Love Conquers Alz
Love Conquers Alz
STEPHAN JACKMAN - CEO ALZAMEND NEURO : New Lithium-based Drug that Offers Alzheimer's Patients Hope.
In Episode 79, my co-host, Don Priess, and I had an enlightening conversation with Stephan Jackman, the CEO of Alzamend Neuro, a clinical stage biotech company committed to “Making Alzheimer’s Just a Memory™.” Stephan shared information about the new lithium-based drug that offers Alzheimer's patients hope.
Stephan is laser focused on his mission to rapidly develop and market safe and effective treatments that address the unmet needs of those living with Alzheimer’s and other neurodegenerative diseases and psychiatric disorders, through advanced research and development.
Their current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and AL002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.
Our primary target, Alzheimer’s disease, was among the most-feared diseases (second only to cancer) among Americans, according to a 2011 survey by the Harvard School of Public Health. Alzheimer’s is also the sixth leading cause of death in the United States according to a 2021 report from the Alzheimer’s Association, a nonprofit that funds research. Existing Alzheimer’s treatments only temporarily relieve symptoms but do not slow or halt the underlying worsening of the disease, which currently affects roughly 6.2 million Americans and that number is expected to grow to 13 million individuals by 2050.
Enjoy the listen.
Love Conquers Alz,
Susie
Alzamend Neuro
Stephan Jackman
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When the world has gotcha down, and Alzheimer's sucks. It's an equal opportunity disease that chips away at everything we hold dear. And to date, there's no cure. So until there is we continue to fight with the most powerful tool in our arsenal. Love. This is Love Conquers Alz. A real and really positive podcast that takes a deep dive into everything. Alzheimer's, The Good, the Bad, and everything in between. And now, here are your hosts Susie Singer Carter, and me, Don Priess.
Susie Singer Carter:Hi, everybody. I'm Susie Singer Carter.
Don Priess:And I'm Don Priess and this is Love Conquers Alz. Hello, Susan.
Susie Singer Carter:Hello, Donald. Out. Oh, you today,
Don Priess:I'm great. Thank you. That's terrible. That's a mate? terrible, terrible accident. I don't even know what accident it was. But it was terrible.
Susie Singer Carter:So mine is mine is circa 1960. Something. Tim, Tim. Tim, Tim and each.
Don Priess:So you were so kind of cockney. Maybe a cab driver. You were a cab driver. Not a chimney sweep .
Susie Singer Carter:Oh, yeah. Wow. Over there.
Don Priess:Wow, just you went to the Dick Van Dyke School of accents.
Susie Singer Carter:That's right.
Don Priess:Wow. Congratulations. We are a little loopy today. We are loopy.
Susie Singer Carter:We are in the editing bay too long. We're like we're like we're like in solitary confinement only with each other. Oh, my God. It Thank God. Thank God. Thank God. We still like each other Don.
Don Priess:Yeah, I know. It's a miracle. It truly is a miracle. But things are going and they're They're going along, as they say. And they're going well. I think we're really making terrific progress on our documentary. No Country for Old people. And I see. I well, I don't see a light at the end of the tunnel yet. Not yet. Not yet. I do see a light at the end of the tunnel. Yeah. And I know as everyone says, and oh my god, it's a train. But no, it's not. We see a true light at the end of the tunnel. Very long tunnel. I never heard of that train coming out. Oh, yeah. Yeah, it's it's a Yeah. Oh, yeah. But it's a train. You know, it's kind of like,
Susie Singer Carter:Oh, that's terrible. That's such a horrible visual. That's a horrible. Terrible. I never heard of that. That's awful. It's well, I'm gonna share this with the audience. I am going to New York next week. I'm excited. I am going to attend the Cantor Fitzgerald charity day in New York, which is a lovely, lovely prestigious event that is based on 911 and the tragedy that we had that Cantor Fitzgerald lost so many of their beloved employees and right after that make over 650 Yeah. And they created a charity day with that is celebrity driven like a list celebrities Robert De Niro and, and Meryl Streep and Goldie Hawn and Bill Clinton and on and on and on and on, and to raise money for the families who were devastated by this tragedy. And since then, they've actually added more charities to their docket and the national consumer voice for quality, long term care who is our fiscal sponsor, and our partner in No Country for Old people, and ourselves have been chosen to go and be and participate with our celebrity sponsor who is on a Sofia Rob. And you might know her from one of the films that I CO produced, which was Soul Surfer about Bethany Hamilton. She's done a zillion things. And we just love her. And we're very, very honored that she's going to be representing long term care and raised helping us raise money for quality care and for No Country for Old people. So exciting. And I get to go to New York and wear clothes that are fun and fancy, and be
Don Priess:on the floor of the New York Stock Exchange and everything you are going to be Yeah, fans. Yeah.
Susie Singer Carter:I'm so fancy and New Yorky
Don Priess:and our partner Rick mountcastle. will be there.
Susie Singer Carter:Yes, yes, yes, yes, yes. And my other partner from my other film that hopefully is going in. Next year, we're we're looking at the spring production date for our dramedy called run bit and my my beloved partner, Barry knee is going to be there because she lives on the East Coast and we're going to go out to dinner and we're going to schmooze with the big shots. So exciting huh? So anyway, but what today is exciting too, because we get this is like a new area for us with this guest and I will just pass the ball to you don and let you introduce him.
Don Priess:PTSD. Their mission is to rapidly develop and market safe and effective treatments. They are led by CEO Stephane Jackman, who is here today to tell us about some potentially exciting breakthroughs in the treatment and prevention of Alzheimer's disease and other neurological disorders. So to find out more, let's welcome Stefan Jackman. Hello, Stefan.
Stephan Jackman:Hello. How are you guys doing today?
Susie Singer Carter:Hi, Stefan. How are you doing?
Stephan Jackman:Hi Susie. I am excellent. And how are you?
Susie Singer Carter:I'm doing well. I'm feeling a little underdressed. You look so nice. If you're not watching I am fashionista but you can't tell because I was rushing this morning. But I am I am great. I am la chic. And I do have Love Conquers Alz hat on so you know,
Stephan Jackman:and you know it's most important you know that you're wearing jewelry. So yes, you're a fashionista. You showed up prepared?
Susie Singer Carter:Thank you, my dear. Yeah. But then ensemblel you guys if you're not watching, just hit hit it up on the YouTube. He's got the he's got a Yeah, his fit is good.
Don Priess:He is dapper. Yeah. You're welcome. Why is no one talking about me?
Susie Singer Carter:So anyway
Stephan Jackman:DOn, you look great.
Susie Singer Carter:anyway, well, we're excited to have you. And, you know, I think for us, this isn't your unique guest for us because we're talking about somebody who is developing, you know, in the in the pharmaceutical arena. And we're very, you know, I don't know if you know, my background at all, but my mom had Alzheimer's for 16 years. Yes. And the drug and the cocktail does your during those 16 years was Namenda and era Sept. Yes. And I'm sure I'm sure you are. And and then, you know, the only other drugs that we talk about are the are the psychotropic drugs that are being used in the facilities to chemically restrain our loved ones, which is, you know, been going on for too long, like Depakote and, you know, Risperdal, Risperdal, and amongst others
Stephan Jackman:have it all began with the vitamin, vitamin H, or were they pretty much are somewhat comatose?
Susie Singer Carter:Absolutely. Absolutely. And also, you know, I experienced hospice last year with my mom and that was a, that was also an another, another instance where drug, the drugs become the choice of when it doesn't need to be, but it become because they're understaffed. It becomes, you know, their their default. Procedure choice,
Stephan Jackman:of course, yes. To restrain the patient, mostly. Right, fortunately.
Susie Singer Carter:Right? And to to hasten death, also, you know, also the morphine to, you know,
Stephan Jackman:we definitely, definitely have to, there's a change that's needed in the system, especially how you care for people and you bring them into the world, but also, they leave the world. So, absolutely, they're both that's a lot that's needed.
Susie Singer Carter:Yes, it both is important. So tell. So first, we like to get personal, because we want to know, what were your heart set? So how'd you get how'd you get to alza? Man? Like, how, why are you? Why is this your focus?
Stephan Jackman:So this is my focus, because I, you know, I graduated from college with a mechanical engineering degree, why? I have no idea. I also made it in steam and nuclear power plant designs, I don't know. I like math. And I like science. Right. Exactly. And so and so I was. So I was recruited for a management program and L'Oreal, you know, working on cosmetics globally. And that was great that said, you know, Hey, I like that, you know, I like fashion. I like, you know, makeup and you know, and I like, you know, I mean, looking good, you know, Cologne, etc. And three years later, I was recruited away by Novartis Pharmaceuticals and said, you know, hey, we have a management program as well, let's, you know, let you come here and you can learn the business from the ground up, and we're actually helping people, you know, cosmetics or grid, the cosmetics industry was great for, you know, kind of like helping the exterior of a person, but now, you know, pharmaceuticals, helping the interior of the person. So I said, you know, this is fantastic. And so I worked at Novartis for eight years, they also developed now, I'm having a little bit of an Alzheimer's you know, Yeah, exactly. blockage because Novartis actually developed Exelon. And I don't know if your mom was on that the Exelon and Exelon patch and that was for Alzheimer's. And that was, I think, prior to look kind of more of an educated man, but that was the last drug that was approved in the early 2000s for Alzheimer's disease. So it was pretty good. And, you know, I think the moment it hit me that I really belonged in the space, you know, I was at, you know, a town hall, you know, the, the organization hosted and, you know, a woman, you know, was there and, and we had a drug at Novartis at the time called Gleevec, you know, and she, you know, said, you know, hey, I was a patient in the clinical trial, and I was only given about four weeks to live. And I thought that, you know, I was, you know, we planned, you know, she said, well, was already conducted, you know, her kids, you know, were two, four and six years old, and she said, I was ready to go. And she said, I took this drug, you know, on a clinical trial in a clinical trial, and it just turned everything around within four weeks. I mean, there wasn't a dry eye in the room, you know, this is like, this is amazing. You know, don't get me wrong, there's a lot of drugs that are, you know, not as good for you. But you know, but when you do find those drugs that are, you know, that are fantastic, and they really help people, and it really does save lives. I mean, it's, it's something that's the I can't it's monumental, it's something unexplainable, you know, so ours, of course, you know, so I said, you know, what this is, this is where I belong. And after being with the organization for eight years, you know, I wanted to get more into really, you know, getting my hands and developing it, you know, from a, a biotech, a small organization, where you can actually get into the weeds and really help to bring certain drugs that you want to work on, and particular units to the forefront. And so that's what led me to ultimate and having family afflicted by it, too. So I think, you know, it's something that, you know, when I'm sure you've been there, when your mom was diagnosed with Alzheimer's, you're pretty much rendered powerless. You know, when you have to go through the system, and like, Okay, how do I take care of her, you know, who's going to pay for the meds? And how are we going to get the meds? And, you know, and what happens when she gets to the point where I can't take care of her? What's going to happen?
Susie Singer Carter:Yeah. Yeah. All that. All that? And the truth is, is that, you know, I got very immersed into the, into the Alzheimer's, Alzheimer's community because of that, and because of my mom's a lengthy journey, and and because of a film that Don and I produced a bout six to seven years ago called my mom and the girl with Valerie Harper. And that, that film really, you know, just rocketed us into the center of this community. And I love it so much. But the frustration that I find it I had it as well, as is the pharmaceuticals because, you know, at best Namenda and arrow cept we think slows it down slows the progression down. Right. So there's that question of, is it good to slow it down? Or because what are what are we? You know, because the journey can be rough, right? So it can be extremely rough, it can be rough? So is it good to slow it down? And and is it actually working?
Don Priess:If you didn't take it? How would our did take it? How do you know if it's actually and what does that? How do you quantify that, that you know it? Did it slow it down? Right? Or what does that mean?
Stephan Jackman:It's one of those things that you know, you've pretty much you pretty much have to get to the right, you know, specialists, you know, to work with them to say, you know, like, is this product actually working? And if it is, is it working long term? Because sometimes it works for a period of time, and then all of a sudden it stops because your body gets accustomed to it. Yeah, you know, so it's one of those things is that, you know, do you continue, so you pretty much it's a cocktail that is ever changing. You know, a lot of times people go to their physicians for whatever ailment that they have. And all of a sudden, it's like they give them unlimited refills, and you're like, okay, yeah, but what if, what if, and if you stopped working in between
Susie Singer Carter:it you're so right, because I you know, I used to get anxiety attacks. And so I've been on a low dose of Prozac since since my 20s. And I got a new doctor. Um, this is a little side trip, you guys but I got
Stephan Jackman:necessary. It's all in all, it all applies. Yeah. And
Susie Singer Carter:I was like, I was like, I wonder if I need to be on this anymore. And is it working? And it's such a low dose, you know, and, and my doctor said, well, one doctor said if it doesn't if you know if it ain't broke, don't fix set, you're fine. You feel good and an end Prozac doesn't really have a bad you know, there's not much, you know, adverse side effects. Yeah with it. So, and I had an ad for an expense Airmont I tried to go off at myself I weaned myself off and I got what I don't even know what the term is, but my whole body felt buzzy. Like it felt like a little withdrawal. Yeah, but it was just like, like, vibrational in your arms and hands and stuff. And and it was really that I knew because I had tried. I tried it a couple of times. Anyway, we went I went off of it just yet, because my new doctor told me to go off of it. And I didn't feel I didn't really need to be on it. Like I'm fine without it for that long. Yeah. And so, but we don't know. And, and like every doctor has a different opinion, like the one doctor said, If it ain't broke, don't fix it. And the other one saying Why didn't you know, let's, let's let's D prescribe you.
Stephan Jackman:It was a moment of time, you know, whatever you were going through that period, or probably a lot of stress, you know, and now you no longer have that. So why continue on that journey are on that regimen? It's really sorry, because we
Susie Singer Carter:don't know what it's actually doing to our bodies? We don't know. And so that brings me back to our Azzaman. So tell me, you know, and they're there. They recently we had an announcement of like a breakthrough drug for Alzheimer's. Earlier in the year right.
Stephan Jackman:We did we did we did for mukana Mab, which is the follow on drug for it basically up at Adji. Canada was approved in 2021. And Luca Mab is I think agile, as you can imagine, was 21%. Effective, and we kind of map is 27% effective. And so that was approved in January of this year.
Susie Singer Carter:And it was you know from for all for all intents and purposes, it was a big hoopla. And of course, everybody was really excited about it. And but when I started when I did a little more reconnaissance on it, it seems to me it's not much different than then Namenda and errorception that it just slows it down the progression. Am I right or wrong? Uh, pretty
Stephan Jackman:much. Yeah, you're spot on, I think what is one of those things that, you know, when you when you think about certain diseases, and you think about how they are drug is actually how you get a drug to market is difficult, because there's a lot of space that there's, you know, the biotechs are the ones that develop, you know, new technology, and then hand it over to the larger pharmaceutical company. Yes, the larger pharmaceutical companies tend to focus on certain spaces. But the issue is that there's no money in those spaces. And, and so you need investors, you know, to invest in those spaces. And when they think that, you know, for the last 20 years, there hasn't been anything new in the Alzheimer's space, it really helps to have something that can actually move the needle, even if it's just a little bit, because that's how you're going to actually get you know, as you continue to progress in the space, you know, you're going to see within the next five to 10 years more investment into the Alzheimer's space, and you're gonna see, you know, actually potentially a full on cure for Alzheimer's. So that's exactly how it happens, you know, think of HIV, remember? Yeah, back in the 80s people were dying left and right, you know, 90s, and then all of a sudden, people started investing into space. And before you know it, you know, I mean, we're at the point now, it's pretty much not a sentence as it used to me. So true.
Susie Singer Carter:That makes so much sense. Again, you know, it's like, we're doing a documentary. I don't know if you know, that called No Country for Old people, which is about our broken nursing home crisis. Right. And, and basically, y'all have stories on that, don't we? Yeah. Well, sadly, we do. And, you know, and we're, our partner on this project. I'm sure you saw it since you're in the pharmaceutical arena is, is the lead prosecutor in the pharmaceutical case against Purdue Pharma. So really, yeah, so it's Rick. And I don't know if you saw
Stephan Jackman:Yeah, I did. I did. And most recently, painkillers. Yes. Yeah.
Don Priess:Yeah. Which he was portrayed in all he was portrayed in that also. Yeah. Yeah.
Susie Singer Carter:Yes, he was. Yeah, but but that was a different story that like painkiller was a bit more I think poetically. fictionalized. Yes. They took a little bit. Yeah,
Stephan Jackman:exactly. But but but but both range drill so yeah. Because, yeah,
Susie Singer Carter:yeah, I think they both are very valuable. But, you know, his mantra is follow the money. So in any in any business, so it's interesting, you know, I think to our listeners that that still still the reason why we probably don't have a cure is because there's not enough interest in Alzheimer's financially. And, and that's where, why we have we don't have as much progress correct in it.
Stephan Jackman:So there is enough interest financially. I mean, you know, picture it, you know, anyone over 65 that actually have So no plaque within the brain, there's a lot of interest to provinces, there's just way too many failures. That's that's been the biggest issue. A lot of people have been tracing like, what exactly is Alzheimer's? Is it plaque buildup in the brain? You know, is it just that you know, you just lose memory over time? Is it your immune system? So, there's been a lot of things that people didn't just like, you know, really researching? And this, you know, and time and time again, you know, these larger pharmaceutical companies have just failed, you know, it's kind of, yeah, they've just failed because the endpoints of seeing, you know, like, okay, is this actually something tangible, to move the needle, that the FDA is going to actually, you know, give you the go ahead to commercialize this product. So that's been, that's been the biggest issue,
Don Priess:I think, unless you can reverse and and reverse to a point where you're not just leaving somebody in a bad stage of Alzheimer's, you could reverse something and take the worst stage, you literally could. So until that happens, where it basically just gets rid of it or gets you to the point where Oh, yeah, I just forget things occasionally, here and there. First of all, there's again, no way to quantify if it's working or not, I don't I don't know there's a value there unless you actually reverse it or get to a point where like, oh, I have all sorts of stopping it. I'm stopping it right now. complete, complete prevention. Yeah, well,
Stephan Jackman:will they will they have the Act? The Alzheimer's cognition scale, you know, so what they do is that when they give you the drug in human clinical trial, they'll test and they want to check and see, you know, your cognition? Is it improving, improving your associative learning? Is it improving cognition? Is it is it improving, you know, you're just basically irritability, you know, and everything else that you know, that you have, that you have going on in your daily life, and if they see an improvement, you know, within that by taking this medication, then yes, and they can say that, you know, you're moving the dial. And that's, that's more of observational, but then they'll also, you know, do you know, basically what the different assays that you know, your blood, you know, they'll check and see, you know, like, what your levels are, you know, within plaque, you know, within the beta amyloid or tau phosphorylation or, you know, basically the ligaments within your blood, but then they'll also do PET scans or MRI, to see if that there is a change within the brain, you know, and that's basically what what a lot of organizations such as ours are working on. I mean, for us, in particular, we have, in our opinion, you know, two shots on goal, you know, we have a tried and true drug, which is the next generation lithium, that's already been shown within human clinical trials to slow down the progression of Alzheimer's. It's a drug that's been on the market since the 70s. And it's been approved for bipolar, it's considered to be the gold, the gold standard for bipolar disorder, right. However, it's also used off label for major depressive disorder, PTSD, you know, and lithium is shown in human clinical trials to pretty much reduce the amount of plaque buildup within the brain. And near it's considered also considered to be very neuroprotective, you know, more so that in 2022, eu, they approved lithium for autism. It really because it because of its neuroprotective properties. So so what we have in our portfolio, and what we're working on, is a new version, next generation lithium, that requires less lithium dosage, you know, so it's much safer. So you're not going to see the same side effects, you know, to go into patients with Alzheimer's to reduce irritability, and pretty much slow the progression, it would be more along the lines of a maintenance drug that can help with irritability. And it can help slow the progression of Alzheimer's, this is more for a mild to moderate Alzheimer's. So if someone has, let's say you're, you know, 65, to set to 85. And you haven't, you know, something that you'll take, of course, it's not a cure, but at the same time, it can help slow the progression until the cure is actually on the market. But then we have a follow on drug, which is a vaccine, that's a potential full on cure for Alzheimer's. And what's interesting about our vaccines, is that as we get older, our immune system pretty much weakens. And what does vaccine is built on a cancer platform, so it's, it's precision medicine. So we take your blood from your body, and we spin up the white blood cells from it. We mix it with our mutant peptide, we create a vaccine tailored to you that we now put back in your body. And what that does is it basically strengthens your immune system to fight and reverse the effects of Alzheimer's.
Susie Singer Carter:Interesting, do they is this technique done in other kinds of you know, where you're removing blood and then putting it back?
Stephan Jackman:So it's done. It's done only it's it's not only done for cancer, it's only done for people who have cancer, and this and this specific this specific This particular technique has been proven in product called Provenge by Dendreon and it's for prostate cancer. So it's pretty much using the same, you know, technique to and platform to pretty much use for Alzheimer's. So it's been a it's been an uphill battle because we're pretty much treating them as if Alzheimer's is a cancer.
Susie Singer Carter:Right. Right. Right. Well, in a way it is, in a way. I always, I mean, in my in my very naive dumb, you know, like not medical mind, but I have good instincts. I always think of Alzheimer's in a way like cholesterol, you know, like, it's, it's, it's, you know, and I know, my mom had high cholesterol. And I think that there must be a correlation between high cholesterol and Alzheimer's. It is a plaque buildup, right? So I know it's different kinds of plaque, but it's the same. It's the same process that's happening. It's it's killing. It's smothering.
Stephan Jackman:Exactly. And how do you clear that up, and also, the current, the current drugs has been approved by the FDA. Unfortunately, they're a one size fit all. So it may work for some, and it may not work for a lot of other people. And then there's also Satan. There's also side effects that comes with that. And so having a vaccine that's tailored specific, specific specifically to you, you're not going to see that because it's pretty much treating you with your own DNA. And that cannot be used for someone else. So by creating this vaccine, it's just hey, this is Susie's treatment only for her. No one else can use it
Susie Singer Carter:sounds like it could be very expensive. No dependents? Yeah,
Stephan Jackman:depending depending on on the manufacturing process. But we were being that we've had a lot of, you know, experience, you know, of being caregivers in general, you know, we try to partner and with organizations that can maintain, you know, a low manufacturing costs.
Don Priess:My sister has MS. She cannot afford the medication. She can't afford the what is it? $7,000 a month, so she just doesn't take it. And I think that's what most people don't either or insurance won't cover it. And so, you know, we see the promise of this and then but if somebody can't afford it, what's the purpose? And how do you safeguard like you say you will partner with other companies that would maybe keep that down? But how do you get it to a point where everyone can do you could use this?
Stephan Jackman:Well, I think Alzheimer's is a different space than than Ms. Alzheimer's right now. It just in 2023 is projected to the government's going to spend over $289 billion, you know, Alzheimer's care, and, and medication. You know, so having a treatment on there, there's a potential cure, you know, it justifies me, technically, you can just hand out everything to everyone for free, because you're pretty much taking away the DNA, you're absorbing the burden from the government. Right. So that kind of justifies it. So that's why, you know, it's kind of like, it's good to go off to the Alzheimer's space. The problem with when you think about Ms. Unfortunately, you know, that's not the same case. But But I think most pharmaceutical companies don't quote me on that, but I think most have some kind of a patient advocacy program, you know, and your sister have actually reached out, you know, to, you know, to say, like, Hey, I have MS. I'd love to take your medication, but you know, I just can't afford it. And they'll, you know, provide her with, you know, with, with, basically drug vouchers and with the drug.
Susie Singer Carter:Yeah, we did that for my mom, we did that for my mom with AirSep. Because every step was really pricey at the time. And I also did it for because I get migraines, and I did it for Relpax at the time, because Relpax is now it's now they now have a generic but when I started using it, they didn't and it was so expensive.
Stephan Jackman:Exactly. You know, so yeah, so when the drug is first released, sometimes, you know, it's a lot more expensive, because of the fact that the development cost of these drugs are just not cheap. You know, you're thinking about just the human clinical trials of itself are hundreds of millions or even billions of dollars, because in order to you have to prove unequivocally that this product is safe, it's not going to kill anyone. You know, so the FDA require you to do a lot of human clinical trials, you do your phase one, twos and threes. And phase one is about 80 patients. Phase two is about 300 patients. And phase three is about 3000 patients. And on average, you're partnering with clinical trial sites, and patients that actually you have to pay to participate in the human clinical trials. So it can run you anywhere from 50 to$200,000 per patient. And that's not including the drug. Right, right. You know, so when you multiply that by 3000, you're like, oh, okay, so you're spending a lot of money to prove that this drug is actually not only efficacious, but it's definitely safe and you can I can give this to my loved one and not worry that they're going to, you know, all of a sudden die.
Susie Singer Carter:Right. Speaking of dying, let's go back to live Then, I don't know why I said that.
Stephan Jackman:It doesn't kill you though. It's bipolar disorder, but but it's used for for Alzheimer's.
Susie Singer Carter:Right? So there's a lot of drugs that are you know, off off marketed, you know, they're off label marketed for different sorts of things, some in a bad way, some in a good way. Hopefully this lithium is in a good way by how do we know for instance, let's let's use Depakote as an example, my mom was given Depakote, you know, off label drug for epilepsy, anti seizure drug, I wasn't told about it, it actually is a black box drug for a back label drug for people with dementia and Alzheimer's. Actually, Rick mountcastle He also led prosecution against Abbott Labs for marketing Depakote, because my mom ended up she was a very vivacious healthy, physically healthy human being. And she became immobile and incontinent after just a month or so, with Depakote. So because it you know, you do all this some semblance, and, you know, in the immobility that it creates, you know, you lose, especially someone with Alzheimer's, you you forget you forget how to walk anymore, you forget how to
Don Priess:permanent it was a perfect talk. Exactly.
Susie Singer Carter:So how do we know that lithium? How what what do you do to safeguard that it isn't a Black Label drug on on somebody with with dementia, because it seems like they are very sensitive to many drugs.
Stephan Jackman:So let's So lithium is considered to be a narrow therapeutic index drug, and it does have a is a blackbox. Warning. So basically, you have to if you're on a lithium regimen, you have to have your blood monitored. So it's considered to be it has this a therapeutic monitoring drug, you know, so you have to, you know, you basically have to monitor your blood if you are on a lithium regimen, because high dosage of it. And that can be toxic to your renal glands, your kidneys, etc. And so you want to make sure that you do check in with your doctor. However, lithium is proven tried and true to be the gold standard for bipolar disorder, it is the number one drug for bipolar. And it's and for most antidepressants, if you're taking it for depression, you know, you have to take sometimes you have to take a lithium as an adjunctive therapy in combination with your antidepressant because it helps with suicidal thoughts or suicidal ideation. So that's so that's kind of the benefits of lithium, you know, so it's and, and it's probably one of the most studied drugs, they've been over 500, you know, human clinical trials with lithium, and over 5500 periodicals articles that have been written, you know, about lithium being studied for everything neurodegenerative, which is Alzheimer's, Parkinson's, Ms. ALS, traumatic brain injury, even down syndrome. And it's also been studied for psychiatric disorders. So we're talking about depression, PTSD, you know, and bipolar disorder. So it's so wildly known. And what we have just released, we released data from our face to a multiple ascending dose study that showed that at the maximum tolerated dose of our product and the next, you know, next generation lithium, and I'll go into what the ingredients are, we came up with a dosage of 240 milligram equivalent of lithium carbonate. And just so you know, in terms of context, the average you know, the recommended dosage of patients with bipolar disorder, or even depression or PTSD is about 300 milligrams. So we can, you know, so even at a maximum dosage of our drug would be about 240 milligrams is just 20% Less lithium that you're taking. And, you know, and we hypothesized that at this dosage, we will not our product will not require therapeutic drug monitoring, so it's much safer. So it would minimize the side effects.
Susie Singer Carter:So you're seeing that though, you're finding that are you found that the lithium This isn't used for agitation in with someone with dementia, or or is that it can be
Stephan Jackman:it has it has been in recent clinical trials, not our product, but lithium carbonate has been studied. And if you were to go to clinical trials.gov Or using like you just Google on on on different periodicals in general you'll see that lithium carbonate has been used for agitation with patients with Alzheimer's, it's even in use at a low dosage because you know, with neurodegenerative diseases, they say that lithium, you will not have to use a high dose that you're using for people with bipolar disorder or depression or PTSD. You can use a much lower dosage that's much safer and it will It will help with cognition, associative learning. And as well, as well as the reduction of plaque within the brain. Because it's because it's very neuroprotective.
Susie Singer Carter:And so is this available now, or this is what you're working on.
Stephan Jackman:So, so our product, we're working on our next generation lithium, we just completed our phase two A. So we're working diligently to get to move into our phase two B, in patients with Alzheimer's. But then we're also working to get into phase two A's for patients with bipolar disorder, which is low hanging fruit, of course, major depressive disorder and PTSD, because even though we have a product that's really beneficial for Alzheimer's, you know, which is basically what our goal is, because we do have family members who are afflicted with this disease. We also don't want to forget the patients who are suffering from bipolar disorder, major depressive disorder and PTSD, I can tell a story, you know, one of my best friends, you know, her and her husband came home from dinner, and sought a daughter in the living room, she broke into the husband, my friend's husband's safe, got the gun, and had it had it to her mouth. And then she's and she was going to commit suicide. And, you know, they caught her just in time, you know, and so it's one of you know, and then they found out, you know, not only she very depressed, but she also somewhat suicidal and, you know, they it after around a test, it took about a year and figured out, does she you know, she does suffer from bipolar disorder, you know, and, of course, then she got on the hamster wheel of the plethora of medications that's out there, and you just have to really find the right one that's good for you. And it's just devastating when you get to that point, because, you know, how do you find the right one to titrate? Have you
Don Priess:found that there are and I don't know what the side effects are? are the side effects are different for each disorder. So for bipolar for PTSD for MDD, or for Alzheimer's, do have the lithium shown different side effects? And if so, what how do how do we overcome those.
Stephan Jackman:So thus far, we're seeing that our product is highly tolerable. And so and we've reported that, so because our lithium is lithium, salicylates and Prolene combined, and then it's, then it's co crystallized. So we have an ironical crystal delivering lithium comprised of, you know, basically salicylates and Prolene. And so what happens is so so, so this later, salicylic acid is an aspirin, which is an anti inflammatory. So we combine that with an amino acid, Prolene and lithium, and then it's called crystallized. So picture sugar, picture sugar, or salt crystals. And what that makes them make the product that gives it greater bioavailability and greater by a distribution, which means that your body absorbs and process it so much better, more efficiently. And so So basically, and it allows the product which lithium to get, basically, to the site of action, the goal is to get lithium to the brain, and spare the body of the toxicity. Because the brain is where lithium does, its magic, it's neuroprotective, and it helps to reduce the plaque buildup within the brain. And so how do we get it to the brain without basically messing up your internal organs. And we believe that the combination that we have, and by also making it cocrystal really does help that and thus far, we've been showing that because it is a cloak wrestle, it allows you to also administer a lower dosage, and you get a higher therapeutic index. So our phase one a week, we compared our product in a bioequivalence study, we we compare the equivalent of 150 milligram of lithium carbonate of our product to the 300 milligram of lithium carbonate, and we achieved by equivalent, which means that you know, pretty much you have, you know, the similar product, but less the dosage right, which which you should see minimal side effects with
Don Priess:that, which is excellent, what are some of the side effects? I mean, what are the side effects of lithium?
Stephan Jackman:So, the side effects of lithium are nausea, vomiting, you know, typical things that, you know, that are with some of the drugs. So, indigestion, diarrhea, and so, if so, so with that, you know, having a lower dosage of a product on the market, you know, makes it a little bit safer. So, our goal is to how can we help our family and your family, you know, with a product and to put a product in the market it's much safer than something that we know to be the gold standard of what's out there. You know, so picture like a better aspirin.
Susie Singer Carter:Right Gotcha. Let me ask you a question. You know, I'm not to be combat confrontive about it, but just blind. But just to be blunt, like, why are you the ones that discovered that that lithium can remove plaque when this is like the you know, are you the only ones that have known this?
Stephan Jackman:No, we're not No, we're not the one so. So this this product we licensed from the University of South Florida, okay, because the inventors of this technology, like I said before, there's been over 500 human clinical trials that have been conducted on lithium carbonate, you know, and over 5500 periodicals have been written about lithium carbonate. So lithium is well documented and characterized. So you know, everything about lithium under the sun is just that it requires therapeutic drug monitoring, and it's also off patent. So it's not prescribed as much,
Susie Singer Carter:right. But that the plaque like,
Stephan Jackman:oh, but the, but the removal of plaque, that that that came from human clinical trials have been conducted to show that, hey, this product actually does. So they've been phase two studies that show that for efficacy for lithium carbonate that showed that, hey, this product is actually viable for Alzheimer's. So why are we not using it? You know, so it's one of those. So it's one of those things that it hasn't gone through a phase three, because of course, a product is off patented, but it hasn't gone through a phase three to get approval from the FDA for that specific indication. The only indication that lithium is approved for by the FDA is for bipolar disorder. However, it is used off label for major depressive disorder and PTSD.
Susie Singer Carter:Right. But and now we want to try to do you're trying to push it through for Alzheimer's.
Stephan Jackman:So now why now so we've come up with a next generation lithium that we want to go for Alzheimer's, as well as bipolar disorder, major depressive disorder, PTSD, we want to come up with an we have a newer, potentially safer, and a better version of this product to put on the market that will actually move the dial and help millions of people within the United States, this product alone can help about 43 million people, probably about 600 million people.
Susie Singer Carter:Right. So for me, it sounds, I mean, it sounds like a miracle drug for me, because you're saying that it helps with agitation, which is a big, which is a big issue and problem with Alzheimer's and dementia. That's one of the things that it makes, you know, caregiving for someone that you love, so difficult, because the agitation is just you know, is a manifestation that comes that is, it's unavoidable in some cases, and it can be really, really devastating for both the person and the person's loved ones and the caregivers. And also those you know, but drugs like that, that help an agitation is, especially in our facilities that don't that are understaffed, and overworked and underpaid. You know, that's why there tends to be abuse of those kinds of drugs, because they, you know, you know, when you say it's crystals, and, you know, like a Depakote. If you remember, they were marketing it as these things called sprinkles, they just sprinkle it on top of food, right? It's like, it sounds cute. Oh, let's get let's give Norma some sprinkles, let's get Norma
Stephan Jackman:it's a way of yes, it's a way of trying to deliver delivered a product, you know, to patients that you know, can't swallow pills, of course, you know, so they'll do it, you know, actually as a sachet, like, you know, basically something sprinkles that they sprinkle into foods, or they'll do it as as basically a liquidity solution where you can pretty much you know, give them the liquid version of the pill, which makes it a little bit better. But, um, but definitely having something like lithium and next generation lithium, that that's a little bit safer for patients with Alzheimer's to take and to help with associative learning and even agitation. I mean, that's great. It gives them a little focus, it gives them back their life, or some semblance of independence, which is most important, because I think one of the major one of the major factors that I don't know about you, but for me, you know, of putting my uncle into a facility was the agitation. You know, once they, once you become unrecognizable to them, and they get extremely agitated, there's really nothing you can do, because, I mean, you just can't calm them down. There's nothing you can and it's devastated.
Susie Singer Carter:Right. I mean, there are behavioral ways to do it. It just takes time it takes it takes manpower. But but, you know, again, I'm gonna go back to how, you know, the responsibility of a pharmaceutical manufacturer, okay, as yourself, the responsibility for me for you that I am saying out loud, how can you help with the responsibility of this abuse that happens with drugs in these situations of, you know, nonprofit, for profit, long term care facilities that rely on this kind of, you know, tool to help ease their day and make it easier for themselves when it actually exasperates the disease.
Stephan Jackman:So that becomes more of a systemic somewhat issue. I think I was reading an article about the HHS Health and Human Services. You know, I think I was reading an article I think was most recently this morning, when, when, when they were talking about, you know, kind of establishing guidelines for nursing home, you know, to say, exactly, you know, and I think one of the things in terms of, you have to make sure that you're not understaffed, you know, what I mean, like one of those things that and you can't get the staff like, okay, for example, you know, like my uncle's nursing home, it's kind of like, you have one nurse's aide is responsible for eight people during her eight hour shift. And, you know, it's going to take her about two hours per person, you know, so it's kind of like a mask gonna happen on him and him or her is going to take them, you know, that time, it's kind of like, they don't have the time to get through the certain amount of patients in that time. It's just not feasible, you know, so I think it's a lot of and, you know, and as a result, they said, Well, hey, why don't you just do this, you know, and the person isn't really getting the care that they really do need? It's it's difficult. And it's something that, you know, if you look at, you know, whether you're looking at, you know, as this is
Susie Singer Carter:systems issue, yes. It should it
Stephan Jackman:should, it should, is it a funding issue, does this need to be heavily subsidized, like, what happens, there's no way that, you know, you have this person who worked their entire lives, pay their taxes, you know, was an upstanding citizen, then at the end, you know, their lives are pretty much relegated. Yeah, that's pretty much useless in a comatose warehouse. medication. Exactly. Which is just not right.
Susie Singer Carter:So how can we I hear you, this is what my documentary is about, I hear you 100%. But what can the pharmaceutical How can we I, you know, probably Rick, if Rick mountcastle was watching this, he's cracking.
Stephan Jackman:Well, he wants to have pharmaceuticals, biotech so far. So we were founded in 2016. And thus far, we're publicly traded. And we have gone public in 2021. And thus far, we've raised a little bit over $30 million. And so we're pretty much you know, at like, the low, low, low, low, low on the totem pole. And we have, we have been scrappy and nimble, we have four full time employees, three part time employees. So when you think about what we have accomplished, when we think about, you know, the average biotech, you know, has a staff of 50, and they have have in their war chest for, you know,$200 million, you know, so we have, you know, we have spent, you know, pretty much 90, you know, over 90% of our capital that we've raised to, you know, to develop these products, because our goal is really to get something on the market as quickly as possible that'll benefit, you know, all these people. So, yeah, so we're not missing,
Susie Singer Carter:what is awesome. And now I've saved it to the end, what is it tell me what is
Stephan Jackman:for all of them, and is a bias a small, a clinical stage biotech company working on treatments and cures for Alzheimer's disease, bipolar disorder, major depressive disorder and PTSD, we want to help not only our family, but your families, you know, that are afflicted by these devastating, you know, diseases and disorders? You know, we've been through it, we've been caregivers, you know, we are caregivers. And so our goal is how can we get something on the market that's much safer than what's actually on the market now. So we and as mentioned before, our next generation lithium would really be you know, a something that's that'll that'll impact public health greatly, because having a product is tried and true, but just much safer, at a much lower dosage that will not require therapeutic drug monitoring. It's pretty much great for the sufferers of bipolar disorder, major depressive disorder and PTSD, you don't want to talk about I don't know, you see all the latest bipolar disorder commercials, and they're like, oh, but the side effects, you know, thoughts of suicide, etc, etc. Well, then they have to use Guess what? Lithium, which is our product, so? So yeah, so it's one of those things that it's great.
Susie Singer Carter:It's just scary for the layman out, like us, you know, like caregivers and just regular folk who don't know a thing about it, you know, and we and there's now I think we're all frightened enough, and rightly so. To trust anything, like there's so much there's so many platforms to market to us, you know, as, as you know, consumers, and we don't know, we don't know. And,
Stephan Jackman:but But that's why that's why you're here. And that's the greatest thing about it. For people like you, you know, who become advocates and say, hey, you know, we're going to educate the public and we're going to bring these people On our podcasts and we're going to talk to them reach out to whomever I think you should, you know, reach out to someone in Big Pharma said, you know, I'd like to have you on my podcast, let's talk about this, let's talk about this product in general, you know, and is it really benefiting people? You know? And is it being abused? Just like, you know, you mentioned in Purdue pharma and dope sick? Is it being abused by the patients? Or is it being abused by, you know, the company or as the physicians who are basically prescribing these, you know, these drugs, it's great to have a sounding board and great to have you guys here. So people can kind of, you know, listen to your podcast and said, Hey, I'm gonna research is great that they have this person that can really help me because, you know, I'm going through the similar situation with my family member, I'm a caregiver, or I'm a patient, and I'm taking that, you know, that product, this may be better for me. So I now get to go to my doctor and said, hey, you know, these are the questions that I can actually ask because Susie sets up. In a good way, you know, what I mean? Like, because, you know, because, you know, a lot of people, you know, we're siloed, right. And sometimes, you know, you know, when we are when we're either a family member is ourselves and diagnosed with something, you know, we don't really have a wealth of resources. And sometimes, you know, yes, I may, not new Susie Carter, but what happens is, I can now listen to her podcast, you know, see her YouTube video and start to do some research on my own, and not just take, you know, my physician or Big Pharma or someone else's word for it, you know, it kind of helps to have something out there. And when you just, and all it takes is Google, you just Google and all of a sudden, you know, like, you know, we're all caregivers, my mom is going through some, you know, some health issues, you know, currently, and I'm the same way, I'm like, Okay, what are you taking that me, me look at all these things, I'm not a doctor, but I will, you know, research and I'll take it, I'll talk to my physician about it, you know, and said, Okay, and let's get a second opinion. Let's, let's get you to all these other people that, you know, let's get a second opinion. Let's understand what we're dealing with here. Because sometimes a lot of people do sometimes second opinion, is all you need.
Susie Singer Carter:So thank you for that. So what just just to to, like, button this up? What do you need more people to? I mean, be part of your tests right now? Or is there some way that our listeners can get involved with you to help you with your,
Stephan Jackman:I think it's more along the lines of, you know, we look at it, you know, the, we just wanted to be a part of this podcast, this, you know, show that there is hope, that there's a lot of organizations such as our developing, you know, really novel, you know, and exciting new, you know, products totally that that are somewhat tried and true and tested. And that will be available, you know, in the market,
Susie Singer Carter:can any of our listeners, can they sign up for any of your trials or anything,
Stephan Jackman:and they can they can reach out to, to us, they can, you know, look at our website, you know, we will be posting, you know, the upcoming clinical trials and how they can get involved and how they can get there, you know, or sign up their loved ones to be involved in our, you know, our human clinical trials. So that's, that's really good.
Susie Singer Carter:That would be great. That would be a big question
Don Priess:is without, and I know, there's so many factors involved, but without pie in the sky, when, when will and I know, the the, and the bipolar and the other ones are going to be first. But for Alzheimer's, when can we realistically say this is something that we will now be, you know, we'll be available? And for a price that people can afford? When When is that?
Stephan Jackman:And you can't quote me on this? But I'd probably say within the next five years. Yeah, exactly. You can't hold me to that. Because, you know, because as a biotech, we, you know, we are always in fundraising mode, of course, you know, we have investors and people do invest in our stock and everything else. But, you know, but we do, you know, I would say, you know, if the planets and everything are aligned, I'd probably say within the next five years, you'll see, you know, you'll see something
Don Priess:we know, sometimes it can take 10 years just to get approved. You know, once you went to everything is the way it's supposed to be.
Stephan Jackman:We're not worried about you know, anything, any of the indications we're going after, you know, yes, bipolar major depressive disorder, and PTSD is more low hanging fruit. It's what lithium is already been used for, you know, so we're just checking the box as far as that concerned. But concerning Alzheimer's, you know, if you do have a product in human clinical trials, once you get to your face to B and you do an efficacy trial, and you show that there is efficacy within the product, the FDA will work with you to fast track that product, you know, to get it through the clinic as quickly as possible. So when we talk about vaccine, we initiated a phase one slash to a in March of this year and so because it is, as I mentioned before, a patient specific vaccine, you have to put it in patients with the disease so we're putting in patients with Alzheimer's So we'll know safety as well as efficacy. And if at the end of that study, we saw, we see like great efficacy, we will meet with the FDA once again and show them the results. And if the results, like I mentioned, is built on a cancer platform, if the results are, oh, my God, it reversed the effects of Alzheimer's, or then the FDA is gonna say, like, that's a goal, you know, like, you have to expedite this the development of this drug. And also understand, I think it was under the, I want to say under the Trump administration, they after phase two, there's a I think they instituted the right to try, you know, where if, you know, if you're reading about different companies who, you know, who are working on human clinical trials, you know, even if you're you can participate in the clinical trial, you can say, hey, this product have gone past this point, can I try it, because, you know, I'm suffering from this, or I'm a caregiver, and my loved one is suffering from this. So and I think that's also great, too, especially if you can kind of read and use the like, the safety, you know, like, it's safe. You know, hey, I want to try
Susie Singer Carter:this as well. And when are your next clinical trials for the vaccine? Sort of
Stephan Jackman:sort of vaccine is underway right now. It's initiated in March. So we'll know, sometime in 2024. You know, if of what's going on with the vaccines
Susie Singer Carter:to like, this next phase, it would,
Stephan Jackman:it would be a phase to be,
Susie Singer Carter:and that would be in the 2024. So we'll keep us posted. And yeah, exactly. Yeah. Because we we also know the pains of fundraising when we've been fundraising. We don't need quite as much as the as they do. Now, you know, we get a little bit Come on, folks, we're trying to help you.
Stephan Jackman:But so how is that going in the midst of the whole strike? Terrible to say that
Susie Singer Carter:terrible, it's terrible. I mean, there's a big old word called ageism that really you know, doesn't make it a very sexy arena to play in. Yeah, we are we are No Country for Old people has to get out people need to we need to, we need good drugs for Alzheimer's and for people that are suffering with with mental challenges in all ways. And and that includes dementia, Alzheimer's, you know, bipolar disease, PTSD, all of them. And, you know, we're doing this is our lane. Our lane right now is is you know, and you have your lane, but you know, what we they all met, they all meet.
Stephan Jackman:I hope it works, you know, because I believe in what you guys are doing. I think that's fantastic. And you know, and any help that we can, you know, if we were a big pharma, I would fund it. We just
Susie Singer Carter:need a couple $100,000
Stephan Jackman:We were a big pharma, it's funded, but unfortunately, we you know, we're trying to get some drugs.
Susie Singer Carter:No, no, I hear you, baby. Well, we just need a couple 100 So, you know, that's all we need anyone? Yeah, but uh, yeah, thank you so much for taking time with us today. You're a delightful human being. And, and, you know, we're rooting for you get this.
Stephan Jackman:Thank you. Hey, we're relentless. We're gonna keep persevering until it happens. So thank you. Very good. God
Susie Singer Carter:bless your heart. Well, that was good, Don.
Don Priess:Yes, it was. You know, I think we we have preconceived notions sometimes about it. You hear pharma or pharmaceutical? And you're like, Yeah,
Susie Singer Carter:you know what, I still I still have that a little bit of the No, no, and it's not it's not so fun. And it's not, you know, hit all 1000 men or anything like it's just the whole industry.
Don Priess:We have ESD Yeah, we have PTSD. Yes, we do. We need some lithium lithium now. Sweet. Sweet.
Susie Singer Carter:Because, honestly, like, I wanted to grill the hell out of him. And I couldn't No, such a nice person. And I feel like well, maybe you know, and you don't want to, you know, obviously, we want people that are passionate. And of course, everything is a business and you have to, you know, me I'm Pollyanna. I'm like, well, you're make in my mind, I think, well, you're making money out of it. So you must be nefarious, you know,
Don Priess:and they're not Yeah, they're not pharma though. They're the they're the tech, but they are going to have to, you know, they're going to have to partner they have to partner with you know, with
Susie Singer Carter:and then once it leaves their hand, then it goes into the farm,
Don Priess:you know, and then into the marketing. Yeah. Oh, that's
Susie Singer Carter:yeah. So it gets all crazy. But in the meantime, I hope that that everybody got a lot out of this. I did because you know, I haven't talked to a biotech company. He before so this was interesting. And to find out, you know how a little bit how these trials go and how long it takes it takes so freaking long.
Don Priess:You know the has to I mean, it's too short. You'd be a little worried if you don't take their time. Yeah,
Susie Singer Carter:we're worked on my dog. Let's go.
Don Priess:He's coming from a place and it sounds like everyone in the company all has been touched. They're all caregivers. He's as he said, his you know, his uncle. And they're going so it's it's more on just a business level. It's on a personal level. And it comes from love. Right? I think it comes from love. It does do good.
Susie Singer Carter:And you know why? Because law is power. Love
Don Priess:is powerful. Yes. And love is contagious. And that's right. And love
Susie Singer Carter:conquers conquers Oles. And we thank you all so much. And if you like us, please, please share and keep listening to us. We have a lot of great guests coming up and like Ashton Applewhite, you can if you haven't listened to our last podcast, please do. She's amazing. Along with you know so many of our other guests and, and have a wonderful day. We love you. Bye.