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I believe she filed because she had to by law, but when quarterly results are filed we'll learn that all warrant holders with the same class of warrants will have received the same extension. If not, they could almost certainly sue and win.
Don't get me wrong, she certainly treats herself well, but I believe the same thing is being done for all in the same class, and perhaps for all expiring classes of warrants. Without such actions, warrant holders could very well sue based on rumors that results were being delayed to eliminate the warrants.
If trial results are positive, I have no doubt that the $.30 threshold will be exceeded dramatically, and we'll never see such prices again. Certainly there will be some volatility, but I believe it will be at a much higher trading range. I suspect we'll see approval from other regulators before the FDA acts, and if the FDA delays approval the result won't be nearly the problem it could be if the other regulators didn't approve.
I'm still of the belief that once the trial is unblinded we may see a BP partnership who'll provide dramatic help in walking the drug through the approval process as well as funding trials for DCVax-Direct. Potentially I believe it will be bigger than DCVax-L.
Gary
XOV,
I understand that placebo's in some cases do result in improvements in those receiving them, but I don't believe that would ever be the case if the person receiving it is unconscious, which would be the case with people on a ventilator.
I frankly disagree with the regulators worldwide in evaluating drugs by insisting that they must achieve an improvement over the SOC. If they equal the SOC they'd be giving the Dr. an additional tool to work with. In some cases drugs that aren't as good as the SOC provide a substantially better quality of life, that too should be considered. Perhaps the biggest reason for more tools in the toolbox is that fact that diseases become refractory to the SOC, when they are, another drug may become effective, and even it it's for a brief period of time, the SOC may again be effective after the treatment with other drugs. My point is that no one has enough money to do trials that produce such results. If they looked at "First, do no harm" as the basis of accepting drug, I believe that many drugs that aren't approved would be, and people in general would live longer and have higher quality of life with a variety of drugs.
In the case of PSTI, I believe trials to date show few if any quality of life issues. If anything, our placenta based cells may be improving conditions in the body they weren't even targeted at, that really hasn't been studied to my knowledge. I really wonder if they've given thought to whether it would have benefits in our most important muscle, the heart. I suspect it could.
As someone who received stem cells I'm very thankful of whoever donated them, while drugs may have maintained a remission, statistically the chance was small it would last over 3 years. The one change I've noted has been an allergy to something common to suntan lotions. I get red and irritated from the lotions, whether I go in the sun or not, I never had that problem before the stem cells, so I'm reasonably certain my donor must have had that allergy. The beauty of our placenta cells is no DNA matching is required at all, whereas I had a 12 point match for my stem cells, which is excellent. Perhaps the day will come when placenta cells can be used in leukemia treatment with no matching required, but I question whether they'd have the time to adopt to a patient and mature to the point where they can restart an immune system that's been eliminated by chemo prior to their introduction. It was rather fascinating each day after the stem cells to see the blood counts, at first their was nothing, but after the first few days they were detected, and each day they grew. Those few stem cells were completely rebuilding my ability to make blood. I would not be surprised if in the future PSTI's drugs may be used in conjunction with donor stem cells to accelerate the process and lessen the hospital time required. I was lucky to go home 19 days after the transplant as my Dr. was out, and an associate permitted me to go earlier than my Dr, who was head of the Dept. would have. I saw him four days later and he indicated that I'd probably have been kept even longer had I not been released earlier. It's not that I was sick, it's out of concern that if something went wrong, they can jump on it if I'm in the hospital. I did have complications later on that did bring me back into the hospital.
Gary
There is another way of looking at the warrants. Certainly if the price you pay is $.30 and the stock's at $1, you net 70 cents when you purchase them.
On the other hand, if you have the money today to purchase them, if you believe in the stock today, you can nearly purchase two shares for each one you'd get for the warrants.
If I had the money today, I'd probably buy those shares today, then if I still had the warrants and they were in the money, I could cash in just a few of the shares I just purchased and pay for them if I didn't want to bring more cash to the table. In the end, I'd have a lot more shares for the same money. Of course if the trial fails, it would be a different matter, so it's a choice each investor must make.
L.P. on the other hand may have information that prevents her from purchasing at today's prices. Key people in all companies are limited from purchasing, or selling stocks much of the time because of information that hasn't yet been made public. It could be based on something that might never come to fruition, like discussions of a partnership, any executive would be prevented from purchasing. On the other hand, stock options, warrants, etc that an officer has can be executed according to the terms of their issuance. I believe anyone with the same series of warrants that L.P. has would get the same extension. If I were L.P. and I believed the results would be positive, I'd rather buy shares now for $.17, but I don't believe she can, not right now.
Gary
Your numbers are probably as good as anyone's, I'm just not sure how much you've priced in the U.K. agreement with. I'm thinking they'll be purchasing a lot of equipment in the U.K., they may be making it there, but PCTL will be paid either way.
I also believe that many new distributors will be announced over the remainder of the year. As America gradually goes back to work sanitizing will grow more important. I believe many companies who're already doing it will see PCTL's way as better than what they're currently doing. For all I know, many of these companies may already be using liquid from the company, often without knowing it, but they'll learn, and they'll see a business opportunity for themselves.
How many U.S. hospitals will be using our equipment by the end of this year, it wouldn't surprise me if it exceeded 100.
Gary
I agree, these things have been around forever. The difference is that PCTL developed a device that produces the Hypochlorous Acid using salt and water, and can do it in the device that also is the electrostatic sprayer if they so choose. The product itself has a limited shelf life, but if you're producing it as you use it, you know it's potent. Adding tracking to their devices produces a record so there is no doubt about the status of a room. In short, the developers took something that already existed, but they made it dramatically better.
They're using electrostatic sprayers to sanitize all sorts of things, I suspect most of them are using hypochlorous acid, as to who's supplying it, it's impossible to tell. I suspect that over time, rather than purchasing it by the gallon, drum, etc companies will get together and generate it at their site. I would suspect one unit at the terminal or a major airport, and perhaps just one for a smaller airport could sanitize every plane that pulls up to the terminal, as well as the terminal itself.
My point is that as people learn what PCTL has they will realize it's better than what they're doing. PCTL's not making small hand held electrostatic sprayers, any brand will work, but getting fresh solution right in the area being worked will prove to be convenient, and over time I believe the cost will actually be lower than purchasing the liquid, but I'd like to see that confirmed by the company. I would suspect that the cost per unit may come down substantially as the numbers go into the hundreds, or thousands of units a month. I believe the demand will grow dramatically, and at the right price point and size all sorts of companies will either want one for themselves, or contract with someone who does.
As I see it, the company is not really looking to be a retail sales organization for the individual units, they have companies that provide both service and sales, like ACE. Want your restaurant sanitized, ACE can do it, or they can sell you the unit where you can do it yourself. The company is looking for more distributors, they'll do both the sales and the service. They make money either way, if the company wishes them to sanitize, they do it, if they wish to do it themselves, they either sell them the solution, or they sell them the equipment that makes the solution. They announce a few new distributors recently, I believe that you'll see more of these all the time, and I'm not talking about just the U.S. Clearly with the U.K. contract we've introduced ourselves to Europe, the U.K. was first, but there is no reason this can't go all over the world.
Gary
You bring up an interesting point, has anyone who received the drug for any purpose gotten coronavirus, and if so, did they get pneumonia. I believe with CLI the drug is injected in completely different muscle than with coronavirus, but does it permeate the body over time, anything is possible.
It's really not enough people to make a real determination on, but it's an interesting thought.
The CLI Trial is proceeding, but apparently slowed by coronavirus, like our lives. In time the trial will conclude, the drug will be approved, and if it's not already approved for pneumonia, it can be used for it off label. I frankly believe it will have benefits for all sorts of things, CLI just happens to be the first to be tested by the company. My leukemia treatment does create some neuropathy, I don't doubt that it could be of benefit with it. Once it's achieve approval I believe we'll see it tried in all sorts of things, and anecdotal evidence will show what it works for, and perhaps what it doesn't.
Gary
You bring up an interesting point, has anyone who received the drug for any purpose gotten coronavirus, and if so, did they get pneumonia. I believe with CLI the drug is injected in completely different muscle than with coronavirus, but does it permeate the body over time, anything is possible.
It's really not enough people to make a real determination on, but it's an interesting thought.
The CLI Trial is proceeding, but apparently slowed by coronavirus, like our lives. In time the trial will conclude, the drug will be approved, and if it's not already approved for pneumonia, it can be used for it off label. I frankly believe it will have benefits for all sorts of things, CLI just happens to be the first to be tested by the company. My leukemia treatment does create some neuropathy, I don't doubt that it could be of benefit with it. Once it's achieve approval I believe we'll see it tried in all sorts of things, and anecdotal evidence will show what it works for, and perhaps what it doesn't.
Gary
The question is, what is the purpose of the placebo, at least with ventilator patients. As I understand it, our drug is injected into muscle in many places. Patients on ventilators won't know they're being injected, is the idea for the Doctors administering the drug not to know who's getting the drug, and who's being injected with some harmless liquid.
I can't see it, there are virtually tens of thousands that could be considered the control group, they're located all over the world. Statistically I've heard that 80% of those put on ventilator pass away, but I believe they may have approved on that slightly, lets say it's improved to 70%. As I understand it, the American as well as some of the Israeli patients given the drug under compassionate use were on the ventilator for a substantial time, still they responded positively. In a trial, I would think that duration of ventilator would be considered, but I certainly believe that at least some patients should get the drug earlier, even before going on ventilator. To me it's goulish to wait for someone to be nearly on deaths door before taking such actions. I'm fine with them giving it to people who're that sick if the drug just arrived for the trial, but ideally give it earlier and watch what happens.
As I understand it many organs are damaged by coronavirus, PLX-PAD may help to offset the damage everywhere, but withholding the drug to make that determination would medically be wrong IMHO. In the case of people almost ready for ventilators, it would be interesting to see if many improved rapidly enough not to need them at all. If they insisted, some of the conscious patients could receive the placebo, but I'm against that. I would hope that if placebo were used, and patients were declining, they'd be checked to determine they were on the placebo, and if so they'd be crossed over to the drug.
I believe we could have the answer to all forms of pneumonia for most people. Certainly not everyone can be treated in a trial situation, but I believe that all who volunteer should be entitled to treatment, crossing over in every case should occur if a patient is declining. I do not know if patients who're dosed the drug would receive a second dosing if they're not improving, if so it should always be the drug, in that way, initial placebo patients would get the drug with the second dose.
Gary
It's not completely discarded, it's noticed, it gets us media coverage which very well may boost stock price. It's certainly good for Public Relations, but the regulators want documented trials, and people like Dr. Fauci certainly counts himself among the regulators.
Frankly, I don't know that the Israeli Govt. might not act on anecdotal evidence to make it available to all there, I see them as more progressive. Approval in Israel would certainly be positive.
I believe it's clear that the numbers getting the drug in Israel has grown, the question is, how much. I don't know how many there are on ventilators, but I suspect the company would have little problem with supplying the drug to all on ventilators if they choose to do it.
Gary
The only way people are counted in a trial is if they're enrolled in the trial and on the trial protocol. In some cases, patients in say a Phase 2 Trial will be counted in a Phase 3 if the protocol is identical. Essentially it's allowing the Phase 2 to transition to a Phase 3. In some cases approval can come out of a Phase 2 Trial without expansion if the data is sufficient to justify it. I believe PSTI is calling the trial we'll start as a Phase 2, but it certainly could lead to approval if we continue to see the sort of results we've heard about from the first 7 to receive the drug.
I would suspect that if our Phase 2 was a 300 person trial, and if we were 100 patients into the trial, and let's say over 80 of those people had already come off ventilators, it would be possible to stop the trial early and gain almost immediate approval. The thing is, it wouldn't be the company suggesting it, it would be the independent people monitoring the trial who'd report what they're seeing to the regulators.
It's unusual for the regulators to stop trials very early, but we're in very unusual time, and I believe that benefits under clinical conditions could get the attention of the regulators very quickly if they're as solid as I believe they could be.
Back in 2001 I first heard of Gleevec when it was approved very early in a Phase 3 Trial. I viewed it as a great drug for the drugmaker, as it held leukemia in remission as long as people stayed on it. Little did I know that I'd be taking it many years later. Even though I've had stem cells, I remain on a chemo, the third generation of Gleevec, because if I didn't the odds of coming out of remission are greater. The odds are on my side regardless, but better if I stay on the drug.
I don't believe that approval can come in under a few months time, but if we get started this month, if great results are seen by June or July, I believe our drug could be available by Fall when the experts believe both flu and coronavirus will be hitting us again. The good news may be, testing wouldn't even be necessary, if someone has pneumonia, regardless of the cause, PLX-PAD will benefit nearly every patient. If we're smart, patients will be dosed as soon as pneumonia is detected, that will keep most of them out of the hospital completely. Such treatment will certainly be expensive up front, but it will save far more as whether it's flu or coronavirus, tens to hundreds of thousands of people die annually, and for many death comes after weeks or even months of time in the hospital.
Of course I'd advise anyone with pneumonia to attempt to get PLX-PAD either by getting into a trial, or on compassionate use, I certainly would if it happened to me.
Gary
Frankly Dr. Bala I have a qualm with virtually all the money that's being spent on CEO's etc everywhere, but it's the sort of greed that's become common in business. I frankly doubt that if you took all the people making over a million a year and moved the decimal point one to the left if many would resign, if it were happening everywhere.
It's been 50 years since I first went to Japan, and at that time the head of Sony there had the opinion that American execs. were greatly overpaid, he pointed out that at that time in Japan the CEO's typically were paid 10 times the wages of their senior workers. I suspect our executives today make at least a hundred times more than they did back then. To me the saddest thing is when a CEO gets a huge bonus for cutting costs by laying of thousands of employees. In Japan, at least back then, employees were looked on as your assets, and the job of the CEO and upper management was developing the products that kept the employees, their assets, working productively. It was a terrible failure on managements part if employees had to be laid off. I know things have changes some since then, but I can remember when millionaires were people worth a million or more in total, and they were few, now the numbers making more than a million a year are huge, and in many cases their bonuses are worth more than their salaries. Meanwhile, the cost of living adjustments for employees is held down to low single digit percentages, and minimum wage is well below a living income. It's sad, but it's reality.
Gary
Cherry, I absolutely agree with what you're saying, but $1 is another big key. There are people, and Institutions, that won't invest at under these levels, at least not officially. Likewise $5 when it comes to Institutions.
I say officially, because an Institution may purchase on or after the first day of a quarter and need not report as long as they sell by or before the last day of that quarter. An Institution who's charter indicates they cannot invest in stocks under $1 could have invested on April 1, and if the stock reached $1 they could hold and announce they had a position, otherwise they must sell by June 30th, but nothing prevents them from purchasing again on July 1st. The MM's are only too nice when it comes to working with them on such transactions.
It's tough to say if we could reach $1 this quarter, much more likely in the 3rd, and I believe almost certain for the 4th. If we should reach $1 in the 3rd, $5 wouldn't be out of the question in the 4th. I believe any such figures will be based on actual, or anticipated earnings. A billion dollar market cap should represent earning tens of millions, with the anticipation of growing into the hundreds of millions. Given what we've heard about from the U.K. contract, the sales of fluid, and the growth in the number of hospitals, etc. that are installing or using our fluids through contractors licensed with us, I believe this is very possible. We just need to give this the time to build, if the company isn't bought out. I certainly hope that the company would take no less than double digit billions in a buyout scenario. It doesn't justify that price today, but with tremendous growth of sales, such a price is possible once the stock is selling for $5 or more. It's doubtful if that could happen before 2021, more likely 2022, but either way, I just don't believe the company's growth rate will diminish for years.
Gary
I know little about how PCTL is operating, but I believe they're smart people, the smaller units that operate in hospitals etc don't need to be monitored when making, or spraying fluid. I would suspect that much the same can be said of the large volume units.
I can't say how many are involved, but I suspect that once the units are loaded up with salt, have water available, and have a vessel to contain all they'll be producing, people can walk away, and go about the business of making other new devices, until the volume to be made is complete. In short, with the demand today for the fluid, I suspect they're operating 24/7 but I don't believe it requires that many people to keep this going.
More time may be spent if it's to be shipped out in smaller containers, but even that may largely be automated, I don't know. If it isn't, as demand increases, as profits do, it can be. If a tanker truck is being filled, I don't know if they don't go directly to it, I believe they could be.
Assembling new devices is probably where the greatest manpower is needed, but I suspect the people doing that can also keep the high volume units operating, so it's really quite an efficient operation. If that's not currently the case, it's certainly where it should be in time.
We do need to remember that when we value the fluid, we're for the most part providing it to a distributor, like ACE, we only get a fraction of the price that's paid to ACE by the retail customer. It's still a lot of money, but don't overestimate the value to the company of every gallon that comes out of the plant. I suspect the cost of making each gallon is a tiny bit of the price we're selling it for.
Gary
In reality she has a BOD who permits her actions, she could have ended the warrants and given her a bonus worth every bit as much, or more and there is nothing we could do about it. It's nothing exclusive to her, CEO and other corporate execs. at all sorts of companies get major bonuses in stock options all the time. We individual investors can complain, but unless the SEC changes all the rules on executive compensation, it's not about to happen.
BOD's are essentially a mutual admiration society, they're made up of people who in many cases are CEO's or other officers in other companies who get similar bonuses. These options are their mothers milk, and they're not about to turn it off. Frankly, if we all do well, I can live with them doing even better, but the key is our doing well. Certainly they will do much better themselves if we're doing well.
Gary
I'm no expert, but I believe warrants are grouped into classes. Unless L.P. is the owner of all warrants in a class, in extending it should apply to all in the same class. If that's not the case, suits will no doubt follow this action by all others who got the warrants at the same time L.P. did on the same terms.
By the way, we're now 100% Sell on barcharts, here's a link:
https://www.barchart.com/stocks/quotes/NWBO/opinion
Some of the greatest gains I've ever seen on the market came when stocks went from 100% sell to 100% buy practically overnight. I believe in saying end of June beginning of July for top line data was estimated with a little wiggle room. Certainly they could be late, but I believe if all goes according to plan they could be early, perhaps mid June or even earlier. That said, selling now because of things like barchart, with the idea that you can get in close to the end of June could prove a big error. I don't know of anything that could be announced before TLD, but if it came 3 weeks early, and you intended to get back in later than that in the month, you could be paying a substantial multiple of the price today. I'd rather just stay invested.
Gary
When push comes to shove Fauci wants to do things in a traditional way. He doesn't take much, if any interest in anecdotal evidence of efficacy, he waits for formal clinical trials. While I still believe PSTI could get a lot of positive press by providing compassionate use for perhaps 1000 to even 10,000 patients, it's not what Fauci would get excited about. Give him a documented clinical trial of a few hundred patients and he'll be thrilled if results are comparable with what we've seen anecdotally.
If in fact the work being done in Germany is being done like a small clinical trial, that could get Fauci's attention. An announcement that we're initiating a trial will be noticed. Hopefully it will be documented in the clinical trial database, have several sites initially, and more added as it progresses, which should be very quickly.
If the initial trial is done with only patients on ventilators, it will mean that families, not the patient, volunteer for the trial, as patients on ventilators are not conscious. I would hope that all volunteers get the drug, there are plenty of people on ventilators who won't be getting the drug that could constitute being the control. That may not be the case, and it's sad to me that someone must pass away before we can say, they were part of the control.
As I understand it, roughly 80% of the patients being put on ventilators pass away, why not accept that figure, or whatever the current numbers are and see what happens to everyone placed on PLX-PAD. I'd certainly like to see another trials using the drug on patients close to requiring ventilators, but not yet on them, finally a third trial where pneumonia is just diagnosed, perhaps even before hospitalization is required would eliminate a lot of people requiring hospitalization at all.
Hopefully we'll see documentation of one or more trials in the next week or two. Once it starts I don't believe it will take very long to be fully enrolled, and one month to 6 weeks after that the results should be quite clear. At that point, I believe we'll have Fauci, and a lot of other peoples attention.
Gary
Out of curiosity, when did the drug get the name Emiplacel. Don't get me wrong, it's a step in the right direction as it's something that typically happens before drugs are approved.
It will be interesting to see if the name is used in all future releases about the development of the drug.
I certainly would like to know what the German's are doing with the drug. If they started a trial shortly after announcing the agreement, they could be several weeks into the trial. It's my belief that one month after a patients been dosed the outcome is pretty well established. It's doubtful if a ventilator patient dosed with the drug would still be on the ventilator, some may die, but I believe the overwhelming majority will be off the ventilator, and most will probably be out of the hospital. As I understand it, side effects can last for months, but patients gradually do get better. I do believe organs beyond the lungs may be harmed, and once again our drug may help with their healing.
Gary
That's not true, a company can call an election whenever they wish as long as they do it IAW SEC guideline. Many partnerships require the concurrence of shareholders, and could require additional shares be authorized. The last thing you'd want would be to force such events to only occur once a year.
Gary
There is little doubt in my mind that you could put Clorox, Simple Green, etc into an electrostatic sprayer and completely sanitize a room. To do so I'd suggest using a scuba tank and mask for breathing, and not getting the chemicals in your eyes. You'd probably want to shower and change clothes as well on leaving the room. The point is, you can do it with our product and not be protected at all, I don't believe I know of any others that can say that. The room will be sanitized as well with our product than any of the others, but no, they won't be applied with an electrostatic sprayer, and even when done by hand anyone doing them for a considerable part of their day should use gloves, masks, etc to protect themselves.
We're not the only ones in the world that can make our fluid, but we're the ones who have a simplified way of making it that allows the end user to make it as they use it, all they need is salt, water, electricity, and our device.
Gary
If a procurement is made by the SEC to sanitize their organization, and PCTL receives the contract, or it's awarded to one of it's suppliers, it should certainly end all discussion of the SEC considering it a coronavirus based scam. Those who would push that scam theory are ignoring many things, but most importantly, PCTL had their systems installed in several hospitals before the name coronavirus was ever heard.
There is no doubt in my mind that coronavirus has emphasized the need for proper sanitation everywhere from hospitals, to virtually anywhere that people are present. The terrible stories coming out of massive meat handling plants and prisons simple demonstrate how great the need can be. By the same token, if any of us attended a party with many attendees in which just one person was highly infected, virtually hundreds or more could be infected if full contact tracing were done. No doubt it would be worst if the party was hosted by the infected party, where everything you touched could infect you, but even in a sanitized place, one infectious person can infect many if no protection is being utilized. I suspect that we'll be using masks, gloves, etc for some time in the future, and not attending crowded events until a vaccine is available and proven.
Gary
No company wants to use nearly all the share authorized before asking for growth from the shareholders. Frankly the company did the responsible thing on doing the R/S by reducing the authorized shares, I've seen many R/S's where that wasn't done, and in no time the O/S ballooned to nearly what it was prior to the R/S.
If we make the assumption that the company over the next couple years dilutes to 50 million shares outstanding, that's saying a billion dollar market cap would be a $20 share price. Does anyone here not believe that with success in CLI we won't be worth at least a few billion. Even without coronavirus that shouldn't be that long. Of course coronavirus is the joker, though I really should say pneumonia. If we gain approval, it will be tried for all forms of pneumonia, off label, but should become the SOC as in the majority of cases it will prevent the need for hospitalization. It may be expensive, but not nearly as expensive as time in the hospital, and it will eliminate many deaths that are pneumonia related. How many billion do people believe a pneumonia drug will bring in, can you see a double, or even triple digit billion market cap for PSTI with it. If we looked at a $10 billion market cap with 50 million shares outstanding, that's $200 a share. Any complaints.
Gary
I think we all need to remember that less than a month ago this was trading for under $4, that's when I bought the last of my shares. We know anecdotally that it produces benefits in Covid-19, it won't be that long before they're confirmed by clinical trials. While I'm uncertain, I believe it's very possible the German's have been utilizing it in what's essentially a small Phase 1/2 Trial, results from that could come at any time.
Now we know the company has submitted paperwork for what they're calling a Phase 2 Trial. In fact, other companies running similar trials are calling them Phase 2/3, and I believe our trial will have the same approval potential, and actually it will be more like a Phase 3 Trial mainly because of its ability to produce commercial quantities of the drug. I don't believe it's competitors already have approved production capability that's normally associated with a drug approval, but I'm not certain of that.
Frankly it doesn't matter, if drug works the FDA's going to be willing to accept a lot of short cuts to making the product that wouldn't be approved under normal circumstances, but to my knowledge, PSTI has the capacity right now, the others don't.
Give it a little time, I believe once we get into the trial it won't take much time to be fully enrolled, and while I have no idea who the lead clinician may be, I've got to believe by one month after the last patient enrolls, that clinician should push to unblind the trial and report results. Normal approval criteria will be ignored, the FDA and other regulators will act without normal submissions based on raw data, just in the same way they are for other products. It may be something less than full approval, which can come later, but it will make the drug available to all in need of it if sufficient production is available.
It's said that coronavirus will have a second wave around November, if so, it will be totally different if the death threat has been removed by the availability of PLX-PAD. Not only that, the flu season, which typically kills more than coronavirus will be much less threatening, as pneumonia, which is normally the killer, will be treated with PLX-PAD as well. I don't know that we'll get back to permitting crowds to assemble, but if we have the treatment that makes it much less deadly, the fear of doing things like going out to dinner or seeing your friends will be far more acceptable to all.
Gary
I've not been involved in manufacturing since I was a kid. When my dad owned a factory, it was 50%, if the cost of something went up a nickel to them, the price went up a dime. While I frankly thought it wrong to make a bigger profit because your price wrose, I also hate it when Govt. adds a tiny tax on anything.
Why? Because if you add a nickel to the price of a beer, every bar in the country will add at least a quarter, some will go up 50 cents, some a dollar, few will leave the price untouched. It's like stamps, I'd rather they be incremented in nickels rather than pennies, that way when it goes up, the new price is more likely to last for awhile. Pennies actually cost more to make than a penny, we really should abandon them.
I'd suspect that the markup may vary by the customer, some who do huge volumes get a discount, others buying retail pay retail. In that most things PCTL sells are sold through distributors, it's very possible that when PCTL sells the distributor something for $100, it cost them $50 to make it, the distributor retails it for $200. If someone wants to buy direct from PCTL, to not undercut their distributor, their price would be $200.
When I was in Japan many years ago the hotel manager explained to my why the Japanese prefer to buy Japanese products in the U.S. It's dramatically cheaper here because the Japanese have numerous middle men. Everything is marked up many times, so if they want an expensive camera, watch, etc that's made in Japan, they come here to buy it and can essentially vacation for free if they're purchasing enough. I don't know if it's changed over the years, but he made it sound like a tradition that wouldn't change.
Gary
In the recent podcast, Gary indicated that what was currently being produced at this time was for U.S. use. This brings up the question, is PCTL Europe manufacturing all the equipment for the U.K. agreement, and any other orders that may occur in Europe.
It's very possible that certain components would be supplied to them by the same contractors supplying certain components here, but other parts would be made on site.
I welcome others thoughts on this matter.
Gary
Most hospitals I've been in have a great deal of additional space for nursing stations, waiting rooms, etc, plus many Doctors either have offices in, or in buildings just adjacent to the hospital. Prior to coronavirus these areas were routinely kept clean, but not sanitized, I believe that for the foreseeable future they will be.
I suspect that most of these spaces may be done with portable electrostatic sprayers, but the fluid will come from our units.
At a place like City of Hope, they have all sorts of buildings, patient housing, etc. that hospital patients hardly ever get into, I suspect their volume may be substantially greater than the hospital itself, and the clinic offices where you go for outpatient labs and Dr. appointments. Sanitizing everything will become routine. Much the same is true at Cedars Sinai, where I had initial treatment, numerous office buildings can be found anywhere from a block, to a few miles from the hospital where offices and outpatient clinics can be found. In the U.K. it was clear they wanted all healthcare facilities to be protected, I believe much the same will be the case here in the U.S. and most of the rest of the world.
Gary
Companies need to have additional shares available to give them flexibility, especially should they get into partnership negotiations. I would expect that if a partnership were proposed, it would bring in a great deal of value to the shareholders, but the partner would very probably want a sizable equity position. Giving the company the authority to issue more shares gives them flexibility. I wouldn't want to own a company that I didn't trust management to use their authority properly.
I previously didn't like the reverse split, but I must admit that it appears to be working out. The company could have issued shares, but doing the loan makes a great deal of sense, even if some dilution is required to meet its terms. If we're successful in coronavirus, I believe we're almost instantly a billion dollar plus market cap, if not, we wait for CLI and then it happens. Certainly are market cap goes higher with more approved diseases approved, but anything we're targeting has billion dollar market cap potential. I'm willing to give the company the flexibility that additional authorized shares give them, if they need to spend some of those shares to either accelerate development, or develop new products, it could greatly enhance the share price in the future.
Gary
If we're successful getting into a clinical trial for coronavirus, I've got to believe our share price goes into double digits. With under 25 million shares outstanding, triple digits would only represent a $2.5 billion market cap. I believe that would be cheap if our drug is being given to those requiring a ventilator, or approaching that point. More importantly, when the world has forgotten coronavirus, sales will still be strong for all who acquire pneumonia. If in reaching that point some dilution is required, so be it, it will be done at double, and perhaps even triple digit share prices, perhaps in just a matter of months.
Gary
The question that needs to be asked is, has the company demonstrated that the share growth has been used to grow the company. I believe if you look at the company today, the answer is clear. I cannot think of a faster growing company anywhere, but it takes time to get the revenue figures.
I've often argued that market cap, not share price, should be what qualifies companies to be on a given exchange, that's not the case, but it's rare that a radical reverse split works to achieve a listing on a higher exchange. Certainly it will take awhile to reach the Nasdaq with 600 million shares outstanding, but when we do, we'll have a $2.4 billion market cap. While it's doubtful this year, I like the odds of it doing it by next year.
A $2.4 billion market cap would require $240 million in earnings based on a P/E of 10, or $80 million on a P/E of 30, while I suspect that with the growth we'll see in PCTL it can justify the P/E of 30, nothing is ever certain. The question might be, is there anyone here that doesn't believe that by the end of next year PCTL won't have earned $80 million for the year. I wouldn't be surprised if the U.K. proceeds alone could be that big or bigger for next year. I suspect that with the growth of fluid sales, they could reach that level as well. Finally I believe the growth in the equipment they're selling, or leasing outside the U.K. deal could grow to that level in the next year. In short, if I'm right, the company could meet the $2.4 billion market cap if I'm right about all three above, so we'd make the $4 Nasdaq requirement on a P/E of 10, but of course if the P/E was 30, we'd have a share price of $12, it's all in the realm of possibilities.
Right now, there is a worldwide desire to get back to where we were before coronavirus. We might never get back to precisely the same place, but I believe whatever we get to, there will be a far greater emphasis on sanitary practices when we do. I believe PCTL is ideally position to help in that area, and it will prove very profitable for them, and at the same time make the world safer to live in.
Gary
If I remember correctly the meeting is still scheduled as one for investors to personally attend. I would think that they'll need to make it a virtual meeting, then all of us can look in. Nothing controversial that I see in what investors are asked to vote on, but I think a reason for attending would be the remarks they should make after the formal business is completed.
Gary
I realize that, I believe the last time a number was reported it was in the 80's, but it's possible that few of them have passed on, and perhaps there were LTFU's who've been found, and are still alive.
I believe most interim results have LTFU's that are found before the trial ends, they just don't put in the same effort in finding all trial participants when it comes to taking an interim look, especially if it doesn't appear to be leading to an early termination of the trial.
Frankly, I believe investors should be thrilled with anything over 50 surviving at the end of the trial, though I believe it will be over 60. As I understand it, 50 would be about three times what would have been anticipated at this point on the SOC.
Gary
When I read an article like this I cannot understand how the stock price stays mired where it is. Without unblinding the trial, Dr. Liau is telling us what the findings will look like. 20 to 30% having longer than anticipated survival is saying it's in the range of 60 to 90 people that may still be alive.
What's wrong with my thinking?
Gary
I don't believe a new trial for coronavirus will be anything like a traditional trial. Most new trials are planned and executed over perhaps a year or more, I believe this trial will be actively recruiting in under a month. Most trials are run for years, this trial could be over a month or so after the last patient is enrolled. Most trials require massive analysis of the data taking months, I believe they'll have all they need in days after the trial ends. Most trials require at least 6 months or more to develop a BLA or NDA for submission to the regulators, then the regulators get 6 months or more to evaluate it, if results are as good as I believe they could be, the regulators will approve the drug based on the raw data. This is certainly JMHO, but I believe it's clear that the medical scientists are not doing business as normal, they're doing business as though their lives were on the line, and in many ways, they are.
Perhaps when all the dust settles, the regulators may demand the formal documentation follow, for full approval, but the drug will be in full use from the time they bless it based on the raw data.
Gary
I really believe all the prior rules for establishing trials, etc. have been abandoned. PSTI should be able to get it's trial started sometime next month, if in fact a trial isn't already started in Germany, which may, or may not be expanded on.
Until coronavirus has been resolved with vaccines and/or therapeutics, and no longer considered a threat, forget business as usual. Look at what they're doing with remdesivir, could you imagine such use if things were being done in a normal way. It would probably be years and many millions more in trial costs before such use would be permitted.
We know Gilead's trial was much larger than the few who've received PLX-PAD, but we also know that the numbers of deaths were only slightly improved. To date we've not had a death in the small number we've treated, all on ventilators, and I believe they're all now off ventilators, and most discharged from the hospitals. I would still love to see the compassionate use numbers grow to hundreds, or thousands, as I believe the results would be so positive you wouldn't have to wait on formal trial results. JMHO
Gary
Falon,
That's great information to have, but as we know from the U.K. agreement, our equipment is needed internationally. We certainly could be very profitable just on the U.S. market, but I believe the U.K. will end up being the first of many such agreements internationally.
Gary
Remember, what you're waiting for right now won't reflect what the company's doing today, at least not in the financial data. That data will still be negative. Even the first quarter report, perhaps out shortly after the annual report may show we're closer to break even, but not there yet. All this will change in the second quarter report, but that's not due till about August.
I believe each report can include dialogue that's more up to date, and there I believe the company can say what's happening, they may even be able to give an estimate for earnings in future quarters. Certainly getting the financials out, so we're not on the hook for something that's delinquent is important, but if you want the really great news, wait till you see what it looks like in next years reports.
I can't tell you what the Annual Report for 2020 will look like, but I expect it to show the companies made millions, the question is, will it be single, double, or triple digit millions, I can't say. All I know is that it's growing very rapidly. I suspect by the end of the year the list of hospitals that utilize our systems could be in the hundreds, when I first bought the stock the end of last year it was 8. Every time we hear about a new service company that's working with our products we see a list of additional hospitals being served. I cannot say if each has units, or if the service agent brings in their own units, sanitizes the hospital as necessary, then moves on to another site, which is possible, but as the need for sanitation increases, units will be permanently placed in all but the smallest of hospitals.
I frankly don't know if the company is maintaining a list of all the hospitals that have their units. If they sell 20 new units to ACE, I don't know that ACE gives them a list of where each unit is deployed. People here attempt to keep up with it, but I don't know that the company does, they know how many units they've sold, or leased to their suppliers, but I don't know what is reported back as to where they're deployed.
In many ways, those who provide both goods and services that utilize PCTL equipment are like car dealers. If you're a Ford dealer, you purchase XXX number of cars from Ford, who you sell or lease them to is up to you. Eventually Ford learns who purchased or leased their vehicles, as they must honor the warranty, but I don't know that they're up to the minute on who owns them, or where they go when traded on the used market. We might be very surprised even now if we had a list of every installation.
While we may not know precisely where each unit is deployed, what I do believe we know is that each month they're producing more units, and selling more fluids then ever in the past. Based on the demand for sanitizing, this growth should continue for the foreseeable future. I cannot imagine our stock price not being dramatically higher by next year, and the growth will continue for the foreseeable future unless the company is bought out.
Gary
Out of curiosity, was the $17 billion estimate you used something that was stated before the coronavirus pandemic began. I suspect that if it was, the numbers will grow after the pandemic, the money spent sanitizing virtually everything will grow dramatically, and it won't stop when the pandemic goes away.
Gary
You're right on the money.
I believe that PCTL is growing in so many ways that it won't be long before they'll be wise to form divisions, each to specifically address one area of expertise.
Right now, supporting hospital and healthcare sanitation may have the greatest emphasis, but when we're beyond the pandemic, greater emphasis may be needed in agriculture, petroleum, etc. Any one of these areas by themselves have the potential of generating substantial cash flow. Together this could become a tremendous company with a double or triple digit billion dollar market cap. We are at the infancy of what can be an industrial giant.
Gary
If our drugs work, why worry about competition, if they don't work, it won't matter. I don't see Europe any differently than elsewhere in the world, if the drug works, all the world will want it. The good news is we may be able to support the demand.
Much has been said about our German study, as far as establishing it. Nothing that I'm aware of has been said by the German's who hopefully are doing it. Perhaps tomorrow we'll learn more about that, and/or clinical trials planed to be initiated worldwide.
I also believe more have probably been added under compassionate use, it would be nice to hear what the numbers there are, as well as the status of those on it.
I just saw a report on Remdesiviv and they indicated that it's mortality benefit was noted, but further testing would be required to determine if it was significant. It is far from a cure all, its lowering the length of hospital stays, but clearly it's not the answer that PLX-PAD may be.
Gary
This tells us the method the FDA could employ to approve PLX-PAD or PLX-R18 for use if some testing demonstrated efficacy similar to what was achieved with Remdesivir. It currently is planned only for hospital patients as I understand it, but I would expect that will expand if it continues to show improvement.
Pneumonia is the killer of most who die of coronavirus. Only time will tell, but I suspect that if at onset of pneumonia our drug could be employed, many might never require hospitalization. I previously indicated that I'd like to see two specific trials, one for people already on ventilators, another for those not yet on ventilators, but in hospitals and thought to be approaching ventilators. A third group should perhaps be considered, those diagnosed with both the coronavirus and the onset of pneumonia, but not yet sick enough to hospitalize, it's that group that might never be hospitalized if our drug is successful.
Their still were deaths in the Remdesiviv trial as I understand it. To date I don't believe we've had a death, but we only know of 7 patients. Thing is, those 7 were all on ventilators, and in the case of the U.S. patient, he didn't receive the drug till after 23 days on the ventilator. I believe very few survive after 23 days on a ventilator.
Gary
ASCO presentations are now available on their site. I've found nothing for NWBO but I don't know if there will be an experts forum, as was the case last year where the company spoke.
I frankly didn't expect to find an abstract as without unblinding the trial, I don't know what more they could have presented. Hopefully SNO will be a very different matter.
Gary