Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Thanks very much, this answers the question about whether the trial is blinded, or not, it's both. The company should be able to tell us the result of the first part of the trial, and they'll only do the second part of the trial if they see efficacy in the first.
What's not shown at this point is an approach at other skin diseases. I suspect that if they see efficacy in psoriasis, then they'll look at other skin diseases.
Now if we could only learn the status of these trials. If they put them in the clinical trials database we'd know.
I was of the belief that they also had Israeli hospitals working with them on the trial, am I wrong about that. I believe the initial safety trial for the cream was done in a hospital.
Gary
While I agree AF becomes the enemy of lots of companies, I also believe that when he finds himself on the wrong side of the judgement's he makes he'll find a way to put himself in the best light possible and get behind it. I suspect he'll say something like, while I was right about the vaccine not achieving original trial results, survival has been excellent and with modifications to the criteria for judging the vaccine based on survival DCVax-L has an excellent chance at being approved.
He's rather like an analysts who downgrades a stock from buy to hold taking credit for the gain the stock makes when it doubles the month following his downgrade, he didn't tell you to sell, just hold. Forget the fact that he gave investors new stocks he rated buy, he said hold and the money to buy the new stocks was supposed to come out of thin air, not selling the companies downgraded to hold.
Gary
While I'm not a great believer that all gaps must fill, I do believe the MM's are a force to be reckoned with, and in the absents of news they can move stocks almost at will. The company had the choice of maintaining a positive spin on where the company's going, or continue their silence, they've chosen silence permitting the MM's to maintain control.
I can's say they'll fill the gap, but it's certainly a possibility, then all who believe it must happen will be satisfied. Nothing in my mind really matters if the cream is effective, or if additional patents are established. If nothing positive occurs, nothing will keep it above sub penny, so I'll wait for the news and let the MM's play their games.
Gary
Of course you're right, the last thing we want to do is kill all the bacteria, some of which are good and benefit us. There are limited places like hospitals where they must be reduced, and places like planes and ships where reducing them will prevent the spread of infection.
We don't need people to spend a fortune sanitizing everything, but there is plenty that needs it, and that could keep the company very busy for the foreseeable future.
Gary
I'm unsure if you knew I was in somewhat the same state, but in remission from leukemia. I've had some of the same thoughts about building sufficient financial reserves should problems reoccur, I've not yet met that goal, but hopefully PCTL will help.
I don't know what you're fighting, but don't give up, some great things are happening. I've seen miracles as a patient at City of Hope and I hope one of them is out there for you.
Hopefully this will be a great financial vehicle for both of us, but I hope you'll also be on the lookout for something that can be a great medical vehicle as well.
Gary
I'm not speaking of another one, I'm speaking of what's been submitted to the regulators a matter of months ago. I believe the company some time ago determined that the original criteria for judging the vaccine was flawed by things like psedoprogression, which wasn't known at the time the trial was initiated. Progression was viewed to have occurred, but it was really pseudoprogression, but clearly survival was improved, and that will have become the major priority for judging the vaccine IMHO.
Gary
You can like AF or hate him, it doesn't matter if your judgement is correct, much the same can be said about management, if you hate the management, but like the product being developed, you'll be rewarded if you're right about the product.
As I see it, management has kept the company alive, I can't hate that. Could it have done differently, sure, but it might have failed. Could the trial have been unblinded a couple years ago, probably, but would it have been likely to succeed in gaining approval, doubtful, but without seeing the data then it's impossible to know. I believe management made the right decision in creating a new SAP and holding off unblinding until they had it accepted. Their decision I believe was based on what they knew without unblinding the trial, and if they're right it will be validated when it's unblinded.
I'm not suggesting that there aren't better managers, or worse ones, you really can't say what would happen if someone else was running the company. What I do believe to be true is that current management will complete the trial, and I think the results will be positive enough to gain a partnership before an approval is being judged, and probably before a BLA is submitted. Even if the regulators asked for something more, the partnership would assure that they would get it, and while the share price would suffer, it wouldn't be anywhere near the level it is today. If I'm right about this, I believe management should be credited by investors for getting us there. If I'm wrong, we may all be hurting unless we're short.
Gary
While I'm pretty new to the stock, I'm not new to the market and I've seen all sorts of companies carry on without bankruptcy that had virtually no products for sale, only products in development for years. While it's possible the company may need to dilute, or to do other types of creative financing, it has products for sale, it has buyers, and it's got markets it's not yet tapped, it won't be going into bankruptcy.
I don't know how high the run it's on may go before it retrenches a bit then hopefully continues up. It may be a few more cents, perhaps a dime, perhaps even higher. At some point, it will be able to sell not that many million shares to bring in a million dollars, and I doubt if they'll have any problem finding buyers.
In the past I've seen companies run from sub penny to double digits with only a concept, PCTL has products, they have people making their products, if the demand increases, they'll be able to hire more people. In short, they have a lot of room to grow as their technology gets accepted in a variety of industries.
I frankly don't generally try to guess what the market will do in a given week or even month, I try to think in terms of years, but in this company I'm seeing an excitement that makes me believe we'll be up substantially tomorrow, and probably for the remainder of the week. I really can't say how high we might end the month, but a dime, or even a quarter are certainly not out of the question.
Don't fear dilution or other means of raising funds, they are a part of growing a company that even very profitable companies do, it's what's needed to permit them to grow. A company need not be profitable to be very successful, just look at Tesla, as long as people believe they'll be successful they're doing just fine. Perhaps the day will come when Tesla makes a profit, but without it, Musk has had little trouble raising the money necessary to keep growing. Frankly, if this company has the sort of success I believe it could, it just might put me into one of their products.
Gary
I know you guys are far more technically knowledgeable than me, but when two or more compounds produce better results than either of them independently, what difference does it make as to which is the adjuvant.
I'm of the belief that our vaccines have benefits, but by themselves are generally not curative. To me the key is, they may continue to produce benefits in combination with drugs that may be years from the marketplace. It's rather like the company that doesn't make anything themselves, but makes what others make better.
If there was a cancer that the SOC achieved cures for 75% of all patients and adding a vaccine took it to 80%, you could say you had a 5% improvement, but for those who were in the group that wouldn't be cured, their chances improve by 20% when using the vaccine.
I don't believe that you stop improving on the treatment of a specific cancer because you can cure 75% or even 90%, not if the 10% remaining represents hundreds, or thousands, or more.
Gary
According to the quote information found here the company currently has just under 273 million shares outstanding. Let's look at that going to a third of a billion by the end of this year. Let's also say that by the end of this year we get a preliminary readout on the Phase 2 for the cannabis cream and it's determined to have benefits in at least one, and perhaps a few forms of skin disease, and a Phase 3 Trial is being planned. What market cap should this bring.
I certainly can't say with any degree of certainty, but I believe it could certainly be somewhere between a half billion, and a billion dollar market cap. Based on a third of a billion shares outstanding, that's $1.50 to $3 in share price.
Could it be higher, or lower, certainly. There is no guarantee that the cream will work, but I suspect they have some anecdotal evidence that it does, even if they'll never admit it. By the end of the year they could have other patents approved, that could certainly bring higher prices, likewise they could get one or more partners, again a higher price. If that fails to occur, they could once again ask for a reverse split, the only way to know for certain, is to let the company do what it's going to do. What will they tell us about that, we'll see, they clearly don't open up about most of their plans.
I believe in being patient, but frankly I was close to selling half my holdings for a stock loss when I heard the news of a patent. To my knowledge they never guided that they were near achieving that patent, and frankly, I don't know if they knew it would happen. I have no idea how close they may be to others, but suspect that if they're going forward with further trials of the sublingual tablet, they believe the patent will eventually come through.
If this makes sense to you, wait and watch what happens. If your a swing trader, there will probably be many opportunities. If you buy and hold, wait and see what happens, perhaps buy on weakness. Let's see where we are by the end of the year.
Gary
It's been roughly 60 years since I saw my first Japanese car, most referred to them as Japanese junk back then. A decade later they were dramatically better and many American's were buying them. By the time another decade past they were entering the luxury market, as well as setting high standards for quality and price generally deemed superior to the American product. By this time American major car makers said it was because of the lower labor costs, but the Japanese companies and others built plants in the U.S. and guess what, the quality was every bit as good as what was coming in from the Orient.
Everything sort of came to a head with the economy tanking in 2008, and GM and Chrysler needing to be bailed out from bankruptcy. Now how does this relate to NWBO. During the entire time, I believe that the CEO's and other key executives at the American named auto makers continued to get bonuses and salaries that would make our CEO's look like a piker. Their companies were virtually collapsing over a 60 year period, and yet the executives were well regarded, and rewarded while managing the collapse of their industry. In recent years they've improved, but so has their foreign named competition, so rarely do they rate as highly by various rating scales.
Our CEO certainly isn't hurting for the way she's managed the company, but I frankly think she's guided it through a much tougher period than the much more highly rewarded heads of the auto makers, adjusted for inflation. I'm not suggesting that others might have not done better, but it's also very possible some would have gone bankrupt, so we wouldn't be in a position to talk about it.
I believe this year we'll be well rewarded for the work the CEO and others have put in over the past decade. While it's doubtful the company will exist a decade from now, as they've made it clear they'll entertain a buyout, if by chance they are, the share price might well be in triple digit dollars. At that time I doubt many will complain about the CEO's wealth because while she may be much wealthier than most of us, none will be hurting who held on and averaged down when they could. We'll all be at or nearly millionaires on NWBO alone.
I've not been here that long, but I've heard much the same sort of criticism in other biotech's, some which have gone belly up, and frankly I'll give our CEO credit for getting us to this point. Certainly she's made money in doing so, but I believe we'll be very successful. I wish I could say the same of those who ran Detroit for over 50 years and ran what were once great companies into the ground.
If I were buying a new car today, it would probably be American made, but it would probably be a Tesla, though I believe the stock to be overpriced. I certainly would look at others, but after driving in them, if money didn't matter, it would probably be a Tesla, and if NWBO is successful, money won't matter.
Gary
Milo,
You may be right, but I believe that if they really wanted a reverse split they'd have proposed something much smaller, and fought for it. They actually did something that I don't believe they had to do which almost certainly defeated it, they counted shares not voted as no votes.
In other similar elections I don't believe this was the case in other companies, if you didn't vote, it didn't count for either side. I also didn't see them fighting to persuade investors that the vote was needed.
I believe they'd send the share price to highs not seen in some time if they did provide a letter and update to the website that provided a course forward from here. It would certainly make raising funds easier if the share price was dramatically improved.
When I indicated I opposed the R/S I indicated that if they drove up the price to a dime or so, and at that point they were looking for a small R/S to achieve higher prices I wouldn't be as opposed, but I'm speaking of not more than a 1 for 10, and preferably only a 1 for 2 or 3. With the approval of the patent and the initiation of a Phase 2 Trial, with the company speaking about plans for the future, I believe a share price of a quarter to fifty cents is very possible, much higher if some initial trial results can be released that are positive. While I would hope that no R/S is needed at all, if we were at a quarter or more, a small R/S to reach $1, shouldn't be toxic, as a 1 for 700 would have been.
Gary
Thanks, that make sense. I tend to think that stock often overreacts to dilutive financing. The first duty of management is keeping the company alive, and sometimes it requires actions which seem bizarre. If the company survives, and ultimately prospers, it is worth whatever they had to do.
I know that in the case of Federal Express, the founder unable to make payroll went to Vegas and was lucky enough to keep the company in business. The world would be a much different place if he had a losing streak. Many successful companies, at some time in their past, made some bizarre moves to stay in business.
Gary
I don't know why the company hasn't said more, they're certainly not hyping what's happening to drive the share price up, but why not an update from Hirsch. I suspect that they're waiting for something, if so, I'm hoping that they can tell us the Phase 2 trial has begun.
This is purely speculation on my part, but if one thing is clear it's that the company, in spite of all sorts of complaints from investors, just keeps working toward getting patents approved and product trials established.
I don't believe they'll go much further with the sublingual tablet unless they're reasonably convinced they'll gain a patent for it. In hindsight, the planning of a Phase 2 for the cream was an indication they believed they'd get that patent.
Most biotech have the same complaint from investors, the companies never provide enough information to satisfy investors, OWCP is no different. Where they're different is in the area they're working in, the cannabis market, as the law is still not clear about using it.
I may be wrong, but I believe if you have FDA drug approval your product can be sold anywhere in the U.S., so even though THC is illegal in many states, approved products may be prescribed there. I believe GWPH's products currently have THC and should be available everywhere, and if I'm right about that, the same will be true or our cream, and hopefully other products when they receive FDA approval. This won't happen for a couple years at best, but it's potentially a multi-billion dollar market, it will be worth the wait.
The company should release quarterly and annual results early March, as I believe they get an extra month to put together annual results. If nothing new has been released by then, I would certainly hope that the Annual Report provides guidance on the path forward from here.
Gary
I certainly can't say when news is coming, but the stock is acting like it's expecting something soon. In the future I believe we'll see moves up, and perhaps down, that are bigger than our entire share price today, but of course that won't happen without news until the share price is well over $1. Stocks trading for a few dollars routinely move up, or down by a quarter or more daily on no real news, but of course there may be rumors.
I don't think it will be that long before we're in that range. Top line data could easily give us well over a double in a day, and that day could be repeated a few times before the price settled into a trading range.
Gary
As a newer investor in the stock I'd like to get some veterans opinions of what brought the share price down so much from prior 52 week highs.
As I see it, they have a product that's needed for sale or lease, why did the bottom fall out previously, and how long do you believe it may be before we're seeing new 52 week highs again.
For those who don't know me, I've had my fair share of times in hospitals in the past 6 years since being discovered to have leukemia. Twice I've had catheters infect while being in the hospital, and it's likely the bug that infected the catheter came from the hospital, though I was frequently in an out. Because the chemo I continue on causes diarrhea they invariably isolate me for awhile until they can rule out C-diff, which I've never had. My point is, I can see the need for these machines and intend to let my Doctor at City of Hope know about them.
Hospitals certainly try to be as clean and germ free as possible, but it's impossible to keep the door open to visitors and unhealthy people checking in all the time, yet stay germ free. I previously voiced the idea of actually being able to apply this technology to the air conditioning and vent systems, studies would certainly need to be done to prove it's in no way harmful to be breathing it 24/7 in very low concentrations, but if that were proven, or if the fact that it's naturally occurring in our bodies would assure it's of no harm, if very low concentrations were effective, this might be a way of keeping an entire hospital far healthier to be in. There is a lot of proof in trying to minimize the time you spend in the hospital to avoid the diseases you'll encounter while there, this could greatly cut that risk.
Gary
What's missing here?
The company has told us they have the patent for the cannabis cream.
The company has told us they have plans for doing a clinical trial for the cream.
While I believe this should be sufficient to warrant a substantially higher price, there is something lacking. What's lacking is guidance from the company on how they intend to get from where they are, to successful completion of trials and drug approval. Clearly this will require funds, but perhaps not substantial funds immediately.
I believe their arrangement with Israeli hospitals permit them to do trials at relatively low expense to them, certainly some dilution may be required, but not that much. Assuming the Phase 2 Trial goes well, the question might be, where does the money to do a more massive and probably multinational Phase 3 come from.
This is far from hopeless, for one thing, where should the share price be after a successful Phase 2 in which investors clearly believe that the product is worthy of approval. I certainly believe it will be somewhere in excess of $1, so further dilution is possible without totally blowing up the O/S. However, at that point it will probably be more logical to partner the cream with someone who can deal with distribution and sales worldwide, and perhaps take over it manufacture as well, though I believe they have a competent manufacturer.
Essentially I'm saying the company needs to paint us a picture, perhaps with the same options I'm mentioning above. They need to provide some estimates of when the trial will start, and when it's estimated to complete. Finally they also need to access the likelihood that other patents will be granted. If they do this, I don't believe it will take that long before the price is well into double digits, and perhaps over $1.
Gary
Who's doing the pumping. Best I can tell the company is still very closed mouth as to their plans, but announcing patent approval is only appropriate. I do however believe you're right about $.01, and perhaps if you said $.001, but there are conditions before you'd be right. The condition is that the cream doesn't work on anything, and that the company gains no further patents.
If the cream works on psoriasis, and nothing else, what's a fair price. How about if it works on acne, and nothing else, or eczema, or any other skin condition you care to name, only one, nothing else, but it's worthy of FDA approval in that condition. Perhaps some of these conditions would only generate hundreds of millions annually, what if OWCP sees just 25% of it. For every $100 million they earn $25 million, at a P/E of 10 that puts their market cap at $250 million. Today their market cap is $15 million, if we allow for 40% growth in the number of shares, that would still be ten times the roughly $.06 we're worth today.
Of course a P/E of 10 is on the low side, we could be 30 and it would still be reasonable, that would make it $1.80, but of course that would be on earning $25 million. I certainly believe we could earn more than that, lets say $100 million, P/E of 10 gives you $2.40, P/E of 30 makes it $7.20.
I for one believe some day we could earn half a billion to a billion or more if we're not bought out, and that would be especially true if additional patents are granted, and products succeed in trials.
In short, if it fails miserably, your prediction may be right, if it succeeds in any way, it should be a ten banger or much more than it is today. I believe the cream will be successful in a few different skin conditions, and I also believe they'll fight for, and win patents on the sublingual tablet and other products in time. Could they earn billions, if they're not bought out I believe it's very possible, but we must give it time.
Gary
We can speculate until we're blue in the face, but until we get the full data package it is doubtful that we'll know. I really doubt that top line data will break down the data to the level of knowing how many on the vaccine received it initially or on cross over, or what the specifics of their cancers were. That's what should be displayed when data's presented for peer review, hopefully at ASCO.
What do I think we'll learn. How may are still alive, and of them, did any never receive the vaccine. I think we'll learn about mean survival, and perhaps some newer data on the Top 100, but nowhere near all the information many would like to see, that will come later. I do believe it will be enough information to get excited about, enough to drive the price substantially higher, and it should get some favorable press. If they already don't have potential partners, or buyers, wanting to know more now, they will once the top line data is revealed.
Gary
Scotty,
You could be right, database lock and unblinding are essentially the same thing in my view, but regardless, most companies I've followed don't do it. Investors generally know when trials are near completion, but they're not told that it's a fact, they're suddenly given top line data, and an assessment of what that data means.
Many people here are technically vary savvy, either Doctors, or somehow educated medically. I'm not, I don't try to understand all the technical language involved in drug development, patents, etc. What I am is a casual observer in what's happening in healthcare, along with the experience of being treated for cancers, which gives anyone a different take on everything.
I do believe the FDA has made some improvements, and perhaps Dr. Padzur has changed some since the loss of his wife, but I still believe they have a long way to go. To me, I don't care about some pre-defined goal, if it's obvious a drug, vaccine, etc is producing a substantial benefit, I believe that should be all that's necessary, whether a goal was met, or not. I believe those monitoring trials who see substantial benefits should be able to go to the FDA for early approval, no NDA or BLA required, just present the facts, and gain the approval. It shouldn't take a year or more to compose a BLA and then have it reviewed for 6 months to get something approved that those monitoring the trial can assure the FDA that it's both safe, and effective. I know these things won't happen, but I can still offer them up for discussion.
Gary
I certainly wish you the miracles I've seen or heard of in others, it can happen, but if it's not to be, I wish you the best quality of life for your remaining time.
Gary
Does anyone really believe we'll make a big move up or down before we get news? I doubt it. Of course news doesn't have to be top line data, it could just be an appearance by someone like Dr. Liau that sounds very positive, but a big move will require the major news we're all looking for beginning with top line data.
Could they tell us the SAP has now been accepted by all regulators, sure, or that the trial has been unblinded and they're gathering data, also sure, but other companies don't generally announce such information, so I doubt that NWBO will. Top line data, and a statement about how it's being perceived is what most companies release. If that data fails to meet the FDA goals they say so, but if they see a course to approval in spite of missing some pre-determined goal they also say so.
While I believe the vaccine will have met the new SAP if in fact the regulators permitted a significant modification of the original goals, we don't know that they've permitted that. If they didn't, and if some originally stated goal failed to be met, I still cannot imagine not being impressed with the number of patients who've survived beyond 4 or 5 years. I've got to believe their would be a path to approval, but when it comes to our FDA, additional trials are always a possibility. I would suspect that the other three regulators could be a different case, and approvals could come from at least one, and perhaps all three.
Sadly it's often been the case that great drugs are available in much of the world for years before they're accepted in the U.S. Likewise, in much of the world things like cannabis, placental stem cells, etc can be experimented for years before it's permitted here. We've become a nation where science is questioned, rather than supported, when it suggests something certain pressure groups don't agree with.
It's up to the company to release the data and describe the findings honestly giving shareholders directions on the way forward. If that way forward requires discussions with the FDA or other regulators prior to submission of a BLA, or doing further trials, we're entitled to be told. I believe regardless or what seen relative to approval goals, the data will be sufficient to attract a partner if that's the direction the company chooses to go. Go it alone until a buy out offer is received that's acceptable is always another choice.
Gary
If the last report on patients alive is correct, it would be a miracle as some would be resurrected from the dead. I think the last time we had a firm count it was in the 80's, but I suppose it's possible that there are some LTFU's that have been found and remain alive, so perhaps it's just near a miracle.
Statistically with the number of patients in the trial, at this time I doubt more than 15 would be expected to be alive, I believe that we could have over 60 alive, over 4 times what would have been expected with SOC treatment, and it might be substantially better than that. I don't think they'll be any doubt about the effectiveness of the vaccine.
Gary
While I agree with you, and have said many times that a market cap of at least $10 billion is needed to get a $20 billion buyout offer, something else you must consider is the market cap won't stay where it is once we get the top line data.
I believe the big thing is how the top line data is received. If major media coverage occurs that recognizes this is a new paradigm in fighting cancer, front page coverage in major newspapers, coverage on network news, etc, no telling how high the price might go. On the other hand, if it's just good news, like most other drugs where top line results suggest a future approval, I would expect the market cap to grow to somewhere in the $1 to $2 billion range.
If emotion took the stock price above a $10 billion market cap, a $20 billion buyout offer could come in immediately, before the stock corrected to where it belonged on the basis of top line data alone. Companies with no products on the market, but one or more headed for approval typically have market caps in the billion dollar range, not ten billion, but on emotion, companies that cure cancer in mice were driven to market caps well into the tens of billions, but they didn't stay there.
DNDN years ago ran up to many billions before crashing, and ultimately going out of business, but while there are similarities, there are major differences. The biggest is that their drug, Provenge, while approved wasn't that superior to other products for prostate cancer, and was very expensive, while the DCVax's are effective for GBM, and may be for other cancers, when little or nothing else is known to be effective.
Personally I believe we could see a sustained stock price somewhere between $1 and $5 after we get top line data, it could move up from there on a partnership, or after a full presentation of the data, and will surely run up on approvals. I can't say that it will see $10 or more before either substantial revenue comes in, or when news of efficacy is released on DCVax-Direct, as a second product deemed to be headed toward approval will certainly add value to the stock. All these things could trigger a buyout offer at $20 billion, or more.
Gary
I don't know when we'll get an update from the company, perhaps it will be tomorrow, perhaps months away, regardless, I believe we'll be up dramatically on that day, and it could mean another gap in trading that probably will never be filled.
I do believe they'll issue quarterly and/or annual results in the manner they normally do, asking for the permitted delay before it's due. In the case of the annual, I believe they're allowed an additional month, so it will probably be early March before we get that report. Hopefully we'll get an update from the company before that time.
Gary
Previously I indicated that we must own the intellectual property rights before we could seriously advance products, we now do own the rights to the skin cream. The next step is proving they work, I believe that shortly the company will clarify the planned trials for the cream.
Hopefully we'll see the same thing occur on the sublingual tablet, i.e. a patent approval. In that case we're at least slightly further along in trials, but still much more major trials will need to be run.
How many others of the patents may be approved, time will tell. The key is in not spending substantial funds until you know you own the rights, but a small expenditure to determine the idea works is reasonable. If it doesn't work, it's foolish to keep fighting for the patent.
Any of the products OWCP has in patent granted or pending status have the potential to sell into the billions of dollars annually. Whether the company keeps any totally to itself, or partners each product is a decision they'll make in time. I believe if investors ask themselves what OWCP should be worth even if they only see a small royalty stream from selling or partnering each product, you cannot help but arrive at the point that the company will eventually sell for double digit dollars. It won't be the case immediately, but give it a few years and watch it happen.
Gary
I'd agree the movement was like that of a P & D, but it's not the company that's orchestrating it. With little fanfare they simply stated they got the patent for the cream. Nothing else has been said, other than we shareholders didn't give them the R/S.
Like essent ially everyone here I think they should be more forthcoming about plans, but it's possible that they were as shocked as anyone that a patent was finally granted, and they're still working on what to do next.
In reality they previously announced how they planned to do the trial with the cream in Israeli hospitals, but few details are out, to my knowledge, and I don't believe it's in the clinical trials database. If I'm wrong about that, someone please provide a link.
To my knowledge, the company hasn't named the product. If they had, and if it were in the clinical trial database, you could search for it, but how would you search for a skin cream containing cannabis. The company should give the cream a name, and of course it should be in the clinical trial database.
Gary
I think you're right on the money.
Gary
Could the technicians that say the gap must fill be right, I really don't know, or care, I don't believe all gaps must fill, but I also know the MM's can move a stock one way, or the other, so it's possible for the gap to fill. In a few weeks, or a month, it will have little influence on the price.
If the company wished to be trading above a quarter, they'd update investors on their approach to going for drug approval for the cream now that they have the patent. If they don't care about the price at this time, they'll stay silent. I frankly don't know how much they care at this time.
They do have a duty to report quarterly, and annually, and beyond that when material events occur. If a trial beginning, ending, etc. isn't tied to a monetary event, while it can be announced, technically it's not a material event, and they may choose not to discuss it with a separate PR. They should update us at the quarterly, but they get to choose the level of detail.
I believe if most investors understood what the company is trying to do, they would value the company much higher than it's currently at, but perhaps they're trying not to dangle a carrot in the fear that the trial failed to meet its goals. Perhaps their intent is to show before and after photo's on the first psoriasis patients in the trial, they're not saying anything, so anything is possible.
The real question is, what is this stock worth if the cream actually clears up psoriasis, or acne, or eczema, etc. What if it benefits them all? If it fails, it's probably where it was mid December, or even lower, but what if it succeeds. I don't have that many shares, but if it succeeds there are very few cars that I couldn't buy for cash if I choose.
Gary
I've viewed some of Clay's posts, I don't see it as gloating, it's just applying the views of a technician to the stock. Retrenchments are normal, and he points out those things. Who that was here 6 months ago, 3 month, etc doesn't feel a lot better about the stock now then you did then.
If we never got another patent approved the potential for success here is still great, but certainly the cream could fail, no clinical test is a sure thing. All prior indications are that it should be effective, but that's true about most drugs that go into trials.
For new investors, you're risking just $.05 with the potential of making 100 times your money in at most a few years, but of course you could lose everything. If the Phase 2 goes well, and a Phase 3 is required for approval, it could take 3 to 5 years to get there. With actual drug approval I believe a market cap no less than $2 billion will be reasonably certain. Substantial dilution could take the shares outstanding to 400 million, thus a $2 billion market cap would be $5 a share, 100 times what it is today.
I believe the above is very conservative with success of the cream, and of course we may gain other patent approvals. A market cap of $10 billion or more is certainly not impossible in a few years time, even before any approvals as long as it's clear products are proceeding toward approval.
Gary
All their trials are in Israeli hospitals, I would suspect that getting people with psoriasis and other skin diseases should be easier than getting healthy people to put up with requirements of the trials. I don't know if the trials will require things like the blood draws that were done to prove safety, but they probably will. The key to what the cream is doing should be visible evidence of efficacy, photos should be convincing, but they'll probably want more.
Gary
Not really, depending on how the Phase 2 trial is structured. In the back of my mind I believe the trial is not blinded, if that's correct I believe we could get an update perhaps as shortly as a month or two after the first patients enter the trial. On the other hand if it's blinded, then the question is, how long will it take, and will they have designed peeks at what's happening.
I really don't believe the trial should take that long, I would believe after a month or two a determination of the benefit of the cream could be made, the only question is, how long will it take to fully enroll the trial.
Gary
Three weeks ago we would have been thrilled with today's prices. This retrenching is nothing to be concerned about as long as the cream shows it's effective in trials, without that the patent is worthless, but with it the stock will gain a billion dollar market cap in time.
Investors need to look at where we've been, and where we're going. The company has spent a great deal of time and money establishing and fighting for patents. Detractors said it would never happen, then it did. No telling how many more may be approved, but clearly the company continues to fight for them.
The company has also run trials, and is planning others, that cannot be ignored. In short, the company's not talking, they're doing, but sooner or later they'll be talking again. I believe when they do, we could easily reach a market cap of at least $100 million while waiting for some proof that the cream has the potential of being approved as a drug.
Does anyone doubt that if efficacy is seen in the trial BP will want to at least have a piece of this product. Partnership, buyout, anything is possible once it's clear we have not just a patent, but a viable product, and I believe that later this year it's possible.
Gary
We're in a world where many want organic produce, if it doesn't violate that it will be worth far more to farming. Pesticides are clearly banned if produce is organic, and I believe they try using natural sources to eliminate pests.
We attended a lecture by a nutritionist who felt it was worthwhile buying certain products that were organic, but felt it was money wasted on others. I do purchase some organic products, but certainly not everything we eat.
It would be great if the company could verify it's approved for use in organic foods.
Gary
Does anyone know if the use of our product in agriculture costs the user the organic food label. If not, the value of it would greatly be enhanced.
Gary
Perhaps I'm missing something, but I believe that NWBO already has agreements for the commercial manufacturing of the product that are already approved by the regulating authorities. It's not like they have to spend hundreds of millions on production capability. I do think they'll partner to avoid the cost of building distribution and sales teams, but as I see it, they're well prepared for such a partnership.
To me the question should be, if TLD supports the probability of approval, what's a fair market cap. I believe that number starts at about $1 billion and moves up from there, that's roughly 8 times our current market cap prior to any partnership, which could certainly take it much higher.
If I'm right, and no questions exist with manufacturing, the approval process for the vaccine might actually be much faster than the 6 months typically taken by the FDA, but it should still take many months to prepare the BLA after the trial is unblinded. Is approval possible this year, I have to believe it's a possibility, and will continue to be so as long as a BLA is submitted by Summer.
A BP partnership soon after the TLD is revealed may very well establish the leading candidate to buyout the company, but it's by no means a lock. The $20 billion price tag that seems to have been floated may no longer apply if DCVax-Direct has further validation, in fact it could prove to be worth more than DCVax-L even if it's a few years from potential approval if it's shown to work on multiple cancers.
The point is, we need to see more results, if they're as positive as they appear to be, $20 billion could be a bargain for a buyout of the company.
Gary
I really wish more people would discuss market cap rather than share price. A stock could be priced at $1, or $100 and still have precisely the same market cap, and it's market cap that says what the company is worth.
If OWCP can bring the cannabis cream to regulatory approval by the FDA and other regulators, meaning that dermatologists and other doctors can prescribe it and have the costs at least partially covered by insurance, the cream should result in billions a year in earnings. I certainly believe that OWCP will partner the product, and while they should receive substantial money up front, they may receive royalties in the 10 to 20% range. That should equate to hundreds of millions or more annually. If we allowed our outstanding shares to nearly double, that would put it at half a billion shares. Each $100 million we earned would equate to $.20 cents a share. A P/E of 10 gives us $2, at 30 it's $6, but remember, that's for each $100 million. In time we could easily reach many times that $100 million figure, a half billion would be almost certain. If we had other products in development as well, I believe the P/E of 30 is more likely, so at half a billion we'd be at a $30 share price if we have 500 million shares outstanding. This won't happen overnight, but it certainly could happen before the next decade.
I certainly don't know that we'll need to expand the O/S to half a billion, 350 million might be plenty. A partner may very well take an equity position, but they should also bring in sufficient funds that little or no further dilution should be required. My discussion above was intentionally conservative, we could do much better. Nothing is certain, but I believe that if the initial trial results look promising, the major partnership will come, and with it our price will be at least a few dollars.
Gary
We shouldn't use the word cure too freely, I believe we may greatly extending lives, but cures can't be claimed without substantially more information. The problem with cancer is even when you believe you're cured, 5 years or more cancer free, it still reoccurs, and often is deadly.
I believe our vaccines have major benefits, in some cases they may result in cures, but in most cases it's not because they're acting alone. The maximum benefit appears to be achieved when combined with other therapies.
I think the good news is, as additional more effective therapies are found, it will be determined that they work better when used in combination with our vaccines. In the future perhaps 50% of GBM patients will live 5 years or longer, but while that's a huge improvement over today, it's still a huge opportunity for improvement. As long as our vaccine has a benefit, it should be a part of the treatment.
Gary
I believe your problem in saying we're overbought is the question of what should the market cap of a company in this position be. I'll contend that the cream has blockbuster potential, it will shortly be in Phase 2 trials, and with patent approval the company owns the intellectual property. I would contend that any other biotech in a similar position would have a market cap somewhere in the range of $100 to $500 million. Our current market cap is $30 million
Does anyone have a link to either the company's announcement of the planned Phase 2 Trial for the cream, or the clinical trials database link to the trial. If so, please sticky it on the home page as well as getting back to me.
Thanks,
Gary