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It's been just a little over 2 months since I planned to sell half my OWCP for a tax loss, then they announced patent approval. We had a substantial gain, but have given back much of it, but nowhere near the sub penny price we were before the announcement.
I made the decision that holding is worthwhile, I'm not worried about the day to day weakness, especially when coronavirus is killing the market. Am I adding to my position, if I had access funds I'd consider it, but not yet. What I do believe is that sometime later this year the company will finally give us another comprehensive update, then we can truly evaluate what we believe the potential is.
Right now, all we know is the skin cream will be further tested, and we believe that further testing of the sublingual tablet is anticipated as well. I believe before substantial funds are put out on the sublingual tablet, they need to know that they've still got a shot at patent approval.
I cannot tell you this stock will go to a dime, a dollar, or ten dollars, but I certainly believe it has that potential and more. Just the cream alone if approved as a drug by our FDA and other International regulators could potentially be a blockbuster drug. Even if OWCP partners the drug and only sees 10% of sales, what would $100 million in earnings do for the company. With the current shares outstanding, that would equate to about $.35 a share, with a P/E of 10, that's $3.50 if the P/E's 30, it's over $10. It could certainly be worth more than that, especially if additional patents come through, and of course if it's found effective against many skin disease, not just psoriasis, it could be a blockbuster many times over.
Gary
I just saw a report that common flu is .1%. Thing about coronavirus is, many people remain infected, impossible to say if they'll be cured, or not. Additionally, I understand that some patients thought to be cured have had the disease reoccur. In the case here in California where they can't identify how the infection occurred, no telling how many have been infected, and the patients gotten worse since the disease was identified.
As some have said, this may be no worse than a bad cold for many, but I think the jury is still out, if they don't come up with a way to fight it, it may be far worse. For now, it's certainly worse than the common flu.
Gary
Coronavirus is clearly killing the market, and I suspect that if it's not under control by the time or our annual meeting, attendance could be limited to purely those in the area, as who'd expose themselves to airline flights to get there.
I have friends who've cancelled cruises they had planned a year ago, as well as upcoming flights. No telling how much further the market will fall, but it's clear it's spreading. Here in California a patient was under treatment for some time before it was identified, no telling how many she exposed before getting sick, and more importantly, they don't know how she was exposed, furthermore, since identifying it, she's getting worse.
As of now no one in my neighborhood has come down, so I intend to vote at the poll next Tuesday, but I wonder if the turnout will be low nationwide as people avoid exposure to other people. Frankly, if the outbreak grows dramatically, I believe the company should webcast the meeting and avoid unnecessary exposure for both employees and investors.
Gary
It seems to me that major companies have already been chosen to make the vaccine, unless we can prove what we have is superior, we don't have much of a chance with coronavirus. The key is making better products and proving they are, not an easy task, but possible.
Gary
While I don't believe that 5 years is necessary, not in a disease where typically the percentage alive at 5 years can be counted on the fingers of one hand. If however you're right, I think the company would be far better off in saying that after discussions with the regulators, that is the case.
I don't believe there is anything special about 5 years. I noted in another trial they used 49 months, I have no idea how they arrived at that number, but that's what they announced. We're now well past 4 years for the last being dosed, but well beyond 5 for the majority in the trial. For all we know we may have some patients alive for over a decade. When top line data is announced, we should learn what's actually the case, but we do know that the median for the top 100 continues to grow, so more than 50 people remain alive beyond the median, which was nearly 60 months the last time it was presented by Dr. Liau, I'm guessing over 6 months ago. Once only 50 are alive, and they're all beyond the median, the median will no longer move up. If only 50 were alive, it would probably be five times what would have been expected beyond 60 months, what do you have to do to prove something is working.
Gary
Just a thought, if shares are available for short sellers, doesn't that actually work for us in a short squeeze where more shorts must cover.
I frankly believe anyone shorting a stock that has the potential of a tremendous upward move is playing with fire. Of course they believe the good news won't be coming, but unless they know something we don't, I believe they're crazy. Even if roughly a year from now the FDA says, they want more proof, it will take a year to reach that point, meanwhile I believe the company could very well partner the vaccine and achieve a market cap in the billions. Clearly, they'll be a short squeeze, and after losing, they'll have the opportunity to short at much higher stock prices, if they choose to play with fire twice.
Gary
When I invested, the company actually had made its symbol HIV until the trial failed, then to CVM though the name of the company was unchanged.
Over the years I've seen announcements made by them where all that needed to be changed was the name of the disease they're targeting, a find and replace could fix up years worth or releases.
Gary
I was speaking with some Dr. friends of mine about Coronavirus and one thing they indicate was, it's from a family of viruses, many that we've had around for years. I would believe that if that's the case, and if we know that our product is effective against others in that family, it should be effective against the current threat from that family. Certainly tests should confirm it, but I believe that it will clearly be the case once tested.
Gary
I see posts about a psoriasis cream, indicating it doesn't exist. I believe they're right, the company isn't calling it that. Why? Because psoriasis may only be one of the skin diseases the cream has benefits for. It may be the first it's tried on, or perhaps they'll look at others, I don't know, but acne, eczema, etc may also see benefit, so until it's tested, lets just call it skin cream.
When I have a skin problem my dermatologist has prescribed a steroid which he's told me is the strongest available, it's uses are many. There is no reason the same may not be the case for our skin cream. By the way, one of the uses of that steroid is psoriasis, but that's not what I'm using it for.
Gary
I just looked at a chart for CVM and it's been decades since I had invested in it, adjusted for reverse splits I'd have had to have paid thousands for it back then. Back at that time they were looking at AIDS, but guess what, the drug was the same one they're talking about today, Multikine.
Since then it's been targeted a many other diseases, and in short it's a cure in search of a disease. If the trial isn't a failure, I'll be very surprised, but I have a feeling they may think it's the answer to Coronavirus.
Gary
I really doubt if anyone has specific dates. Institutions may get some more info than DI provides the rest of us as they generally can speak directly with the CEO and other officers, but I still believe they're getting guidance like DI would give us, but perhaps a little more specific.
If the SAP has cleared all 4 regulators the company should be in the process of unblinding and determining what to say in top line data. Some companies provide little, others far more when it comes to TLD. I would hope that NWBO provides more, especially about those remaining alive at the end of the trial. It would not surprise me if some of these people could be presented at the Annual Meeting as long as the trial has been unblinded.
Annual Meetings aren't where new information is revealed, that should come out through proper channels to everyone, but once out, it can be discussed there. I'd encourage anyone nearby to attend, but for me, I'd rather have the thousands of shares I could buy for what it would cost me to attend. I look forward to anything investors in attendance can tell us about the meeting, as well as any unofficial discussions they may be able to participate in before or after with key people there from the company.
Gary
Doc,
Once a date was announced by the company, I doubt if any judge would change the date. Had nothing been announced, I believe that you could get an order and deadline from the court, and it may have been sooner than the announced date. While technically the company should have held the meeting sooner, I believe they announced it in time to avoid a court overruling what they wanted to do.
I believe they have a reason for the delay, and if I'm correct about that, I believe investors will be much happier by what they hear at the slightly delayed meeting, than what they would have heard had the meeting been held by the proper deadline. JMHO.
Gary
It seems to me that who supplies our vaccine either before or after approval doesn't matter as long as what they provide meet the standards set by the company, and accepted by the regulators. The key is, we profit from any product that's sold, as well as our cost being acceptable when using what's provided in trials.
Should we gain a partnership, or buyout, it would be up to the partner or buyer to reach an agreement on how product will be manufactured. Will they want to do it in house, or maintain current suppliers, that would be up to them.
Our consideration should be, what is NWBO doing, as long as they don't own the manufacturing sites, it shouldn't be of that great a concern to us as long as they're sufficient to meet the demand once we have an approval.
With all my medical treatment I take a lot of drugs. Frankly I don't worry about who they come from, some are generic, others still under patent, but regardless, a drug with a BP label may still be produced by someone contracted by the BP. Perhaps this may concern some, but to me, as long as the drugs are working as the Dr. intends them to, I'm fine with whoever is the source.
I do believe that it's sad that Doctors must fight to put patients on drugs still under patent, as the price is generally much higher. I recently had a change in blood pressure meds and the Dr. anticipated a fight, but it didn't occur because a generic form of the drug is now available. The problem is this philosophy is preventing the sale of a lot of newly approved medications, and they're often being withheld from the patients until all available generic alternatives have been tried. I'm not saying this would be the case with deadly diseases like cancer, but SOC treatment will be tried first until the newly approved drug becomes part of the SOC.
I have great drug coverage, but I know people who don't, they routinely drive down to Tijuana and purchase drugs at price that are lower than what I pay, but not enough to make it worth the trip. In almost every case, their drugs carry the names of BP's, but those BP's produce their drugs in Mexico. I don't believe they've had a problem from the drugs, but I think that it's interesting that down there the retail price is lower than the price I pay which is supposed to be a small fraction of the total cost, with the insurance paying the difference. I should note that in Mexico, most of those drugs do not require a prescription.
Gary
Is Hirsch to lazy to write 2 messages to shareholders a year. I think not. I believe the entire management team at OWCP has made a decision to keep investors in the dark until some specific events occur. They make the required releases, quarterlies, announcing key events, like patents or trial related plans, but the guidelines for the future that we were told would be semi-annually be release by Dr. Hirsch have not been forthcoming.
I wish I could say why not, I certainly can't, but it should be clear the company is moving forward in the manner that it can. I can think of one possibility that would prevent such an update, they're in negotiations of either a partnership, or buyout. While after this much time it seems unlikely, but in another company I'm aware that discussions were ongoing for roughly 2 years before the partnership was finally consummated.
If by chance this were the case, and if an update letter was sent out, it wouldn't be truthful if it failed to state that discussions were underway, but making such a statement would probably violate a confidentiality agreement specified by both parties. It would be a Catch 22 situation that could only be resolved by saying nothing.
I have no idea that this is the case, but I do believe the company is waiting for some key event to do such a release and until it finally happens, nothing new is being said. Look for an annual report sometime late next month, if they take all the time allotted them. Certainly an annual report should provide some future guidance, I just don't know how much they'll say, or if they're muzzled by something that's in negotiations. Of course much the same can be said about patents, they're in negotiations until either they're issued, or the company abandons the effort on one or more of them. I cannot say if the company has completely given up on any of their patents.
Gary
Any thoughts on the possibility that whoever purchased at $.17 led the charge to push the price higher. Not saying they did, just looking at possibilities.
Today's action could certainly been figured, especially in a dramatically down market, the question is, where does it go tomorrow.
If they're right about the coronavirus being weather related, and disappearing once temperatures rise, what prevents it from moving to the Southern Hemisphere as the season changes. It may be true, but we need better ways of treating it, not just hope that it goes away.
In the recent post with a map of where it can be found, while something like 25,000 were cured, and 2500 passed on, roughly 50,000 still have it. I don't see how mortality figures can really be determined until more is known about those who're still fighting the disease.
Common flu takes more lives, but millions get the flu, we can only hope that by the time this is over coronavirus won't afflict millions.
I understand that Trump eliminated leadership positions that would have been expected to lead the fight here. It's fine to cut budgets if you're lucky enough not to need the people who were cut, perhaps they'd have been twiddling their thumbs until now, but now they're needed, but they're no longer there. Coronavirus is a real threat, and it can spread here, just as it has elsewhere if it gets started. Communities where they'd like to put patients in are saying NIMBY, we need to determine how it can be safely handled in all our back yards.
Gary
I would hope that at least some of the money will be used to initiate the next trial of DCVax-Direct. I don't oppose dilution if there is a good reason for doing it.
Gary
Meirluc,
Today you're completely right, the cost of personalized drugs for all sorts of illnesses would be prohibitive. Technology could change all of that. I suspect that years from now a blood sample may be all that's needed for many personalized drugs, and once you have the sample, much of the process will be nearly completely automated. It won't happen overnight, but I believe it will be the future.
Today surgery is often done robotic-ally, but Drs. are in charge. In time, it's very possible that the computers will completely control the robots, or nano-bots will be injected and do the surgery without even a single cut. I doubt I'll be alive to see it, but my kids will.
I suspect that vaccines will lower the incidence of cancer, and other diseases, and also play a much greater role in it's cure, our vaccines are just the beginning. I frankly wonder if our DCVax-Direct couldn't be made from a patient who appeared healthy which might eliminate cancers that could be found only as molecules inside the body. Of course attempting such a trial is nearly impossible, you'd have to recruit thousands of healthy people and track them for decades to see if they had fewer cancer incidents than the general population, and of course you'd probably also give boosters to some, but not all, to determine if they were necessary.
I suspect the day will come when our annual checkup will include some sort of full body scan, it won't be that expensive as it will be done by a machine that's almost totally automatic, and results are determined by computers. Cancers and other problems will be able to be dealt with while they're tiny and may not show symptoms for many months, or even a few years.
Gary
You're right, but I've been assured that people do. Much the same applies to stocks trading sub penny as the shorter believes the company will go belly up.
If I were looking at a company to short, I'd consider TSLA, but if I did, I'd probably end up like others who did, I'd lose. I like the car, and while I wish I'd bought years ago, right now I can't see it, and I'll probably be wrong about that.
Gary
Thanks Moxa,
I really believe what we're doing superior to hydrogen peroxide, even if it can be used in a similar manner. The thing I like about what we're doing is that it's something that's naturally occurring as well. It could be used in agricultural ways and the products remain organic, according to a discussion I had with the company. The key will be mass producing units to the point where it's cost effective to use them in all sorts of applications and in all sorts of sizes. It will take money to do that, but as the technology proves itself, I think the money will be found.
I and friends of mine have recently had several small surgeries that haven't been done in hospitals, but rather in surgery centers. I would suspect that if a really small unit were available for use in such places at a reasonable price, it would be very popular. In many cases the centers are owned by major hospitals, like Cedars Sinai here in L.A. I believe they see it as safer to visit a surgery center than a hospital where they're treating all sorts of diseases that you can potentially be exposed to in just checking in.
There are so many potential applications, the question is, what's the best way to grow. Concentrating on hospitals for now is probably the right strategy, and as the revenue grows branch into other areas unless companies doing things like indoor cannabis growth wish to fund producing the equipment up front.
As I see it, we occupy a tiny niche that could grow exponentially, it's not certain, but it certainly has that possibility.
Gary
I'd much rather see the company gain the authority to add a quarter billion new shares than to be able to dilute to 4 times the number after a 1 of 4 reverse split. Share price almost always comes down after a reverse split. I can wait for the Nasdaq, but I think current shareholders would be poorly served by maintaining the authorized shares at a billion or more, someone said it's actually 1.25 billion, but cut the outstanding shares to under a quarter billion.
A compromise that could be acceptable would be the 1 for 4, but reducing the authorized share to a half billion or less without an investors vote permitting more. I fully believe in giving management some flexibility, but not so much that investors today own a tiny percentage of the company in a matter of a few years.
I've see companies use 1 for 100 shares multiple times, many here seem to follow CVM, it's one that's done that, and they keep going on the very same drug I learned about decades ago. I still have hope for PSTI which did a 1 for 10 to stay on the Nasdaq with a substantial degree of safety, but while I believe in the company, I think the price would be higher had they not done it, though they'd be on the OTC.
By the end of next year I expect that NWBO will have gained approval of DCVax-L, without a reverse split I believe we'll be above $4 and on the Nasdaq, that should serve investors well. The price could come much quicker with a partnership, and the partner may want an equity position, a good reason to authorize some more shares.
With drug approval I believe we'll be highly successful regardless of whether we do a R/S or not. I just don't see the need to rush getting on the Nasdaq. Few R/S's work as well as people think, in practically every case I've seen the share price will drop substantially both on the announcement of the intent to do one, then even more when it happens.
I would expect the prospectus for the Annual Meeting any day, should a R/S be on the agenda, it will probably be far greater than a 1 for 4 as to get on the Nasdaq with today's prices you'd need about a 1 for 15 if the share price didn't fall after it's announcement. Most likely, they'd propose 1 for 20 or 25 if being on the Nasdaq was the reason. I would hope investors rejected any such proposal.
If the company waited for a $1 to $2 share price, then called a special meeting to do a small R/S to reach the Nasdaq, while I wouldn't like it, I would go along. I can't tell you how many companies I've seen where multiple reverse splits were done. In some cases people who originally held 10,000 or even 100,000 shares now hold 1 share, and it's practically worthless. It's simply not the right way of building a company and even a small R/S is a step in the wrong direction.
Gary
Uplisting cannot be done until the share price is in excess of $4 for a specific amount of time. Let's get the price in compliance before discussing how quickly it can happen, and lets not do it with a reverse split. Once TLD is out and perhaps a partnership added, we could be there, or certainly much closer to being there. Let the company grow without doing something radical, like a reverse split, to get there.
Gary
I read in someone's post that our CEO is only taking $500 a week as salary. I would hope if that's the case he's getting sufficient stock to make him well compensated if the company does well.
I've only been invested here about a month, I don't know all that's occurred in the past. It sounds like he took over shortly before a quarterly was do, and that's probably a good part of the reason it's still not out, but should be shortly according to the conference call. Likewise the Annual Report, on, or nearly on time. While I know of OTC stocks that didn't report for years, it's good that PCTL intends to be caught up shortly, and that should permit its purchase at brokerages which currently aren't permitting it.
As someone who's spent substantial time in hospitals, I'm currently approaching 5 years post stem cells for leukemia, I know of their concern with cleanliness. I believe the companies equipment properly used would result in biologically cleaner hospitals, and that's the key. I know the system works on C-Diff, but I suspect they'd still isolate me each time as the chemo I'm on causes diarrhea, and they insist on culture before clearing a patient of C-Diff. It's funny, the nurses all put on protective outfits, the Doctors could care less. Visitors of course must take precautions. All that disposable stuff has to cost a fair amount of money, I don't know if it can be eliminated by the companies equipment, but a room treated with it should be quite healthy to be in.
I don't know if anyone else has anything that competes with this, I certainly never saw anything in a hospital. I frankly wonder if it's use in Doctor's offices wouldn't be very wise as where do you go when you're sick, either your Dr. or Emergency Rooms and Trauma Care, where you become threatened by what others are bringing in there. In reality, I don't know that our equipment isn't needed more in these places than inside the hospital itself as that's where it's most likely to be spread from.
Today if possible patients go home the same day they have surgery simply to cut down on their exposure to the wide variety of germs found in hospitals. During my hospitalizations I had two catheter infections, in each case they cultured the infections, and while they can never be certain, they were rare enough to probably have come from the hospital, not something I'd normally find outside of it.
I do believe that the potential of our products is tremendous, while this doesn't guarantee success, the potential is certainly there. In time I'd hope that they develop a home unit that's a few hundred dollars, but something that virtually everyone will want to have.
Gary
I believe if the company had a webcast after announcing quarterly results, at least a few, possibly more, analysts would ask questions even if their brokerages haven't yet committed to cover the company. In other companies I've heard questions from analysts who weren't yet covering the company.
Gary
You're right, I believe anything they wish to discuss will come out before the meeting, and in that the meeting's on a Saturday it will probably come out before the market closes on Friday. I'm not certain that's the case, but I'm reasonable certain that information needs to be announced to discuss it at the Annual Meeting.
I do believe that investors questions can be answered at Annual Meetings, and that can provide information not generally available. If that should occur I believe it would need to be discussed in a PR indicating what occurred in the meeting, as well as announcing any votes that occurred at the meeting.
I believe we're in for many interesting days between now and the Annual Meeting.
Gary
There is no reason to rush into the Nasdaq, it will come in time. I believe that if they wished, once at $1 I believe it's possible to get on the American Exchange, it's a step above the OTC, and I believe it's now owned by the Nasdaq.
Frankly exchange rules make little sense when market cap isn't taken into consideration at all. With a $1 share price NWBO will have a market cap approaching $1 billion. Meanwhile if what you're saying is correct, a company with a $45 million market cap can be on the Nasdaq purely because they have few shares outstanding. Market cap should be more important than it's being given credit for.
I don't like reverse splits purely for the intent of getting, or staying on an exchange, I've found they rarely work as even though temporarily they meet some figure, in little time they often lose much of that gain. Splits, on the other hand, may be very constructive, as they permit more people to invest in reasonable quantities of a stock. People generally like to buy 100 shares, or 1000 shares at a time, once stocks are trading at triple digits, it becomes difficult for many investors. Of course the one company that violates that thinking is Berkshire Hathaway, look at what a share of it costs.
Gary
This is one of the times I can agree, the development of virtually any oncology product is exceptionally expensive and time taking, largely because it takes so long to prove you actually have a benefit that's meaningful.
Fortunately, just the opposite should be true for psoriasis in the case of a topical cream for it. In a matter or days or weeks improvement should be clear. The FDA may want a number of months to prove it's durable, but it won't take years, to even decades as some oncology products due. Then it should be possible to permit the earnings from the psoriasis cream to fund the MM trial, at least in part. A substantially higher stock price could certainly fund it with some dilutive funding as well. Investors may not like dilution, but when the share price reaches high single digit to low double digit dollars, I don't believe investors will mind.
I believe there is other good news on many of the products the company is working on. Once patent approvals come it, the trial process for the conditions they're directed at may be longer than psoriasis, but it's nowhere near as long, or expensive as going after MM or other cancers.
I suspect that once more is known about patent, and trials of the cream, the likelihood of a BP partnering with OWCP will be far greater, and that too will greatly take care of funding for the companies many products.
Gary
The normal wisdom is that bad news comes out on Friday's after the close. Good news usually is timed to be out early in the weeks for stockbrokers to be able to work the stock as much as possible while it's still in the news. The worst news is often seen on the last trading day of a holiday weekend.
The long weekend is thought to permit shareholders time to digest the bad news, rather than selling as soon as they hear it. The stock may be down dramatically when it opens after the long weekend, but rather than sell at the bottom, many investors who might have sold on the news will wait in the belief that it will recover, and often it does.
I'd be thrilled if prior to market open on a Monday or Tuesday the announcement of TLD was made, that's what would really kill the shorts as the price moves up dramatically before the market opens, perhaps with a delayed opening because of an imbalance of orders. That's a gap up that will never be filled.
Gary
I tend to like the role of Devil's Advocate, and as such, I hope I'm wrong about why BP may buy us out. Don't get me wrong, we'll be very well rewarded if they do, but I just wonder about their motives for doing so.
In the past, I've seen petroleum giants buy up companies involved in energy savings that had promising new products in development. After the buyout I've yet to see any of those products reach the marketplace. In short they shut it down at a healthy profit to those who developed it, so they didn't need to compete with it.
BP likes the idea of mass produced drugs that they can sell at high prices. I really cannot say they relish the thought of more effective drugs that are personalized to make them far more effective for the individual. They could award us very well, even after data for Direct shows it works in numerous cancers, but rather than advancing the concept, they'd be buried in the corporation. Sure, they might pay $20 billion or more, but it would be easy to tell their shareholders that they prioritize their product development, and currently other drugs have greater priority because of the way they judge their potential.
I'm not saying this will happen, I certainly hope it won't, we'll be well paid regardless, however, I believe the best way of preventing it would be to keep the company independent, but partnered with a BP that could both provide funding and services to the company, but permit it to grow.
I'm very much a senior, I don't know if I'll see the day when much medicine is personalized, but I believe that by the next century that will often be the case, and when it is, treatment will be far more effective. It's hard to say if the major providers of personalized drugs will be BP, as we know it today, or if the future will consist of a great many smaller labs where blood or other body samples can be taken, and personalized drugs are made and administered in a matter of hours, or days.
If partnered, but not sold out, I believe the time to $20 may be a year or more longer than if bought out when the price was $10 or more, but while it takes longer to $20, it won't stop there, and triple digits could be just a couple years longer.
Gary
I think we all need to realize that no one knows for certain what will cure the coronavirus, but the odds are very good that our device will kill it off if it's contaminating a space. Eventually it will probably be tested, as will all sorts of products that may benefit those who have it.
In reality, flu, which we can get vaccines for each year, will kill far more people than the coronavirus, and our products work with it. The reason we don't panic about the flu is it kills a very small percentage of the total who get it, while coronavirus is killing a much higher percentage of those who contract it.
Like so many other similar threats, we'll either learn how to treat it, or mother nature will step in and it will essentially disappear as quickly as it's come. The thing is, our devices can reduce the spread of all sorts of things, their deployment in many places can reduce disease spread substantially. Emergency rooms and Doctors offices are probably some of the places where exposure is the greatest because it's where you go when you're sick.
Gary
It's my belief that after TLD is released the share price will exceed $1. If that proves to be true, the company would be very well served by having perhaps a quarter billion more shares authorized, rather than a reverse split of even 1 for 2 which would permit them to double the shares outstanding without getting an increase.
I believe money will be needed, but what I'm suggested would give them access to substantial money without trimming our ownership by 50% over time. Looking for others opinions.
Gary
I've corresponded with DI on a few occasions and I cannot remember him ever giving concrete dates for any specific event. I believe he's honest about what he's saying, and while he may make it sound like it won't be that long, soon can be interpreted very differently by different people.
Year's ago Mitch Sayare was the CEO of IMGN, when he said something would happen soon, you could be certain it would happen, but sometimes soon meant in a year or so. It got to the point where posters spelled it backwards when Mitch used soon, it became NOOS in our posts.
In investing in biotech's, I've learned nothing happens quickly. It's been said that Congress would take 6 months to determine how to make 3 minute eggs, but the FDA isn't as fast as Congress. I believe the SAP is what's resulted in delays, I wish I was sure it's now behind us. I believe the problem is you cannot simply sit down with the regulators and pound out an agreement. You submit, they comment, you submit again. Each time you submit they take another 30, 60, 90, whatever days before they comment. The same thing occurs on BLA or NDA submissions, they get 6 months, or 1 year to act, and if their action is to ask for something, once you provide it they get another 6 months or a year to consider your reply. In most every case cancer drugs gain the 6 months priority, but regardless, why not have sit downs with the FDA and make decisions then and there. When trial results clearly justify approval, why not reach that agreement immediately and move into a Phase 4 where all results need to be reported to verify how good the product is.
Gary
I believe that it's clear that our products have growing demand. In the brief yesterday it was clear that it won't be long before the missing quarterly and new annual report are out, I believe that will eliminate many doubts people have, and permit purchasing through brokerages that are holding out until that information is in. I suspect the price will be up substantially once the reports are out, but almost certainly they'll see where the company will need to add funds to substantially increase production as ordering increases.
Each time you hear about many people being infected with a disease on a ship, a plane, or in a hospital, you can't help but wonder if they had one of our devices if it would still have happened. Right now it's coronavirus that people worry about, but influenza kills thousands as well, the difference is millions or more get influenza annually, and thousands die, whereas with coronavirus tens of thousands get it, and thousands die, it's far more deadly, and we can only hope that it doesn't spread into hundreds of thousands or millions.
Our device can reduce the spread of disease, but tens or hundreds of thousands of units are really needed to do so, that will require a lot of growth.
Gary
Being up on a day when the Dow is down over 200 isn't a bad thing, even if it's less than a penny. It's my belief that a matter of months from now we'll be trading at a price where a good day might find us up more than our entire current share price today, but naturally a bad day could find us down that much. I expect many more good days, then bad, but nothing goes up every day.
Gary
With a couple minutes to go, we're close to making it an up day by a penny. Yesterday was great, but a penny a day for awhile could make us wealthy in time.
Gary
Please correct me if I'm wrong. I believe there are currently a few places that are either certified or working on it for providing DCVax-L. Does anyone know what their capability is monthly.
It's also my belief that with proper handling, it wouldn't matter which facility made the vaccine, though clearly the closest one would be ideal.
I know in the case of stem cells, they come from all over the world. Mine most likely came from Europe as in at least some countries there, if you want a drivers license you provide a DNA sample, so a lot of stem cell transplants come from Europe. If it were up to me, that would be the case world wide, though I'm sure many would fight to say it's an invasion of their privacy.
I have no idea if a sample of my DNA at age 16 would have shown I would develop leukemia at 70, I don't think so, but some people are concerned about their DNA revealing future health problems. I don't think it should be used that way, but I'm fine if it's used to prevent those problems from occurring. We know DNA solves crimes, but I would hope that those who view it as an invasion of their privacy aren't planning on being criminals, if you are, all the more reason for getting it for crime prevention purposes.
On approval, if sufficient production capability doesn't exist, more will be added. I know City of Hope can make personalized drugs, I would suspect that if they were supplied sufficient information, they could make the vaccine in limited quantities. The thing is, the company would have to be paid to allow it, but COH might be able to support their patients who need it, and perhaps even take the overflow of additional needed vaccine in a pinch. I'm only suggesting that until sufficient sites are commercially available, places like COH and UCLA who clearly can make the vaccine in limited quantity can provide it.
The key is gaining approval, after that meeting demand will result in new capability developing. BP has generally wanted products it can mass produce, which clearly isn't the case here. In the future, I believe the entire industry will be moving in the direction of personalized drugs. BP will either adopt to this technology, or give up what will be a growing business that starts with something from the patient, and delivers a product strictly for that patient.
Gary
I can't say what shareholders will be asked to vote on at the annual meeting, but I do believe that in some way the company will need the flexibility of having additional shares to fund operations, or perhaps permit a buy-in by a partner.
I'm certainly not a big fan of reverse splits, even when intended to be constructive, I find they normally end up with some loss before the price regains parity. Even a small reverse split, say 2 for 3 would be taken as negative by some.
There are no rules for how many shares may be authorized, I'd rather see the authorized shares raised to 1.2, or even 1.5 billion rather than do even the smallest reverse split. Certainly, we'd all like to see the stock on a more major exchange, like the Nasdaq, but I don't believe the way to get there is by reverse split, I believe it's by growing the share price, and I think that will happen once top line data is in, and we'll easily make Nasdaq requirements when a partnership is consummated, or once we have regulator approval of DCVax-L.
A look at other companies shows that companies like GE have over 8 billion shares outstanding, while AMGN has under 600 million, both have market caps of over $100 billion. I find the lower share price of GE more attractive to small investors, while AMGN probably attracts more large investors and Institutions. Certainly Institutions are important, but most can invest once the share price exceeds $5, and that could come rapidly once more is known about the company.
I certainly welcome the thoughts of others, but if you really believe the company needs the flexibility of raising more funds, which I do, think about authorizing more shares and see if that doesn't make sense to you.
Of course it's possible the company won't ask for either at the annual meeting, if all the warrants are converted they'll have adequate funding for now, and they could wait for the need before asking. I doubt if there's a shareholder that wouldn't welcome a partner under the right terms, and those terms may require the partner owning a substantial percentage of the company. Even if perhaps half those shares came from current shareholders tendering their shares at an established price, the other half would be newly issued by the company, which will require a vote that would agree on both the partnership, and the increase in authorized shares.
I would expect that we'll see what the company will be proposing in less than a month, and we'll have some time to discuss it. I really cannot say if the management controls sufficient shares to gain approval of anything they recommend, or not, perhaps others can tell me what's happened in the past. Should the company take on a partner who takes 20% or more ownership in the company it should be realized that the partner effectively has control. It's very hard to overcome a single voting block of 20% or more, though 30% would make it a surer thing when issues come down to a vote. Any partner with that sort of ownership would also be entitled to one or more seats on the Board.
I certainly welcome others thoughts about this.
Gary
While a buyout in the future would be very desirable, I believe more than one company could be interested, and nothing would be better than a bidding war to decide who gets the company.
If a number of companies suspect that others are interested, it can put them off if they're not willing to get into a bidding war. I don't know if the company already has confidentiality agreements in place with one or more companies. If so, those companies will actually be able to get into the data as soon as it's unblinded, rather than waiting for TLD to be announced. If they wish, they could create their own K-M plots before they're presented for peer review, and they should be accurate because they're able to get to all the data. I suspect this could lead to a partnership rather quickly, before any buyout, as a potential buyer will want at least some preliminary data from DCVax-Direct, and partnership money can accelerate that process. Without that, it's doubtful that a potential buyer will be willing to pay what the company believes it's worth.
Gary
I don't know when OWCP will announce anything, but suspect that year end results will be provided in an annual report by the end of March. Will we get anything before, your guess is as good as mine. The company said nothing, then suddenly we had patent approval, they say nothing, but things keep happening.
I suspect the next thing to happen may be the initiation of the Phase 2 Trial in psoriasis, and they may, or may not tell us about it. I do believe after a decision is made to go into the blinded portion of the trial they'll tell us so. Remember the first part of the trial is intended to determine the best does to use in the blinded trial, and in that they see the results, I'm hoping we will as well.
There are people who create doubt because things like Phase 1 trial results are not presented for peer review, check other companies, I believe you'll find that's the case with nearly all of them. The fact that safety is established in Phase 1 is clear because Phase 2 is being initiated. In our case, the Phase 1 was done in healthy people, so no indication of efficacy was possible, the cream is safe, no peer review required.
I suspect that if the work the company has done were being done here in the U.S. the cost would probably be ten times or more than what's been spent, or is needed to complete Phase 2's. It's not impossible to gain approval in Phase 2, at least for a limited number of countries. I suspect the U.S. would insist on a Phase 3 with at least some trial sites being here in the U.S., the cost will be far higher, and they'll probably need a partner before they can do it unless they do have approvals in at least a few countries generating the funds necessary to do it.
Much the same will be true for the sublingual tablet, etc. IMHO they don't proceed until patent approval is established.
Gary
While what you say is true, I believe that when we do get top line data we could more than double that day if we're below $1 when it hits. Of course we may move up so much in anticipation that it doesn't make that big a move, but a $1 to $2 billion market cap is very possible on great news, and I believe TLD will be great news.
Gary
That is probably as much as can be detected. In analyzing my leukemia they could look for the presents of defective cells down to .0001%, I was found to have .0000% on at least a few occasions before the heavy chemo prior to stem cells, but a month later I could be back to .0001% or more. The point is, they couldn't see below .0001% but that doesn't mean nothing is there.
Our product can probably only say 99.9999% germ free because they simply cannot see further than that.
Gary