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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
It can only be sadly guessing the results will be approvable to shorts, clearly the longs are thrilled with approval. Certainly I'll agree it's a guess, because no one can ever be certain of what the FDA will do, so guessing is as good as any other word you might use.
The trial will be unblinded when the SAP is accepted, if there is any guessing it's what they put into the SAP, and what has been accepted, or rejected by the 4 regulators prior to it's overall acceptance.
I certainly cannot say with certainty that people who're friends of decision makers at the FDA, etc. have not profited from FDA decisions, especially when they do what isn't expected. I have seen many drug rejections by them where virtually everyone expected approval, I cannot think of a single one where approval didn't come later. Someone who knew this was happening could make a lot of money with put options if available, or just being short the stock. It's sad, but the FDA never seems to care how much money, or how many lives it may cost when they delay approval with their actions. I cannot say that people like Dr. Padzur has personally profited, but I really wonder about friends who wouldn't be traced to him.
Gary
I'm speaking of this year, so now it's just under a month away.
No doubt long term investors are frustrated, but I believe they'll be happy in time, especially if they've averaged down to somewhere in the dollar range.
Personally I'd like a partnership prior to a buyout to learn the capability of DCVax-Direct so it can be properly valued. A partnership will provide all the funds needed for trials that take things that far. If both Direct and L truly work on many cancers, those saying triple digit billions to purchase the company are not wrong, while it would be hard to turn down $20 billion near term, in a year or so that might not be the case.
Gary
What you say is true if the regulators are acting on a BLA which should be based on the SAP. I really can't speak of the others beyond the FDA, but I suspect most of them will take roughly 6 months after the BLA is submitted to decide, like the FDA does.
If we gain top line results before year's end, I frankly doubt a BLA submission will occur before near the end of the second quarter of next year, and perhaps later. That would make approval, or denial, at near the end of 2020, or later. That leaves a great deal of time for things like a partnership, or buyout, either way, the stock price should move up dramatically. I don't know just how high the price may go, in part it might be based on DCVax-Direct if new interim trial results came in before then. I certainly believe our share price could be in the $5 to $10 range if we have a partner, and in the worst case, if the regulators want an additional trial, the partner would pay. It wouldn't be a good thing, but with funding established investors would recognize it as a delay, the approval would still be inevitable.
First thing is seeing the top line data, I certainly believe if 70 patients or more are still alive, at least a dollar should be certain. If that number is in the 80's, $2 or more is very possible as practically no one would have passed on since the last time a number was seen. I believe that when we hear about those living in the trial we may learn that many don't have detectable cancer. It doesn't mean they're cured, even if it's beyond 5 years, but they're probably not seeing their oncologist very often, unless they're concerned about something. I'm not quite 5 years past receiving stem cells and I go in quarterly, by next year I wouldn't be surprised if it became semi-annually. I believe our vaccine has that sort of capability. One nice thing about City of Hope is that they keep in touch with patients, even those cancer free for decades typically come in once a year, and they also get thousands on the day they have their transplant reunion.
Gary
I'm not quite as optimistic as you, I believe they're very close to the presumptive approval by the regulators, virtually counting down to however many days they get to comment, but if we were there, I believe they'd unblind. Certainly it may be TLD that's the first thing we actually hear, so you may be right, I just don't know that's a fact.
Barring changes required by the regulators, I believe we'll have the TLD by XMAS, so it should be a great Holiday Season.
Happy Thanksgiving all,
Gary
I'd like to wish a Happy Thanksgiving to all investors, but can't say we're thankful for being in OWCP. Perhaps we will be by this time next year. I believe the key remains the patents, and hopefully we'll get lucky in the coming year. A buyout would probably be the fastest way we could cash in, but only after we have patent approval.
Meanwhile, unless something happens their R/S will not be approved and perhaps then they'll talk with us. Personally I think Hirsch should have brought us up to date, given us a reason to vote yes, but also put out a proposal for a much smaller R/S. Work the share price up to a dime, then ask for a 1 for 10, that's something investors could live with.
Gary
Happy Thanksgiving all, and Happy Birthday to Senti and Evaluate as well.
I believe by the end of this Holiday Season we'll be thankful for being in NWBO, but not nearly as much as we will be when Thanksgiving rolls around next year.
Gary
Please correct me where I'm wrong. I'm of the belief that while blinded as to the specifics about the specifics of each patient in the trial, whether they received the vaccine up front, or crossed over, or never received it, that's what they don't know. I believe that they pretty much know how long each patient lived, or if they're still living. In short, with just a few assumptions they pretty much know what's happening in the trial.
What assumptions do I believe they'd make? I believe they'd assume that with only about 30+ patients who didn't cross over, all who entered the trial roughly 5 years or more ago, 10% still being alive would be far better than what's statistically probable, that would be 3 patients or less that probably never received the vaccine. They probably know precisely how many are still alive, and if that number is in the 60's, 70's, or 80's the fact that only 3 or less didn't get the vaccine certainly is a very positive indication of efficacy. Certainly they cannot be certain, a worst case scenario would say that all 30+ who never received the vaccine are alive, I simply don't believe that's the case. If an extraordinarily number of these people were still alive, it might be 5 or 6, still the vaccine is spectacular by comparison as the reason these people are alive is that the SOC worked for them, so they didn't progress and cross over. It's more likely that the majority of these people passed on before they had the opportunity to cross over, but that will only be known when they unblind.
Yes, they are blinded, but I believe with what they know, constructing a SAP that leads to approval ought to be very probable. Nothing is certain until the trial is unblinded, but I believe they know a great deal and they will get it done.
Happy Thanksgiving all,
Gary
I really believe Hirsch owes us much more than has been provided about the company's plan for the future, we were supposed to get at least semi-annual letters from him, I don't believe he's lived up to that promise.
Gary
I certainly plan to vote no, but I also noted that anyone failing to vote is counted as a no vote. Unless the company has distributed lots of shares to those who'll vote with them, they were defeated before and I believe they can be defeated again.
Gary
The problem is that people keep talking about cancer like it's a single disease, I don't know a precise number, but suspect it goes into the thousands or more. Our vaccines may very well have benefits in many forms of cancer, and they may even achieve cures for some of those who receive them. The problem is some is far from all, and cancer won't be cured until all can be cured.
If better ways of using our vaccines result in 50% achieving sustained remissions or cures, their would still be huge numbers who aren't cured. I would hope that some time in the future cancer will be less of a problem than it is today, perhaps much less surgery and chemo will be required, but I don't believe there will be a time when cancer can be eliminated completely.
Gary
I believe that remaining silent is considered to be presumptive approval. Of course if they comment, they're either asking for a change or clarification and either way they probably need to give them more time if a change is made.
I suspect this is rather like filing an IND, it's considered to be accepted if nothing is said in a precise number of days. No document is sent approving the submission, but changes requested are documented, and the IND must be resubmitted after the change is made, and they have to wait the same number of days before they can presume the approval.
I have a feeling that they're counting down to the presumptive approval, but nothing can be said until they're beyond the review period without comments.
Gary
I don't know, but NWBO's words may mean that the SAP was submitted in a manner in which there is a presumptive acceptance if no comments come in after a specified number of days. Hopefully they don't get comments so the SAP is accepted, but that's never a guarantee. If this is the case, we're getting close, but if some change is requested, after it's been made and submitted, they'd have the same number of days to review it again.
I suspect that everything is in place to unblind quickly after the SAP acceptance has occurred, top line data might be just a matter of days later. I'm not expecting news by Thanksgiving, but this could be a very Happy Holiday's coming up by the New Year's.
We are heading up to Tahoe tomorrow and I'll probably spend less time on the net, so I'll wish a Happy Thanksgiving to all early.
Gary
I don't know, but NWBO's words may mean that the SAP was submitted in a manner in which there is a presumptive acceptance if no comments come in after a specified number of days. Hopefully they don't get comments so the SAP is accepted, but that's never a guarantee. If this is the case, we're getting close, but if some change is requested, after it's been made and submitted, they'd have the same number of days to review it again.
I suspect that everything is in place to unblind quickly after the SAP acceptance has occurred, top line data might be just a matter of days later. I'm not expecting news by Thanksgiving, but this could be a very Happy Holiday's coming up by the New Year's.
We are heading up to Tahoe tomorrow and I'll probably spend less time on the net, so I'll wish a Happy Thanksgiving to all early.
Gary
I certainly agree, but I also believe that at minimum a partnership will occur before regulatory approval, it could be a few partnerships, with each partner having distribution and sales responsibility for a given portion of the world. Of course the company could be acquired, but as I see it, the real value for DCVax-Direct can't be estimated until they're well into a Phase 2 Trial, and I can't see them selling the company before it's value is determined unless they get a spectacular offer.
It's my belief that Direct could very well be bigger than L, but it would not only be used on inoperable tumors. I believe it could be used before operable tumors were operated on to stunt their growth pre-surgery, and possibly eliminate mets. Surgery often isn't performed immediately after a tumor is discovered, it very well could be a month or more before the surgery takes place. If Direct can be made in a week or so, doing the leukapheresis immediately on finding the tumor could give it weeks or longer to work. They might even determine it's best to permit it, and perhaps other treatment forms, to work for a period of time before removing the mass.
I have a friend who had a successful Whipple procedure many months after the tumor was found. Initially it was inoperative, but chemo shrunk it till it could be operated on. DCVax-Direct could be part of such treatment, and when the tumor was removed, DCVax-L could be created if it was determined to be a workable one-two punch.
Of course the other question may be, if the tumor is shrinking with DCVax-Direct, do you continue to treat with it, or do you surgically remove it because you can. Trials may show that with repeated treatment with the vaccine it virtually disappears. The other big question is, just how many different types of cancer do these vaccines work for. If the answer to both these questions are positive, buying the company for anything under triple digit billions would be a bargain, but it will take awhile before the questions can be answered.
Gary
I think it's clear that NWBO didn't have an Abstract accepted at SNO, they may or may not have submitted one, but if they did, it may have been rejected for not discussing anything that hadn't previously been presented. I believe it's equally clear that they met with people a couple times, they were shown on the itinerary for the conference. Dr. Bosch or someone else may have made a presentation at either, or both of these events, and that presentation may be something the company will share with investors.
Whether this is the case, or not, we know it's not long before presentations are scheduled to be made, at that time we should learn what they're up to.
Gary
If in the past they've released blinded information at SNO, they should do it again. If they never did, then the regulators, or the SEC might have concerns about it. While I haven't been in the stock that long, I believe they have issued updates from SNO and at one point guided that more information would be available there.
Gary