Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I agree with your earlier post that it was in the CRO's hands, not management, but I don't agree that DI has mucked it up. I don't believe he ever promised more than they would announce data lock, he didn't say when he expected it to occur to the best of my knowledge.
I don't doubt that the CRO etc were optimistic if they told the company the job could be done by the end of June. It's hard to say how much of the delay was Covid-19 related, and how much was things simply not being ready that they believed were.
I purchased more today, I doubt if I'll be buying more, but if the price were substantially lower again, I'd have to consider it. I don't believe that will happen, but then I didn't expect the weakness today, but was happy to react to it.
I'd be thrilled to have data lock called before the open tomorrow, but won't be concerned if it isn't, even if it isn't in July. What's important is the trial is concluding, how long it takes will be of little concern once it's done.
Gary
Jamie,
I can't remember where I heard or saw it, but I believe someone indicated that they've had over 40 events in the trial. I hope everyone knows that event is the polite way the FDA refers to death. If it's correct that over 40 have already died in the trial, I'd have to suspect that it's nearly fully enrolled.
The trial will enroll 140 ventilator patients. I believe statistics are improving some for ventilator patients, initially I believe over 80% on ventilators passed away, for talking purposes, lets say it's improved to 60% passing away. That would be 102 passing away under current treatment if my 60% figure is near correct. To put it another way, if we had two groups of 70 each, one on PLX-PAD the other on placebo, 51 of each group would be expected to pass if PLX-PAD had zero efficacy.
I don't know if the people monitoring the trial are permitted to unblind the trial at any time prior to it's full evaluation, but it would seem prudent for the monitors to be able to take a peek after perhaps 50 deaths, roughly half the total if PLX-PAD had no effect. What if they did look after 50 deaths, and what if they saw that over 40 of those who passed on were on the placebo. Do you think they'd tell their superiors about it. Might the trial be ended early?
If I heard correctly and over 40 have evented, I would suspect at this point we're only a matter of perhaps 6 to 8 weeks at most from completing the trial. The primary completion date is September 2020, so that should be about right.
Here's a link to the trial:
https://clinicaltrials.gov/ct2/show/NCT04389450?term=PLX-PAD&draw=2&rank=1
It would be nice if the company updated the trial, I'm certain all listed sites are enrolling by now, more sites have been added, but an update is needed to say so.
If I remember correctly the company indicated 4th quarter for reporting the trial. A completion in September could have data out in October, the first month of the 4th quarter. If the data's as strong as we hope, I believe it could achieve approval rather than requiring a larger Phase 3.
Gary
I wish I thought you were right, as that would mean things are much better, but actually that isn't the case. We may not have a second wave here in the U.S. because we're still atop the first wave, but all indications still seem to say a second wave will be seen elsewhere, as well as our numbers being terrible. I believe we'll see data by October and if it's as good as I believe it will be, it should be approved on that basis. There may be other therapeutics that are helping as well, but I believe we've got the one that helps in multiple organs, and we may be the only one that achieves that.
This isn't going away, even with a vaccine, the best of vaccines are only partially effective. I trust Dr. Fauci much more than Trump, while Trump is saying it will disappear, Fauci is saying it will stay around. Certainly it won't be as bad in the future as both vaccines and better therapeutics lessen the threat, but by then it will have proven the ability to work with all forms of pneumonia, and that will be big business as well.
Gary
Thanks Meirluc,
I think we've come a long way since the quarterly, but no telling just how much is holding up hard lock. I have almost no doubt that soft lock was done some time ago. I think today's weakness provided a tremendous buying opportunity and I gather several longs have taken advantage of it. Perhaps some shorts used it to get out of their short positions as well.
I don't know how some people are suggesting specific dates for data lock and/or TLD, I'd be surprised if we don't have both occur prior to Labor Day, but beyond that I'd hate to guess.
Gary
How are you guys finding what sites are complete, I've not seen that sort of information from the company, but you no doubt have sources that I don't.
I suspect that even if one living trial patient couldn't be found to verify they're still alive they'd wait on the lock, but everything else would be collected under soft lock. That's just my view, I'm no expert, but I don't believe in a final report you want even a single LTFU if in time they'll be found, and they're believed to be alive, and hopefully healthy.
If something that minor was what was holding up data lock, I believe the contractor could have well over 99% of their work done, get that one tiny bit of information in and they can finalize their work in minutes. Data lock would be called, the company would get the report, then it's about how long before they issue TLD, could be days, could be weeks, or it could be hours if the contractor was tasked with preparing a recommended TLD statement, and the company agreed to what they said.
Gary
I couldn't stand to see the bargain basement prices today without purchasing at least some shares. I don't know when we'll get news of the data lock, but I don't think it will be much longer. Once that occurs I don't think we'll ever see these kind of prices again.
Gary
We all have choices, my belief is that success in Covid-19 would result in a market cap of $10 billion or more, even with 50 million shares outstanding, that's $200 a share. If as I suspect it were to happen overnight, as could occur with the admission we're curing Covid-19, you'd be sold out of everything if your orders are already in place.
I'd rather put no sale orders in, but if good news comes out watch and wait to see what happens. You can always put in stop losses at below the price the stock moves to, then move them up if it continues up, if it drops you've out, but it's potentially much higher prices than your original sell would have been.
I believe pneumonia is ultimately the killer that takes people with all sort of diseases, including the common flu, it doesn't get the concern that Covid-19 does, because most who get pneumonia survive. Once the drug proves it's ability to cure pneumonia in Covid-19 it will almost certainly be applied to other forms where people are seriously sick. That will be a multi-billion dollar market annually.
Gary
I've previously heard that a GTC sales order would prevent the shares from being used by a short, but there is a risk. Most brokers will limit how far above the current price you can set that order at.
Let's say your broker allowed $100, I believe even that could be at risk of a sale if trial results are great in Covid-19. We know the company is raising funds, what if the shares outstanding grows to 50 million, a billion dollar market cap would represent a $20 share price. I believe a drug seen as curing Covid-19 could easily achieve a market cap of $10 billion, and it might gap up to $100 or more on the news, you'd be out. Certainly a nice profit, but out.
Frankly, I don't mind what happens to people who're short with good news. If someone is foolish enough to short PSTI with a Covid-19 trial going, they risk such an event occurring. Certainly we know the trial won't be over for awhile, but what if those monitoring the trial saw a tremendous advantage for some in the trial and spoke with the FDA about it, could that result in an early termination. Even in a trial as small and short as this, I believe it could. If they unblinded, found that all who passed on were in the control group, all who came off the ventilator were on PLX-PAD, do you think it's possible the FDA might expedite taking actions.
I'm not saying this is the case, but if it were, what would happen to anyone short the stock. The short squeeze would be a thing of beauty for us longs.
Gary
Ziv,
I don't know about the laws in Israel, but I know of a CEO that got in trouble with the SEC when posting on a chat site. I suggest you look into the legality of it, and in that the stock traded in the U.S., make sure that you're not violating the laws in both places.
As to what you're proposing, it's far more palatable then the numbers previously discussed. Still, I believe it will go down to defeat if you don't give investors a better reason for doing it beginning with doing something to boost the price from where it is.
I for one would be encouraged if looking at a dime, or at least a nickel share price before I voted. I suspect that if you had positive results from the cream trial the stock would be substantially higher, if you can find a way to get that done, at least a positive initial peek at the data, I think you'd have something. If data was really great you might get a price that wouldn't require a reverse split at all.
Gary
If someone is foolish enough to put in a market sell, someone, probably a MM could buy some cheap shares if the $.05 is sitting there when the market opens. Market sell orders often lead to being ripped off by the MM's, I've seen stocks close down significantly when someone puts in a market sell at the close.
Gary
In other companies I've known where the company got in trouble for what the SEC, or FDA considered hype. The FDA frequently costs months to years in the approval of drugs and has little concern for the time and money they waste. If you look at the company being perhaps a month late, I'm not sure the regulators might not consider it hype if they came out with something which could be viewed as promotional if they came out with a statement explaining the delay.
The quarterly report is certainly one place they can properly talk about what's happening. If that's timely, they can do that the end of next week and it's the sort of information that should be conveyed in a quarterly.
I don't know if they'll put out the quarterly next week, they probably can take to the 15th of August if they wish, perhaps even longer with the Covid-19 excuse, but perhaps they'll be on time. While I'd hope we have TLD before then, and they could discuss it in the quarterly, it's becoming doubtful.
As for data lock, I think they soft locked shortly after they mentioned the possibility, but clearly it's the hard lock they're referring to when it comes to an announcement. I believe we could hear about hard lock any day, but the company cannot control those who're gathering the data, so they won't know the date until it occurs. They've told the appropriate people to do it, now they wait, as we do.
Gary
Poor Man,
I agree with what you've said, but unfortunately in other biotechs I've owned, I've found it much the same. I've mentioned the CEO of IMGN using soon so many times, and what he said would happen did, sometimes over a year later. Investors got to posting his soon's backwards, he'd say soon, we'd write NOOS.
I believe that DI is frustrated with having to answer all our inquiries the same way, but I don't believe he can vary, the answer is we'll be informed of data lock, and he'll provide nothing more than that.
I frankly had hoped to be purchasing more near term, but I'm going to have to wait for next year. I suspect by then it will be at a much greater price, and I'll have to consider what I want to buy at that time. For now I believe we're seeing bargain basement prices.
Gary
D.E., while I'm sure you're right, I suspect that last year the company went through some chaos with a great deal of new funding, as well as musical chairs in management. I believe they're going through a tremendous growth cycle, and it's very possible the financial records they maintained are confusing. Add that to Covid-19 which makes getting things together easily, and there is good reason to believe that the company as well as the accountant have slowed the process of getting financials out in a timely way.
Hopefully they're more organized today, and after we get the annual report and first quarter the second quarter won't be that far behind. Another company I'm invested in is reporting next Friday, and they conduct a webcast with each quarterly, which is a nice way of communicating with investors.
I can't say just how profitable the company is today, but I believe they're operating in the black. Hosting a webcast with the quarterly release no doubt adds cost, but if the result drives up the share price, it could be very worthwhile. We all know that at times dilution is needed, the higher the stock price the fewer shares needed for the same cash amount. Clearly if spending some money to better inform shareholders and build share price may have tremendous benefits for the company, quarterly webcasts may be money well spent.
Gary
I think many of us thought the company was staging to make an announcement today, some believing it would be data lock, still others thinking it would be TLD in spite of not calling data lock. It seems we all were wrong.
Perhaps what's really happened is what the company said, Covid-19 has complicated the process of getting the data together that's needed for the lock.
I certainly don't know this is the case, but I believe that most of the people involved have medical backgrounds. I wonder if many of them have been called on to try to help Covid patients, rather than performing their normal duties. If that were the case, lets hope that some of them aren't fighting for their own lives.
Certainly the company could tell us more, but perhaps they truly believe we're getting very close and would just like it to happen as soon as it will. They also might wait an update for second quarter results, which could come as early as the end of next week if they're ready, and they choose to issue on time, rather than delay, which they certainly can do, but don't have to do. Hopefully we'll see second quarter financial by Mid August, and if we've heard nothing before than they should update us at that time. I'd certainly prefer TLD by then, but we'll see.
Gary
Last year about this time many were saying let the trial go until we have 48 months behind the last to be treated, now people say 60. The company has said they're going for TLD, which should have been here by now, but they were delayed getting all the data. My point is the company didn't care about 60 months, why should we.
If we go beyond 60 months are people going to say, let's go for 72. I don't believe any of this is meaningful, the company will provide TLD as soon as they can, once contractors can properly do their jobs.
Gary
You're right on the money, and to much of the rest of the world we do look like the third world company a poster indicated Hillary would have had us looking like. Hillary would have maintained the pandemic team, perhaps 100,000 or more American's would still be alive because we'd have reacted months before we did, and we'd have plenty of supplies, not hospital workers still begging for PPE's, but of course Trump denies what the healthcare professionals say. Of course they don't say it on Fox, so he never hears it.
Gary
I have a theory, coincidences rarely are coincidences. One would think that quarterly reports and news would be issued on completion, yet if they're bad, you can almost bet they'll come after the close on Friday, if good it will be at a better time.
What's the likelihood that every last bit of trial data comes in by tonight, not that great after all this time, yet I'd not be surprised to find we went to data lock on GBM Awareness Day. Just a coincidence, I doubt it, but if it should happen, the question might be, how long did they wait before telling us. TLD would be an even bigger surprise, especially when they've assured so many that they'd notify about data lock, but I doubt if anyone would say it's impossible.
Of course nothing may be said tomorrow, if nothing else that would tell us they're not holding back, they're simply not there yet. As for the idea they're waiting for 5 months from when the last patient was operated on, what difference does it make if it's 59 months, I believe it's meaningless in terms of demonstrating efficacy. If the person who's 59 months past surgery is alive, he's the living person with the least time who's still alive. I'm more interested in the longest living, and what their current prognosis is. That much detail won't come out of TLD, I'm uncertain all will be revealed when the complete data set is revealed for peer review, but it certainly would interest me.
Let's see if we have more to discuss tomorrow.
Gary
Unsure what you mean by HB, haven't been there. I'm certainly a senior and am unaware of many things other people are into.
Gary
It seems to me that PSTI is lowering expectations on completing trials on Covid-19 to the point where data on CLI could lead to approval. Should that occur, just the data on Covid-19 could lead to its use without a formal approval as off label use.
Of course just getting approvable data doesn't mean approval comes instantaneously, but perhaps it could if the regulators made the determination that this is the course to take to make the drug available.
Perhaps I'm wrong, perhaps the company will reveal what's happened with many more of the patients who received the drug under compassionate use terms, but if not, the guidance is saying it will be awhile before we see data from any of the formal trials.
Gary
I think we're gradually recognizing that we're living in a different world, and we're learning how to deal with it. Covid-19 has changed how everything is to be done, and ways are being found to do them, at least for now.
Frankly as we go into Winter it gets harder. Here in California, where things seem to largely be closing back down until we have it under better control, it sound like things like barber and nail salons may be able to be open, if they're outdoors. I was in a beach community the other day where they've actually built patios into the street so outdoor dining is available, as no indoor dining is permitted. All this is fine now, but by November it won't be nearly as nice, even with space heaters, and that's California, in the colder climates this will probably be true in October.
Hopefully we can get it under control, but with roughly 4 millions with it, and probably millions more undetected, it's getting harder to keep it under control. Perhaps by November restaurants indoors can reopen, but I suspect that if others like gyms and bars do, it will be with very limited number at any given time, and heavy fines for violations. It's clear that people require some strict rules, they do a poor job of policing themselves, especially the younger set.
Companies like PCTL can operate safely, but things like financials are going to require far greater effort as Covid just makes doing anything far more difficult. I would suspect that our accountants don't work out of an office, rather working primarily from home, so getting information that's at their office becomes far more difficult. Things that could previously be done in minutes now takes days. They'll learn to do things better, and I suspect when this is all over many jobs will largely be allowed to remain at home, and ways will be found not to slow down the process in doing it. It certainly will have economies as less space will be required for many businesses. Manufacturing processes, like PCTL's will still require people at the working site, but even there certain clerical tasks may be home based.
I suspect that even when Covid is gone a lot of kids will be partially home schooled because it will prove to be both safe, and high quality as we change the way we operate. There will still be plenty of social interaction as it will be done in a planned way, but it will prove to be a better education with what I'd call a hybrid education, partly at school, partly at home.
For now, lets get the financial out and PCTL will start to fly, but prepare for business as usual to become very different than it was before Covid-19.
Gary
Most of what I've learned about Islam came from a Rabbi, I found it very interesting. It really should be taught as much as any of the worlds religions should be taught. In my public school education, I cannot actually remember classes on the worlds great religions, that was a long time ago, but I cannot say if it's different today.
I'd like to know if religion is being taught in public schools, if it is Islam should be included. On the other hand, if it isn't, then it shouldn't be singled out a a religion to teach. I don't know how much is being taught about other religions in various religious training, I know as a reform Jew we did have comparative religion classes and were able to hear from Christian Priests, and question them. I don't know that it belongs in public schools, but it is something we all should learn about. I believe there is good, and bad in every religion, but discussion leads to understanding and respect. It's much better than hatred.
Gary
Agreed, he takes a small salary, but substantial stock and options, he's certainly got skin in the game as a shareholder. I believe he's very much into the company long term, he's reasonably certain of what the future should bring, so he's not overly concerned with the present.
I believe by now he's given the auditors all they've asked for, but that doesn't mean they're satisfied, and won't ask for something more. I'm sure he's cooperating and doing all he can to get the financials out, but ultimately they must do it, and they're the ones who sign up for the audit.
The only question in my mind is whether all statements by the company that discuss the company, it's prior year and future anticipations are provided by him. Would all these statements have been prepared and placed into the report. I doubt that, I believe they may have been written, but when the audited financials are provided to the company, I believe they should be added, and might be edited if something in the financials was deemed to require comments.
If I'm correct about this, the company will be in control of when the financial is released. While we know that last years financial results were not good, which would suggest a release after the bell on Friday, just the fact that they're out would be a big positive, so I'd suspect they'll come out before the open as soon as they're ready to release, regardless of the day.
Gary
I agree that he's responsible for resolving the problem, but it's very possible that the auditor is asking for something that occurred before he was the CEO, though clearly he was involved.
Few companies have CEO's that please all the shareholders all the time, it just simply never happens. I think Gary is trying to do his best, people like D.E. who's worked with him clearly seem satisfied, but clearly many aren't currently satisfied. I cannot say specifically who's to blame.
Gary's responsible, just as the Captain of a ship is, when his ship collides with something, even though he was sleeping at the time. The captain is always the captain, just as the CEO is the CEO as long as he's in the position, even if he wasn't at the time the action in question occurred.
Once we get these financial reports behind us, hopefully things will start to run smoother.
Gary
I can't say this will be the week, or even the month that data lock is announced, or the month that TLD is announced. I feel reasonably certain that this will be the quarter that both will be announced, and if at the Annual Meeting they'd said that they expected it by third quarter, none of us would have been concerned, or had that much to talk about.
Of course that's not what they did, they said late June, early July for TLD, and we were told by DI that we'd be told of data lock as well, clearly they're running nearly a month behind, while they probably did a soft lock, they're still well behind.
I would suspect that before they ever made the commitment they asked those who'd be responsible for doing the work how quickly it could be done. We must remember, it's not the people at the company that are doing this work, it's clinicians and others, and they're blinded to what's being collected. I cannot say if they're told where the hangups are, or specifically what's causing them. I'm sure they're well aware of how frustrated stockholders are, but they also know that the SEC views certain things as hype, so they may not want to release something that the SEC could object to.
Another company I'm invested in has already announced that they'll post results for the past quarter, and hold a webcast to review the quarter on July 31st. I'm not saying that NWBO can be ready by then, or that they have to, but if they could, and if data lock and/or TLD is not available by whenever they announce quarterly results, it certainly would be an opportunity to discuss it both in the manuscript for the report, and they could do something they haven't previously, host a webcast. Hopefully we won't have to wait that long, but if we do, it would be the appropriate time for the company to update us, and the SEC would have no qualms about such an update.
Gary
It's hard to know who should be condemned between the auditor and the company. Is the auditor dogging it, or have they asked for something from the company that they company hasn't provided, or they're unwilling to accept what the company submitted, and wants something further. My point is, we really don't know, and we never will.
All of a sudden the 10-K will be out, so will the 10-Q, we might question something within either document, but we won't know what caused the delay between the company and the auditor. I suspect that both may have been to some degree responsible for the delays.
I know people who prepare others taxes. In some cases the people who's taxes are being prepared are very organized, they take little time to do. In other cases, people bring boxes full of records and let the accountant sort their way through everything. Clearly the client who's organized pays less, but both get a tax return that considers everything that's been provided to the accountant.
With all the scrambling PCTL did last year, substantial financing, changes in management, etc I suspect that the company may have provided boxes full of information that wasn't well organized to the accountant. After going through all those boxes the accountant may have asked for more, to fill in holes where data was believe to be missing, or at least poorly documented. Ultimately they'll agree to what's in the report, if there are holes in the data, they'll be patched up as best they can, and a report will be issued. Investors will never know if or where the accountant had problems, and how the holes were filled in, but ultimately the accountant must be satisfied with the document that's being signed by them.
As PCTL becomes profitable, something I gather that they've not been over the many years they've been in existence for, I hope they'll spend a little more time and money on record keeping so their accountant can more easily deliver a product on time. I know of no one who likes to do their taxes, but ultimately we do it, because we must. The same is true corporations doing quarterly and annual reports, as well as taxes, no one loves doing it, but it must be done.
Gary
I've not kept up with all MJNA's moves. Do they still hold a major stake in AXIM which is now making products that analyze Covid 19 and other ailments. I don't know if they're still working on cannabis based gum.
I hope we still own a piece of the company as it's come alive since announcing the development of the test equipment that apparently not only indicates whether you have Covid or not, but also indicates the strength of your resistance is.
Thanks,
Gary
Great post D.E.
I hope the moderators will pin this on the board.
Gary
I once held a stock that didn't produce financials for over 2 years, but traded the entire time. Suddenly multiple financials started coming in, in a matter of weeks they were current, and the corporate shell was sold.
It's unusual, and I gather that certain brokerages would not permit purchasing such a stock, but you could get a quote on the stock at any time and it did fluctuate in price, mostly sub-penny, over all the time that no financial were being issued. I know months ago Fidelity wouldn't allow purchasing PCTL due to financials not being filed, I've not tried it recently, so I'm uncertain if they'd permit it today, or not.
Frankly, I don't believe the SEC does much to police the Pinks, perhaps they do a little more on the OTC. More attention is paid to stocks on the Nasdaq or other major exchanges. I suspect that even the podcasts that Gary has done could only be done on other exchanges if a P.R. was issued will in advance, though I'm not positive of that. I do know a CEO who got in trouble for posting on a message board, I believe the fine was considerable. On the other hand, Elon Musk has been in trouble on more than one occasion with the SEC and he's still become one of the worlds wealthiest men. I don't think that Gary Grieco has to worry about that, but hope that he becomes wealthy as that will mean the rest of us are doing well too.
Gary
I suppose the question that should be asked is, is there a problem with Sadler Gibb, or is it the sort of firms they audit. I would suspect it's a little bit of both.
PCTL from all appearances is moving up from a Pink struggling to stay in business to a OTC that'll be turning a profit. As this occurs, timely accounting becomes more important, and fortunately they'll have the funds needed to pay for it.
I know nothing about the accountants, but suspect that if you pay more, you get more, whether it's with the same accounting firm, or someone else. I believe they'll be looking for another accountant, but we're now half way through the year, it's tough to switch at this point.
I believe that part of what the shareholders typically vote on in an annual meeting is the accountant. I'm uncertain when PCTL has it's annual meeting.
Perhaps this will be the week that we become completely current.
Gary
I frankly have mixed emotions about Turner, but I don't see how it can be any worse, so I'll welcome whatever he does until near year's end. At that time I'll decide whether I want to give it another year, take a tax loss, or surprise, have a gain.
Ziv when I first invested was telling investors that they'd be marketing products in months. Clearly these wouldn't be clinically tried and approved products, but that's true of everything sold in most cannabis stores.
I don't know if that's Ziv's intention today. I would hope that at least the trials planed for the cream proceed, even if the cream is made available in cannabis stores before. Achieving drug approval would mean it could be prescribed and covered by insurance, no doubt that would price it dramatically below the price in the cannabis store, yet the company would probably receive as much or more for sales made through a pharmacy.
There are many drugs that are available over the counter that are far cheaper if prescribed, if you have insurance. I believe our cream would be in that category if it actually received FDA approval.
It will also be interesting to see if Ziv puts products that are yet to receive patents on cannabis store shelves, with patent pending shown on the label. I think we've all bought products that were patent pending before, I certainly believe it's a possibility. I don't believe it's something that prior management was willing to do. Zev might just be great for us.
Gary
Thanks D.E., we're in complete agreement. I suspect that while we're closing down some to bring the curve down, since we clearly reopened to fast, I do believe that in another month or so, we'll see things reopening again. Hopefully limits will be placed on how many are permitted in bars, gyms, etc at a time, so that we don't need to close down again.
I believe that many of these places will be looking at sanitizing with electrostatic sprayers using HOCL. As I gather it, if you were generating a fine mist, essentially a fog, customers would be fine if it were done while they're present. I don't know that this will ever occur as a standard way of knowing a gym, bar, or restaurant is very safe to be in, but I believe people could accept such a situation if they knew it was completely safe.
I gather that with the right nozzles electrostatic sprayers can essentially fill a room with fog, am I correct about that. If so, do you believe they try using them with customers present, or will sanitation normally be done after hours or before such facilities open when it comes to places like gyms, bars and restaurants.
I don't know that once we have a vaccine for Covid-19 that we'll be as cautious as we are today, but I believe we'll be far more sanitary than we were before it hit, and the cost of doing so won't be that high. Overall it may result in less illnesses, like common colds and flu, and actually prove to be cost saving as time lost to illness decreases.
Once we get caught up on the financial I truly believe we'll be at the right place at the right time, but hopefully we'll never be as late as we currently are with financials again. As things stand, second quarters for other companies I'm in have been announced at the end of July, it would be wonderful if our second quarter were out anywhere near that point.
Gary
Thanks Anders,
I thought that regulators had to approve BLA's before sales could be made, from what you're saying essentially the regulators are looking at the results and saying you're authorized to sell. Frankly I wish that were the case here, I believe that the knowledgeable people at the FDA know drugs are worthy of approval from the time they see trial results, yet it's probably nearly 2 years on average before they're approved.
Worst case I've recently heard of it the FDA's inability to inspect the foreign site where a drug worthy of approval is made, so their inability to do their job is holding up approval. Our FDA won't trust European authorities to approve the manufacturing facility, and now because of Covid-19 no telling when they'll be able to make the inspection.
I look forward to hearing about which countries approve the sale of DCVax-L and at what price they agree to pay. Here in the U.S. I really don't know the price that's actually paid by my insurance for a product, I know the list price is outrageous, and I know I only pay a few dollars, but the actual price paid is a mystery.
I recently had a nuclear heart scan. I was told the cash price was $2K if the insurance didn't approved, but when I came in, before insurance approval was granted, I was told I'd have to pay the insurance price if it wasn't approved, that was $20K. While I was certain the insurance would be authorized in time, I didn't want to delay, in that I was there, and finally they agreed to limit me to the cash price as the worst case. Now I know the insurance won't actually pay $20K, but the problem is they consider that I got a $20K benefit, it's the game they play with our healthcare system. I believe this is just a small example of what's wrong with our healthcare system, and why we spend more than anywhere else in the world for it.
Gary
The Chinese are working on things like electric cars, cutting down on coal fired generation, etc. They know that they need to reduce their air pollution and they're taking it seriously. I certainly agree that we need to push them on maintaining intellectual property rights, but I believe more can be done with negotiations than tariffs, we certainly continue to buy their products, but now American's get the privilege of paying more for them, even though Trump proclaims the Chinese are paying.
Trump is the bull in the China shop when it comes to negotiations. It's one thing when you screw a contractor who's finished his work on a Trump Tower and say you'll take half or I'll go bankrupt, and you'll get nothing. It's another when you're running a country and tell another country it's my way or the highway, that's not negotiating, it's bullying, dictating, etc. I'm not saying his allegations were all wrong, but we don't have to alienate our allies to attempt to improve terms of agreements, and even worse we don't need to kowtow to the dictators in places like Russia and North Korea. If Obama had done what Trump did in North Korea they'd have accused him of treason, but it's fine for Trump to do it.
Democrats are accused of not cooperating with Trump, but of course the Republican's would cooperate with Obama, give me a break. Obama inherited a financial mess from Bush and brought the country back, Trump did keep it going with tremendous tax incentives for the wealthy, but what about the debt conservatives always throw at the Democrats, even without Covid-19 it was growing much faster.
If you want real growth, invest in industries of the future, as well as making the infrastructure sound, not the industries of the past. None of us will be around in 100 years, but if humanity is, I'll bet that we pollute much less, hopefully most energy comes from fusion, or solar and wind generations, and even our planes only produce water vapor as hydrogen becomes the primary energy source. I'm not saying zero petroleum will be used, but it will be a tiny fraction of what's used today. Carbon nanotubes will replace all sorts of other materials, and many structures will be lighter and stronger than the are today without any metal or wood at all. The industries that will get us there are the ones to build, not the coal and petroleum Trump would grow.
Gary
Don't think the availability of vaccines will diminish the need for HOCL or other sanitizing methods. Hospital Acquired Infections (HAI's) were a problem well before we ever heard of Covid-19. In addition hardly any time went by between hearing of numerous people having serious health problems on cruises. Likewise people flying commercially frequently got sick, gyms were known to be germ factories, etc. People have become more conscious of sanitation based on Covid-19, but as it goes away, I believe we'll still be practicing improved sanitizing in all sorts of places.
I believe we'll get financial soon, and more importantly future financial will show how much the company is growing. That picture won't change because we have a vaccine for Covid-19.
When I first invested in PCTL, late last year, no one had heard of Covid-19, but I still read about the trial they were doing in the U.K., several hospitals equipped with their products, etc. That's why I purchased, not because of Covid. While I'm not certain, I believe the D.E. and certainly other distributors were interested in the company well before they heard of Covid-19, the company was growing quite rapidly before it. Certainly it's probably accelerated because of Covid-19, but on the other hand many place are closed that could use it, so demand will grow as we reopen.
Personally I've been treated in hospitals that worked hard to maintain sanitary conditions, yet I've had two catheter infections which have to be classed as HAI's. Nothing can absolutely eliminate them, but I believe that HOCL will become used in ever increasing numbers of hospitals and other healthcare facilities. Today people avoid going to Doctors offices and emergency rooms because they know they're likely to be exposed to diseases worse than what they have by going there. Improved sanitation can help dramatically in what otherwise is a Catch 22 situation.
Gary
I have a problem with what you're suggesting. I believe a partnership, or even a buyout, is very possible between TLD being revealed, and I believe it could very well come before submission of the BLA. I'm not a trader, but may trade on Roth IRA shares if I sense the price retrenching after a substantial gain, but the intent will be to buy more shares at the lower price from the gain.
I do realize it will be a year or more between TLD and approval, but during that time there will be several potentially positive opportunities, beside one or more partnerships, if they go to partnering regionally, rather than a single partner sharing the vaccine throughout the worlder. The data will be presented at one, or more technical conferences, then far more information can be seen by investors, that can be a substantial positive. Then there is the filing of the BLA, then anticipation of approval. All these things are positives.
I do expect the company to initiate trials in DCVax-Direct, while it certainly takes money, can lead to positive headlines as well. If the money comes from a partnership, all the better, but if the share price is in dollars the dilution required if they do it themselves won't be nearly as bad as if they did it at prices in the past.
I'm not saying that your strategy isn't positive, we all have our ideas on how to invest, but I believe you'll be getting out just at the time Institutions will be getting in. I believe that individual investors often make the greatest percentage gains, but Institutions make the biggest dollar gains as they purchase from the individual investors when stocks have their greatest dollar growth. I may sell some of the stock when I've seen a massive percentage gain, but as long as I believe it should achieve $20 or more in time, I'll hold the majority for that time. Remember, I only got into the company in the last couple years, I have no stock that I've paid more than current prices for, and most of it was at much lower prices. I know some here own at averages well above what it's selling for today, some may not be break even until it's above $1, I'll have a ten banger when it's a little over $2, but that's far from where I believe the stock will go.
Gary
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