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Here's the problem, all of this should happen, but it will take money, lots of it, and the State's, like all sorts of other businesses are going broke because of the economy.
I know they're talking about another $3 trillion dollar bill to help, but in reality, I believe it's going to take a lot more than that. It's not that we have to get all sorts of places back in business, we have to get them back to business in much safer ways then how they operated before the pandemic.
It would be great if the average class size was cut in half, so proper social distancing could be established. Any idea how much that will cost. Likewise restaurants, bars, etc are being asked to cut numbers to somewhere between 25% and 50% of their normal capacity, the business will clearly be diminished, and sanitation costs will rise dramatically, will the govt. subsidize all these businesses until normal operations can be resumed when we have an effective vaccine.
I suspect before this is all over we'll have more than doubled our national debt, but so will all the rest of the world, it's all relative. I still believe we're worth more than out debt, but that's not making financial assumptions, like depreciation, it's based on what things could be sold for if you actually put them on the market. Of course we'd never do that, but the value is still there.
Gary
Falon,
You're clearly very knowledgeable about cleaning. I believe a big part of the problem may be differentiating between dirty, and biologically hazardous. The cleaning done in schools, etc right now, while they're empty really has far more to do with dirt. Schools, offices, restaurants, etc have been closed for a month or more, any biological hazards there when they closed should have died off well before now. I'm fine with cleaning to make them tidier, but that's not the problem.
The day they reopen, whether it's students and teachers in schools, or any of us in bars, restaurants, etc, it will be people that bring biological hazards back into these places, and that's when routine cleaning, or more properly sanitizing needs to begin. I don't believe that most schools have electrostatic sprayers, nor do most restaurants, bars, etc. Janitorial staff may wipe down tables, desks, etc routinely, but a sneeze, cough, or even just breathing may deposit all sorts of things on surfaces that won't be wiped down. We cannot make all these places germ free, but if the germ load is to be dropped dramatically, electrostatic sprayers should be deployed, and HOCL is the ideal agent to do it with.
From what I've gathered, a portable electrostatic sprayer can probably sanitize a classroom in a matter of a few minutes, a restaurant or bar may take a bit longer. It would be safe to use in the kitchen as HOCL is cleared to use with food.
My point is that schools, restaurants, etc are all going to need to either invest in new equipment, or pay for new services they currently don't use if they really want to sanitize their facilities. Clearly all of them won't be tied to PCTL, but if we get our fair share, we'll do just fine.
Gary
If you're looking to buy more that level may be important, if not should it be of concern. I don't think so. I believe the next thing we may be concerned about is when the added people on compassionate use reach the 28 day mark, when the company is saying they'll be reported on. If most of these people are of ventilator, and if few or none have died, what do you believe happens to the share price. I believe that $20 could be in play.
I also wouldn't be surprised if some countries acted on that information and didn't wait for the Phase 2 Trial to make it available to their people. Time will tell, but anecdotal evidence when it's really strong can cause such things, perhaps even Trump gets excited, Fauci and others may want to wait, but if out of over 20 people on ventilators only one or two passed on and all, or nearly all others were off the ventilators, and many discharged from the hospital, I believe you have the sort of story that some will act on, not waiting for further validation. I should add, their action might be conditional, requiring confirmation from the trial, but it would provide the drug to all until there was a reason not to.
Gary
I agree, and believe they are, but I really don't know who the other bulk producers are, but I'd have to guess that they too are expanding production.
What I believe we have, that others don't is a system, it doesn't just make the product, if deployed in a hospital and used properly it will provide the information needed to know what needs to be sanitized when, then track the fact that it's done.
I cannot say what share we have of the market, I have no idea what the bulk manufacturing capability is in much of the world, outside the U.S., but if it's not high, our high production units may be in high demand there as well, as we take on distributors in foreign countries.
As I see it, a distributor has multiple roles. For one they may produce bulk HOCL utilizing our equipment. They provide services which use it to do sanitizing by contract. At the same time they're marketing our equipment and showing companies that they can supply units that will permit them to do it themselves. Finally they're also the service agents for units that are sold or leased to make certain they're working right and are equipped with the latest upgrades.
There is no doubt, some companies even hospitals, may prefer having other do the sanitizing, and perhaps the company doing it will install a unit in the hospital for their use only. Others will want to do it themselves and just lease, or purchase the equipment. Either way, both PCTL and their distributor should profit nicely.
Gary
When we discuss the median for the Top 100, we must recognize that over a decade ago a patient may have started the trial and lived for say 66 months before passing on. That person, in spite of dying perhaps 5 or more years ago is boosting the median until half or more of the top 100 have passed that 66 month mark. Clearly only the living can expand on it, but as long as there are living people with less months in treatment than the median, they have the opportunity to live beyond the current median, and therefore cause it to go up.
When the median for the Top 100 is fixed, i.e. all the living are beyond the median, the length of the tail continues to grow, and it would be easy to look at the Top 50, who's median should still be growing. I don't believe that most FDA Trials speak about Top 100, but it certainly is an impressive figure that can't help but say, something good is happening here.
Gary
We must recognize that others make HOCL, but all appearances seem to be that we are rapidly expanding bulk manufacturing capability, distribution of both the liquid, and devices that make it on site, and ultimately the electrostatic sprayer that will do a good sized room unattended.
I'm sure many of our distributors are selling hand held electrostatic sprayers, it's a device that the company could add to their product line, but I really believe the Survivalite if I understand it does both, it makes the fluid, then it sprays it as an electrostatic sprayer. Please correct me if I'm wrong about that. As I understand the unit, it would be filled with the water and salt, plugged in and it would make the fluid and charge the battery that powers the electrostatic sprayer. Once the fluid is made, the unit can be unplugged and the sprayer used until all fluid is used up.
I haven't seen the company actively marketing this unit, suggesting it's still under development, but if I'm correct about that being what it does, and if it's size and weight is low enough to be easily handled, it should become the ideal tool for use in smaller buildings, offices, restaurants, etc. Certainly a portable electrostatic sprayer will be smaller and lighter, but it will require having a constant supply of fresh HOCL. It's much easier and cheaper to maintain a supply of water and salt, and not require shelf space to keep gallons of HOCL which must be used in a timely way, but clearly the HOCL generating unit will be somewhat larger and heavier.
If I've got this wrong, please let me know.
Gary
I do agree that this is a life changing event, but I'm saddened to see people returning to bars as crowded as they were before the pandemic hit because a Governor or a court said they could. I've also seen history repeat itself because we simply don't learn that much from the past.
Look at tornado's and hurricane's, there are ways of building structures to withstand them, and they don't cost that much more than stick construction, but we don't change the building codes to insist on it, and in fact we make it hard to change building codes. The same can be said for fire and earthquake resistance, but stick frame builders won't go away.
We may be better prepared for the next pandemic, but if it's over a hundred years from now, like the last really bad one, it's doubtful, though our technology should be much improved. We could have been far better prepared, but books on pandemics and experts were ignored, now we're catching up, so I really don't know that it can't happen again. We'll be living differently, many companies may find that many people can work from home, and save the company lots of money in doing so. Education will probably be changed as well with more courses taught on line. Some colleges are going to zoom classes completely in the Fall, if the quality of education can be maintained, or improved on, it should substantially lower the cost.
Certain things do require hands on training, but they're the more practical courses like shop classes, music, art, etc. I can remember when slide rule accuracy was fine, now people calculate things down to unlimited decimal places, even when the assumptions the calcs are based on are accurate to only two or three places, just like the slide rule.
We're now at the point where work will be needed for many people who's companies won't exist after the pandemic. If they wanted to do things wisely they'd spend trillions on the infrastructure they always talk about, but rarely do more than band-aid fixes on. When a 100 year old pipe fails do they replace it all, absolutely not, they replace just the failed portion knowing that other parts will fail some time in the not to distant future, but we don't have the money to do it right.
We used to have an expression, we never have the time to do it right, we always have the time to do it over. That's how we work on our infrastructure. Here in California perfectly good homes are frequently torn down that are no more than 50 or so years old. In much of Europe, many of the buildings have existed for centuries and have been adapted to bring in things like electricity, running water, sewers, etc.
I do hope we learn, but I expect some States who had the curve leveling off or starting down will be back on an upward trajectory in a few weeks, it's sad but they all listen to the President rather than the scientists.
Gary
I don't disagree Sherman, hospitals are starting to be allowed to do elective procedures, but many Doctors are putting things off until Covid-19 isn't feared as it is today. I've had a number of appointments deferred by my doctors after initially being told to come in, we're not taking any sick patients.
City of Hope has delayed appointments, and announced the screening everyone that doesn't delay an appointment will go through. I have one really important blood test that verifies my remission, it's been fine for nearly 5 years, but I always like to know it is. It takes about a week from the time the blood is drawn to know, so if I don't hear from my Dr. I know all is well. The other labs they run are generally fully processed in the roughly 45 minutes between when my blood is drawn and when I see the Dr. so can immediately know if my blood chemistry is showing a need to do anything, typically like adding magnesium or potassium to my diet, or taking supplements. I believe that the next time I'm there they'll test my blood for covid-19, I certainly haven't been very sick, but the way the disease seems to work it's not impossible to have it and never know it, and what's terrible is passing it on to someone without ever knowing it. People are dying who got the illness from people who even today may not know they had it, and passed it on to others.
PCTL can lessen the risk of hospital based infections, but nothing can eliminate it completely if someone sneezes or coughs and you're the one who breaths in or touches a lot of the germs.
Gary
While I certainly hope you're right, I'm not certain that Trump won't adopt it whether the scientists urge caution, or not. I don't like the way he bully's scientists, but in this case I believe a lot of people would actually live with it.
I know nothing about the clinicians at either site they've currently announced for the trial, perhaps they'll add more but I've got to wonder if even in a trial as short as this one, if clinicians observe something really excellent happening, I wonder if they could call for the trial to be unblinded.
Let's hope they can get it fully enrolled in a matter of days, if they do, we should have an answer in a couple months.
I would hope that the CLI Trial would get back on track as hospitals are no longer taxed to the extreme and can once again do elective work. We may not have brought the curve way down, but we've brought it below the level of rooms and ventilators available, so other things may proceed in most States, some may still be, or may be getting into trouble with opening up too soon, it will take a few weeks to really know.
Gary
Longfellow,
I believe it's very possible that the bottom 100 did no better than the SOC, the next 100 may have done little to no better, and that may very well have been the reason the trial design moved to survival. I don't know this, going by what I've heard from others, but the key is, what happens to roughly the top third of those in the trial, many of them are still alive, the least of which would be alive roughly 4.5 years, but the longest may be over a decade, we really don't know, and we won't until after the trial unblinds.
What I do believe we know is that people outside this trial have spoken out at times, and they've done very well. Some of them may have been in Phase 1, others received the drug under compassionate use, some may have been for cancers other than GBM, the point is, some people have some terrific long term benefits, peoples who's lives were thought to be in months to very few years. Are they cured, some may be thought to be, but with cancer you never can be totally certain.
Gary
On a compassionate use basis, I would really like to see what happens if a few patients not yet sick enough to go on ventilator were given the drug. I suspect that they'd avoid it completely in most cases. Then I'd like to see it go a step further and give it to newly diagnosed pneumonia patients.
I believe that early intervention would prevent hospitalization of many pneumonia patients. I've had pneumonia a few times in my life and was never hospitalized until the leukemia diagnosis weakened my systems to the point that they don't risk it getting worse, I've twice been hospitalized due to it.
Of course the only way we'll learn the capability of the drug is to try it, and it really should be tried at multiple places in the diseases progression. I cannot say it would start to have benefits even before pneumonia was noted, though perhaps it would. For all I know it would also help cure the common cold, but it would be a rather expensive cure unless only a tiny number of cells had to be dosed. If what's contained in a single vial of PLX-PAD could cure 1000 people with colds, it might very well be marketable in that indication.
Gary
I really don't believe anyone but the company knows how many times the company has provided the drug under compassionate use provisions. 500 is certainly not out of the question if you count patients enrolled in every trial plus unknown numbers under compassionate use.
I don't know where it's permitted under compassionate use today, I've heard that in England or Germany it may be available. Clearly here in the U.S. they aren't making it available for free under right to try, and to charge they must reveal all sorts of information about costs, and practically no company is willing to make such disclosures.
Right to try has a nice sound, but in fact it's off little use, and that won't change until some other means of receiving a fair price for the product being tried is developed. If you wanted to make right to try an immediate success, just let the drug company charge a reasonable fraction of the cost of the SOC, no other accounting information required, and companies will gladly participate. As is, it's a nice sound bite that doesn't work.
Gary
When you read about how much more hospitals will be spending on sanitizing, ask yourself something. Do you think that gyms, restaurants, bars, factories, etc won't actually be spending even more percentage wise. I believe the growth outside hospitals, on a percentage basis, will be greater than what's being spent in hospitals, which have always been concerned with sanitizing.
In reality, once our equipment is installed in most hospitals, I don't know that they're overall costs won't come down as our electrostatic sprayer requires less labor than sanitizing manually. I believe that our distributors, who can supply both equipment, and services, will grow dramatically as many places that are too small to justify having the equipment on site will opt for services where our distributors utilize our equipment and fluids to clean their facilities.
Gary
As the company matures the amount of publicity they put out, or seek generally diminishes. I believe it largely has to do with the attention they get from the SEC, who warns companies and can fine them for excessive hype. While on the Pinks, practically anything goes, on the OTC which we're looking to move on, it may get a bit more restrictive.
Certainly real news can be revealed, and if it's considered to be material, it must be. Companies may define what a material event is, based on their size, for a small company, a payment of $100K can certainly be considered material, and requires an announcement, whereas a larger company might not announce $1 million until the quarterly in which the payment was made.
I don't know for certain, but I believe the new distributors are announced because they certainly will increase earnings in the future, but in that no financial terms are provided, if the company is paid when they sign up, it's not at a level the company considers material. I really can't say if they're paid at all, but they may be. Certainly I would think that they're buying some amount of product, but the company doesn't announce each time it sells a product.
By the growth in the number of hospitals served, it's clear we'll not be informed each time a hospital is added, and frankly the company may not actually know. They may know that ACE was supplied 7 new units in the month of April, but until ACE lists all it's installations they don't know if they all went into hospitals, or other places, or if ACE is using some of them themselves to service multiple locations where they're being paid to sanitize the facility, not provide sanitizing equipment to be used in it.
In that we now have multiple distributors, similar to ACE, unless they each list who they're either serving, or where they've installed our equipment, I don't know that even the company knows every hospital where the equipment is now functioning in. I'm uncertain if a hospital purchases, or leases the equipment, whether the paperwork eventually goes to PCTL, or if the distributor is responsible for everything related to that equipment placement.
As I understand it, most hospitals lease, it keeps the cost lower monthly, and assures the hospital of receiving all updates to the equipment or software that's installed. Again, I believe it's the distributor who's responsible to make that happen, but naturally the company would need to provide it to those distributors.
It may be a few years, but I believe that eventually we can look forward to a Nasdaq listing. At that time little will be heard from the company, outside of quarterly financials. All we'll know is that the share price will continue its general upward movement, we'll have both up and down days that will be multiples of the current price. It will take a multi-billion dollar market cap to achieve that, but I have little doubt that the company in time will earn hundreds of millions annually, and that will warrant a multi-billion dollar market cap. By that time, I believe you'll find our equipment being used in many countries around the world.
Gary
No, even with Orphan Drug status you have to file NDA or BLA and wait for the FDA to act, the approval criteria is somewhat less, but drug makers still go through FDA hell in getting approvals.
What's being done with Covid-19 is nothing I've seen before in my lifetime.
Gary
I've now received it as well. I frankly hate to see this as a Red/Blue issue, but our President is pushing State's to do what his science advisors are telling him not to do, and many Red State's are following his lead.
I cannot blame people for wanting to be productive again, but if it's going to kill thousands more, I believe the Govt. would be better to support the people and businesses until they can safely reopen. The idea of saying we're winning the battle so go out and live is just what's needed to have it take off again.
Here in California they're opening up slowly, I believe it's working. We see friend in Zoom conferences a few times a week, but I really don't know that we'll truly have a party where 100 or more would attend for the remainder of this year if there is no vaccine that would make such a party safe. People are to wear masks everywhere, of course the President won't do it, and set a good example, but had it been done from the beginning, I suspect that perhaps tens of thousands fewer would be dead. It's not that masks are germ proof, but they greatly restrict the distance germs travel, and they do filter out some of them. The point is, I remember masks being used in Japan 40 years ago, now when it's impossible to tell if you have the disease, all need to wear them until the numbers come way down. It's clear that in the Red States few do it, whereas in the Blue States many more do it. I wish it were otherwise, I don't like wearing a mask, had to do it for months after stem cells, but everyone is better protected with it, than without. Most of the elderly people, like myself, do wear them, some younger people don't, yet the one person known to pass away was a friend of my daughter, so youth doesn't assure a cure if you get it. Too many young are dying, it's foolish to risk your life to party with friends for a few days, but some still do it. Crowds could be seen in bars in State's where they've been opened. I look forward to when restaurants and bars are opened here, but I know people will be spaced out, and they'll be masked when not eating or drinking. It's really a small sacrifice until the pandemic is gone.
Gary
No I've been pretty open about it, I don't mind repeating. I was diagnosed with PH+ ALL about 6 and 1/2 years ago. My initial treatment was at Cedars Sinai, and it was actually during my first catheter infection, which occurred after half of 8 planned courses of chemo, I went to City of Hope to discuss a stem cell transplant after the chemo. It turned out the infection was a blessing as my Dr. at City of Hope determined that he believed that I'd not need the additional 4 courses of chemo, he believed oral chemo would be able to achieve what was needed to do the stem cells, which he agreed would be done at COH.
I had some complications with colds and flu that prolonged when I'd get the stem cells but they were donated, and cryogenically preserved. That required a Hickman catheter which is larger in diameter and goes into the chest. I'd been pushing for it's removal once I left the hospital, but my Dr. liked the fact that in an emergency they could push medications in immediately, so it wasn't removed until it finally infected causing another brief hospital stay.
In the five years since the stem cell transplant I've had other complications a few times, a couple cases of pneumonia, shingles, as well as the infection. Otherwise I'm reasonably healthy, though still on the chemo, which does have some negative side effects, but I can do most things I'd like to. I can't say enough about how great the treatment is at COH.
Both Cedars Sinai and COH try to do an excellent job of keeping rooms sanitary, yet I had rare infections at both that were believed to be picked up in the hospital. I'm also an investor in PCTL and I believe their system might have prevented it. As I said, the first infection proved to be a blessing, but I would probably have seen COH well before the 8th course of chemo. Essentially I was home for at least a few days between each course. During one home break I was actually able to arrange a trade in for a 34 ft sailboat we owned for a 41 footer. I've not used it that much as my daughter is living on it, but hopefully if Covid-19 permits we'll make a few trips to Catalina this Summer.
Gary
I don't know how it's possible to fix a non problem. Problems are easy, you solve them and they're gone. Non problems on the other hand just keep coming back, they cannot be solved.
An example of a non problem is the allegation that without Covid-19 the company would be bankrupt.
I invested in the company just before the end of last year when I first heard of it. When you can buy a company for under a penny it's a hint that it's financials aren't superb, but I liked what they were doing, the new installations they were making, and having had 2 hospital based catheter infections was very interested in how they could be lessened. In short, I believed in the potential of the company before Covid-19 existed in the minds of anyone here in the U.S.
Did Covid-19 benefit PCTL, no doubt it did as the discussions of properly sanitizing everything suddenly became a major topic of discussion. The thing is, without it the trial in the U.K. would still have reached the same result. The demand might not have been as great, instead of growing 40% month over month we might have been growing 10%, but that's still great growth for most companies.
My thoughts above still don't eliminate the non problem, I'd be willing to bet that in the next week there will be multiple bashers who'll say that PCTL would be belly up if it weren't for Covid-19. Someone might link them to this post.
When Covid-19 is gone, I believe we'll find our sanitizing units in hundreds of hospitals, and that number will continue to grow dramatically every year. It will be used in many other places we've yet to consider as well. For us investors the stock may very well be among the greatest success stories of this decade.
Gary
I wonder how many are like me. I read about a company selling HOCL based product, then I find out that company is either wholly owned by PCTL, or I learn it's in some way affiliated with them.
I think it would be great if the company put out an Organization Chart that showed all these relationship. Wholly owned companies would fall directly under the company, those that exclusively used and distributed their product would be outside the central company, and finally those who used their products, but not exclusively, and not distributing them would be further outside. I think it would enhance all of our abilities to know what we have and once established, it would be easy to edit as new companies were added, or established under company ownership.
I'd hope it could be done on a computer, it would be easy to edit, and it could be built on, for instance to add the product names being sold by a particular distributor who doesn't sell with the PCTL label on the product.
Gary
I believe that in reality if the company had unlimited funding they would have many more trials against many different targeted diseases. They don't have that unlimited funding, so they made choices that they believed could get them approvals in a reasonable amount of time and cost. Of course that was before Covid-19.
Covid-19 provides an opportunity that I've never seen before. I have no doubt that if our Phase 2 Trial is clearly saving lives, it might not even have to reach it's conclusion before the drug is made available for sale. You'll not I'm not saying they can provide TLD, prepare a BLA which might take 6 months, then have the FDA take 6 months to review it, No all that can be eliminated, the FDA and regulators all over the world will give the okay to treat with our drug.
I believe it will be up to those running the trial to consider stopping it early, though I believe it's to complete in a few short months. If the clinician clearly see some people getting better, some not, they could suggest unblinding early, and if those getting worse were all on the placebo, they could be given the drug.
If I were running the FDA, all in the trial would be getting the drug, I don't know how a placebo that's injected into an unconscious patient can possibly create a placebo effect. Last I read roughly 80% of those put on ventilators don't survive, why not let all not getting the drug be your control, and all those in the trial the subject of the trial. Yes, that lets the clinician know, why shouldn't the clinician be trusted to do it correctly. There really are only three possible outcomes after 28 days on treatment, two of them are very observable, one is you're better, and off the ventilator, the second is you're dead, that outcome can't be denied. The third is that you're still on the ventilator after 28 days, perhaps another dose could be considered, or the patient just stays on the ventilator, eventually they'll join one of the two groups.
I would suspect that by October or November at the latest we'll know, and if the results are positive, they'll be an approval to use it. It may not be like a normal drug approval, but PLX-PAD will be available, and hopefully the company will have sufficient drug to reach all on ventilator, and those nearly on ventilators. Ultimately it will be given prior to hospitalization, and hopefully most will never need to be hospitalized.
Gary
I think your approach could pay off, but I'm not a trader, and was holding PSTI before covid-19, and believe it will have tremendous success in time whether it's successful with covid, or not.
I think it's most undervalued asset is it's bioreactor, and that's why the question about it being used to manufacture vaccine, once one is thought to be right, and they want to mass produce it. I also believe that the bioreactor could be the answer should one of the other drugs prove more effective, as again I think mass production is a problem.
I'm an older retired engineer, not technically knowledgeable medically, but I see PSTI as being able to engineer therapeutics, and placenta cells being the tool they've learned how to build with. I don't think anyone fully understands the magic these cells can do, just as years ago they didn't realize it was stem cells they were transplanting when the did bone marrow transplants.
I'm a stem cell recipient and look forward to the reunion City of Hope holds annually. It's been delayed by Covid-19 this year, and they still refer to it as the BMT reunion. If I remember correctly this is the 44th year. I've met a patient that had his transplant over 40 years ago. My point was that they really didn't know that much about why what they were doing back then worked, they just knew that it did. I believe that's roughly where we are today regarding placenta cells.
Gary
In thinking about a vaccine for covid-19, as I understand it, in at least some vaccines they actually use something extracted from mice, etc in it's production. I don't know if that's the case in what's being developed, but I gather it's bulk production is a problem, especially if you're trying to get it to the worlds entire population.
I'm curious if people here believe that PSTI's bioreactor could be used to mass produce vaccine. If so, once again out technology might be a key to ending the pandemic, in addition to PLX-PAD to cure pneumonia.
By the way, I received an email from City of Hope about Covid-19 and they indicated that they have two drugs developed there that should be in trials shortly. I'm a believer in a choice of therapeutics where if one fails to achieve the goal others may be tried. I believe PLX-PAD may benefit many, but it could very well be even more effective with other drugs, perhaps COH's will be among them.
Gary
The whole regulatory process for developing drugs is loaded with delays. I've seen trials take 6 months or more just getting underway after the IND was approved. The IRB and lead clinician couldn't schedule it any sooner.
It disturbs me how much trials cost, especially when they're for diseases that are deadly and have been proven safe in Phase 1. I believe it's very different if you want to be certain a new headache, arthritis, etc medicine is safe and effective, be very safe in that trial, but when you are testing a drug for people with deadly diseases, like GBM, trials should not take over a decade and require the sort of proof that this one has.
I realize the company made the choice to go for survival, probably because only a certain number of patients had a big benefit, while other may have had none at all, and an earlier look wouldn't have shown the advantage. A big part of the problem is the way the FDA wants to do everything with statistical analysis, rather than opening their eyes to what is an obvious advantage of certain new drugs. I've seen many drugs not approved that clearly had some advantage, but didn't meet their statistics. The problem is, companies don't have the funds to redo trials based on what they've learned, to achieve the greater advantage required, even though they believe in a differently designed trial that they could do it.
Most tiny biotechs simply don't have sufficient funds to run a series of trials to get a drug approved, if they should get a BP partner, additional trials might be run. The problem is, the BP wants the drug for a tiny fraction of what it should be worth, and companies won't sell many of the time. LP is doing this the right way, show what the drug can do before considering a partnership, or buyout. I just hope the data is so strong it leaves no doubt, and that DCVax-Direct can be in trials shortly, either financed by a partnership, or limited dilution because of a substantially higher stock price.
Gary
I believe there are some serious misconceptions about the normal time to approval of a drug after a trial concluded. This isn't the case with Covid-19 treatments which are being okayed without the normal formal process. Normally companies typically spend 6 months or more just in preparing the BLA or NDA that must be submitted to the regulators. On priority drugs our FDA gets 6 months to evaluate them, I'm uncertain if any foreign regulators move faster, or course faster determinations are being attempted, and sometime they occur, but figure 6 months.
It's not impossible for a regulator to act faster, perhaps without even a submission asking it to, but it's very rare. If you figure it will be a year from seeing TLD and approval, you'll rarely be surprised by approval sooner than that, and frankly it can take longer even if no regulatory delays occur. If the regulators request anything more, they get the full review time once a new submission is made that answers their request. Sadly, once that new information is received, they're perfectly free to ask another question on a subject totally unrelated to the initial question. It's sad, but in the past I've seen a drugs approval delay by a few years by totally unrelated question being asked and answered, but the drug was eventually approved. You can imagine how the stock moved based on each delay.
Gary
Other positive news from ASCO may be revealed in the presentation posted on IV here.
https://www.investorvillage.com/smbd.asp?mb=1316&mn=50635&pt=msg&mid=20700311
I don't know how much excitement the Virtual ASCO will create, but the news presented there is sounding pretty good.
Gary
I'll certainly agree, Gary has kept us well informed about what's happening at the company. While it would have been nice to see the financial on time, if in doing that production work was in any way delayed, I'd rather see the reports late.
I don't believe this will create the sort of delinquency that the late third quarter did, as long as they meet the dates specified in their filing.
As I see it right now, the equipment and fluids the company is delivering is primarily for fighting Covid-19, they're delivering on that, so I can live with being late on financials, just as many companies are. If I have a criticism, it's that they shouldn't have been anticipating being on time. Had they previously stated that we hope to be ontime, but are uncertain if we can, it couldn't be taken as a promise broken by bashers. We know they're busy, hopefully in future quarters they can be on time.
Gary
Thanks Moxa,
When you spray the masks, do you just mist them, or get them pretty wet. I know they have machines they're using to sanitize paper masks so they can be reused, I don't know what they're treating them with. I know their was a time the single use paper masks cost pennies, but the demand has driven up the price. If production was up, I don't know that they shouldn't be back to costing pennies, and I doubt they're worth sanitizing if that were again the case. The cloth masks on the other hand are probably all we civilians need for routine living. It would be good to see some practical information on how to deal with them.
Gary
Wanted to solicit the thoughts of the more technically knowledgeable people here about using HOCL. If you have it available, or in my case have ordered a small generator, would it be wise to use it routinely on cloth masks, if that's what you're using.
I purchased some masks that have the replaceable N-25 filters in them. I've heard that it's wise to wash cloth masks daily, but practically I know that won't happen. I do believe they could either be sprayed with HOCL nightly, and be dried by morning, but I'd also question, might it be wise to lightly spray them with HOCL before venturing out to kill whatever they might encounter.
If this was something that would be wise to do, it would offer a sales opportunity for marketing small sprayers to meet this need. It's essentially what I purchased on Amazon, but it will be a month or more before I receive it, and yes, it's coming from China. If this would be a smart practice, it would be great if it were documented and approved by the appropriate Govt. agency.
Gary
Given what we know about the bioreactor, wouldn't it make sense to treat it like the ventilators were where manufacturing was ramped up in making additional bioreactors, all under license from PSTI. It seems to me that if we had them, we could not only push the production of PLX-PAD, but could greatly accelerate vaccine production when one or more vaccines are determined effective if they're suited to production with our bioreactor.
As I see it, the need for PLX-PAD would potentially be for all who have pneumonia, which is substantial, but still a tiny fraction of the worlds total population which will ultimately need the vaccine. While the U.S.'s primary consideration may be protecting it's citizens, in reality if the entire world fails to get the vaccine it will lead to newly infected people who're traveling bringing it back to other places in the world. No vaccine is 100%, so each time the disease is reintroduced, some people will get it.
In watching the testimony of Dr. Bright it just reinforces how much better prepared we could have been if we listened to the scientists rather than the politicians. I'm embarrassed by the American efforts to date.
Gary
I wonder if our process is suitable for production of the vaccine once they have one ready to mass produce.
Gary
We've all seen pictures of all sorts of things being sanitized by sprayers, some may be just sprayers, others electrostatic. My question to everyone is, does anyone believe that what's being sprayed is not HOCL. Certainly there are other things that sanitize, but are any of them something that people can comfortably occupy shortly after they're applied.
Now we're not the only one that makes HOCL, so it's use doesn't guarantee that it's coming from PCTL, but the way the company's growing, the odds of that being the case grow with each day.
Hopefully we'll have the annual report tomorrow, that will end the reluctance of some investors waiting for it to act. We know the financial figures within it won't be positive, but I'd hope a description of how things stand currently, including the U.K. arrangement should make it clear that the future is far brighter than the past.
No one can deny that the company diluted substantially in the past to give them the funds needed to stay in business. Nor can anyone deny that Covid-19 created even greater attention in what PCTL was doing. I purchased the stock before what was happening in Wuhan was known, but personally having had two catheter infections thought to be hospital acquired, I knew it was a problem. I believe it was the right idea at the right time even before Covid-19 hit, but since then it's potential has grown tremendously. Why? Because now we're seeing so many other places paying far more attention to sanitizing if they're open, and who will be paying even more attention when they reopen.
I don't know about anyone else, but when they say that we're free to return to the gym, restaurants, stores, etc I'd be far more inclined to go to places that are proud to discuss how they're sanitizing their facilities. As someone who's elderly and somewhat immune compromised, I know I need to be careful, it's clear that some people don't believe in it as they're see at the beaches, or protesting to open the country without taking precautions. I'm all for gradually reopening in a careful way, from the beginning I saw no reasons people couldn't play golf if they maintained distances, and either drove their own carts, or only rode with people they were living with. Now they seem to be opening golf courses all over the country. Beaches are being opened here for recreation, but they don't want people just sunbathing, again, I'd be fine with that too, if people maintained distances, and wore masks when moving around. If we had locked things up the way they did in South Korea, and tested as they did, perhaps we'd have less that 1000 dead, rather than over 80,000. I don't know that the South Korean numbers are totally trustworthy, but clearly they treated the disease more seriously, and the benefit was terrific for them.
Gary
In general I've found few reverse splits that worked well, but it might here, but only after we've seen the TLD and the share price reacts to it. I expect it to reach the dollar range, or more, I really don't know that it's that great an advantage to get on the Nasdaq, but if the company wished to shorten the time to achieving that, I wouldn't fight that hard if they said, let's do a 1 for 2.
Frankly allowing the O/S to exceed a billion shares is no big thing either, people who feel it won't work just need to look at Apple. Without a R/S I still believe we'll see the $4 required for the Nasdaq on approval, and perhaps far sooner on the announcement of a partnership.
The negative connotation of R/S's are reason enough not to do it, stock's rarely do it where they don't lose substantial value between the time it's announced and weeks after it's executed, certainly it can recover after that by why go through the pain.
With the approval of DCVax-L and positive trials data with DCVax-Direct, I believe that a market cap between $10 and $25 billion is certainly possible, if we did have a billion shares outstanding that would give us a $10 to $25 share price. What would the benefit be at that point of having done a R/S, a small one I suggested would mean $20 to $50, but something like a 1 for 10 would give you $100 to $250. I see no advantage to that high a price unless it's gradually earned by building the business.
In the 1990's AMGN had a great business model, IMHO, each time the stock approached $100 they'd split. Splits certainly have a positive sentiment, all total in that decade they'd split a total of 48 to 1. I'm not suggesting a split, at least not until the share price approached $100, not an impossible number if in fact our products work in many cancers, not just GBM.
Gary
What's true is they announced tomorrow as the target date, but they would only be delinquent if they don't file by Friday, which I still believe they could do after the close and still not be considered delinquent.
I do believe that regardless of what's in the report the company will move up once it's filed, and likewise when they file the 10-Q the end of the month to stay current. Covid-19 has moved all these dates, but the reality is that it's making it hard to achieve all that's required while people attempt to stay free of the disease.
I feel for all the small businesses that cannot function, but I'd feel worse if tens to hundreds of thousands more were added to the fatalities. I believe if you go back a month we were being told they anticipated 60K deaths, now we're looking at 100K above that figure, and if we open too quickly, that number will grow. As a Californian I believe we've done a reasonably good job, but too many people can still be found without masks and not maintaining proper distance. For the most part they're young, outdoors, and near the beach, but that doesn't mean they don't have the disease, and can't spread it.
We have reached the point where trillions of dollars hardly matter. I suspect that it will take a few trillion more to bail out states and provide money to reestablish small businesses forced out of business by the disease. If they fail to spend that money, it will take years longer for the economy to recover. There are no winners in putting people out of business because they can't pay the rent as the owner will not find anyone who can, soon he'll not be able to pay the mortgage, then the banks will once again be overloaded with foreclosed properties and be in trouble. Better to pay, not lend, the prior owner of the business to reopen and rehire staff, let them pay the rent, and keep the owner from being foreclosed. Yes, it's giving away a lot of money, but at least taxes will be paid again, if the economy is totally in the tank tax revenue will be greatly diminished, and all sorts of money will be needed for public assistance.
Gary
Almost no trial is perfect, and our trial will not be the exception. Much has been learned over the more than a decade the trial has been run and if you were doing it again, it would be done very differently. That doesn't mean it's a failure, only that it's imperfect.
When TLD are revealed, I believe investors will be thrilled with the results, and it will be shown in the price. Shorts will point to any flaws, and in reality you never know how the FDA or other regulators will react, so nothing is certain. I believe the many survivors that are announced will be why the vaccine should be approved, but when it comes to the FDA, nothing is certain.
Between TLD and approval there is usually a period of 9 to 18 months before regulator actions are taken. It takes at least a few months to prepare the BLA for submission to the regulators, then they get 6 months to consider, but may have questions, or simply state that they're taking more time. I believe the greatest likelihood of a partnership will come after TLD is revealed, and may very well come before the BLA submission, so the partner will at least share in its development.
My point is that much may happen between TLD and approval. The data will almost certainly be presented at one or more major technical conferences for peer review, then it can be distributed to investors. Of course under confidentiality agreements potential partners, or buyers can have access to the data as soon as it's unblinded, even before the TLD statement is prepared.
We have roughly a month and a half to TLD if it's on time. We have a year or more before regulatory actions should be anticipated. An awful lot can happen between now, and then.
Gary
I'll predict that we get the quarterly sometime in the not to distant future, and little or no mention will be made to whatever the German issue is. I'm not saying it's not legitimate, it probably is, but we won't be given the details regardless.
I doubt if much of the language in the quarterly will change much, if at all, as I'm not thinking anything they'd announce will happen in say two weeks. The quarterly will come out, bashers will pick on any weaknesses, pumpers will point out the positive, the stock may react slightly, and we'll move on toward something meaningful, TLD.
Gary
I,t's happening, but in many cases the large companies are being bailed out, which may hurt those on the short side. Most of the companies that will be out of business don't have stock, they're mama and papa stores, restaurants, etc that may have lots of employees, and while they're supposed to get some of the Federal money, it's clear that it isn't going there that much.
If PSTI is successful in it's covid-19 trial, it could potentially be a vehicle for turning this around. It can't happen instantly, but if first they can make enough PLX-PAD to cover those on ventilators, and ultimately make enough to reach patients when the pneumonia is initially diagnosed, it would largely remove the threat that covid-19 poses. If the fear of death wasn't keeping us out of the gym, restaurant, etc life could become a lot closer to a norm. When getting covid-19 is no worse than having the flu, the risk would be greatly reduced and hopefully many things could reopen. People want to eat out in restaurants, go shopping, to the gym, the theater, watch sports, etc, but not if it's a potential death sentence.
I look forward to sports resuming, I'm not big at watching reruns, even if I'm unsure of the outcome. I really don't know how I'll feel about watching a football game with no fans in the stands. I do plan to watch, but I don't feel like it will be the same.
Gary
Sorry, I'll agree that most politicians in Washington will take money from whoever hands it to them, but might be leary if they know it's foreign. A high ranking military officer is a different matter IMHO.
As for lying, CNN is a piker by comparison to Trump and Fox, they make up the truth as they go. CNN will at least apologize when they clearly tell a lie, what was the last time Trump apologized for anything.
Trump's biggest lie is that things are getting better with Covid-19, every day the forecast of how many deaths are anticipated rises. How can you say things are better when the forecast is more will die.
If Trump were wearing a mask, encouraging all others to do so, saying we can do things with greater protection, etc perhaps we could ease up and not increase the deaths, but that's not how he operates. Ordering workers into highly infected meat processing plants is essentially ordering certain people to die unless many things are done to protect them. I like my meat, but not at the cost of people's lives, especially when farmers and rancher are dumping product because they can't get it processed. Find a way to pay them and make the food available to the people, it will get eaten.
This pandemic has clearly lacked centralize leadership. People like Fauci are knowledgeable, but the President's message constantly contradict the experts. They continuously lie about the availability of everything from test kits, to masks and other PPE. You don't have to believe a thing I'm saying, just look at the deaths, the numbers and the estimates just keep growing. That's real leadership.
Gary
When I first invested the stock was just under $.007. Now it's $.07. Our CEO and other officers may not have previously served in such positions in Fortune 500 companies, or any others for that matter, they may serve in other companies as well, but I don't care about that, or the fact that they're getting solid stock options for themselves. What I care about is a ten banger in 5 months, and I honestly believe they'll do equally well in the 7 months remaining this year, that will bring us to over $1.
Could I be wrong, certainly, would most people be happy with a ten banger in a year, sure, but I truly believe we're in the right place at the right time, and over a 100 banger is certainly bigger than a ten banger, and that's a real possibility.
By the time the potential of this investment flattens out, a great percentage of the hospital, healthcare, gyms, restaurants, etc all over the world will have a device that's either ours, or something similar from someone else. Certainly there is competition, I know of nothing as good today, in spite of patents, I wouldn't put it past the Chinese to copy it for domestic use in China. My point is, this has a long way to run, it's in its infancy.
We all know that getting infections, etc at hospitals, gyms, etc has always been a problem, it's not that they're not cleaned or sanitized, it's that it's not that thorough. When our fluid and an electrostatic sprayer are used it's far more through, and it costs less in the long run than manual cleaning. It won't be perfect, new hazards can arrive after the old ones are eliminated, but these places will be much more sanitary after cleaning.
One of the news shows I was watching explained that most infections come from either picking up something from touching it, or with fairly long duration exposure with someone having it. The point was, just passing someone who has it doesn't normally pass it on unless they sneeze, cough, etc right at you. Apparently we all can take a number of germs before we're infected, if the exposure is light, our body can normally overcome it. That said, if the hospital, gym, etc starts out really well sanitized, it's unlikely that we'll you'll get an infection in the near term. The key will be sanitizing frequently. When our device can do it in a matter of minutes, and when the fluid cost is near zero, it really does make doing it frequently easy.
Gary
I know that's coming at some point. I believe that some investors believe that the data will be sufficient to gain approval from some regulators, but not the FDA. Of course until they have the data no one knows, but I believe the benefit is significant. The thing about covid-19 is you don't need to wait years to know, a month or so into the trial, if the results are close to what happened with the first 7 to try the drug, even if the trial has longer to go, the clinicians could recommend terminating early with such positive results.
I know they're testing at various dosing levels, it's hard to say if the lowest level could be as effective as higher levels, but if it is, it would bring the price down as less would be required per patient. In many ways I believe that PLX-PAD may be like stem cells. As a stem cell recipient I know that not that many cells were needed, they reproduced when they arrived at the right place. I don't know that's the case, but if it is, a fairly tiny dose may be all that's necessary, though more cells will probably be faster acting.
I'm completely unsure, but wonder if people treated with PLX-PAD have benefits never considered in the trial. I.E. were improvements noted in organs other than the injected tissue when it's used on CLI. If the injected cells do reproduce and migrate in time, could benefits be seen in the heart, or other organs. It would be interesting to see if that's been studied with people who entered other trials years ago, we might find unexpected benefits.
Gary
I took my eyes off the stock for a few minutes and the gain for the day nearly doubled. I've got to believe that someone knows something that hasn't yet been stated by the company. We know there are more than 7 compassionate use patients, yet they're all the company has chosen to speak about. I cannot say when, or if the company will bring us up to date on what's been shown in the compassionate dose cases, or is all they report on the status of the Phase 2 Trial.
It's very possible some to receive the drug have passed on, it's practically impossible to cure all who've been hit with the disease. Many of those on ventilators have serious health conditions before ever getting covid-19. I believe anything that saves 50% or more of ventilator patients would be considered nearly a miracle, and thus far we're doing much better than that.
I really wish we could see what happens when the drug is given to newly diagnosed pneumonia patients, but that won't happen until it's been tried on those who're much sicker. I'm of the believe that a lighter dose in a healthier patient may be all that's needed to quickly cure the pneumonia. I don't know how many patients might be treated with a single vial of the medicine, but even if it's just a few, it would greatly lower the cost, and keeping people out of the hospital would certainly prove cost effective.
Gary