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I'd like to ask a question of those who know what's practiced in Europe. People are making it sound like once TLD is revealed, DCVax-L will be available for sale in at least part of Europe. Is that actually the case, or will it only be available under compassionate use, or right to try, and if so, at what price.
Here in the U.S. I don't believe anything changes regarding right to try, a company can make a drug available, but to be paid for it they must reveal proprietary information that practically no company is willing to provide, the other choice is making it available for free. I don't believe anything changes on TLD, or after submission of a BLA, when approved the company can sell the drug, but until that time it's under right to try provisions.
I wish it were different, but barring a change in the way the FDA works, I believe it will be something over a year between the time the TLD is revealed, and FDA approval. Why? Because the BLS is so complex it will take 6 months or more to put together, than once submitted the FDA is allowed 6 months to review it and if they don't have questions or request more information, it's approved. If the do request anything, from the time that information is provided to the FDA they get 6 more months to evaluate it. In the past I've seen very approvable drugs delayed by over 3 years by a series of FDA concerns that caused the delays. The FDA never seems to be concerned by patients who fail to see the benefits of superior drugs, until they approve them they're simply not available if the company won't participate under right to try.
Gary
You couldn't be more wrong, the biggest mistake California made was opening up sooner than they should, in spite of all of Trumps push to do it. We had it under reasonable control, and hopefully are bringing it back under control, but people, mostly Republicans were pushing to open up, and they did it too soon.
California is up, but we're by far the most populous State, but the States that are growing fastest have Republican Governors who all tried to stick to the message coming from the White House. Look at what's happening in places like Florida, Georgia and Texas, Covid-19 is going crazy and in many cases Mayors are fighting with the Governors to add restrictions to bring down the disease transmission. Many of the fighting Mayors are Democrats, but some are Republicans, but they see what's coming out of the White House is wrong.
Covid-19 is a horrible disease, it's often highly contagious before any symptoms are felt, and often the biggest spreader never has serious disease, yet may spread it to someone who dies. Testing is questionable at best, and only those who're really sick are tested quickly, most tests take a week for results. This needs to stop, we need tests where those tested know in minutes, not days. It can be done, they do it routinely at the White House, we need it in most of our houses.
Gary
That's true, but let's look at how it could have been done properly. At that time the Chinese and others had effective tests, what if instead of stopping flights he said all much be tested.
Right now, we can't travel to Europe, etc. How hard would it be to put the 15 minute testing equipment at the airport and test every passenger, or member of a flight crew, before they could get on a properly sanitized plane. Even with such precautions some will get through, but most will be eliminated. Covid-19 exists practically everywhere in the world, we need to cut it's spread, but if we can bring it down dramatically, I believe we can live with some who're carring it. Of course once a working vaccine is out, much will change.
Trump could have had far greater success if he'd have worked with Congress, both houses, in how to approach Covid-19. Of course he could have started much earlier, but then he ignored the threat for a month or more before stopping the flights from China. By the time he did it, New York found that most of their infections came from Europe, so clearly it was spreading everywhere. Had the pandemic task force not been abandoned, I suspect we'd have reacted months earlier and been prepared. We're still being reckless in not ordering industry to build more PPE, as well as more protective gear for consumers.
We're now at the point where far more financial relief is needed. States and cities will need it as much as businesses and the unemployed as all their revenues are down dramatically. Once Covid-19 is under control, things can open up slowly, but clearly they can't be opened until things are under control. Something like 30% of the kids at school age in Florida were found to be infected, clearly that's a number that doesn't permit schools opening. I'm not sure it would be safe if 5% of kids had it, and all were routinely tested and positives eliminated. Bar's reopening led to tremendous spikes in infections as they were crowded, we can't have the schools do the same next month. I would suspect that the Black Lives Matter marches also caused spread, but they were outdoors, which is safer. Clearly distance and masks are important, but being outdoors is far safer, so clearly as the weather worsens going into Winter, greater problems will be coming if we don't have this under serious control.
Gary
Frankly I'm amazed each time I see all the companies that are legitimately operating as distributors of PCTL. At times I believe we've all seen companies that we thought to be competitors that on further examination were actually distributors at some level.
What I'm frankly unsure of is whether a distributor can sell in bulk to someone who isn't a distributor who in turn will bottle and sell their own product names, but identify the product to PCTL's approval. It is the approved product, but they're not officially a PCTL distributor, but they're buying from one.
It's clear that distributors can package and sell products under their own names and identities. I suspect that in the future we'll go into a market, Costco, CVS, etc and find multiple HOCL based product under a variety of labels, and if we tracked them to their originator, we'd find they came from different PCTL distributors, some in fact might be made from bulk deliveries that came right from PCTL itself.
I think that people like D.E. will be very successful with PCTL, and I believe we're still in the infancy of the industry. Five to ten years from now new distributors may need to be more careful in knowing what the existing competition is, or what specific niche they intend to fill. I would suspect that one hundred times our current distributors could be successful in the U.S. as people learn the benefits of HOCL, but there probably are already some locations where additional distributors aren't badly needed. Of course I'm speaking about just the U.S. I believe most of the rest of the world is untouched, with the exceptions of healthcare facilities in the U.K.
As for the companies that sell products that are not PCTL, but claim they are, the laws should apply to them, and PCTL should be compensated. One remedy may eventually be them becoming a PCTL distributor at some level. I really have no idea how many there are, as so many we find are tied legitimately to PCTL.
Gary
I certainly agree the economy is important, had the money that the govt. put out gone to the people who needed it, rather than a lot of big industry, and some of Trump's best friends, they could have survived being down. If we'd shut down perhaps no more than a month longer we'd not be getting the peaks now that are forcing us to shut down again.
In 2008 the Bush Administration threw out money much in the same way, when Obama took over they added some accounting to it, and much was actually paid back as they bailed out the likes of General Motors. The wealthy, like the DeVos's didn't need a thing, but I believe they got millions. Many of the small business owners got nothing, or very little. Teams like the Lakers got money, but gave it back after it was revealed, there is no doubt that billionaires that own teams like the Lakers are losing money this year, but they're in no way hurting. The funds went out to a lot of people or companies that really aren't hurting, while those who'll probably never get back into business have largely been abandoned.
Let them put out a list of all who received the funds, then you can compare it with who needed it. I feel for all who've lost their jobs, or lost their companies, but if the money had been properly spent, they would be okay, but clearly it wasn't. At least Betsy DeVos can now add another yacht to her fleet, good for her.
Gary
While I hope you're right, that's still a small number of people compared to all that could use the vaccine. If the world would arrive at a fair way of pricing drugs that the drug developers would accept under right to try or compassionate use, a great deal more of it would be authorized. I cannot blame drug makers for not providing all that govts. want in order to sell product under the provisions for offering it while under trials.
I really believe that if a price was established for SOC treatment and the drug makers could sell their products for half the SOC price under compassionate use, most drug makers would opt in to such an arrangement.
What I'm suggesting goes for all drugs that have demonstrated both safety and efficacy in Phase 2 or 3 Trials. It's especially true for the period after a Pivotal Trial ends while a year or more is spent in developing a BLA or NDA than getting it approved by regulators, perhaps the price for the drug could be higher based on some formula.
As far as I'm concerned, the Right to Try, sounded like a positive thing, but like compassionate use before it, to be paid drug makers had to provide information they're simply not willing to provide. The result is they either give the drug away, or don't participate in the program. Most don't participate. It's all about giving up propriatary information, and there should be a better way of doing it, and making the program work.
Gary
We'll have to agree to disagree. First, Trump dismissed the pandemic team that Obama put together. Then months later he disregarded the warnings about the problems in China that could result in a pandemic, by the time he put the restrictions on Chinese travel tens of thousands or more were already here from there, and Europe. Trump insisted on developing our own testing rather than going to either the Chinese, or South Koreans who clearly had developed good testing capability, we wasted months developing testing, and still are taking weeks in most cases to get results of bulk testing. Trump criticised hospital workers for using too much PPE, rather than acting to get more, as well as recognizing the benefits of wearing masks to lower transmission, even if it's just a simple scarf.
I worked in Japan nearly half a century ago and saw people in masks back then, they knew it reduced the spread, but only sick people would wear them. We have a disease where people don't know they're sick, and it's often most infectious before you have symptoms, masks would clearly reduce it's spread and ideally all American's could be provided with medical grade masks, but Trump made it a political statement not to wear them.
I'm sorry, but I believe we could have saved hundreds of thousands had we acted prudently, but we didn't, we've never brought the curve down as Trump pushed opening up too early, and now we're still on top of the first wave rather than at a low rate of infection and being cautious about going into fall with a second wave. Trumps emphasis on the economy and not on lives is costing us not only more lives, but is taking a much worse hit at the long term economy than if we got the curve down as it is elsewhere before reopening. Now all sorts of places that opened, in some cases for less than a week, are forced to close again, and with virtually millions infected, no telling when they can reopen again.
What do you imagine might have happened if the pandemic panel had been working the entire time and reacted, very probably in late 2019 to prepare. I don't know that they'd have stopped transportation, but I suspect that people may have been tested before they ever got on a plane. Tests did exist in China, South Korea, etc well before they were available here, and I believe our pandemic staff would have been acquiring them, or rights to use the technology, and make them here, but of course Trump fired that staff.
Gary
Here's the data for Covid-19 all over the world. You can call us the leader if leading is having the most deaths or infected people, then we are the leader.
https://covid19.healthdata.org/projections
If you deny the truth of this, give me another source that's better.
Gary
If you accept everything you hear on Fox, how can you deny the fact that hospitals are filled to the brim in so many States. That is not fake, nor is the fact that we're still short of PPE, nor is the total deaths, or the data you can find in the Covid-19 database.
We as a nation have done a terrible job in arresting the spread of Covid-19, look at all the players who're turning up infected as they try to get Pro sports started again. Deny all you want, you cannot deny hospitals filled and trailers ordered because the morgues can't handle all the dying.
I'm sorry, none of this may be seen on Fox, they may not even show the Republican Governor's who're calling for more restrictions, I don't know, I only occasionally watch Fox, but the rest of us know what's happening in the world. We'll be lucky if 300,000 don't die of Covid-19 in the U.S. by the end of the year.
Gary
Remember, they're blinded as to actual results in the trial, but I believe they could update the clinical trials database and at least we'd know if trial sites were added and recruiting. As far as compassionate use, I've gathered that after reporting on the original ones to receive it, they've made the choice not to report on additional use, though I believe the numbers are substantial. I don't know if they received anything from the SEC or FDA saying that they considered such reports as hype, or if they purely decided on their own to leave it to the Phase 2 Trial to demonstrate what PLX-PAD is capable of. It is frustrating, but it's a short trial, we should know by October at the latest.
I'm uncertain when they'll be able to report more on the CLI or other trials, I do believe they have a peek at some point before the trial is concluded, but such peeks only suggest continuing the trial, halting the trial for futility, or suggest going for early approval. Most times they recommend continuing, but if results are spectacular early termination is always possible. I believe our drug is doing very well, but the criteria for early termination is quite rigorous, so I wouldn't bet on that.
Gary
Jaime,
I'm uncertain, but I believe that was before a decision was made to go into trials for Covid-19. I would hope they could come out of Covid-19 with an approval from a rather small Phase 2, but it's possible they're guessing, or know that it will require a larger trial, possibly expanding on the data from the Phase 2.
I believe the pneumonia market to be huge, but the trial in general for pneumonia would be an enormous Phase 3 as most people who acquire pneumonia do survive it. Covid-19 gives us the opportunity to prove what the drug can do in a deadlier form of pneumonia, but if approved in it, you can bet it will be used off label for other forms until such time as it's proven worthy of a label expansion.
I believe regardless of what the initial approval for PLX-PAD is, it will be tried off label for many things, and often found to be effective. Covid-19 may gain initial approval, but don't write off any of the other trials, I believe we'll see approvals as well as they move forward.
Gary
In terms of who's the ultimate last to deal with Annual or Quarterly reports, to me it's uncertain. Does the company provide the manuscript that's to be included to the accountant, or do they add it to what the accountant provides to them.
I would believe that they would be the last to review what the accountant provided, and even if they had written the manuscript in advance, they could modify what was said if something in the accounting required further discussion in their opinion. Ultimately I believe it's Gary's signature that appears in the document as releasing the entire report.
It's certainly true that they're held up until the accountant provides the financial portion of the report, but I'm practically certain they'll be the one who issues it.
Gary
I think you're being overly pessimistic. As I read it, if the company in the TLD commits to the submission of a BLA, over 80% of the time they're being approved. I do believe we'll get that commitment either in the TLD, or in the company's discussion of the future once the TLD is filed.
We'll learn much more about the trial details once the data's been peer reviewed, and it can be discussed with investors, but I believe we'll have a commitment to submit a BLA before that time.
In that practically nothing is working for GBM, I'd say our odds are better than the 80+% shown in the data for oncology products from BLA to approval.
Gary
I don't believe it's possible to say with absolute certainty that the FDA will approve a drug. That stated, I don't believe that anyone looking at what we believe will be in the TLD not to be enthusiastic about what the vaccine has achieved. If I'm right about that, I can't see the share price not being substantially higher over roughly the next year or so while we're going through the approval process by the FDA and other regulators.
Personally, I believe at some point between now and then a partnership is likely, and that will establish a new trading range for the stock, and in some way act as a cushion should the FDA demand some further proof before the vaccine could be approved. Meanwhile, hopefully, DCVax-Direct will initiate further trials, and perhaps there will be a readout of that trial by the time the regulators act on DCVax-L. If all of this occurs in a positive manner, the ultimate potential of NWBO having a triple digit market cap in time should certainly be seen. If someone is interested in acquiring the company, they should realize the kind of money they'll need to offer to make it happen.
Gary
I'm uncertain what's in our distributors agreement, but doubt if they're prevented from selling to people who're prevented to repackage and resell.
It will be a nightmare to determine if someone using PCTL's number purchased a bulk quantity of HOCL from a legal distributor, then added their own label, packaging, etc and resold the product, identifying it to the original PCTL based approval.
What would be illegal is generating the HOCL themselves, or purchasing it from someone totally unrelated to PCTL and using our number for a fluid that's not been through the approval process..
As for PCTL being paid, I believe they're paid when any licensed distributor makes fluid. I don't believe it matters how that fluid is used. If someone wants 500 gallons of the fluid, it will probably cost them several thousands of dollars if purchased in bulk, probably over $10,000 if in 1 gallon bottles. If someone purchases just 10 gallons, let's say at $25 a gallon, they could make a very healthy profit if they sold 1 oz. spray bottles for a few dollars as a specialty item, like for removing eye makeup.
My point is that one gallon could bring hundreds of dollars if packaged as something special, it doesn't matter, if that gallon was produced by one of the PCTL distributor, the company will be paid based on the agreement with the distributor regardless of how that gallon is ultimately marketed.
Gary
Is there anyone here who believed that when PSTI did the reverse split the O/S would remain under 50 million shares very long. I don't know when it will exceed that, but I certainly believe it will in time.
At 50 million shares that's still saying a $1 billion market cap is $20 a share. I believe if the Covid-19 data achieves approval to give the drug we could easily see a $5 to $10 billion dollar market cap, any complaint if the O/S is up to 50 million.
I still believe the other trials the company has in place, or may add, will result in approvals and eventually the market cap will go well into double digit billions, but Covid-19 could greatly accelerate that achievement.
Gary
Doc,
By the time that determination was made I believe it was clear that survival was greater, and they made the determination that all should get the vaccine. I never meant to say the trial failed, I meant it needed to be redefined because of what they learned. Had the trial been run precisely as originally specified, I believe it would have concluded some time ago, and because of people who actually had pseudoprogression being identified as progressed could have failed, but based on what they learned, they made a course correction.
If the company had wished to be clearer about what they were doing, the trial as it appears in the clinical trials database could have been updated. The company has played its cards close to the vest, so they didn't update clinical trials, they've kept shareholders guessing. I only invested a few years ago, at the time I did, many believed the trial would end when the last patient to enter the trial had 3 years. Then many were sure it would be 4 years. The company never varied, they didn't give real guidance as to when it would end until the guidance at the recent Annual Meeting.
It's not that the company didn't say what was happening in the trial, presentations by Dr. Liau and others were very informative, but until the Annual Meeting investors didn't have an anticipated date for locking the trial. Sure, that's slipped, but we're down to nearly the end, I can't say with certainty it will lock in the next week, or in July absolutely certainly, but I believe the odds are good that it will. Same thing with TLD, can't be certain we'll have them in August or before, but the odds are good that we will.
Gary
I will admit that I've been confused by what Gary has said. I believe that he thinks the Nasdaq is a possibility this year, and he said he'll not do a reverse split, that tells me he thinks we can achieve a $2 share price, which I believe could put us on the Nasdaq. On the other hand his statement of something North of $4 million in earnings would have to be off by a substantial multiple to justify even $1, yet alone $2.
That statement, and the lack of overdue financials is holding us down. Hopefully the financials will be out shortly, but it's still results in the second and third quarter that's what will say where this year can go.
I believe that D.E. has a good handle on what the company's doing, his pictures at Werk's certainly are impressive as to the facility. I believe they're doing far more there than just PCTL manufacturing, but there seems to be substantial capability there to meet production demands as they build up the capability.
I can't help gaining enthusiasm when I see what various PCTL distributors are doing, but I do hope that PCTL in the future will do more in supplying some of the units they're selling. I know D.E. seemed to be developing a substantial line of electrostatic sprayers, but I'd like to see the day that at least many of what the distributors offer come from PCTL. Our hospital unit is great, and I know they discuss something smaller, but there is little information about it.
As investors, we need to recognize that our distributors have the freedom to build in the way they see fit, some are working on all sorts of consumer products, while others specialize at sanitizing hospitals and other facilities. D.E. is the only one I know of who's going after petroleum as well as sanitizing, etc. I think it's healthy that they can grow in so many ways, but I would like to see more equipment developed by the company be available to all distributors.
Out biggest unknown IMHO is what's happening in the U.K. and the other European countries our U.K. agency is permitted to work in. I'm of the belief that this will be a big profit center, but I don't know how big, or how quickly it will mature.
As we get the second and third quarter earnings I believe we'll get some of the questions answered. I believe the answers will have us earning far more than $4 million, and they'll justify the higher share price we've been told we should achieve. If we truly earned just $4 million, I believe the analysis that said it justified about a $.21 cent share price would be about right, that's over 5 times what we're selling for today, certainly not bad for any stock, but many believe it can do much better than that.
Gary
I wasn't involved back then and don't know anything about what went on, I'm purely using my judgement that they made a decision to push O/S rather than PFS which lengthened the duration of the trial.
Everything I'm seeing says the vaccine's doing great it terms of O/S. Because early on pseudoprogression was thought to be progression, my thinking was that the PFS data would have been confused because of the diagnosis of progression which was actually pseudoprogression. I would certainly think anyone alive today after much more than say 6 or 7 years would be recognized as having pseudoprogressed, rather than progressed, even though originally progression may have been called. I don't believe the same for those who entered the trial in the first few years after it was initiated, who may have been viewed as progressing after a matter of months, but lived for 3 years or more.
I don't believe anything was wrong with what the company did, but I do believe they reacted to what they learned while in the trial. The new SPA is what I believe they needed to have the trial judged based on what was learned even though the numbers living alone should be evidence of the vaccines efficacy. Sometimes the FDA cannot see the forest through the trees.
Gary
It's rare that I believe you've written something that's worthy of comment, but in this case, at least in part I believe you're right. I wasn't involved with the company back then, but I suspect that you're correct that roughly 5 years ago the company determined that the trial as originally designed would fail. It would fail because they didn't know about pseudoprogression or how to differentiate between it, and actual progression going into the trial. Too many people, both dead and alive at that point were viewed as having progressed, though many lived on when they weren't expected to.
At that point I believe they made a determination that O/S, which would take additional years of trials, could prove the benefits of the vaccine, whereas PFS which could shorten the trial, could result in its failure.
Dr. Liau or the company are not at fault in the design of the trial, there is no way they could have known about what was learned in the process of doing the trial. What they did do was adapt the trial to one which not only should work, but the data it produces on O/S should be so clear that no one can deny the benefits of the vaccine.
In the past I've seen many drugs fail and be totally abandoned that very probably could succeed in a better designed trial. The problem is financing an additional trial, and many small companies just can't afford it. In that the genesis of most drugs is well over a decade from the time it fails, much new technology exists by the time of the failure. While a better designed trial may succeed, other drugs are now priority, if they have the funds to advance anything, so the failed trial results in the abandonment of the drug. NWBO recognizing 5 years ago that a change in direction was needed, or it would fail isn't bad management or science, it's good, they made a modification to make it work.
Gary
I don't fear the competition, I see all that works as tools that ought to be in the Doctor's tool kit. I'm of the belief that the more we learn about PLX-PAD the more we'll see that it can benefit many organs, not just the lungs, and will work on all forms of pneumonia, and other diseases.
By itself, it may not be the answer to everything, which is why I'm happy with the development of other technologies. If PLX-PAD reduced the deaths in covid-19 by 80% it would still be a serious disease, especially considering that many people who recover continue to have problems that may never be fully recovered from. I believe to limit the negative side effects, PLX-PAD or something will be needed well before ventilators to avoid other organ damage. No doubt, PLX-PAD will be more expensive than many of the therapies they're working with, on the other hand, if it prevents or improves on other organ damage, while others save a life, but leave the patient in a more weakened state, the added cost will save on treatment in the long run.
Gary
I know DI continues to tell investors that they'll announce data lock, but it's possible this is a strategy by the company to surprise the world with announcing TLD. I could certainly accept such a strategy, but I'm still of the belief that DI is telling us what he believes to be true.
If in fact the company won't keep the I.R. person knowledgeable to what's happening, he will lose credibility with investors, which is not a good position to be in. On the other hand, if he acknowledges knowing he was following a corporate strategy, investors will question whether they're to believe what he's saying. Either way this is a losing strategy for him, he only becomes credible if they do announce data lock before TLD.
Frankly I'd be thrilled if data lock were announced after the close on a Friday, and TLD before the open on Monday. If the company responsible for data consolidation in fact had 99% of the data, and developed recommended TLD statements, such a thing could happen when the 1% missing data came in, and data lock was called. It's a sort of shady way of getting the shorts, but it would be truthful that data lock wasn't called till that last bit of data came in, and practically nothing had to be done to incorporate it into the report from the contractor.
Gary
I'm unclear on whether PFS may have ended with progression diagnosed in some of the earlier patients in the trial, who then went on and lived for several more years. While the PFS that was seen was probably pseudoprogression, were they able to go back and make that determination, essentially changing the earlier data in the trial.
I would suspect that if pseudoprogression had been understood from the beginning, and if a means was determined to differentiate from the beginning that patients had real progression or pseudoprogression, the trial could probably have been much shorter. Perhaps it's just my belief that their was uncertainty in the beginning that required making OS the primary consideration as no one can deny the numbers surviving for 5 years or more. I believe those who are living today may largely be judged as PFS, yet at an earlier stage of the trial they may have been thought to have progressed.
Gary
Let's look at what the advantages and disadvantages are of declaring a data lock. To me, the biggest advantage is the higher stock price most believe will occur once it happens in anticipation of TLD being announced. The disadvantage is providing some idea of timing to those who're short the stock.
The advantage of not announcing data lock, just suddenly announcing TLD is the impact of it coming with no warning that may create a greater short squeeze. The disadvantage is that it's being announced at a lower stock price, while the percentage gain might be greater, it's uncertain if the stock price will be higher if you begin at a higher price anticipating TLD or have the impact of the statement with no forewarning that it will be occurring.
I don't know that one month after TLD is announced any of this will make much difference, but if hurting the shorts is a goal, not announcing data lock probably will have the greatest impact. Yesterday I believe someone indicated that the number of shares documented as short was actually pretty small. I never know with any degree of certainty how accurate such data is, but I believe the shorts know some positive things are happening here, they should be out of their position for now. You can bet they'll be back if the stock moves up to a level that they don't believe will be sustainable.
Gary
I will admit to seeing it happen in the Pinks, but everyone that I can think of that didn't have a product to sell came crashing back to pennies, or worse. PCTL doesn't have one product, they have many, and perhaps more importantly, they have distributors. In some cases they make the product sold by their distributors, in some cases the distributors make the product using equipment from the company, and in most cases the distributors can sell or lease the production equipment to agencies, like hospitals, and everyone profits.
I don't believe we'll remain on the Pinks too long, but we've got to get caught up on the financials, and stay there long enough to move to the OTC, then it's a matter of reaching a couple dollars for the Nasdaq, though I believe the AMEX is a possibility at $1.
I'm hoping by August we've seen the second quarter, if we have, we might be able to be on the OTC shortly thereafter.
Gary
I certainly agree, the Orthodox do have the toughest decision, but that's true every weekend for them as well, though more so on the High Holiday's. We've recently lost a few friends at our club, while the families would like to have a memorial, it may well not be until next year.
I just heard they've cancelled the Rose Parade on New Year's, it's sad, but they're recognizing that even nearly a half year from now it would be too dangerous to have the crowds, and the tight quarters in the people assembling the floats. This New Year's will probably be the least celebrated Holiday Season in our lives, even if PLX-PAD can limit the risks, I can't see threatening our lives to party.
We were about to open the restaurant and bar at our club when the State ordered all indoor restaurants closed again. Fortunately we have a patio with more casual food where they're serving. We do eat there with friends, but substantial spacing, and masks on if we're not eating or drinking. I really doubt if many restaurants will survive, some are setting up limited outdoor tables, others take out only, but many have closed and I really don't know that they'll ever reopen.
If PLX-PAD, or other therapeutic was found so effective that it could avoid most hospitalization and prevent the damage done to a variety of organs if administered early it could change the game. I believe it has possibilities, but the regulators will move slowly I'm afraid. I believe they'll accept it quickly enough for those on ventilators, but I'd be very surprised if it could be given at diagnosis of pneumonia prior to hospitalization before they have substantial additional trials. By that time, we'll probably have a vaccine, but I still believe the drug will be worth billions in curing pneumonia, regardless of the source. It will take a few years to reach that point, but the benefits were recognized in the patents, now they're being tested in a manner that would never have been possible had it not been for Covid-19.
Gary
I've got my feelings about what ranges our stock will trade at once all delinquent filings come in, then after second quarter is in, then third quarter. I've been pretty open in believing that by year's end we could see $1 or more, but I'd like to hear the thoughts of others.
Again, first after both the Annual Report and 10-Q for the 1st quarter is in. Second, after the 10-Q for the 2nd quarter is in, and finally after the 10-Q for the third quarter is in. Feel free to give either a price, or range you believe the stock will be trading in.
I'm not a big believer that financials say that much about the future of a company, I'm more curious about what the company has to say that they're anticipating. However, in the case of PCTL, I believe the financials may tell us more about both what the future may bring from the U.K. as well as from the various distributors.
Gary
Trump's logic says don't test anyone, then nobody dies from it, he's an absolutely perfect president. Also, let everyone wear used PPE, so what if all sorts of medical professionals get sick and some die, he's saving money.
Gary
I would suspect that investors in Israel know more than elsewhere as I believe that most of the compassionate use is in Israel, and it's expanding as the disease worsened there.
What's sad is Israel had a good handle on it, but a more normal life was permitted, things like weddings could be held, and clearly it didn't work.
Barring something miraculous, I've got to believe that the Jewish High Holidays all over the world will be done with webcasts and Zoom conferences. If that isn't acceptable, I'm afraid that spikes will be created that are horrific for the temples that insist on praying as a congregation.
The worst part of this disease is that everyone attending an event can feel perfectly well, but just one may have it but will never know it unless they're tested, yet essentially everyone in attendance can get it, and some could die. The person who spread the disease might never know it if never tested, and if tested for the antibody, would be positive, but still have no idea that he spread the disease.
Gary
I think we're all of the belief that once hard lock is called we'll start to move us dramatically as we approach TLD. The question might be, how long between hard lock and TLD.
If you believe what I do, that soft lock was done a few weeks ago and the contractor has gathered in perhaps as much as 99% of the data, if the contractor was also tasked to prepare recommended TLD statements, the time from data lock to TLD might be just a few days.
On the other hand if no soft lock was done, or if it had been, but only 50% to perhaps 80% of the work had been done, the contractor will have weeks of work to do. Then if it's purely the company preparing the TLD statement, and they've been totally blind to what's collected, another week or so should be allowed.
This give us quite a window, anywhere from days after the hard lock to perhaps slightly over a month.
If going after shorts is something the company is looking to do, they do it in the shortest time possible, perhaps they lie to investors by suddenly releasing TLD in spite of promising a notification of data lock. Would any of us really be mad if they suddenly announced TLD, I suspect only the shorts would be. Perhaps there are longs waiting to purchase at somewhat higher prices after data lock is announced, though I don't know why anyone would want to pay more when it's known to be coming in time.
DI would owe people apologies, but I think we'd be forgiving as long as the TLD is as good as most of us believe it will be.
What's the company doing? Time will tell, I believe we'll be a very different company by Labor Day.
Gary
GoldiS,
What do you figure the distributors who buy or lease the bulk generator from PCTL pay the company for each gallon it produces. I've got to believe it's substantially below what they pay for the bulk fluid from the company, but it certainly shouldn't be free.
I believe the business is truly win-win as the more the distributors make the more the company makes. As the company develops more types of equipment for sale through the distributor it will grow all the more. I would suspect that 5 years from now we'll be amazed at all the equipment that's coming from PCTL. I would suspect that they'll have smaller generating units, several models of electrostatic sprayers, perhaps one model that's like the robotic vacuum cleaners that will sanitize multiple rooms on a floor then return to where it's begun for a recharge.
Gary
I agree that in cruise control we should be just fine, but that's provided that our accountants and management do their jobs, and don't remain in cruise control when actions are needed.
Annual reports are expected 2 months after the year's close, with Covid-19 some added time was permitted, but we're now months beyond that, the quarterly can't be done before the annual, so naturally it's very late as well. Someone needs to take control and end these delays.
One or two years from now this will be meaningless, but right now it needs to be dealt with, not with a promise, we've had them, we need a delivery. If two months ago the company said we'll not be on time, in fact we need an extra three months, taking us into August, investors would have been happier being told we have problems, rather than being told we'll be on time, missing that, wait, it will be next week, missing that, next week, sorry, next week. If management wants to be believed, they need to achieve what they say will happen, if they're unsure, say we're trying to release it next week, but there are problems, and we're working to resolve them.
I know we're a Pink, and this is not unusual behaviour for a Pink, but we're speaking like we wish to move onto major exchanges in time. If that's truly our intent, we have to start acting like we belong on higher level exchanges. Even a move to the OTC is a step up from the Pinks, we need to be current to even attempt that move.
Gary
There is no doubt that Covid-19 and other germs can be killed with sprays, U-V, heat, and all sorts of other ways, but that can only stop the pandemic if we stop people from transferring it from person to person.
I live in L.A. where our school system is remaining virtual in the immediate future. Just to the south of us is Orange County, where they have just announced they're fully reopening schools, no distancing, no masks required. This sort of insanity will not end the pandemic.
What's the difference between the two Counties, L.A. is more Democratic leaning, Orange County more Republican. We need National and Statewide guidance that sets at least minimums which must be done. Actually stating that we'll neither distance, or mask people who can spread the disease is a statement that we'll except a spike to make a political point.
I could understand National minimums that stated schools can open with distancing, students and teachers wearing masks, and testing routinely done, but that should be the minimum. It's the lack of any such guidance that has us near the top of our fires wave, instead of being down dramatically as we reopened before bringing down the curves. We need to get this under control, not ignore it.
Gary
I'm thinking that by September we're really saying by third quarter results, which really aren't out till early November if on time. I believe that if the company is open about what's happening $.50 in September is possible, but if we must wait for the financial figures it won't be till November.
It's my belief that by that time we're seeing substantial funds from the U.K. as well as all the distributor growth.
I believe that Gary misspoke when he mentioned $4 million and made it sound like the total income. I believe we demonstrated where that could warrant about 20 cents with a P/E of 30, but I expect that we're doing much better than that and the financial reports will show it if better forecasts don't come out of newer podcasts if Gary continues to do them.
We need to remember that Gary too forecast a buck or more at the end of the year, his $4 million statement and $1 prediction are completely out of sync with one another. D.E. certainly understands the business, possibly as well, or even better, than Gary. He's in the business in two ways, a major stockholder as well as a Level 3 distributor.
I'm of the belief that HOCL is a great product, but I also believe that it's price will diminish as it becomes more readily available. That's fine if virtually billions of gallons are used monthly, if PCTL distributors were paying the company one penny for each gallon produced a billion gallons would generate $10 million. I'm not saying it will ever go that low, but even there it would be $120 million a year from the distributors for fluid production plus a lot more in equipment purchases or leases. Remember, PCTL is expanding beyond the U.S. when I speak of over a billion gallons a month being sold it's a tiny part of a gallon for every man, woman and child on the planet. This won't happen overnight, but with all it's advantages, I believe a decade from now it will largely be available most everywhere in the world, and much of the equipment that supplies it will come from PCTL.
Gary
I certainly agree with you, and I believe that second quarter results will really show how PCTL is moving into profitability. I believe that D.E. has nailed it and investors just need to give it time to play out. By year's end this will be a very different company.
Gary
It seems to me that we're trading in a very tight range, and it's not going to change until we get at least the Annual Report. We know good things are happening, but it hasn't mattered. We also know that last year they lost money, that won't matter either.
I don't believe anything that's in the annual report is going to matter, what will matter is that it's out. Likewise the quarterly, but I think we'll get some movement up after the annual, then more after the quarterly.
I'm not sure whether the company had assurances from the auditors on the timeline, or believed they could tell the auditor when they had to have it, and they'd get it, but clearly it hasn't happened. It will happen when it happens, at this point I don't care who says when, all that matters is it happening.
Gary
While you're certainly right, there is nothing we can do about it. I believe that soft lock was done weeks ago, the contractor may very well have done most of their work, while waiting for a tiny percentage of the total data to make it complete. I believe that once we get the announcement of hard lock things may come together really quickly.
Frankly, in many ways I wish the company wouldn't have told they'd announce hard lock, everyone's waiting for it. Had that not been stated, it would be TLD we'd be waiting for, and frankly I think the price would be much higher. Data lock is an intermediate step, and it not being announced yet is what's holding the stock down.
Gary
It's up to the company to update the clinical trials database, while I'd like to see them do it, it's there call. Such an update would tell us if any clinical sites have been added, as well as the recruitment status. Clearly if the trial was fully enrolled, no site would be recruiting.
Some companies practically never update the site, others do it quite frequently, it's too early to say what PSTI intends to do, but the trial is scheduled to end in a few months, some indication would be nice, but if not, it won't be that long before it's over and something is announced.
The company clearly won't discuss compassionate use any further, but that doesn't prevent either those who've received it, or the hospitals administering it to speak out. We've see a few very positive stories already, perhaps there will be some more in the near future. After trial results I believe the company will also summarize results in compassionate use to reinforce the trial results.
Gary
Meirluc,
Look at the patents, they clearly covered pneumonia. I don't believe they initially choose pneumonia to go after approval as I think such a trial would have been dramatically larger as so many people get pneumonia, and most survive, though it's still a major killer. With Covid-19 deaths of those on ventilators is so high they should easily show a major benefit.
From what I've read from the few cases sited where it was given for compassionate use, by the time patients go on ventilator, other organs besides the lungs are also damaged. PLX-PAD has been shown to achieve benefits in the other damaged organs. I believe it's being administered into muscle not specifically in the organs involved, much as it is in the CLI trial, I'm not technically knowledgeable, so I simply see the placental stem cells as miracle workers that find something wrong and work to fix it.
I believe there are parallels, and differences between PSTI and NWBO. While both use cells from people to create their products, NWBO's are cells from the specific patient, whereas PSTI's are placental. I do believe that if NWBO were looking to produce greater quantities of their personalized vaccines, they might find that it could be done in the 3-D bioreactors that PSTI has developed and patented. As I understand it, they are far superior to other similar bioreactors, and they're what leads them to being able to get 20K doses from a single placenta. I don't believe that NWBO needs anything close to that many doses, but some increase may be of benefit to the patients.
As I've indicated, I don't technically understand all that they're doing, and don't try to get a medical education at my age, just trying to have a laymen's understanding of what's happening. I may be off in my judgement that the two technologies might benefit from one another, time will tell about that.
From what I gather, if one of the other companies products that use a bioreactor is found to be successful, and mass production is planned, they may be smart to consider licensing the use of the PSTI's 3-D bioreactor over those currently available to increase the output of product.
Gary
When I hear about drug prices I often wonder about what's really paid. I'm on a chemo that retails for about $8000 a month. I pay $30, I frankly doubt if my insurance pays anywhere close to the list price, but I'm sure they pay more than $30.
I recently had a cardiac procedure, I was told that I didn't yet have insurance coverage and I'd have to pay if it wasn't approved, I was given a $2000 price. When I arrived I was told the approval wasn't in, but the price was $20,000 to the insurance company, so that was what I was committing to. After a little discussion they agreed that if I didn't get coverage I could pay the cash price. This shows a lot of what's wrong in our healthcare system. No one can doubt that insurance requires paperwork that costs money, but a $2000 cash price, and $20,000 insurance price is ridiculous. Of course we know the insurance won't pay that, but the insured is told they got $20K in benefits. The point is, you never know how much is really paid, my guess would be perhaps $2200 which includes all the added paperwork.
If we ever want to get serious about healthcare reform, reasonable pricing needs to be part of the package, and real costs need to be considered. I believe that Doctors and nurses are entitled to what they earn, but accountants and attorneys that add dramatically to costs need to be cut way back. Doctors should be able to order the treatment they deem best for patients, not the once authorized by the accountants.
Gary