regulators, but it doesn't have to. It could say the trial is now unblinded, but it doesn't have to. Finally it could say, here are the top line results, that's the one thing that eventually has to be said, it may not be the first thing to be said, but you don't have top line results until they're announced.
I still hope TLD will come this year, just because it would be nice if it did so, but I cannot say it will. I certainly expect it before the end of the first quarter of next year based on what we've heard from DI, but it wouldn't be the end of the world if that didn't happen. I know it's frustrating, especially for those who invested many years, or even a decade or more ago, but it still has the potential of being the biggest investment gain of your lifetime, at least on a percentage basis if you've averaged down to somewhere around a dollar or less.
I would like to see a BLA filed by the third quarter of next year, or before, but if it isn't filed before the end of the year, I can live with it, as long as we have reassurances that it will be filed. I still believe that before it's filed a partnership will be established, but again, not the end of the world if it isn't.
The key IMHO is all the people who're still alive, as long as that is true, I have faith that the vaccine will eventually be approved, even if it's not on first FDA approach, it will be approved. No one likes delays, but given the FDA history, I don't care how great the data looks, and I believe the numbers alive make it great, the FDA can cause delays, and possibly additional trials. I believe approval by the other regulators will be easier than the FDA, but it's very possible that all will come in without delay. To me, overall survival is the gold standard for approval, few trials go for it as it takes much longer, but I believe our results are solid because so many patients in the trial are still alive, and that many who passed on did so after 3, 4, 5 years or longer in a disease that typically kills 95% in 5 years.
I certainly don't know, but I believe that much has been learned in the trial that would increase longevity if it were initiated today. It's speculation that the last group to enter the trial have greater percentages alive than those at the same point in the earlier trial. If true, future patients may have a 50% shot at living 5 years or longer, ten times that of the SOC today. As I understand it, 31 patients were initiated after the hold, now more than 4 years ago, if more than 16 of them are still alive, the odds are pretty good that half of them will reach 5 years, the K-M curve should tell that tale.
Gary
I believe your $25 to $40 is reasonable, but only after the current share price is in the $15 to $25 range, that won't happen this year, but it's not impossible by the end of next. What would it take to get there by the end of next year, a few things would be needed. One would certainly be a partnership for DCVax-L, and the anticipation that approval was just a matter of a few months away, if it wasn't already achieved. Another would be positive results in multiple cancers in the Phase 2 Trial for DCVax-Direct.
Actually such news in Direct might actually be worth more than pending approval of L as Direct would clearly bring in tens to hundreds of billions annually. While the same could be true of L, substantially more clinical testing would be required, but anecdotally it's true.
I don't know when the Phase 2 for Direct will be underway, or the earliest it could report, but if it could report by the end of next year, and if it was quite positive in many cancers, it's valuation would be huge.
Realistically a BLA for DCVax-L will probably take 6 months or longer to create, so even if we unblinded today, approval by the end a next year would be doubtful if you allow 6 months for the regulators to review the BLA.
It may be very possible that whoever partners at this time may wish to buyout the company later. The partnership would certainly move the share price closer to a figure where investors would agree to a buyout, but it will take more than that to reach the price the company wants. One thing is certain, buyouts occur when the buyer is paying no more, and usually less than double the current price. If we're at $10, than $20's not out of the question, but the buyers aren't crazy.
Anything is possible on some really good press, a $.20 stock could go to ten or more times that on a front page article in something like the Wall Street Journal or New York Times, it could happen on a feature in 60 Minutes, etc. If the demand was huge, it could shoot up to $10 or more, but in time it would settle back down to a few dollars unless something happened that validated a double digit billion dollar market cap. Personally I'll sell some shares if emotion takes the price over about $5, and I'll look to buy back in somewhere around half the price I sell at.
I know your price was in gist, at least for this year, but it is a price that could well be met in a few years, perhaps sooner as long as trial news is really good.
Gary
I do agree that $25 to $40 could be a reasonable price, but only after the share price already reached at least $15 to perhaps $25 for the $40 to
Cure is a big stretch, though it may be for some patients in the trial. I don't believe you have a cure for a disease until the overwhelming majority who get it are cured, and with cancer even after 5 years you cannot say you're cured as the cancer may reoccur substantially beyond 5 years and still be related to the prior cancer.
I believe our vaccine is a step in the right direction. Who knows, if ever most patients with GBM or other cancers are being cured, our vaccine might still be a part of the treatment. The point is, it won't do it alone, and we don't know what in the future will be developed that either supplements it, or replaces it completely in improving cancer treatment. Right now, both DCVax-L and Direct appear to show promise when added to SOC or other treatment, they are not stand alone products that are better than the SOC.
Who knows, perhaps NWBO's technology leads to using the personalized vaccine approach and giving it prior to any cancer ever being found. Direct is intended to be injected into the tumor, but perhaps giving it by shot or IV might eliminate undetectable cancerous cells so the cancers would never occur. I'm not suggesting this is the case, but a vaccine that prevents cancer would be huge, perhaps we're taking a step in th at direction.
One of the things about many failed trials is that some people in the trial might actually be cured. The problem is, not enough achieved that benefit to approve the drug, even though those who did probably wouldn't be alive had it not been for the trial. I believe many failed trials were for drugs which were abandoned, but which .if funded could have been approved. It's sad, but many companies don't have the funds to do additional trials when their first shot misses. Frankly I don't know that the vaccine wouldn't have had greater success against a different cancer, but GBM may have been chosen as results should come faster as it's so deadly, not because it's the cancer determined by the company to have the greatest opportunity for a cure. Trials based on survival are far more expensive if the patients have a cancer where life expediencies are already 5 to 10 years, and that's the case for some slower growing cancers, or where good treatment options already exist.
I've seen many trials directed at pancreatic cancer as it's so deadly, and they failed, while small Phase 1 and 2 Trials showed the product quite effective for something like colon cancer. That may have succeeded, but it would have taken years, perhaps even decades longer, and therefore cost far more.
Gary
There is a huge problem with right to try here in the U.S. Most companies are not participating because to do so they have to let the Govt. into costs, and it's not something companies are willing to do. Of course they have another choice, they can give the product away, again not something they like to do.
If they really want to make right to try successful, their needs to be some formula for what can be charged for the drug, perhaps based on the cost of the current SOC treatment. Insurance participation also should be part of what's proposed. In reality, right to try is little different than compassionate use had been, a new name, but drug developers largely wouldn't participate because of the provisions they had to comply with, and the risk a negative outcome could reflect back on the trial.
I exchanged emails with DI about this and I believe he indicated that the company does permit what would be called right to try in the U.S., but it's only being done elsewhere, I think he indicated it was being done in Germany.
I cannot blame the drug makers from not wanting Govt. authorities to get into everything they do. When you time most products down to just the raw materials that go into them, they don't cost much. Billions might be spent before you can turn those raw materials into a product, but the actual cost of making one more might be insignificant. I believe that what the Govt. wants companies to charge under right to try is something like the cost of the raw material and the manpower, energy, etc. needed to make it. It's rather like looking at a car as so much steel, plastic, etc and saying to sell it somewhat above that price. A Rolls Royce that has less material than most large SUV's would be worth less under such a system.
To me, the saddest thing is when someone is attempting to raise the funds needed to try an experimental drug to stay alive, and must travel to a foreign country to do so, as in the U.S. it's not available at any price.
Gary
I believe a blinded trial, and a blinded clinician are very different matters. Dr. Liau is blinded in that she doesn't know which patients are initially given the vaccine, and which the placebo. On the other hand, once either progression occurs, or when a second course of treatment is initiated, she knows the patients are getting the vaccine, as all are crossed over to the vaccine. I believe that even if blinded, when the second course shows improvement not seen in the original course, she can recognize that this patient is now seeing benefits from the vaccine, and very probably had gotten the placebo in the first place.
I think the benefits have been clear, and seen by the DSMB, and perhaps the regulators, and that's why the last 31 to enter the trial were all given the vaccine up front.
When we see the results, I suspect we'll see the overwhelming majority of the longest survivors received the vaccine up front, in second position will be those who crossed over, and finally few, if none will be those who never received the vaccine at all. The question of why roughly 33 never received the vaccine at all might be answered by the fact that they passed on before the second course of treatment would be administered, which is to say roughly a third of the control group passed on in a few months, statistically it's probably not unexpected in this very deadly disease. That's not to say that someone in the control isn't alive, perhaps their reaction to the SOC was so good that they choose not to take further treatment, where they would have been crossed over, but I believe that number will be few, or none.
My point is that Dr. Liau, and all the other clinicians can observe these things and even though blinded, their observations should be clear. It also should be clear that the earlier you can get intervention into a disease, the more likely success in treating it is. Certainly some who didn't receive the vaccine until they crossed over should be alive, or lived to become part of the Top 100, but the chance of a benefit should certainly increase if the vaccine were administered sooner rather than later.
I suspect if Dr. Liau and others had to guess about which patient received the vaccine up front, and which didn't, before the trial was unblinded, they'd be right in over 70% of their guesses based on their observations. They're blinded, but they're not blind.
Gary
I've voted no on both issues, why give them more time to collect yes votes.
I still challenge them to give us a reason to say yes to anything. If I knew the company had positive news and was working to build the share price back well over $.01, I might agree to a 1 for 10 or perhaps even 25, but something must be done to build up from where we are.
Gary
I realize that, but certain conferences create far greater interest, and JPM is one of them. Of the technical conferences ASCO is probably at the top, and in spite of the conference not being until late May, I believe the cutoff for Abstracts is in February. Hopefully we can at least provide a placeholder Abstract for that conference.
SNO was certainly the conference that is the best opportunity in the form of cancer our vaccine targets, and I frankly don't know which others are coming up with comparable impact in GBM. I'm sure the company was sincere when they thought they'd present there, but it was OBE as the SAP no doubt took much longer than they thought, and I'm unsure if it's yet complete, or will be by the end of the year. Frankly it really is more important that they do it right than do it quickly.
I certainly hope that by the time a BLA submission is being prepared we have a BP partner who's supporting that effort. I believe the FDA is strongly biased toward BP, and a partner will not only assure the document is well drafted, it will also give it the impact of being backed by BP. I'm not suggesting it cannot be done if they go it along, but I believe the probability of approval on initial submission would increase dramatically if we have a BP partner, and of course the share price will be much higher as well.
Gary
I would hope that sufficient news may be out to warrant an invitation to the JPM Healthcare conference in early January. It is probably a long shot, but I know it is a conference companies look forward to presenting at.
I don't know what the cutoff is for invitation, but really positive news might get them an invitation even after the cutoff.
Gary
Years ago the CEO of IMGN would tell us things were going to happen soon. Month's and sometimes years later they happened. Investors started to express soon backward in their posts, we'd write NOOS. We knew he was reading the board, but he never changes.
I'm certain that he thought that things could be done faster than they did, but soon was used and we joked about it. What was important was eventually things did happen.
Gary
While I agree with what you're saying, it does go beyond that. Some institutions are permitted by their charter to work with penny stocks, but some whose charter say don't touch them do.
Institutions only report what they hold over the quarter, if they purchase the first day of the quarter and sell by the last day, nothing is ever reported. MM's are happy to accommodate them. I was told this by a broker many years ago, but I'm sure it still applies today.
Gary
If an Institutional Investor wished to purchase NWBO I suspect that they'd work with a brokerage to arrange to purchase stock. Whether NWBO is soliciting such action, or not, such an offer is always tempting to companies with limited funds regardless of what they believe is upcoming.
I hate to say it, but I believe that companies like shares in the hands of institutions and in other companies I've seen this sort of deals made shortly before good news was forthcoming, and the share price was up dramatically. I never liked it, but it seemed to be a fact of life.
Gary
The Piper Jaffray presentation may have had an influence as well, I'm listening to it as I type, but saw where others were impressed with it.
I believe the bigger news will come out of ASH where hopefully the entire presentation will become available. Among other things I understand that a fast path to approval may be available for IMGN632 in one of the indications being treated. This could have the potential of an approval prior to the conclusion of the Phase 3 for IMGN853, but it's also indicated that a partnership there is certainly in discussion.
Gary
Flipper,
I believe DNDN investors were pro-active even before their trial was unblinded. While we don't know about the delays which may have occurred in the establishment of the SPA, I do believe the company believed that they'd present the complete data at SNO back at the time of ASCO. I'd suspect that dealing with the regulators has taken longer than anticipated, and of the regulators, our FDA is more likely to cause such delays than others. I have no proof of this, and the company will never tell that story, as to criticize the FDA lessens the likelihood of things going well there.
Many years ago Genentech attempted to gain approval of Kadcyla from a registrational Phase 2. It was pretty clear that they had worked with the FDA staff in designing the trial, but when they submitted the BLA, Dr. Padzur refused to read it. He disagreed with the protocol and simply wouldn't look. No complaint came out of Genentech, the drug was approved out of Phase 3 years later. I believe that Dr. Padzur was sending a message to his staff as much as he was to Genentech, who's the boss.
The FDA has people like Dr. Padzur in essentially all departments, and essentially all are G-D's. If you want your product approved, you don't fool around and criticize a G-D. I don't believe all the pro-active things investors did with DNDN had little effect other than perhaps delay as they were tangling with a G-D, even Congress wouldn't challenge his actions.
Gary
For those who remember DNDN and their drug, Provenge, I believe investors here have become the polar opposite of their investors. Actually the companies were similar in that both were personalized, but there is a huge difference. DNDN's drug was targeted at prostate cancer, which has many other effective treatments, so few wouldn't see benefits from other far cheaper treatments. Ours is targeted at a very deadly cancer, and may be effective against many more cancers, and in many cases the SOC isn't effective at all.
The big difference with investors is that they had an almost cult like belief in the product, and when FDA delays occurred, the investors started pushing everything from the FDA to the U.S. Congress to pressure for approval. The drug, which eventually was approved created tremendous stock moves, and many who traded on the movement made lots of money, but those who purchased at or near highs were killed as the company didn't achieve either partnership or buyout, and eventually totally failed.
I believe we're just the opposite, we don't push the authorities to accept the SAP, etc. We may not be happy with the time it's taking, but we take it out on the company, not the FDA or other regulators. However, I believe that unlike DNDN, our product will be highly regarded, first by GBM patients, but ultimately by many others, and BP will want in either by partnership of buyout. Personally I had little involvement with DNDN, but some I knew had one tremendous ride and I believe the upside potential here will be far greater than DNDN once the news of top line results are out. It may be a bumpy ride, as authorities could cause delays, but long term is should be tremendous, and for the active trader there may be many short term opportunities.
Gary
Marzan, I believe we're now beyond 48 months for all survivors, but in a totally unrelated trial I understand that they chose 49 months, I don't know the reason, but we're now about there.
I believe we're very close to SAP acceptance, or perhaps it's actually happened and they're currently unblinding. I believe once they make that decision, each clinician in the trial should attempt to check the status of every patient that remains alive in the trial. I could see this effort taking a few days, with perhaps a few who can't be reached at this time, who could be deemed LTFU, but who almost certainly would be found before the full trial data was compiled and presented. I don't think it takes very long to determine which patient got the vaccine up front, who crossed over, and who never received it, that should be available almost immediately.
Gary
Without unblinding I believe there is much that Dr. Liau could report in an upcoming presentation. In the past she's spoken of the Top 100, I certainly believe she can update that, which would include what the median in that group is, she could also tell us how many are alive in the trial, not every one of them may be in the Top 100, though they may be. She could probably tell us the longest living patient in the trial, and whether that patient remains alive.
It's my belief that all of this is information as the lead clinician Dr. Liau can compile without unblinding, and I think she can share that with the company at any time, so the same data could be presented in a corporate presentation. We cannot say that the longest living patient in the trial was actually on the vaccine, the trial would have to be unblinded to know that, though the odds are certainly on our side. Likewise the odds are on our side that few, or perhaps even none of those still surviving only received the SOC, that's what unblinding is all about.
Gary
I'm not saying it isn't different, I don't know the acceptance criteria for a SAP, it may be as little as 30 days, I doubt it would be less than that. Regardless, if there is a presumptive time to approval, each time a modification is submitted you'd have to wait that presumptive time unless all four regulators got together and said, insert this change and it's approved, while I doubt they'd work together in that way, anything is possible.
I may be wrong, but I believe the presumptive approval on submission of an IND is either 30 or 45 days, I'd guess that an SAP would be treated somewhat similarly.
Gary
It's my belief that the regulators have a specific number of days to comment on the SAP, like if it were an IND, or it's a preemptive approval. That stated, if one of the regulators requests a change, or clarification, after the company makes any change, the newly modified SAP has to be reviewed by the regulators, and the calendar starts again. The SAP is presumed to be approved after XX days with no comments or changes requested.
Something I've learned to hate about the FDA is that in reviewing an NDA or BLA, if they ask for something on a given issue, once that is provided they get another 6 months, or a year on less critical drugs to review it. After that review, if they ask another question on a totally unrelated item it doesn't matter, the clock starts over from when they reply. I've seen approvals delayed by years without further trials being required, but a couple questions requiring answers, typically this happen much more to tiny biotechs than BP who pays much of their bills.
Gary
I certainly agree and think it's very possible that one or more of the other regulators may grant approval before the U.S. FDA. Our FDA does however carry a lot of weight as the U.S. alone represents something like 35% of worldwide sales of most healthcare products as I understand it because of our prices. I also believe a lot of countries accept FDA approval as all they need to approve a drug.
Frankly I'm saddened by our healthcare costs and by the influence BP has on our politicians on both sides of the aisle. We're paying so much money and don't have access to many great drugs and it's resulted in top flight American physicians offering overseas treatment in 5 star hospitals elsewhere, 60 Minutes did a report on it some time ago. I have many friends who've gone down to Tijuana for dental work from an American dentists who lives in San Diego, but practices in TJ. Sadly it's cheaper to go there then pay a U.S. dentist even when you have some dental insurance.
Gary
You should see the snow we're seeing up here in Tahoe. I've only seen snow a few times in the valley, as a kid one time we sledded in my cousin's back yard in a home on the hills South of Ventura Blvd in Sherman Oaks. It's rare there, but a lot of fun.
The ski area by our home, Diamond Peak, hasn't yet opened, but many are. While I'd love to give skiing a shot, between my bad back and the leukemia it's doubtful that I'll do it again.
NWBO will hopefully provide the funds to upgrade our lifestyle, which isn't currently that bad, but it would be nice to not think about spending tens of thousands freely. I'm of the belief that the share price could be up substantially before years end, now just a month away, but of course I could be wrong. Unblinding the trial is certainly what must happen before significant growth occurs.
Gary