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The difference with Joe is he would have taken the experts advice from day one. We'd have had plenty of tests, masks, glove, and all the other protective equipment. We'd have been prepared, because among other thing he would have never eliminated the pandemic staff, but that was an Obama idea, so clearly it had to be eliminated.
There is a reason our numbers are growing faster than anywhere else, we had the time to prepare, but didn't. People here had it well before China was ever shut down, but it was ignored as you couldn't easily differentiate it from the flu.
I just heard the Mayor of L.A. saying how it's increasing here, while I believe most here are isolating well, we still represent a very large population and clearly it's being found in many people. I'm sick and tired of a President who declares everything his predecessors did was wrong, glorifies all he's done, and is doing nothing really dynamic to deal with the problem. State's are now having to outbid one another for things like protective equipment, then are told the Federal Govt. took their order. Clearly, the Federal Govt should have told the states we're ordering all that will be needed, and we'll be delivering them everywhere. He brags about his tarrifs bringing in revenue from China, when clearly the Chinese just increase the prices American's pay. It's clear that the U.S. Armed Forces need to be fully involved, not just the National Guard from all the states. I'm only speaking of the medical people in the Armed Forces, but that includes many trained to be medics, not formally Drs. or nurses, but educated so they can help.
The idea of people going back to work before the curve is well over the top and receding dramatically will simply send the curve right back up, only our President could arrive at such a conclusion against the advice of all the medical experts around him, and speaking on all sorts of TV and internet sites, maybe not on Fox.
I'll take Joe, or most any of the prior candidates of either the Democratic or Republican party over who's currently in the White House for advice, the difference with all of them is they know they're not the smartest person in the world on every subject, Trump believe's he's smarter than all the experts on everything and must be talked down from everything he wants to do. We're fortunate that Governor's and Mayor's can tell people to continue to protect themselves, but they do not have the funds to procure all that's needed, and the Federal Govt has been very slow to act in doing so according to all who ask for it, but not the President.
Gary
Milo, you could be very right, but what if they have something the really big players in the industry want. That could be a big game changer for a tiny company like this. I believe anything is possible until it's determined that they have one or more vaccines they're ready to mass produce and get out to the population.
I'm no fan of Trump, but I wouldn't be surprised if a vaccine were rushed into production so this Fall we can get it, roughly in 8 months rather than the year to 18 months experts like Dr. Fauci indicated. I don't suspect that it will be as thoroughly tested as people like Dr. Fauci would prefer, but it will be out, and hopefully it will work.
Sadly, we just overtook Italy in terms of numbers infected, and shortly we'll overtake China, not in deaths, but in people confirmed to be infected. Clearly we need to take more stringent measures, not ease up as the President would like to do.
Gary
Thanks Egold,
People might note it falls on the second to last page in the listing. Now there should be no doubt that our units work on coronavirus. The beauty of what we're doing is that for those who invest in our equipment, they have an unlimited supply as long as they have the water and salt needed to operate the equipment, along with power to run it.
It clearly sounds like the company is also supplying a lot of bulk product to those who want it, but clearly others do that as well. The beauty of what we're doing is, customers have all the product that they wish to make.
I'm not suggesting this, but I wonder if a mist from our product were ongoing in places where many coronavirus patients were located if both the staff wouldn't be better protected, and perhaps the patients actually gain benefits. Could there be a medical benefit from a breathing a mist from our machines.
Gary
Thanks Whitewater,
It sounds like the answers you got from Dave answer the questions I believe he'd be authorized to answer. No need to innundate him with calls.
On the subject of the trial, it would make absolutely no sense to me to say, lots of people are still alive, or lived for over 5 years, statistically 4, 5, 6 or more times what would have been expected in comparison with the SOC, but the trials a failure. Certainly, by some bizarre formula it may not have met some goal established well over a decade ago, but I credit the regulators to be smart enough to see thru that, people alive, many people alive have to send the message that the vaccine needs to be approved.
This to me is frustrating, but even more frustrating is hearing from another company, PSTI, that it's making it's drug available to try for coronavirus, and has trial sites planned in both Israel and Germany, and two weeks later it appears the drug has yet to be administered to the first patient. This is not a time to spend weeks or months designing a trial protocol and getting regulatory approval, it's a time that within hours these drugs should be administered to people near death. It may turn out that intervention is needed earlier, that certainly should be tried as well, the point is, things need to happen now, it's not business as usual.
I'm happy to hear they're intending to webcast the meeting, I wish that were the case annually, but people in the area under normal conditions should be welcome to attend as well. It sounds like nothing controvercial is to be expected in the Proxy, but we'll know for certain when we have it.
Gary
Sorry, but I'm very frustrated with the clinical trials community. As I see it, business as normal is wrong today, a drug which may help coronavirus victims shouldn't be put through months, weeks, or even days in designing a trial. Get it into some of the worst victims, work backwards from there in developing how to make sense of the data.
From what I'm reading, I believe it's been well over a week since the company said patients could get it under compassionate use, yet it appears as no one has yet to get it. It's time for the regulators and clinicians to throw out the procedures books and give this, and all other similarly statused drug a try. As some positive results are seen, work to both formalize what they're doing, and expand the use into many more.
This is a worldwide emergency, waiting to formally submit trials and getting them into the clinical trials database, getting regulatory approvals, IRB approvals, etc needs to be forgotten. Get the drugs into the people who look like they're on deaths door, then to those who seem to be approaching it. If people start to improve, expand this dramatically, and yes, organize the data so all results are counted, and early approval should be made by regulators, no NDA's or BLA's, approvals based on what they can see with their own eyes.
Gary
Thank you for all that information.
As I understand it, there are no limitations in shipping commercial materials back and forth to the U.K., or anywhere else. I'm also not of the belief that our equipment requires a great deal of assembly. Clearly it would have to be built for the correct current, voltage, and plugs, but that should be done before it's ever shipped. There are a lot of un or underemployed people everywhere, I would suspect that most hospitals have a small engineering staff. If we ship the equipment there with proper instructions, I believe they can get it put together and operating. If the people we've hired over there don't have the experience, they should be there as a few units are put together.
If the demand for bulk liquid is really great, it seems to me that having units strategically placed throughout the country would be wise, but if others are already providing it, it hardly pays to go to a price war. People who use it may be better served if they're sold their own unit, or perhaps purchase, or lease a shared unit with others nearby who can use it.
The key, IMHO, is having units that are sized to the application. A service company, that may be sanitizing many different structures, may want a lot of hand held electrostatic sprayers, and one large genrator that runs 24/7 to produce what they use all week. Meanwhile a hospital may want one of the units that's programmed to sanitize an entire hospital room in minutes for every XXX many rooms, some hospitals may require several units. I'd love to see something that cost no more than a couple hundred, ideally less, that could be used with an electrostatic sprayer at home. This unit might run for days to produce sufficient liquid for one thorough home sanitation, it would be small, probably not be plumbed, just fill it with the water and salt, plug it in and a day or two later you have sufficient fluid to cover the house. The same unit would be ideal for places like doctors offices, and perhaps be sufficient to do smaller E.R. or Urgent Care facilities.
Of course a big part of their system is tracking what's been done, and keeping track that the liquid is still potent, or when it should be replaced. I believe the company has the opportunity to build this equipment in all sorts of shapes and sizes. It really could be used in so many ways, and that's not including all the industrial uses.
Gary
If I understand it correctly, if you're working, or being paid, even thought they want you to stay home, you'll get it above and beyone your pay. If you're laid off, you'll get unemployment plus these checks which should be as much or more as if you remained employed.
For employers, they're looking to lend money to keep them in business, if the companies don't lay off or fire their employees, but instead keep them under salary, the loan becomes a grant, they don't have to pay it back. It's unclear if they're lending an ammount that's sufficient to both pay employees and pay other monthly expenses. If a company is essentially shut down, they'll need to see what works best for them, as well as their employees. I believe the unemployment will go to 4 months as of now, but they're all conceding this could extend beyond 4 months, and additional funding, especially for medical facilities will be required.
Gary
If you'd like to see a compiled list of all that's being tried with coronavirus, here's the best link I've seen:
https://milkeninstitute.org/sites/default/files/2020-03/Covid19%20Tracker%20NEW3-24-20-REVISED.pdf
I believe that many of these therapies may show some benefit, and if they do I think they'll become available and permit Doctors to try a variety of things to attempt to keep their patients alive, and hopefully actually keep most of them out of the hospitals.
Gary
I was up to use the bathroom about half an hour before the market open and I read what posters had to say, and the company's release. It did look positive to me, but I went back to bed as I like to sleep later. By the time I got up something was clear, the market didn't take the information nearly the way existing investors did.
I believe the message from the market was, give us the financials, not what they are judging as hype, even if they're completely truthful. I don't know how much time and money went into the release, but it would have been better spent if it was used to get the reports out. The information in the release could have been contained in the Annual Report, and something similar should be.
I'm not down on the company at all, but I am saying that no matter how bad the information in the past due quarterly is, get it out. No matter how bad the financials are in the Annual Report, get them out. Nothing prevents them from making a positive statement in the Annual Report, even though financials don't look positive in them. I believe they can reveal how many new orders have come in right up to the time they issue the report, they're not reported as part of the financials, that won't happen until first quarter results are reported, but they can still talk about it.
I believe they have a great story to tell and it will only get better as more facts come in, but investors, looking at the market moving up dramatically on Congressional actions want to be in the stocks on the rise, so at least some of them sold and took profits to put their money elsewhere. If they fail to get back in, I believe they'll regret it, but I also think the company needs to realize that meeting SEC requirements should be stressed above creating good sounding P.R.'s.
When this stock is selling for dollars, which it will, you'll not see the CEO making many appearances in the places where he has, rather you'll see him presenting at Investors Conferences held by major brokerages. Quarterly results will hopefully be accompanied with webcasts discussing results, and answering Analysts questions. The question is, how long will it take to get from here to there, that's where financials really come into play. If the company receives orders and starts delivering many more systems, the financials will say the growth warrants significantly higher price. It could come in just the coming month if the U.K. makes a massive order, but it's also possible they choose to purchase over a longer period of time, certainly good news, but not as much shock value. Give it a little time, we'll get there.
Gary
I certainly can't say how high PCTL will go, but I can predict that if it goes to say $10, the greatest dollar gains won't be made by most of us. We'll have the greatest percentage gains, but while we're approaching $5, it will be Institutions who'll be sweeping in and buying most of the company.
My choice would be to hold the stock, I'd even consider borrowing on margin if I needed some cash, rather than selling, but of course that wouldn't happen till the stock was over $4, Nasdaq listed, etc.
We're underestimating the company in looking primarily at U.S. and U.K. hospitals, they're a great start, but hardly the finish. This system can be used worldwide, and it can be used in so many ways beyond healthcare related areas. Certainly, a buyout is a possibility, but if not I don't see when the company will stop growing.
Gary
I frankly don't pay close attention to what the FDA's doing. I believe they could spend 6 months deciding how to cook 4 minute eggs.
As far as we're concerned, I believe the key is our new SAP being accepted, even though it was written while they were still blinded, I believe they know so much more about the drug now, than when the trial was initiated, that approval is practically assured if the SAP is accepted.
It will be interesting to hear if we have sent an abstract to ASCO, even if the presentation would be part of a virtual conference, as it's no longer a meeting. It will be interesting to see how it's handled. I frankly wonder if any of the usual conferences scheduled this year will be held live, I don't believe Doctors would want to be part of large crowds until they feel safe in doing so.
I'm a Ram's fan and while I hope they play and the new stadium's complete for the season, I doubt if I'd take a free ticket if in doing so I felt I was risking my life. If they get a really effective theraputic it all changes, but without that only a vaccine will really tame the disease.
Gary
I do believe in some cases you have an options in a buyout. You can take the cash, but you may have the option of taking stock in the acquiring company. If you take the stock, I don't believe you have a capital gain until you sell that stock, your broker would establish the price and time you held for long or short term considerations based on when you purchased the original stock.
As far as the price we might see in a buyout, it would be based on the price before it was announced. If a contract with the U.K. took us to dollars, it might be double the price at that time. Of course the best possibility would be 2 or more companies who'd like to buy, no telling how high a bidding war could drive the price to.
It's my belief that in time this company certainly has the potential to have a market cap in the billions. How many shares will be outstanding then, hard to know for certain, but let's say it won't exceed one billion. Could the market cap reach double digit billions, sure, triple digit, doubtful.
Gary
I believe that the cross over design of the trial assured virtually all who entered the trial the opportunity of getting the drug. Certainly, roughly a third knew they might not receive it initially, but as long as they lived long enought, they'd get it. This to me brings up the possibility that most, if not all those in the control group, roughly 10%, actually passed on before they had the opportunity to cross over.
Of course we won't know until the trial is unblinded, how many who never took the vaccine are alive today, or how many lived 1, 2, 3, or 4 years. I suspect the number will be very low, if not zero.
In reading what Dr. Liau said, people would clearly like to be able to get DCVax-L today, but Dr. Liau is a scientist, she knows if it were approved today it is just a step in the right direction, no where near all would be cured. Scientists will keep going until cures are achieved for nearly everyone.
In some ways it's like finding a drug that's effective for coronavirus, if it benefits 30%, that would lower the numbers in the hospitals, make it more tolerable, but they'd still need to keep working. Perhaps if 80% were benefitted they could back off on research, and strive to get a vaccine, but even 80% of something that's killing over 1% of those who get it would make it more deadly than the common flu.
If I were around at the end of this century, I suspect that many cancers would be less of a threat, but their would still be many suffering and dying from it, just relatively lower numbers. In the mid 1990's, it was widely forcast that by the year 2000 cancer would be cured, and all our electricity would come from fusion. While we've pulsed fusion, we can't sustain it, and clearly cancer is far from cured. We will not be through the coronavirus by Easter, at least not Easter 2020, hopefully life will be near normal by Easter 2021.
Gary
I agree with you, but if anyone gets stock quotes from CNBC, which I do, look at what they're saying about the company. I don't doubt that what they have in their manuscript may have been true at some time, but I believe it changed well before I got in late last year.
I don't know who can be contacted to change their mind.
On the subject of the quarterly and annual report, I once saw another company that was years behind in such reports come current in a matter of a couple days. It's very possible that both reports will be issued either the same day, or within a couple days of one another.
In some ways, PCTL is like a biotech where you're waiting for data when a trial concludes. It's not quite the same, but where would we be tomorrow if the U.K. committed to purchasing virtually something close to a thousand systems to put them in each hospital, urgent care facility, ER, etc that fall under the coverage of their healthcare system. I'm not suggesting it will happen this way, only that it could. If in fact they're satisfied with the trial, there are all sorts of ways they could impliment it's use. Sure, it could be right now, but it also could be phased in over many years. They might even license the rights to build the units themselves, but they would still pay a substantial sum for doing so.
Gary
We really know next to nothing about the trials in Israel and Germany, hopefully they are going to expand them to 100 or more if they see efficacy as the trials move forward. I believe they may want enough information to leave no doubt, not like the products being tried without substantial trials to date. If the benefits prove to be substantial, I believe PSTI would almost instantly take on a multi-billion dollar market cap, and if they actually have sufficient drug to cover the world, this crisis would rapidly go away.
This would not prevent the spread of coronavirus, it could be permitted to spread, just as the normal flu does, but for those who had a bad case, it would be administered and they'd get better. It ought to also apply to those with pneumonia from other diseases, like the flu which kills tens of thousands annually, mostly because of pneumonia.
Can we change the world with our drug, time will tell, but hopefully not too much time. Anyone close to needing a ventilator should be put on the drug, how they do at that point should be all that's needed to say it works, or it doesn't. I think a week or less after the dose was administered to each patient you'd know. It might be a Phase 1 Trial, but if results are as positive as they could be, it should be approved, no red tape, no time to analyze results, put it on the market.
Gary
We're mentioned in the following:
https://mail.google.com/mail/u/0/#inbox/FMfcgxwHMZGdSPfTDSMJDKcZGLNmtLbX
There are a number of companies working on utilizing stem cells. I don't believe anyone is more advanced than PSTI in terms of the number of doses that can be created from a placenta. I'd really like to see both of our drugs in trial as I believe that someone indicated pneumonia was cited in the patents for each of them.
Gary
I believe we're truly one of the most underpriced companies in history. Of course we don't know that we could be the answer to coronavirus, but even if that's not the case, our drugs have blockbuster potential that should come to fruition in a couple years. We have a process that if others wish to use, they'll pay for the rights.
I understand the Chinese used placeta based products successfully in coronavirus. I don't know much about it, but I don't believe that China is getting anything close to 20,000 doses from a single placenta. I have no idea if PLX-PAD works how many doses are necessary, if the number is one, or very low the company probably has sufficient drug on hand to dose all who's coronavirus has created pneumonia, because it's the pneumonia that it benefits, not the coronavirus itself. While it's at it, it can also work on other pneumonia cases, from flu and other diseases where death often comes from pneumonia, not the disease itself. The company is essentially saying nothing other than it's being tried in both Israel and Germany. It shouldn't take that long to know if benefits are being seen.
Should the drug work, the need for ventilators would go down dramatically, as the drug would prevent the pneumonia worsening to the point where a ventilator was needed. Of course an awful lot would need to happen to benefit New York in under two to three weeks when they say they'll need 30,000 more ventilators.
Gary
Hopester,
It's unfortunate, but legislation is like making sausage, you don't want to see it, but it's good to eat. No doubt the Democrat's threw in a lot of things to be eliminated so they could change some of the pure give aways the Republican's threw in. At the end of the Bush Administration, a similar bill was passed that had zero responsibility on the part of those receiving the money. This bill was practically the same as written by the Senate Republicans. It's not the corporations don't need the money, but it needs to be spent responsibily and that's what's being put into the bill.
Obama spent a whole lot more money when he took office, but companies like GM were lent the money they needed, rather than a pure gift, and eventually the govt had the money returned. Multi-trillion dollar bills shouldn't be done so quickly that they're just giving the money away, just as the tax bill was poorly constructed. I was all for lowering corporate tax rates, but only if the loophole were removed. That didn't happen, corporations earning billions are paying no taxes, wealthy people are paying less taxes, and mid and low income people are paying a little less taxes, it simply was bad, and very rushed legislation.
I believe Congress needs to take the time to properly construct legislation that won't simply be overturned each time the Administrations change. If it were up to me, all tax laws would be thrown out, and we'd start from scratch and really think through all of the law. As is, our laws are so complex that IRS is called on for advice, gives it, and the tax courts say they were wrong. Things need to be greatly simplified, and businesses that earn millions or billions need to pay a fair share.
Gary
I'd suggest you read the actual trial results, not what's being said on Fox news. 6 of 20 had some improvement in their nasal passages, one died, one dropped out, others still being treated. Statistically it's just not very good, and they cannot be certain if the 6 who saw benefits were actually drug related. Trump is selling snake oil.
Gary
The bill the Repulican Senate attempted to pass was something commentators said could have been written by lobbiests for major corporations. That's the very same thing Bush passed before leaving office, a gift to corporations and their management. I know American corporations need help, but our people need to be the primary ones considered.
What Pelosi said today was spot on, Trump is trying to take away healthcare in court rather than doing what's right for the people.
Gary
Doc,
The key is finding something that works, from the trial I saw, the therapy touted by the President is essentially useless for most who tried it. I'm very much hoping that PSTI's placental based drug PLX-PAD is beneficial, it's being tried in Israel and Germany, but they're being low key about it. Basically it's patents have it covered for pneumonia, but the initial trial was for CLI.
Gary
Feel better Captain, that little blood oxygen does far more than that if you purchase one that shows your pulse, it actually shows arrhythmias, etc that can be seen in the pulse. I know because I asked one of the inventors as he was one of my Doctors at City of Hope. I know they don't sell it to do all it's capable of, but we tried it on a Dr. friend who has an irregular heartbeat and he saw it for himself.
Frankly, I don't use mine often if I'm feeling fine, but if I'm not I check to see what it has to show, it's almost as valuable as a thermometer.
Gary
No, I for one listen to every word. If you take places that only have a few with it, and let go of all that's being done to reduce contact, in no time you'll be talking hundreds. We need to get this under control and have a working profilactic before life can return to what's normal.
Let the scientists establish when it's safe to start moving things back to normal. Trump is fighting for the economy, he's fighting to get reelected, but he's not fighting for the American people. Sure, I'd love to see the stock market back in record territory, but it won't happen if hundreds of thousands, or worse, were dying. It can only happen when American's feel it's safe to live a normal life, and that life may not be what normal was before we heard the name coronavirus.
Gary
There are no shortage of experts who can be called on who'll agree with Trump's views on everything. For each of those experts, there are probably 100 scientists who disagree. I think we need to err on the side of the majority of the experts.
If they opened all the restaurants in L.A., as much as I love eating out, I wouldn't do so until I knew the likelihood of being infected was dramatically lower than it is today.
We all know that far more people have died of the flu than coronavirus, but we also know it's only about .1%. Coronavirus still appears to kill well over 1% so it's at least ten times more deadly. If later this week it were announced that PSTI's PLX-PAD was tested in 100 people thought to be near death, and over 90 were well on the road to recovery, we'd have reason to rejoice. If the Govt. announced that they had purchased tens or hundreds of millions of doses of the drug and it would be available throughout the U.S. in a matter of days, then in a matter of days I believe that life could return to something more normal as we'd have knocked that percentage down to substantially below 1% rather than well above it.
If the other theraputics are proven to work as well, fine, buts let's not go out and get infected until we know we have a great shot at being cured.
Gary
Thanks,
I hope these people are protecting themselves.
What's sad is that most people can't get tested, but those in certain positions do. I'm not against such testing, it would be a mess if Rand Paul infected much of the Senate, but much the same could be said about an infection going through the patent people. People working with many other people to get things done should have access to test kits.
If you're isolated at home, I can understand not testing until you clearly have symptoms, though others with you will also probably have it. Meanwhile people working in places like markets, drug stores, etc should be tested rather routinely as if they're infected they'll infect many others.
Gary
I just wonder if the people working on things like patents are currently working. At this point I don't see a few weeks delay as a problem, so I question if such people remain on the job, unless they're set up to work from home.
I do believe our management could work from home on providing information to investors, getting the website updated, etc, and the annual report could be done. The point is, there are things that can be done in relative isolation, other things can largely be put off.
Gary
If you believe it, it's saying news pending. These signals may be legit, but they also can be someone playing with the system. With brokers not charging commissions on trades, it doesn't cost much to put in such an order just to screw with people.
Gary
It's clear to me that PSTI has chosen to fly under the radar, yes they're testing in coronavirus, but not publicizing their efforts. It won't take long to get data, and if that data's good, then they should announce what they're doing.
As for all the politics, the last time the Republican's pushed out legislation throwing money out under Bush, their was no accountability. Obama followed up with even more money, but their was accountability. I believe the Democrats are trying to get the money to the people who need it most. If major corporation need help, which I agree with, it ought to be under terms similar to what Obama did in bailing out the likes of GM, who actually paid it back ahead of time. A few days can be spent in trying to do what they're doing correctly rather than just dumping money out, especially money in bulk headed to some of our biggest corporations. Boeing, Hilton, etc won't go broke in weeks, or even months, but some individuals, especially gig workers, will. This bill shouldn't be passed the way the tax bill was, it needs to be thought out in depth.
The FED is making plenty of money available, Congress does need to act, but they do need to consider what they're doing. Certainly not everything should be a loan, but in some cases it should be. Meanwhile they're talking like Trump is going to turn everyone loose in spite what all the scientists are saying, that will turn a very serious problem into a catastrophy. No one loves what this is doing to the stock market, but allowing the infections to grow is the most foolish course we could possibly take.
Gary
I'm not advocating a single payer plan, but to those who put it down, how do you explain all the countries who have it, and where medical costs are substantially cheaper than here. Certainly in some case I've heard things take longer in Canada, and that may be true in the U.K. etc but I really don't know.
I believe that like Medicare, if you have Medicare as the single payer, you also have the choice of supplemental insurance with a variety of options from free, essentially managing your Medicare, to greater coverage which covers more, lessens co-pays, etc.
If Insurance companies can provide better service than Medicare, it won't ever come down to single payer, but if a Medicare option is available it will evolve into single payer as people choose Medicare over their independent insurance providers.
A Doctor friend has told me the overhead costs of medicare are in single digits, for most health insurance it's roughly 50%. Clearly, the patient can get far more from the system if 50% of their money isn't spent on overhead costs.
Gary
Someone please correct me if I'm wrong. I believe that most, if not all OWCP personnel are working as part time, and many are at least in part taking stock in the company over cash. If this is still the case, it certainly would make it clear that they're working to succeed, and if in fact they're working for others as well, great as long as there is no conflict of interest.
With the clear change of management at the top, I would certainly hope we'll be hearing from them sometime soon. An Annual Report should be out in the next few weeks if it's on time. I cannot say I'm thrilled with the caliber of what I've seen, but believe we need to give them a chance.
If patent submissions previously done can lead to approvals, much of what they're attempting to achieve will be achieved. Once trials prove even a single product is effective, I believe they'll get the funding needed to bring home many products.
Gary
Any thoughts on using our own stem cells to fight coronavirus. People who donate stem cells get doses of Neupogen to increase stem cell production so it can be harvested from the blood. Any thoughts about using Neupogen to get the extra stem cells to fight off the coronavirus.
Thanks,
Gary
I'd like the opinion of those involved in medicine. Neupogen is given to people donating stem cells to spur production prior to harvesting the stem cells. Is it possible that if stem cell production were boosted for coronavirus patients those extra stem cells might have benefits?
I realize that some people have some bad side effects with Neupogen, but I think they'd be tolerable if in fact they would help to defeat the coronavirus.
Gary
We know the drug isn't very expensive, but a Dr. must prescribe it. I just saw Dr. Gottleib discuss it, and it seemed that benefit was limite, and applied to roughly 6 of 20 who took it. He suggested that several drugs which may have benefits be tested to determine which of them may have the greatest benefit. That seems reasonable if it's done quickly.
I believe they have a tremendous supply of sick patients, if there are 10 such drugs, why not immediately try each of the drug on perhaps 25 to 50 patients and evaluate them in a week or two at most. This shouldn't be like a clinical trial where cohorts are tiny, and a second cohort doesn't start until the first is evaluated. With all the patients to select from, I believe ten drugs could each be in 50 patients tomorrow if that was determined to be the course of action to be taken.
The FDA wants nothing to change, trials take years, not days, but in this sort of situation the first do no harm must apply, if they are reasonably certain product are safe, let they Doctors choose what to use. Otherwise, it will take years to determine which product is best, millions will die while waiting.
Each year they guess on what viruses to apply to our annual flu shots, if they waited longer they'd know more, but then they couldn't have the vaccine ready. If there are safe vaccines created for coronavirus in the next few months, why not put them in production and get a vaccine by this Fall even though they can't be certain. They can be more certain by next Summer, and we can all get another shot then.
Gary
Just a thought, could the company be delaying the Proxy and guidance about the annual meeting in an attempt to know what the Federal Govt. intends to do after the initial 14 days of limiting physical contact. Clearly, long term guidance hasn't been established.
There is no doubt in my mind that a virtual meeting could be done, and then regardless of the guidelines at the time, what they're doing should work, but it's equally clear that some shareholders would rather attend a meeting where they can speak personally with key people from the company. With the proper venue, all in attendance could be 6 feet or more apart and a live meeting conducted, but even that may not be legal by the time of the meeting.
Of course what's to be voted at the meeting probably won't change regardless of how the meeting is to be conducted, but another possibility is the Govt. essentially saying such meeting should be delayed, no matter how they're to be conducted. The idea of maximizing separation may make even the act of voting a proxy on line one which requires more people to work, and that's not what the Govt. wants. As to clinicians gathering trial data, that too might be something the Govt. would rather wait on if it can't be done from home.
I would not be surprised to see something shortly, but it's something that might be cancelled or modified based on Govt. actions.
Gary
While I agree with you, it won't be formally put through clinical trials. What's needed is Federal action that clearly states it may be prescribed and full insurance coverage will apply, or the drug should be free. It would be easy to call it a Phase 4 and let the prescribing Dr. provide a simple report on how well it worked, and after gathering data from it's use on thousands, or tens of thousands of patients do a label expansion based on what's received.
I believe much the same can be said with a drug developed with placental stem cells currently being tried on coronavirus based in Israel and Germany, only it's only proven safe with efficacy being judged in a trial for CLI that's well into Phase 3. It may very well be the answer to all sorts of pneumonias, but Pluristem, it's developer, hasn't yet put it into those trials. I believe they have a lot of the drug in cryogenic storage, and the achieve 20,000 doses from a single placenta, and while it may be the answer, with standard FDA procedures we should know that's the case in the time period between 2025 and 2030 when it probably could go through normal Phase 1, 2, and 3 Trials.
Gary
Why shouldn't it be business as usual at the FDA. Let them start a Phase 1, it may be finished by the end of this year. If results look good, we could do a registrational Phase 2 and by 2022 or 2023 we could actually have an approval. So what if millions die, the FDA will have taken their responsibility of determining the drugs we take are safe and effective.
How is that different from the many who've died over the more than a decade that it's taken to do the trial we're all concerned with in GBM.
As far as I'm concerned, First, do no harm, makes sense. A Phase 1/2 can both determine you're doing no harm, and in fact you're seeing benefits. Why must they go so much further, and to so much more expense to determine one product is better than others. Why not let the marketplace determine which products to use. Furthermore, if the goal is to make each new product better than those of the past, why are the lesser products still permitted to be marketed.
What if we took the same attitude toward a common item like shampoo. We could put all shampoo's through Phase 1, elimanate perhaps all but 5 who'd go into Phase 2, zero it down to the top two and put them through Phase 3, then only 1 shampoo would be selected for all to use.
As absurd as the above is, so is taking over a decade to try drugs that clearly demonstrate efficacy in Phase 1/2 Trials.
Gary
If I remember the statistics I heard this morning, the number of coronavirus tested people was approaching 100,0000, and roughly 10% tested positively. That's telling us a lot about the problem, people with a common cold, the flu, a runny nose, etc can't tell the difference, and neither can the Doctors.
Perhaps an even bigger problem is that for the roughly 10,000 who tested positive, how many did they infect before they were tested. In today's world, where we're largely living at home with our families, that number may be small, but these 10,000, and many more not yet tested, haven't been isolated for 14 days, we just started it early this week. I would suspect that beginning a couple weeks ago, when many became infectious, even though they didn't feel bad, probably infected 10 to 50 people depending how much they got out in the prior week.
Currently we're testing people who have the symptoms, but if we really want to stop the spread, we need to eventually test everyone, so even someone who feels fine doesn't go to the market, Costco, etc because even if taking precaustions, the disease is being spread. Sadly, until we have an effective vaccine, we'll probably have to repeat that test every XX number of days.
On the other hand, if PLX-PAD or other therapies can greatly lessen the risk of the disease, so it's no worse than common flu, then perhaps we could get back to life as normal. The only reason to test at all would be if treatment from the flu was different from coronavirus, but I'm hoping that all forms of pneumonia can benefit from PLX-PAD, and if that's the case, why shouldn't it be used on everyone. I would suspect that if it's used in a timely way, a Dr. will be able to administer it in an office, or Urgent Care facility, hospitalization would only be required if the pneumonia was advanced to the point that hospitalization was needed. The drug might be higher in cost than conventional treatment, but if hospitalizations were reduced, the net costs would go down with far less hospital treatment.
Gary
We need to get beyond FEAR (False Evidence Appearing Real) with facts. If we can establish that we can provide therapies for those who're at greatest risk, so the percentage passing on is greatly reduced, we can greatly diminish the fear of the disease. The existing malaria drug has benefits, but speaking to someone who was on it for other things, it also has risks, and one of them potentially is blindness. That's a worse case risk, but if PLX-PAD proves effective, it's negative side effects, which are known from trials, are nil by comparison.
It shouldn't take more than a week or two to see benefits, if they're seen, the FDA and other regulators around the world need to act to make PLX-PAD available at the point people are lapsing into pneumonia. No one is saying it will prevent acquiring the disease, which the malaria drug may do, but it will lead to cures in the sickest people, and essentially all others recover as though they had a case of the flu, and not a terribly severe one. The good news may very well be, those with flu based pneumonia may also get relief. In fact, if that's proven, it may not be necessary to even test for what a patient has, give them the drug and they get better. It probably will be equally true of many who have cancer, but die of pneumonia.
The point is that people who's immunity is weakened by numerous different diseases often die of pneumonia. Curing the pneumonia won't cure the disease that caused it, but in some cases their life might be extended indefinitely.
As a leukemia patient, I've been very open about what I have. I recently attended the funeral of a friend who never disclosed he had been fighting leukemia for many years, he was in remission, but in a weakened state pneumonia took his life. I cannot say I'm that weakened, but I certainly know I must be careful. If in fact our drugs are capable of curing pneumonia in many people, the fear can be reduced, but shouldn't be to the point that it's business as usual as that still would overwhelm our hospitals, which untimately will be where the worst pneumonia is being treated.
Gary
If the FDA were to act dynamically, they'd unblind the CLI trial immediately and approve PLX-PAD without reservations, or a NDA or BLA. That would permit it's use in off label applications, such as pneumonia, without violating any of their regulations.
Clearly, even after they have data from a few patients they wouldn't have enough data to meet any approval requirements, but approve it for CLI and they'd be covered. It's a dynamic move on their part, but if they did it, money could be charged for the approved drug, and the Govt. who's said people should be treated for coronavirus for free, ought to make a bulk purchase from PSTI to make it available.
Frankly, if they did something like this, in under 30 days they could probably have efficacy results for over 10,000 people who received the drug, it would then be easy to add to the label covering its use in pneumonia. Clearly this is a way around their rules that still makes them look like scientists who're willing to do what's right rather than follow rules which would normally take years to do so.
Frankly I'm still uncertain that both drugs don't have benefits, so depending on what's available, both could be tried in a similar manner, and using their authority to approve on animal rules, they could do the same thing for radiation, making it available for off label us in pneumonia as well, if trials also demonstrated efficacy.
The FDA is able to move quickly on an urgent need. As a patient on Gleevec I knew how it had been approved decades before when the FDA stopped a trial after very limited results. The reason was simple, people with the disease I was diagnose with were dying without it. Frankly today I'm not certain it couldn't have been approved in Phase 1 or 2 if they really made a case for it. In short, the FDA can act dynamically, it's time for them to do so.
Gary
Got this on the I-V site, PSTI is mentioned in the video.
https://www.bnnbloomberg.ca/video/coronavirus-related-biotech-stocks-for-investors-to-consider~1925464
What we need is evidence of efficacy, it shouldn't take that long if anyone is talking about how patients respond.
Gary