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The question is, do they need to wait for comments from the regulators on submitting the draft, or can they submit and consider it established. We all should realize that even when the FDA agrees to a trial criteria, and the criteria is met in the trial, the FDA can still delay approval with questions about things never considered in the originally accepted criteria.
I learned this lesson many decades ago when Genentech first submitted TPA for approval. Virtually all who looked at it were sure of the FDA's decision, they'd approve. I with little money to invest purchased options that should certainly be well in the money according to what all the experts were saying. The FDA not only delayed the approval by asking a question, the question they asked which dealt with long term benefits, had never been discussed, and couldn't be answered without further testing. Clearly approval was delayed dramatically, the stock tanked, the options naturally were worthless, and once again the FDA had prevented a potentially life saving drug from reaching the market for an extended period of time. Of course the drug eventually was approved and has been a blockbuster ever since, but it certainly illustrates the power of the FDA. We'll never know if anyone at the FDA, or their friends, benefitted by being on the short side or owning puts at that time, but I always wonder if someone on the inside hasn't profited by such actions.
Another question could be asked, while I believe the statement made by the company is up to the minute on status, I'm uncertain that it must be. If the company didn't wish investors to know just how close they were to unblinding, the statement could reflect the condition on September 30th, not November 11th. I still believe they'll have something to say at SNO, but it's hard to say what it will be.
Gary
I this conference being webcast?
Anyone a Jeffries customer in London and planning to attend.
Gary
When I speak about the Pinks being different, I'm talking about things like PR's to say they filed, or were issued a new patent. I know posters who do a great job of finding new patents, but only Pink stocks making a big point about them. On the other hand I do have cannabis stocks where they're attempting to patent their products, and patent approval would be big news.
I don't believe an event must be material to issue a P.R. as long as it falls under SEC guidance, but many events that investors think are material really aren't.
Gary
Alexander,
I believe a billion dollar market cap would certainly be justified, but if the announcement generates a great deal of enthusiasm for the company, no telling how high it might go. If fully diluted we have nearly a billion shares outstanding, a $10 share price certainly isn't impossible, giving you nearly a $10 billion market cap. What can be sustained may be a different matter, and unless there is a partnership or buyout, I doubt if over a $5 billion market cap would be sustained, and it might go back to $1 billion, still a substantial increase over todays prices.
I believe another question ought to be, where could it be in a few years if DCVax-L is approved, and DCVax-Direct is turning in positive trial results. There I believe almost any price you name is possible as more is being learned about the earning potential of both products. Earnings might not yet justify say a $50 billion market cap, but if it was clear that earnings would be growing by billions annually in the not to distant future, it would certainly be possible.
I believe that GBM by itself has blockbuster potential, but what if a few, or even dozens of different cancers are determined to benefit from vaccines made with NWBO's processes. I would expect the company to be bought out by BP, but I have no idea how high the price may be.
Gary
Material events in most companies I've invested in have money tied to them. If NWBO had a partner, and unblinding the trial was a milestone where the partner paid them, it would clearly be a material event. I don't believe this is the case for anything upcoming. That's not to say that certain things won't be announced, but it's very possible that Top Line Data will be the first thing we learn about, that's what I've seen before from other companies.
Even what's material seems to vary, for a small company with little available funds, a half million dollar payment may be announced. On the other hand, that same company years later may only discuss a multi-million dollar milestone payment in the quarterly report. A few million is no longer considered material. I believe it largely is up to their interpretation.
I suspect that what market you're being traded on makes a difference. On the Pinks, almost anything goes, the SEC never seems to get into what probably violates their guidance. On the Nasdaq, etc. following SEC and FDA guidance has much greater compliance, both these agencies abhor what they view as hype. At one time I knew a CEO who posted on a chat site, he heard from the SEC for doing so, and we never heard from him in that manner again. I suspect most corporate employees are told not to post about the company they're working for, certainly they can post, just not anywhere where something they say could be considered inside information.
Gary
I was impressed with today's letter and forwarded it to my Dr. at COH, I hope in the future they get involved with trials on their products. Clearly the market doesn't agree with my opinion, but I believe there is more to come which will demonstrate what the company is saying is clinically proven factual, and I think it's clinical results the Street is really looking for.
Gary
You could be right, in that we now know that the wrong chemicals used in vaping can be deadly, perhaps knowing the cartridges are safe could make our pens profitable. Personally I'd look for other ways to gain the benefits, as I still question putting any sort of smoke in my lungs, but if still legal, the units will be sold. Better to have one where the cartridges are known to meet proper quality standards.
Thing is, they need to get their products into the hands of consumers, talking about them and issuing more shares won't hack it.
Gary
My criticism isn't of you, it's the company. I remember when a shareholder attended an investors conference and was thrilled after spending time with those in attendance there. Sadly many have been misled, but it doesn't mean they totally lied, but clearly they couldn't deliver what they said they had planned. I believe the biggest failure was in gaining patent approval, but that's really where development has to start. If you don't own the intellectual property, who would invest the tens or hundreds of millions needed to run pivotal trials.
The reverse split will be meaningless if they cannot gain patent approvals, and if they do get patent approvals I believe they could be successful with much less than a 1 for 700, but something may be needed to either gain needed financing, or meet the demands of a potential partner. The key is still the patents, they don't need all of them, but they need something to build upon.
Gary
I would agree that an R/S is probably needed, just not a 1 for 700, or even a 1 for 100. I believe if they would be more open with investors about what they're doing they could rally the stock to somewhere around a nickle, at that point a 1 for 20 or 25 would bring a $1 or better share price. That sort of action I could support.
I cannot support keeping us in the blind about what they're working on, but asking us to support up to a 1 for 700.
Gary
I agree, I oppose such a R/S, but it's not worth enough to sell except for a stock loss, which I intend to do unless it's up dramatically before the end of the year. I doubled my holding months ago, so I intend to sell off the dramatically more expensive shares regardless of the R/S.
I hope they don't have sufficient control to assure the R/S on whatever terms they wish. I believe we need and deserve an update from the company, and hopefully what they're doing will take us above a penny, and hopefully to a few pennies. Once there, hopefully if they're still looking at an R/S it will be a much smaller one.
Gary
I agree with you, I've often said that I expect a partnership, or buyout, any time after the trial has been unblinded. I hope it's a partnership as I believe that to get a buyout offer for what the company may truly be worth, you need to know more about DCVax-Direct.
A partnership could be for one, both, or all products under development, but it would be for a limited amount of the company. The partner might gain the right of first refusal to meet, or beat any buyout offer, but it wouldn't guarantee they'd buy the company at some time in the future. Regardless of how much money a partner brought in, I'd expect them to pay for all trial costs of any product they had an interest in.
I don't know if confidentiality agreements currently exist with any of the BP's, but if they do, it would entitle them to look at the data immediately on unblinding, some time before even top line data is released. I believe in other companies such agreements have been created well in advance of either a partnership or a buyout.
It's currently 3 months since our last quarterly, so a new one could be announced any day. Hopefully there will be some guidance on SNO and other things that should be upcoming in the quarterly, I suspect it will happen sometime in the next week or so.
Gary
I would think they'd take the K-M to the point of the longest life of anyone in the trial, whether alive or dead. I think if they're alive, the line would end at that point, while if they're dead there would be a tiny tick down. The line of course could be extended as long as someone lived longer than the line showed.
If all the patients were shown in a single K-M and nearly 80 are still alive, the level at the end of the line would indicate roughly 25% are still alive. If only a couple people who didn't receive the vaccine remain alive, the percentage for those who did might be closer to 30%. Regardless, the line would be about 5 to 7 times higher than if drawn with only patients on the SOC. People can argue that the vaccine isn't that effective, but the K-M charts don't lie.
As I understand it, there are people who received the vaccine either in Phase 1 or under compassionate use over a decade ago who're still alive. It's impossible to say who the longest living person in the trial is, but if it's one of the earliest participants, the line might extend to over a decade. If the Doctors concurred, it might be possible to say that several of the longest living patients essentially are cured, but only if no cancer can be found.
Gary
I-G,
I believe the people who were affiliated with OWCP were qualified to build such a company, but clearly they underestimated the effort it would take to gain approvals for patents. I believe their product design to be good, but without patent approval, funding clinical development is fruitless.
On the other hand, there is no shortage of products using cannabis for all sorts of things, little or nothing is proven, much the same can be said for most nutriceuticals found everywhere. Now it seems vitamin e oil used in vapes is causing the vaping problems, but if we eliminate it, can anyone say the 5, 10, or 20 years from now they won't find lung problems due to what's been accepted as safe.
OWCP was attempting to do clinical trials properly with cannabis, but authorities that don't recognize that it should be legal, but tested, won't grant patent approvals needed to do such trials. How many products currently available in stores would have to be pulled if proof of efficacy were demanded.
If there is such a thing as Vitamin X, if someone says it's of benefit, and the FDA doesn't think it's harmful, before you know it, Costco will be selling it with both a nationally sold product, and one with the Kirkland label. They don't know that it works, but they know of the demand for it, and as long as it's legal, supply will meet demand.
Penny stocks are clearly a gamble, OWCP may never move up again, but then again it might. If you gamble on a number of them and only one moves up to eventually be on an exchange, like the Nasdaq, you could be way ahead. I don't know that OWCP will get there, but if a couple of their patents eventually are approved, and even one becomes an FDA approved drug, they could be very successful. It won't happen instantly, but if say the patent for psoriasis cream is upheld, and clinical trials are positive, it could be huge. Why? I know there are meds that can be taken for psoriasis, but they all have potential risk. I know people with the disease who wouldn't take the risk, but a topical cream would be a different matter. Perhaps some similar creams didn't violate patents, but even if somewhat effective, if you had drug approval, insurance would pay much of the cost, which cream do you think would be a potential blockbuster seller.
I believe the entire cannabis market is poorly structured, lots of companies, few that are profitable. Over time I expect consolidation, some companies may survive and prosper, others will be acquired, some just disappear. I can't say what will happen with OWCP, but I still believe there are possibilities that still exist for success.
Gary
While I agree with you in general, those alive today don't represent those alive at 4 years, they represent those alive for four years or more, and there is much to learn about what more constitutes. Could some of those alive be alive for a decade or more, it's possible. Once unblinded those who are still alive should be able to tell their stories, and hopefully the media will be speaking with some of the longest living in the trial.
We need to realize that much can happen between the time the trial is unblinded and we have a decision from the first regulator to decide, it will probably take roughly a year or more between these two events. It's taking many months to create a SPA, unless they gain a partner to assist, it could easily take 6 months to a year to properly develop a BLA. Even with a BP partner, I doubt if a BLA would be completed in much less than six months. In the interim time, presentations will be made at major conferences like ASCO, but you also can't discount the media coverage that some of the longest living patients may bring on TV, newspapers, etc. Each story leads to people who've never heard of NWBO before looking at it.
I know the top 100 story isn't normally discussed, but even if the trial were ended today, I don't know that a year from now if Dr. Liau were speaking if she couldn't say, here's what's happened to the top 100 since the trial was unblinded. If more than 50 still remained alive, that median number may have grown to 65 months or more, not a huge headline, but still information worth knowing. I suspect that patients alive beyond 5 years may largely be pretty healthy, so the number of deaths in the next year might be very few, and some deaths might not be related to GBM.
All I'm suggesting is that in the year or more between unblinding and potential approval lots of stories about our vaccine are probable, and each of them can be a positive for the stock.
Gary
Good find, perhaps after they present they'll update investors on what's been presented. The norm isn't to discuss technical information until it's been presented for peer review, this should constitute that review.
Gary
I'm currently approaching 5 years post stem cells, I still have quarterly appointments at City of Hope. I do not know if the patients in the trial still see the clinician they originally were treated by, but I would think they all would have quarterly, or at least semi-annual appointments with their oncologist. I suppose someone with more than perhaps 6 years in remission might only come in annually.
At City of Hope patients have annual checkups decades after their treatment, it's honestly something I believe both the Doctors and patients look forward to. Annually they also host a picnic with entertainment for all the BMT patients, donors, and families, it's in it's 43rd year if I remember correctly, and it's attended by thousands. My Dr. is normally the M.C. It's interesting that stem cells are still referred to as bone marrow, and certainly that's where it started. I don't really know when they learned that while they were transplanting marrow, it was the stem cells within it that were doing the work. I don't know if marrow is transplanted any more, but perhaps in some cases it has a function beyond the stem cells alone.
My point is that finding the status of most patients shouldn't be too difficult, I would think their oncologist is pretty well informed, and probably their GP or internist as well.
Gary
The way to get a Nasdaq listing isn't with a huge R/S, the Nasdaq has requirements that go beyond just a $4 price. If they're able to discuss what they're doing with investors and create enough value to bring it back to say 3 to 6 cents, then roughly a dollar could be achieved with say a 1 for 20. At that point they should be able to raise some funds, and more importantly have something to build on. If a year or so from then they achieved $4, then they'd have earned a Nasdaq listing.
It's rare that R/S's work, and when they do it's when they have the support of the shareholders, or at least their understanding. Smaller R/S's are far more likely to get that support than say 1 for 100 or larger. If the company approached shareholders asking for authority for a R/S of up to say 1 for 50, it would be a level I and many others might live with, but asking for 1 for 700 isn't. Even if 1 for 700 could bring a $4 share price, or more, without a message that sustains it the price could go below $1 in no time. Give shareholders a reason to bring it back above a nickle, then let's consider doing something to reach a dollar again.
Gary
It's my belief that in interim checks the clinicians aren't overly concerned about LTFU, but at the end of the trial, they will work much harder to eliminate all of them. Perhaps a couple won't be located, but I believe very few will be found in the final data.
At this point in the trial, where all who are alive have been for 48 months or more, I would suspect that most are feeling pretty healthy. That's not to say none are in failing health, but I believe the numbers are small. If 80+ were alive a year ago, I doubt if more than 10% passed on in the last year. If I'm right about that, the number alive today should be in the 70's.
I believe that by, or before SNO we'll have some news, it may not be an unblinded trial and top line data, but I see no reason they can't verify the status of all still thought to be alive in the trial. Even if we have a couple LTFU's, I believe we'll hear a very impressive number.
Hopefully whenever they do discuss status with investors they will establish goals for when the events needed to conclude the trial will occur, as well as an update to the trial for DCVax-Direct. Who knows, they might have a surprise for us and actually provide top line data.
Gary
I believe there are a number of major technical conferences coming before the year's end. Does anyone here believe that PSTI will be presenting new trial data at any of these conferences.
Thanks,
Gary
Let's say a company has a billion shares authorized, and a half billion outstanding. They do a 1 for 100 reverse split, that takes the outstanding shares down to 5 million. If the share authorized remains 1 billion, where are you after a few years if the shares outstanding has grown back to half a billion. The original half billion shares now represents 1% of the company.
I can show you companies that have done this multiple times, investors who began with hundreds of thousands of share now have 100 or less. The company can stay in business, but investors are totally screwed. I believe under the right conditions a R/S can work, but not at numbers anywhere close to 1 for 700, it may work for the company, but over time investors will be killed, even if the company is eventually successful.
If the company worked to build the price and got it up to at least a few cents, then something that brought it to near $1 would give them a price worthy of attracting some investors, but the key would be showing approvable products. If they do that, gaining a reasonable stock price should be just a matter of supply and demand, the price will go up once investors like the products being developed.
Gary
I do like to stir the pot. As far as insurance companies paying for experimental treatment, if I expanded that it would be at a cost that was no higher, and probably less than the conventional treatment would cost them.
If the insurance company stated conventional treatment for GBM was $100K annually, what if those choosing experimental treatment received $75K from the insurance company. That 25% reduction ought to make it work for them.
The thing is, I don't think the insurance companies ever reveal what they actually pay, they reveal the list price as though that's what they're paying. I believe most companies would be happy to let their therapies be used under right to try if they could collect 50% of the list price, perhaps even at 25%, but frankly I don't know that the insurance companies pay even 25%, maybe not even 10%. I know drugs in other countries often sell for a small fraction of what they do here, I don't know that insurance companies don't buy them for the same price that they can find elsewhere.
What I know for a fact is that the people negotiating prices tell Doctor's what to use. On more than one occasion my drugs were changed by my Dr. because he was told to switch patients from A to B, I only complained if B didn't work as well, that was rare, but occasionally did occur. What really disturbed me was being on a drug for a substantial period of time and complaining about it not working the well, then being told by the Dr. that he had enough information from me for him to justify for the dramatically better product that was available all along. This was when I was in an HMO, but I suspect it's the same from normal insurance.
The surgeon who removed part of a disk that was impinging on a nerve agreed to try a shot in another location where there is a bulging disk in another location. The fact that he prescribes it isn't enough, someone at Medicare, or one of my insurance companies has to approve of what he recommends. It's been several days and I've still not received the okay. I believe if he'd said surgery, he could have done it, but he's trying a much cheaper alternative and hopefully it can be effective. My point is that it's accountants and attorneys that are saying a lot more about our treatment, I believe long term costs would come down if Doctors could do what they believe right, and they didn't have to submit a ton of paperwork to do it.
Gary
To those who say a R/S makes financing easier, your right, but it does something else, it dramatically lowers your interest in the company.
I could live with a small R/S after the price was at a few cents, but one for 700 is an invitation to issue so many shares that before you know it the shares currently outstanding might represent less than 1% of the company.
I'm not for tying the hands of the company completely, but if say a 1 for 50 R/S were done, I'd also like to see them reduce the authorized share to 10% of what it was previously without a shareholders vote to permit more. Such an action would still dramatically lower the O/S but still allow substantial growth.
I will vote no to any proposal that I believe would lead to current investors being reduced to under 10% of what the company will be in a few years.
Gary
I ought to be easy to show that a treatment in which people live dramatically longer than the norm and have a decent quality of life should be approved. The fact that it isn't easy is not a condemnation of the company, but rather should be of the regulators.
It's been clear that certain drugmakers tried to hide negative side effects of blockbuster drugs, but they weren't drugs addressing deadly diseases, and survival wasn't what gained approval. I don't know how credible clinicians could cheat in this trial, unless the patient didn't have GBM, and I believe they were quite certain they did, they used the tumor to make the vaccine, how could they cheat. Perhaps those who're still alive after 4, 5, 6 or more years really aren't alive, they're zombees, we can get them into the movies, but if not, something positive is happening here, and it's undeniable.
Why does it need a new SAP or anything else to prove it, why can the FDA and other regulators have a look at the patients themselves. Why not have the patients gathered up in a few places in the world, near where they've been treated, let the regulators hear from them first hand, they could even determine if any were zombees, it would cost less to pay for everyone to gather in a 5 star resort than it will to prepare all the paperwork needed to gain approval, and it will take far more time. Let all the clinician attend as well, they deserve the perks.
This won't happen, the FDA and others cannot trust their own eyes and other senses, they have to see it reduced to paper that proves what's obvious to the senses.
Gary
I believe they're asking for way to much at 1 for 700. If they fought to get the share price back to a few cents I might support something that would see the price go over $1, but not until they've created sufficient value to bring us over a few cents.
I believe they can do this by being more transparent about what they're developing instead of treating investors like mushrooms, you know what that means, keeping us in the dark and covering us with sh--.
I strongly believe that research will prove cannabis has benefits, but I also suspect that most cannabis products available are both unproven, and may not be strong enough to achieve the benefit unless you take a lot of them. Clinical trials should show the strength needed for a given condition. Products like OWCP's sublingual tablet could be made, and prescribed in numerous strengths, the key here is prescribed. If Doctors say use it based on clinical trials, insurance will pay, at least in part, for it, and its proper use will have benefit.
I just read that the culprit in the vaping problems may be vitamin E. Certainly it's safe to eat, but smoking it apparently turns it into something that coats the lungs and can be deadly. Supposedly it was used in illegal devices, but how much testing has been done with any of them.
My point is that companies like OWCP are needed to create safe and effective products that use cannabis, but I won't support a decision that's based on poor management. Let management tell us more about what they're doing, what they're planning, build some equity, then ask for something that's far more reasonable.
Gary
I wish I could say I made money in IMGN, but not yet. I still believe that conjugates have a place, but clearly they're not what they were thought to be over a quarter century ago when I first invested. Of course back then a stock went through the roof based on an article on Judah Folkman curing mice. Back then the Times thought Dr. Folkman's ideas about angiogenesis would lead to a cure for cancer, yes, all cancers, in just a few years.
We've gone from curing mice driving a stock up about 100 points to stocks occasionally actually falling after FDA approval as earnings estimates aren't determined to warrant the stock price. In some cases, like DNDN, even after approval the company wasn't viable.
That said, I believe if our vaccines are approved we'll be very viable, if we're not bought out. The only question is, will BP pay enough to purchase NWBO, or will the company grow based on increasing earnings for the foreseeable future. I still believe a partner will get into the act at some point after the trial is unblinded, but whether that partner, or another BP comes up with enough to buy out the company will be undecided.
Here's a question for investors. If say in 2 years a combination of a drug approval and positive trial results for DCVax-Direct as well as a partnership that provides sufficient funds for all planned trial raises the company's market cap to somewhere in high single digit billions or more, would you want a buyout for say 30% to 50% more than the current market cap. If the above is true, I suspect many investors would believe that left alone for the remainder of the decade, the company would reach triple digit billions market cap, at least 5 times the buyout offering. Now is not when to make that decision, but it's the sort of thing I hope we'll be looking to decide a couple years from now.
Gary
As long term holders of IMGN, patience goes a long way, but I'll agree with Druggie, much more info is needed here by ASCO. I in fact believe we'll get much more at SNO, though the trial may not be unblinded by then. I cannot say whether the company will present there, or only Dr. Liau or her team, but I think we'll learn for example how many remain alive in the trial, and I think the Top 100 will again be discussed, and the median survival will have moved over 60 months for that group.
I believe it is somewhat clear that some patients see little or no benefit from the vaccine, it's not harmful, but little or no added survival time seems to occur. Perhaps in the future they'll be able to pre-determine who's unlikely to benefit and target them with something else. Until that determination can be made, all should be given a chance with the vaccine.
Too many people view cancer as a disease that can be conquered, it's not. I have no idea of how many forms of cancer exist, but each is it's own disease. As a victim of Leukemia, before being diagnosed I had no idea how many variations of it occur, I still can't say what the number is, but I know it's substantial, and I know in many cases drugs tested on one form have benefits in others, but aren't included in the FDA approved label for the product.
I believe our vaccines may be a major advancement in many cancers, but it certainly won't be curative for a substantial percentage, at least it won't by itself. The good news is some substantial percentage may see benefits, and some will be cured, but in practically every case it will come with the vaccine combined with other therapies. To the person who's life is extended, it really doesn't matter which products used in achieving remission were effective, and which weren't, what matters is achieving the remission, and perhaps ultimately a cure.
I hope I'm surprised at SNO, and at least top line results are announced, but at this point I cannot say it will happen. I do think Dr. Liau can say 60, 70, or 80 some patients are still alive. If that number happens to still be in the 80's, it would indicate those alive are really quite stable, as it's been awhile since we got the number, and that's where it was at the time. On the other hand, if it's in the 60's that's still roughly 20% of those who started the trial, and many are alive well in excess of 5 years if the median of the top 100 is now over 5 years. We would certainly know that all were alive for over 4 years as it will have been over 4 years since the last patient was dosed at SNO.
I would also think that by SNO we'll get a commitment from the company on when they anticipate unblinding, and hopefully an explanation of what has delayed it. While most believe it's the SAP, it would be nice if that were confirmed by the company.
I believe we're getting close, a month from now we should know much more, I hope we can avoid sniping at one another while we're waiting.
Gary
The quarterly report makes it sound like the initial approval could come in South Korea, does anyone know why that's the case, or am I reading something into it that really isn't there.
Gary
Sorry to hear that Druggie, let's hope this time is the time.
My kids are in or approaching 40 often still live at home. Not our plan but they're basically good kids and we haven't pushed them into normal 40 hour jobs, they're both doing their own thing and making enough not to come to us for daily expenses.
Hopefully a near death experience will turn things around for your son.
Gary
Happy to hear of the progress. I hope your son accepts the warning he's been given and can break the vaping habit, but clearly like cigarettes it's an addiction.
I believe that cannabis does have medicinal benefits, but that any sort of smoke can't be good for the lungs. Personally I've been given products to try and never really felt anything, but they had low levels of THC, I cannot say how more of it might affect me, I really haven't pushed for it. Some of what I tried was in candy, other in drops, and I did try a little with a vape, I felt nothing, but my kids said they felt the effect of some of it. Thing is, I would support the idea of the Govt. at least approving it's development in drug trials, but achieving patents for products containing it has been problematical. Without a patent, a company would be foolish to spend the funds needed for clinical trials if nothing gave them rights to market an approved product exclusively, at least for a period of time.
Many years ago an person who worked as an Air Force medic told me they found hiccup's could be resolved with a spoonful of sugar under the tongue. Of course no research has ever been done on it as their is no commercial value to such a cure. There are so many cannabis based products legally available in State's where it's legal that almost nothing is being done to determine what really has benefits, and what doesn't. I hope your son can break the vaping habit, but find benefits from cannabis if needed in other ways.
Gary
Milo,
Products with THC are certainly available in legal cannabis stores in many States, but clearly they too are untested. On another board an investor prhas told us of a personal problem where his son vaped THC, he's in the hospital with his lungs coated with an oil that's related and they have yet to find a way to break it down. I have no idea if the devices he used were legal or not, it's been said that most of the vaping problems have come from illegal devices, but virtually no testing's been done with either tobacco or cannabis based devices. Frankly I don't think smoke of any kind is beneficial to your lungs. Clearly tobacco creates problems, and even chewing it has led to mouth cancers. I suspect if both tobacco and cannabis were studied for approval today, cannabis would be more likely to gain it, but we tried taking away alcohol at one point, that got us nowhere, so I doubt they'll try it again with tobacco, but if it wasn't around for centuries, it wouldn't be legal today.
I would hope our sublingual tablet would prove a safe way of administering all sorts of formulations of cannabis for a variety of uses. Likewise our cream for psoriasis and other skin diseases. I believe the Phase 1 Trial which was run with the cream demonstrated that the product being rubbed on didn't get into the bloodstream, so the THC in it wasn't getting people high. The sublingual tablets are an entirely different matter, they can get people high, which may, or may not have certain medicinal benefits.
Gary
Milo,
There are a ton of similar products using CBD in all sorts of ways, I frankly tried some of the pain cream but can't say my back pain which radiates down my leg improved at all. I believe the difference is that OWCP is also using THC and other components found in cannabis, and to gain acceptance they actually intend to run clinical trials.
I don't believe clinical trials exist for nearly all the products that can be found containing CBD practically everywhere. Check out Amazon, they have hundreds of products listed there.
I would hope that the inclusion of THC will make things like the psoriasis cream far more effective. I cannot say that no benefits can be seen from CBD alone, but I hope formulations actually tried in clinical trials can't really be shown to be more effective. If in fact OWCP's products were clinically tried and approved, I believe sales would greatly exceed that of anything else on the market, and it would be far more effective and prescribed or recommended by Doctors, and perhaps covered by insurance.
Gary
I heard briefly from Dave I, he promised more to follow. On a question I asked on right to try he indicated it's far more complex than they've made it sound publicly, right now it's possible to get DCVax-L in the UK.
I don't believe many companies are permitting right to try, just as in the past they didn't support compassionate use. It's sad that the FDA cannot arrive at a procedure for right to try that drug makers and insurance companies will go along with so that many who wish to try something that may be of benefit to them can get it.
Gary
Druggie, how is your son doing?
I've heard that most having problems are using black market products. Clearly more testing is needed. Here in California it's said that more sales are coming from illegal stores. I don't know that is a fact, but revenue isn't as high as anticipated.
Gary
I look at these things as long term and I still believe that NWBO will prove to be a great investment, especially for people like me that got in at an average price below $.25. I would hope that anyone who got in for double digit dollars have averaged down to close to, if not under $1. If not, it may take awhile to be positive, but it should happen in time.
Of course if you're among those who believe the trial will never end, if you're right, you could be right about the stock. I believe that what I've seen from Dr. Liau is reason to unblind, even if survival isn't the measure that's considered primary in determining approval. I don't believe the survival benefit can be ignored, regardless of the original approval criteria.
Gary
I'd like to chime in on this. I believe that investors have been waiting so long for the unblinding that no one is certain of when it will happen.
When I first invested over a year ago, many were certain that 36 months after the last patient enrolled it would happen. Some now believe that 48 months is the key. In a trial for a totally different product I saw that they keyed on 49 months, I have no idea what was behind that choice. The point is, investors don't know, and the company is providing little guidance.
Just today I wrote Dave Innis about errors in the website regarding the Phase 3 Trial. I suggested a change wasn't critical if something is happening near term, but if not it should be fixed.
I wouldn't be at all surprised if the company has confidentiality agreements with one, or more potential partners, and that might handcuff them wrt what they can tell investors at this point. Under confidentiality potential partners my be able to see the raw data as soon as the trial is unblinded, even before top line data is announced.
Gary
On another stock board I've heard from someone who's been in pharmaceuticals for many years who's son is hospitalized because of vaping a THC based product. They've found his lungs are thoroughly coated with an oil that's fairly impervious to current treatment. I certainly hope they find a way of treating this, but more importantly, it seems like vaping of any product may be hazardous as some of the deaths have been associated with tobacco products.
I really cannot say the act of vaping is satisfying, it may be to some, but I believe it's the THC that's satisfying, and our sublingual tablet may provide as much satisfaction, and hopefully has zero negative side effects. The only way of actually knowing is clinical trials, and perhaps if patent approvals are coming, they'll actually be done.
I suspect that the oil used in vaping is far more concentrated than what's in the cannabis if smoked, that may be why similar problems didn't seem to be the case with smoking cannabis. I suspect no form of smoke is good for the lungs, but Congress is hard pressed to make smoking of anything illegal. If there are benefits from tobacco, I wonder if it too could be handled with a sublingual tablet. I cannot say that whatever the benefit is from smoking will be equaled by a sublingual tablet, but if some feeling is achieved by it, perhaps the same feeling may come from using the tablet. Of course it's known that people who use chewing tobacco have cancer problems in their mouth, so it's impossible without testing to say that won't be the case with a sublingual tablet.
I wish I could say that all sorts of other products were safe, but clearly many of the nutriceuticals found in all sorts of stores have no proof of efficacy or safety. In reality, little that we eat and drink is proven safe, but some things have been used essentially forever.
Gary
My timing has been terrible, yesterday I sold stock in a position I've held for years in IMGN which is up 25% today including after hours to fill out my position in NWBO, which is down roughly 5% since I bought it. The good news I believe it that my position is now as great as I ever planned, and I still believe the future is bright, so having some of it in Roth IRA's will pay off well.
When it comes to a 25% gain, right now 6 cents essentially represents that. I believe the future will hold many gains of 6 cents or substantially more, in fact, once top line data is announced, I believe a double or more could easily occur in one day. I can't say when that day will occur, but each day, we're one day closer.
By the way, anyone heard how Druggie's son is doing. He should be in all our thoughts and prayers.
Gary
What we need to realize is that we don't prevent people from doing what's clearly harmful to them. Roughly 60 years ago my father told me about a friend in Texas who he'd visit with a few times a year, he was a lung surgeon. He'd chosen lung surgery because he knew that cigarettes would give him a lot of business. He described how blackened the lungs of cigarette smokers were to my dad, clearly tobacco's harm was know then, and probably many years prior to then, yet the most we've done is putting a warning on the pack.
I was of the belief that some who've died from vaping were using tobacco based products, not cannabis, so I'd suspect that some similar type of oil may be associated with tobacco as well. I really wonder if practically any type of smoke may be hazardous to your lungs, whether it comes from tobacco, cannabis, or a burning forest or building, it all causes harm. We cannot stop fires by laws, but the law can be used to stop what's currently legal, but harmful. Don't get me wrong, I believe there are many benefits that may be derived from cannabis, and possibly even from tobacco, but there are other ways of administering it, some of which should be totally safe to use.
The problem is tobacco has been legal practically forever, even though it may be more harmful than cannabis, which is only legal in some stated. Perhaps the answer isn't making it illegal, but rather developing or determining ways to use it that are safe and effective, and removing the harmful ways of using it by making that illegal. I doubt that Congress will act, if they would, tobacco, or at least cigarettes would have been illegal half a century or more ago. Cannabis probably has greater benefits, and less health problems, but there too, Congress won't do what's needed to make it completely legal, but they've gone along with permitting states to do so.
Perhaps smoking marijuana isn't actually as dangerous as vaping it, in that no real clinical testing has been done, who can say. If Congress acted to permit clinical trials, perhaps more would be done to determine how to, and not to use it, not just CBD and THC, but all the compounds that can be extracted from cannabis.
I know nothing about the oil found in Druggies son's lungs, but suspect that it's highly concentrated in vaping, but perhaps hardly found in smoking. Perhaps a similar oil is used to vape tobacco, as some deaths have been attributed to it as well. The oil might actually be safe to use in many ways, as long as it wasn't converted to a smoke that could coat the lungs. I've been told that the lungs of cigarette smokers who quit do improve over time, hopefully that will be the case for Druggie's son as well provided he can beat the habit.
Gary
It seems to me that the patient treated under compassionate use had already been given a death sentence by the disease, the fact that the PLX treatment couldn't overcome it should have been expected. It would have been a spectacular outcome had the treatment worked, but it didn't.
Compassionate use shouldn't work against a company, nor should the right to try, which seems to be the current term for what was previously called compassionate use. One reason many companies don't permit their products to be used in this manner is that in the past bad outcomes have occasionally delayed trials. No one should be surprised when someone who's dying actually dies, yet some people make a big deal of it in spite of the fact that asking for the right to try only occurs when the Doctors know of nothing better to try.
I frankly wish the FDA would establish a way of pricing drugs under right to try that was a percentage of what the list price was expected to be, ideally 50% or less. I suspect that if the price were established, and if the insurance company had to pay, a lot more uses of right to try would be permitted. Essentially this would apply to drugs in, or beyond, Phase 3 Trials to be used while an approval decision was approaching consideration. In every case, the outcome should be reported, but only in a database where the patient isn't identified, but the disease being treated and the outcome is.
Gary
With SNO just a little over 2 weeks away I felt it was time to put some NWBO in both mine, and my wife's Roth IRA's. Essentially I wanted to fill out the position I wanted to hold and used other stocks to do it.
I cannot be certain our trial will be unblinded by SNO, but I believe we'll learn more about when it should be unblinded, it in fact it isn't. I would think we'll get a quarterly report before then, and perhaps that will provide some additional information about it as well.
I believe that much will be revealed by the end of the year and I certainly expect top line data by then. If I'm right about that, I suspect the company will submit a BLA before the end of the second quarter of next year. With a six month review by the FDA we'd be talking about approval potentially by the end of next year.
Many people are convinced the trial won't be approved because the original trial goals won't be met. In their mind in spite of a lot of patients living well over 5 years, many still alive, the FDA will want a trial properly structured to demonstrate what the vaccine can do. While I believe they're wrong, I must concede that they could be right. My point here is to point out, it will probably be a year of so before we'll know what the FDA or other authorities intend to do.
I believe in the mean time, we have a tremendous opportunity. To begin with, I believe the top line results will be impressive. Then at some technical conference we'll get the full data, also very impressive. At any time we could see a partnership, that could be huge. I can't say that these things will take the stock to double digit dollars, it's possible, but doubtful, but I do believe something over $1 is very probable, and it could easily be a 5 to 10 banger over current prices, and perhaps substantially more than that, depending on the terms of the partnership. If after something like a ten banger investors wanted protection going into the approval decision, selling a small part of the shares would bring in more than what's invested today.
The this is, right now, before top line data is released is an ideal time to invest, and if I'm right, you can hold for a year and still sell if you so choose before the FDA should act. I.E. shares added now would be held for over 12 months and be qualified as a long term gain. Of course if you already have shares at a higher price, if you sell you may want to designate the more expensive ones to lessen the gain, or perhaps even have a loss. The key is, you have plenty of time. Meanwhile, it's very possible that something more may come from trials of DCVax-Direct, that could also be very positive as long as it's showing positive results. If these things occur, it's not impossible for NWBO to receive a buyout offer at a price acceptable to management, which I believe would be into double digit billions based on what others have said. A ten banger from where we are today is essentially $2.50, a one hundred banger would be $25. I suspect an acceptable buyout will be something over a forty banger from today prices, perhaps substantially more.
Gary