The Future of Self-Care with OTC Prescription Medications | Fady Boctor, MBA, Petros Pharma

This transcript was generated automatically. Its accuracy may vary.

[00:01:05] Mike Koelzer: Fady for those that haven't come across you online, introduce yourself and tell our listeners what [00:01:12] we're talking about today.

[00:01:13] Fady Boctor: I'm Fady Boctor, president and Chief Commercial Officer of Petros Pharmaceuticals, a publicly traded company on nasdaq. Tick is PTPI. We have one prescription erectile dysfunction medication currently on the market [00:01:27] and happens to be our core subject and ambition to switch to over the counter, which we'll dive deeper into. And that leads me into the thing for everybody to tune into. It's a fascinating marketplace. It's an emerging marketplace with very few windows in life. We have [00:01:42] opportunities to get ahold of something before it's Caught mainstream and before it's become ubiquitously known. And I think this podcast serves as a precursor to such a thing, such an opportunity.

And that is the emerging self-care marketplace more specifically involves [00:01:57] prescription to over-the-counter switches. So imagine a lot of your preferred and dependent upon prescription medications now being available to you in this coming era available to you without a prescription. So you no longer have to set an appointment with your physician. We'll talk about a [00:02:12] tremendous physician shortage that counteracts that. And the medication being available to you at your local pharmacy or for you to purchase online without a prescription. A tremendous empowerment to the US consumer patient.

[00:02:23] Mike Koelzer: Now Fadi, we old farts as we look back. , [00:02:27] I'm not saying you, I'm saying

[00:02:29] Fady Boctor: Oh, I'm right there with you.

[00:02:31] Mike Koelzer: I'm saying me and some of our listeners,

[00:02:33] Fady Boctor: I.

[00:02:33] Mike Koelzer: old farts. As we go back, we think, alright. You're seeing emerging, but we know all these products that have gone to [00:02:42] OTC. Is there an upward slope in your mind, or is something different from what you're seeing now?

Or are you just championing the cause which has been going on?

[00:02:55] Fady Boctor: Phenomenal question because [00:02:57] it touches on a dichotomy separation. Let me share with you what's occurring. So, CHPA Consumer Healthcare Products Association, they're out there watching and monitoring this marketplace and they've been looking at it for some time on their website.

[00:03:12] They've captured all the molecules, all the medications that were switched from prescription. So lemme give you a flavor. Since 19 74, 75, there's been about 106 switches. Of those, you'll find that the vast majority were essentially antihistamines allergy [00:03:27] medications, topicals, gels, and creams.

And that's fantastic. 'cause it's enabled by the consumer, I've got allergy season coming up. I can go buy my Flonase,

get my nasal spray, my topical gel, my antihistamine eye drops, all of it. So phenomenal work. But that is one class of [00:03:42] prescription OTC the class

I'm referring to relatively benign medications in terms of risk and adverse events.

And yes, it has been awhile. some may say maybe they should have never been prescription in the first place, But

nevertheless it [00:03:57] speaks to the dynamic and the gravity of those switches. What we're talking about as a new horizon is now we're talking about medications that have never been imagined for over the counter.

Switch, and that's where the new horizon comes in. So today,

think of your standard [00:04:12] migraine medication, your standard antidepressant medication, your standard hypertension medication medications that are critical for your chronic therapeutic value. But sometimes you can't see your doctor.

Sometimes you can't get your refills. Sometimes you just need the fluidity of those [00:04:27] medications that have never been entertained over the counter. In 2022, specifically the FDA had proposed a rule, proposed a new stipulation of additional conditions for non-prescription use.

That essentially opens a door for companies [00:04:42] like ours to begin to introduce technology that enables the consumer to appropriately self-select nuanced, and quote unquote complex pharmaceuticals without the physician intermediary that opens up a new gateway. It almost [00:04:57] redefines what this OTC self-care marketplace can and should look like. And I think that's the new horizon. It's a new grade of prescription grade medications that are now becoming prospects for over the counter switch. That is exciting. [00:05:12] 

[00:05:12] Mike Koelzer: it's interesting as you go on to I'm just gonna say Amazon or any of these places that have the online telemedicine, and they're very . Divided by different categories. And so [00:05:27] it's interesting to me because it used to be that people would go to the doctor and they'd say, Hey Doc, I'm just not feeling quite right.

But now you really go onto these things and you have to choose between, a urinary tract infection, the flu, a pulled [00:05:42] muscle in your side or something like that. In other words, they almost make you diagnose 

yourself 

before Before you pick what the doctor's gonna do for you.

 The word that caught me was technology. What do you mean by technology in this space?

[00:05:56] Fady Boctor: Yeah, [00:05:57] so technology, emerging and I'll say inherently, and I'll confess this, I'm not a huge technology buff.

I don't look at technology in everything to make it a better world.

In this particular scenario, it's different Technology in this particular scenario is essentially back and [00:06:12] backstage designed and calculated algorithms that

Ask the patient's medical history questions.

For example, ask patients about their symptoms and what brings them to this product today. based on the patient's response, what it [00:06:27] does is it enables the appropriate label, FDA approved label and drug facts label guided knowledge to apply to that patient's disposition, and then interpret whether or not they're appropriate for selection or necessary for deselection, in [00:06:42] which case refer to a physician for, greater care. I believe. I think it's overdue

the algorithms are the same decision models that physicians will often use in the primary care

setting, and now we're just putting them instantaneously at the fingertips of the patient, [00:06:57] potentially on a mobile phone , potentially by way of a QR code, potentially

in a very transient engagement mechanism that enables what would normally be a 30 minute visit, not including the TRA travel to the office and

back for it to be a few minutes for the patient to [00:07:12] say, here's my symptoms, here's my condition, here's what I'm looking for.

Here's my medical history. Am I good? You're, and if it's approved, and this is all mandated and governed by the FDA, by the way, that patient can go home with medication that very moment.

[00:07:25] Mike Koelzer: What do you mean they can go home [00:07:27] with it in that regard?

[00:07:28] Fady Boctor: it's in the pharmacy as quick as the re the local retail pharmacy,

whether it's

[00:07:33] Mike Koelzer: Instead of through the doctors doing 

[00:07:35] Fady Boctor: exactly, or

order it online for it to be delivered. As you can

tell today, 24 to 48 hours. So online [00:07:42] purchasing, no physician visit necessary

or at the local retail pharmacy.

[00:07:46] Mike Koelzer: Well, there's a lot. I mean, now if I go in, let's say for a yearly checkup or something, and I'm in the medical field, so it's not really, a fair, comparison, [00:07:57] but when I go into the doctor, I don't need really to talk about how my cholesterol is doing or how my weight is doing, or how's this rash you had last year?

And that kind of thing. When I go in there, I want to talk to them about, oh, this weird [00:08:12] tickle in my throat, and it coming from the, larynx or the pharynx, or is it coming from, I don't even know, pharynx, the word is that what

[00:08:19] Fady Boctor: It is now.

[00:08:20] Mike Koelzer: I don't know. It's now , it's coming from the larynx or is it postnasal drip?

 Let's [00:08:27] talk about something that is needed person to person, rather than the stuff that can be done with technology.

[00:08:34] Fady Boctor: That's a good point. Let me know if this touches on your points, but I think in light of the massive direct to consumer education and awareness [00:08:42] and advertising, many patients, first of all know how to self-diagnose. They know all about WebMD. They see this commercials for various medications

in the erectile dysfunction space. A class of medications called PDE iv inhibitors dominates it really. And this will touch on [00:08:57] your point,

PDE iv inhibitors include Viagra, Cialis, LA Vitras, and then our flagship pharmaceutical. All are in the same class. There's a tremendous amount of education to the public as to whether there is a prescription grade ed medication for you. And [00:09:12] what is erectile dysfunction? It's when I cannot attain an erection for sexual intercourse.

Very self acknowledged circumstance and symptom. The question is, there are risks with these medications.

There are guidelines for safe use. [00:09:27] So on the front end, to your point, on the front end, relatively easily, self diagnosable on the front end, readily and easily identifiable as a class therapeutic on the back end.

Wait a minute. There's some concerns. This is the FDA's job. There [00:09:42] are concerns. How do we ensure they are not on nitrates, which is a contraindication? How do they ensure that they don't have any cardiovascular conditions? That are warnings and precautions for use. How do we know that they've been ill-advised for sexual activity and therefore shouldn't take this medication and so forth and so on.[00:09:57] 

Where technology comes in is this is our job and this is the technology platform we're charged to build. It has to speak to those guardrails and controls to ensure the FDA assures them. We've covered off on all the critical matters of [00:10:12] issue and concern that the patient responds and self-identifies as appropriate, no markers of risk, then they could easily and readily pick up the prescription from the retail pharmacy or order online for it to be delivered within a few [00:10:27] hours to a few days. And I think that's where innovation lies. Never before has there been a drug device combination in this space to enable nuanced medications to be readily available to the right patients.[00:10:42] 

And I think that's where it changes the game.

[00:10:45] Mike Koelzer: Alright, Fadi, mentioned some of this earlier, here's what I'm imagining now. If somebody made me invent this right now. So I would make a handheld app [00:10:57] and that app, I don't know if I would trust. If it's non-controlled, I would probably trust people enough to tell me they're on nitrate or have other blood pressure things or stuff going on.

But I might [00:11:12] log into something with the cell phone . That proves to the FDA and you guys that I'm not on one of these, I don't know how quiet I would do that, [00:11:27] but then when everything gets correct to me, maybe I would have a QR code that the pharmacy would have to scan to allow this to go out or something like that.

Alright, now tell me what reality [00:11:42] is.

[00:11:42] Fady Boctor: You are not far. We're the reality of technology. And this is relatively nascent. This is emerging. We've got a few companies that are in this space today that we know of. And just keep in mind that this technology will continue to evolve.

But let me shed some light as to where some of [00:11:57] might be trending. So imagine that today there's a massive movement for health data health exchange. So whether it's your electronic health records prescription data already covers 95% of the US population, and that could be [00:12:12] readily integratable potentially that doesn't exist today, but that could exist in the future.

So the nitrate question that you mentioned, that's one mechanism. That could enable our product and future products to say, well, let's do a quick prescription history check to see what you've been on. And that

could happen instantaneously, [00:12:27] that could be

integrated and has the potential of being integrated doesn't exist today, but could we're imagining and hypothesizing for the future that's readily available. EHR, same concept, interoperability. There are a, there, there is a plethora and disparity among [00:12:42] EHRs, but there is a national standard existing today where everything should speak to everything.

So if we needed to check in on the EHRs for the patient, we could do that

instantaneously. Well, it doesn't exist today, but it has a promise of coming to the future.

The way we ask the [00:12:57] questions is another element. If you ask a question, for example, nitrates, we ran into this issue and I think many, many of the individuals in this field would know this. Sometimes some patients have been advised by their patient that it's okay for them to take

this [00:13:12] class of medication with nitrates.

That is a no-go for the FDA and by our label standards, we align. What we could do is ask them several questions. Do you have a nitrate? But you were approved by your physician? Do you, have you had a nitrate prescription but you've never [00:13:27] filled it? Have you had a nitrate prescription that you filled but never used?

And we can kind of dissect all the nuances and implicit biases within the patient and say,

okay, we now know your true disposition. It's okay, but you're not right for this medication, so go see your physician and get your prescription [00:13:42] through him or her.

That's where some of these nuances are captured and dealt with, and that's where the near future emerging technology will come into play in terms of integration with big data.

[00:13:52] Mike Koelzer: I see that being valuable because the example I gave, well, [00:13:57] now you're using data that's weak. I mean, we know that, I don't know a certain percentage of the medicine's not picked up from the pharmacy, and then maybe someone's not using their [00:14:12] nitrates because it's giving them a headache and they're not really on 'em and all this kind of stuff.

Well, I don't really know who has that information except for somebody telling the truth on their handheld and maybe like, again, maybe, maybe [00:14:27] there's some fibbing going on with controlled drugs and stuff like that. But I think most people probably want to, especially if they think people are looking out for them.

Wanna be honest on those questions? I don't know.

[00:14:40] Fady Boctor: You would hope so. You'd hope [00:14:42] so. And you'd think so Nevertheless. And rightfully so, the FDA won't accept those chances and they won't accept those assumptions. So they're gonna wanna know there's an ironclad or relatively close to ironclad assurance that the consumer is responding accurately

and [00:14:57] or there's a technology assisted feature that ensures that they're compliant. And that is a reality of, process. 

[00:15:04] Mike Koelzer: I got a relatively new Google Watch. I was waiting for the second one to come out, so I've got that now. And I was at my daughter's cheer [00:15:12] competition. She's coaching middle school people. And so, I went there with my wife and the problem is my wife was sitting to my 

left

And I was right in the line of sight of her looking down to the cheer competition. [00:15:27] I knew that wouldn't work 'cause then I couldn't play on my watch . So I got on the left side of her and I just searched around on my watch and it felt like an important time to take my electrocardiogram or something like, what is that?

I know EKG or something . I [00:15:42] thought this is the right time for me to check my heart. and anyways, I just sat there and I put my finger on the crown and it gave me my EKG and stuff. And I mean, you don't even have to. Lie about, instead of answering [00:15:57] questions about blood pressure with the nitrates and how is it gonna go with this drug and all that.

I mean, it could basically give you a diagnosis on your wrist with EKG, the blood pressure, your heart rate. I don't know what else would be in [00:16:12] there. Maybe a breathalyzer test or something down the road. It may not even take human honesty.

 A lot of it might be right there for you.

[00:16:19] Fady Boctor: I personally, I love that you brought that up. I think that is a phenomenal attribute and also another marker to this exciting [00:16:27] emergence for this marketplace because to your point, I've seen, and this exists and it's public, it's ubiquitous. There is technology out there, utilities that can take your vital signs right up from your phone.

And we're talking pretty advanced vital

signs. We're talking [00:16:42] blood pressure, A1C, believe it or not.

EKG, to your point. And we're so peculiar as creatures, I think as human beings, sometimes we're not. We're not as well calculated about managing our health the way we hope we would or the way [00:16:57] we think we are because we're busy and we're so saturated.

So to your point,

you could be in the middle of an event, in the middle of a game or a cheer event and decide, huh, I wonder what my EKG looks like.

I wonder what my blood pressure looks like

in my a1c. And this is where [00:17:12] you make change.

And this is where you begin to inform yourself. Where in the past we, we were so bottlenecked with, the only place you can get this done is either at the pharmacy or with the physician,

but think at the time and energy and scheduling that [00:17:27] requires for you to get such simple data at the fingertips. So that. Phenomenal point that you bring up. 'cause there are also components of the technology to come, which will be objective, vital signs taken right at the moment of transaction or in passing to let the [00:17:42] consumer know, wait a minute, I think I have a blood pressure issue. Wait

for a minute, I think I have a heart issue. Who do I go see and what do I go get and what do I do?

And that is, that's how you incite change

[00:17:51] Mike Koelzer: Well, my stuff at the game. I was just bored and goofing around, but. Part of what led [00:17:57] up to that is we have a number of children and now all of them are passed to cheerleading age and stuff. And a lot of the sports, and my wife was commenting when we came in there, she said, boy, this is kind of a blast from the past and we don't do this as much anymore.

[00:18:12] And like I say, my daughter was coaching, so that was up a level. But it makes me think like, well, why did I do that right then? Number one, I was bored, but two, it was implanted in me that I'm getting older, I'm now gonna be the grandpa figure, and I'm [00:18:27] moving up a generation and I wanna say that I just did my watch just for the hell of it.

But probably in the back of my head, you just think about how's my health compared to everybody else? Now who knows why I did it, but the point is that [00:18:42] you can do it when you're ready for it. When I was sitting there thinking about longevity, my health. Family, that's when this health, whatever came to me and I decided to do this.

There's so much out there. Everybody [00:18:57] knows we're supposed to take care of ourselves, but unless you talk to yourself in the right instant, or somebody else brings it to you in the right instant it doesn't matter as much. So, being able to do these things on your phone and this and [00:19:12] that when the urge strikes is maybe better than trying to fit your life into the medical system.

[00:19:17] Fady Boctor: I love the way you coined that and it's fascinating perspective and it, when you were saying that, the first thing that struck me was life's circumstance drives perspective [00:19:27] and life's circumstance and life's. Moments drive motivation. I'll share this with you and it'll speak to the same concept in many respects. So there are 30 million men who suffer from erectile dysfunction in this country, and a recent [00:19:42] study went out and looked at 6 million men and their claims, actual insurance claims, and those men that were diagnosed with ed. So 6 million men are diagnosed with Ed according to their insurance claims. Only 25% of them sought prescription therapy, the [00:19:57] other three

quarters did not.

And it speaks to the circumstance, the moment, the motivation, what will mobilize you? What will give you just insight to move, to, to act.

And three quarters have not. It's funny though, you say what you just said, and you're sitting there and you're [00:20:12] reflecting and all of a sudden those questions and that self-reflection leads you to taking a step and to learn more.

Am I there? And what do I need to do? And what have

I did not think about it? And then now you're inciting And I'll tell you one quickly, quick, important piece. [00:20:27] When it comes to erectile dysfunction, it's been demonstrated that often there's an underlying cardiovascular condition. The artery in the penis is a factor of the size of the artery in the heart. If you are beginning to experience atherosclerosis plaque, [00:20:42] it'll show up in your erections before it

shows up as a heart attack in your heart. And

so the millions of men out there that are deciding uh, ed, I'm too embarrassed. I don't

want to, I don't want to. What if you reached out to that individual or those individuals and said to them, [00:20:57] Hey, do you know that you might have an underlying cardiovascular condition that could translate into a heart attack in 3, 4, 5, 6 years? Then you'll start to get different mobility and different motivation to not only treat erectile dysfunction, which is the least important component, although for social engagement, it's critical. [00:21:12] It'll also get them to start asking questions. What else is happening? And, and I never knew I have no symptoms for any heart conditions,

but in fact. Your ED is a symptom from your heart condition. And so to your point, meet the consumer when they have those [00:21:27] invaluable, precious moments of self-reflection, insight, and motivation . Give them the data they need, give them the information and the access they need, and then watch public health transform.

[00:21:40] Mike Koelzer: Fadi, I don't allow [00:21:42] myself to talk about medical stuff on here because I usually either embarrass myself or I'm at about a second grade level and people turn off the show. when you look at some of this stuff about the past, like they always say [00:21:57] Americans are obese.

And you look at these pictures from concerts in the 1970s, and look, you can't see fat people in the group. They're all slender and have no bellies and stuff like that. Ed, is that, Is that getting worse? Is it not related? [00:22:12] Do you think the same prevalence was here a hundred years ago that is now just being talked about and so on?

Or is there any, you mentioned cholesterol. I don't know even those stats if it's getting worse or not, but would you say Ed's getting worse or is it just the same and now it's more [00:22:27] talked about?

[00:22:28] Fady Boctor: I'll bolt onto your comment to say, yes, as the country experiences a tremendous increase in obesity and diabetes, those are absolutely core or comorbid issues for erectile dysfunction. [00:22:42] So I would imagine that ED is increasing. And I'll tell you something that's interesting recently that we've learned. We used to think that erectile dysfunction was just an aging man's problem. 40 plus the percentages begin to increase exponentially as you age. Well, recently what they realized and what they've [00:22:57] discovered through recent research studies is that we're starting to see men, one out of four men, 25%. Of men emerging with a diagnosis of ED under the age of 40,

and then that begins to speak to potentially substance abuse, earlier [00:23:12] age or earlier onset of obesity, earlier onset of diabetes. Because we are living unhealthily,

We are living more, more static. We're not moving, we're not exercising.

So all, for all those reasons, I would say often, yes, public health trends such as [00:23:27] poor health maintenance will begin to show an increase in erectile dysfunction, generally speaking. Yes.

And age younger. And they're getting younger and younger as far as prevalence. So, it is sad. But the promising thing is that we can begin to see the [00:23:42] correlation. And we think some people might, might spin off erectile dysfunction. So what, you wanna take your prescription medication and switch it over the counter. So what, there's actually a big so what, because the more you engage patients for one condition, you might be turning them on and educating them [00:23:57] on a plethora of

other comorbidities or another core comorbidity that they've never turned on, tuned into.

And so it matters. It's all integrated, it matters.

[00:24:07] Mike Koelzer: In this march towards getting this and the whole [00:24:12] country moving in this direction with over the counter switches and things like that,

Is there any part of it that kind of pisses you off, like ? This government agency is stalling. And what would piss [00:24:27] me off even more is if it was stalling because of somebody greasing their palms instead of maybe stalling for medical reasons. And I, as I say that now, I'm thinking of, who's out there on the [00:24:42] other side, the dark side compared to you guys trying to put the kibosh on that if there is anyone.

[00:24:50] Fady Boctor: It is an interesting perspective. I'll coin it this way. I think there's a healthy I don't wanna even call it tension, but there is a [00:24:57] healthy Tug of war with the FDA. The FDA has a big job to do, tremendous responsibility to keep the public health at the forefront of their thoughts. That is a challenge, especially when you start to move into new emerging technologies, new emerging platforms. [00:25:12] have to make sure they do their due diligence and ensure that we're, an industry, are coming to them with the very best, with the very proven and with assurance that this is a, a contributor to better public health versus simply just a new marketing ploy. [00:25:27] So for that reason, I respect their rigidity.

I respect their standard, I respect their timeliness. On the other hand, from an industry perspective, where there's tremendous investment and risk as there should be, it's tough sometimes to track [00:25:42] where we should be and how we're progressing. While we're sort of operating in somewhat Ambiguity. So I'll say that if I had to name a frustration, it is trying to meet the standard of the FDA with consistent [00:25:57] and constant and reliable feedback to ensure that the public health is safe. But we're both on the same team. We're both fighting for the same endpoint. And think we're gonna get there.

And I think the FDA has made tremendous strides in recent history. Especially we're talking mid 2022, [00:26:12] I'll applaud them. Since 2012, they had indicated they wanted to launch Ensure non-prescription utilization regulation. And so we have been working through that together and they have a country to carry.

They have a country to care for, for the past 10 plus years. In [00:26:27] 2022, they proceeded with a proposed rule and they're looking to Bring that proposed role to policy by April of next year. So we see them moving and we see them

taking leaps forward. So that's promising, and that helps alleviate some of the [00:26:42] procedural challenges that are before us. And hopefully we'll continue to find ourselves kind of aligning better, better, and better. So the investment dollars are truly producing innovative technologies for the sake of the American public. But that is a rate limiting factor that's always on [00:26:57] top of our minds.

[00:26:59] Mike Koelzer: Is there anybody that would not be happy to see this go through? And I'm talking about prescription competitors. Uh, The [00:27:12] a MA, a pharmacy group not so much a consumer group, but the sales of some big organizations, things like that.

Anybody this would not be good for,

[00:27:22] Fady Boctor: So it's interesting, I think. One or two entities come to mind. [00:27:27] This is not definitive, but this is anecdotal

and this is also us trying to foresee where some of the tension might come from. The MA physicians primary care physicians might feel as though this impedes on their territory. And we have data to show it [00:27:42] will not for several reasons. We see that in 2023, and sure, sure enough, 2030, we're going to face a hundred thousand plus physician shortage in this country. And we're already backlogged in terms of people being able to make just ordinary appointments. Even [00:27:57] with the advent of telemedicine being so ubiquitous, there's still tremendous delay.

There's still tremendous gaps. So I imagine that will be on their minds, we'll have to try to align with them and show them the data and, and, and also listen to see what, what their concerns are. [00:28:12] But I do imagine primary care physicians might see this impeding on their territory. Although again, nothing definitive, nothing formal,

and that's really it.

I'll say that the FDA has bought into the resounding preference by the American public to take [00:28:27] control of their health and to have more self-care options. And I'll quickly mention this, we're not, there's a proxy, there's a precedent for this. And that precedent is NicoDerm and for tobacco use and, and cigarette use when it was prescription. It was utilized in a [00:28:42] relatively light manner. When it went OTC, they saw 150 to 200% increase in utilization.

And so we think that those kinds of truths, those kinds of data points will consolidate and gather at whatever misalignments exist out there to [00:28:57] show that this is in fact will be, it will be better for the public.

Primary care physicians now will see patients who have maybe taken the first step or two of their self-care and they're coming to see the physician to say, I've tried such and such, but it's not working. What else can I do, what else can I do and what else should I pay attention to? And then the [00:29:12] education on nutrition and the education on lifestyle adjustments.

And sue better than the consumer, being isolated from healthcare, and not even taking a first step.

So we think there will be some synergies that will present themselves.

[00:29:26] Mike Koelzer: [00:29:27] Alright. So I see this fadi kind of, working around the edges where it's good for the consumer because they can get this information and get the product and it's safe for them and it's good for the PCP [00:29:42] maybe because it takes some of the stress off the fringe, you know, and let people do some of their stuff.

Do you always see these just kind of going together, like puzzle pieces?

Or is there a, a bigger shift that could come?

[00:29:55] Fady Boctor: Let me approach it this way. Let me know if [00:29:57] this doesn't touch your point. I think it's all contributory. I think it's all additive. And by that I mean when you look at our health, and this is integrative medicine is becoming, well-known,

Integrative medicine says that. The fact that [00:30:12] you have a runny nose could indicate that you have other issues.

The fact that you have migraines or headaches means you might have other issues. There are superficial elements to our healthcare that only begin to scratch the surface. So a deeper purpose and issue. You think of Toni Fungus, well, you've got gut health issues.

[00:30:27] You think of obesity. Sometimes that is your fault. Sometimes it's not. Sometimes it's A1C and blood sugars and

diabetes. I think this is all contributory because the more engagement a consumer has with healthcare, I think the more informed they are and the more skin in the game they have, [00:30:42] which means it's their metrics, it's their data, it's their vital signs. It's their trial of certain medications in the failure or success of those medications that begin to tell them a story of what else do I need to do? It's better than lack of engagement. Lack of engagement has us drown in [00:30:57] our ignorance and we sort of, we get, we forget the core. We forget the underlying conditions.

So I believe the better we get Engaging the consumer, even if it's superficially, even if it's at the retail or pharmacy aisle. The better [00:31:12] we engage them and form them and educate them to say, keep digging. 'cause there's something deeper going on. Keep going.

Then physicians will begin to see their patients, seeing them for the right reasons after the right walk-in experiences.

[00:31:24] Mike Koelzer: It's interesting you mentioned about the [00:31:27] prevalence of the ed patients or people that don't get help, because you always hear that, you'll always hear somebody say I went into the doctor and I was, doing great, and I got on the treadmill, and before they could even [00:31:42] tell me to stop, they whisked me off the treadmill and they gave me a, quadruple bypass.

And they said, my, I only had this long to live and all that kind of stuff. And I'm thinking how I, it's either, I don't know, it's either [00:31:57] people embellishing the story to make it sound good or we don't have very good tests to find that stuff because it always seems like. I'm, I guess that's what it's for.

It's a treadmill test, but how valuable might [00:32:12] that be of those 75% of the people or whatever the figure was that people don't get help if somehow, maybe it doesn't tell them, Hey, we're making a doctor appointment for you, but at least it might say, Hey, the fact [00:32:27] that you're looking at this ED stuff, have you thought about heart stuff?

Have you taken your EKG with your phone? , do you wanna sign up for something to wear a heart monitor or something? It's like that might be the first step [00:32:42] into something that you could go to a doctor's appointment and if you're embarrassed about, let's say Ed, you don't bring that up.

You don't bring up anything about a heart palpitations because you didn't really know what it was, this and that. And apparently those can go unnoticed because we got the treadmill [00:32:57] stories.

[00:32:57] Fady Boctor: Bullseye. That's the exact bullseye. 100% agreed. Imagine this for a moment. Imagine you have a 35, 40-year-old man, but male and let's say that, he's got young kids and let's call them in their middle school, early high school era. And

Obviously he wants to take [00:33:12] care of himself because he wants to make sure that he's there for them. No symptoms, no, no other symptoms. Relatively healthy. Maybe minorly obese, but you know, plays in the local men's baseball league or basketball league. And, he thinks he's generally healthy.

He [00:33:27] engages sexual dysfunction or he realizes and comes across sexual dysfunction with his wife. All of a sudden, erectile dysfunction's starting to show up more and more often, more and more frequently. And he's like, this is interesting. I must just be getting older.

And so let's say he is now. [00:33:42] He has options. He can call up his primary care doctor to say, Hey, I'm generally healthy, but, and I have no other symptoms, but I just can't, I just can't make it work anymore. What's wrong? But he is like, that the reward risk, reward for that engagement not really my 

my, [00:33:57] my interest. Then they can go on WebMD and read, and then you'll get a, you'll get a plethora of information on erectile dysfunction and medications and

therapies. All good in there. Okay. What should I do? I have to get a prescription, I have to go see a physician to get a prescription. [00:34:12] What we're trying to achieve is the following scenario. Imagine he says he goes to the local retail because he sees an ad to say, now pick up your prescription grade ed medication at your local pharmacy. He goes and he picks it up and this, the FDA will require this. On the label, it says, [00:34:27] ED can be a sign of cardiovascular conditions even without symptoms. Other symptoms that are, and then also it shows and continues on in the medical history questionnaire, says have you ever had a heart attack? Have you ever had such and such? And then even then [00:34:42] in that cardiovascular line of questioning, it could be a sign of silent cardiovascular conditions. Now all of a sudden, this father who wants to make sure he takes care of his health, he's no longer looking at his ED alone. Now he's thinking about, wait a minute, I've heard of the widowmakers. [00:34:57] I've heard of massive heart attacks. I've heard of it affecting my uncle at the age of 50. I've

I heard it. I've heard of it affecting my father at the age of 55. Huh. Now he sets an appointment exactly like you just said, and then meets the cardiologist. Not to say I have Ed, but to say, Hey [00:35:12] could you work me up?

Could you see this thing about coronary artery disease? And can you just make sure I have no underlying cardiovascular conditions? The

cardiologist might say, are you suffering anything else?

And he might say, actually, yeah, ed. And that's how I learned to come here. Then it becomes a secondary, but [00:35:27] the primary is to look for the underlying disease. 100% agree. I think that is the journey that we're after.

 There might be some men, they have a little bit of chest pain. They think it's indigestion or they pulled a muscle or something like that. [00:35:42] But if they were to have read seven days earlier that Ed might be related to heart problems or issues, it might be a different story when they feel that compared to thinking they have the two I mentioned.

[00:35:56] Fady Boctor: [00:35:57] That's right. Absolutely. That's right. Then the motivation and the follow through. It's like you mentioned with your friend who went and had a stress test and all of a sudden they're putting him on a stretcher and giving

him stents and. and. a triple or quadruple bypass

 I can imagine it changed his world.

[00:36:12] He's probably coming out thinking, what am I eating? What am I drinking? How am I living? How much am I drinking? How much am I smoking? And then all of a sudden the motivation behind the change becomes significant. So I agree

with you, but why wait till you're, God forbid [00:36:27] death store.

Why not get the shocker when everything is relatively silent

 and change could have a major impact on trajectory.

[00:36:36] Mike Koelzer: Fadi let's talk about the business in general. So you're the [00:36:42] chief commercial officer . When I think of commercials, I'm thinking of sales, but I'm also thinking more of you don't hear that term as much, I don't think in medicine, because that's more the clinical discussions with the doctor and that kind of stuff.

Commercial kind of sounds to me [00:36:57] more like, the commercial, you a direct to patient kind of thing. Does that word have that meaning as far as your title?

[00:37:05] Fady Boctor: It has meaning. I've been. I've been blessed and afforded with a great deal of responsibility with the organization. So [00:37:12] commercial is certainly probably the core and the prominent presence because the medication that we're looking at and the medications that we're gonna be looking at in the future have already been clinically proven.

These are medications that have undergone extensive clinical studies,

and now we're just [00:37:27] looking to switch them from prescription to OTC. A lot of those studies are qualitative in nature. A lot of them are clinically relevant and clinically related and specific, but they're qualitative in perspective.

And then on top of that, it's the commercialization component. It's the FD labeling, it's the [00:37:42] FD approval, it's the management of vendors and collaborators and partners. For all those reasons I currently do. I do touch regulatory, I do touch operations, all things from current existing sales to current existing commercial [00:37:57] to future forecast and commercial to investor relations.

And so it is a, it's a diverse role. We do not have a sitting, CEO I am essentially the acting executive officer. We are backed by true two tremendous [00:38:12] thought leaders in the space. John Schulman, who's the principal of Juggernaut Capital Partners, and Greg Bradley, who's the president, and CEO of Foundation Consumer Healthcare.

His company after Plan B, one step went from prescription to OTC, commercialized it to [00:38:27] becoming the number one selling SKU in the us. That's another good proxy story to show tremendous use once the hindrance of a visit is removed. They are our leads and guides and I'm sort of the execution officer.

So I, [00:38:42] I help. Execute on execute all things commercial, all things regulatory, all things clinical. I'm grateful for it but my role, my true role does broaden beyond Chief Commercial Officer.

[00:38:53] Mike Koelzer: Is that any kind of a strategy to [00:38:57] not have a CEO or does it just so happen that you're in this situation?

[00:39:04] Fady Boctor: There is a strategy behind it, and the predominant strategy is you have two well-known figures on your board and John [00:39:12] Schulman. Him and his team have worked with Dwayne the Rock Johnson, you might know zoa, which is an energy drink and drove it to tremendous commercialization. And again, with Plan B, one step, the track records known, and I've got two tremendous thought leaders guiding and leading.

So [00:39:27] the strategy there is why bring in a chief executive officer when really what needs to be executed is to tell the story, pull through the story.

Bring the unprecedented market. Make sure that you manage a team. It's lean, it's nimble, and [00:39:42] optimize your dollars for the sake of execution when you already have visionaries and tremendous experience on your board. I think it's been a very productive and beneficial strategy. I would say we, we move quickly. I consult with those two all the time [00:39:57] and they share their network, they share their partners, they share their experience and expertise. What's left is now go and execute and go pull through so

[00:40:06] Mike Koelzer: Do you have anybody else in the c-suite? In other words, uh, chief [00:40:12] this, chief that, absolutely. So I, I do have a Chief financial officer, an interim Chief financial Officer, Bob Weinstein. He's on the team. I have a Chief accounting officer Mitch Arnold. He's also on the team. And together we come together and talk about the financial health of the company, the [00:40:27] performance future forecast, future considerations. We talk about gross tens all the time, net profits and what we're doing today with prescription medication and what we would like to do in the future while keeping it unit economic friendly to the

[00:40:41] Fady Boctor: consumer. [00:40:42] So yeah, we do have a, Lean C-Suite team.

[00:40:45] Mike Koelzer: All right, Fadi. So, out of all the groups that you have to work with that you mentioned the FDA and this regulation and that kind of stuff, are there [00:40:57] any personalities, any of those groups attract certain personalities that it's hard to work with? Let me give you an example. I don't like talking to nurses so much at the pharmacy because [00:41:12] they always seem to call and they're so dogmatic in what happened.

It's like . We faxed over this to so and so and you didn't fill it, this and that. And it's like, I don't know, I've got record of every fax [00:41:27] that came and I never saw it in the morning that you said you did it, this and that, whatever. And they're so dogmatic about it. I wish they would say, Hey, we think we sent this over.

Can you check this and that. My thought is that they get their ass [00:41:42] chewed out by the doctors all the time and then they've gotta chew somebody out, so let's chew out the pharmacist. Any groups that you don't seem to gel with because they have a chip on their shoulder, whether it's the [00:41:57] FDA or the A MA or wall Street, this or that

[00:42:00] Fady Boctor: To be honest with you not a single. Point of attention today. Today.

Now I'll say everybody we've talked to we have an amazing consultancy advisory board [00:42:12] with urologists, cardiologists

primary care internists, all have been advocates of this transition in the switch.

The FDA we, you know, we recently had a meeting with them and we, we announced this publicly. They've been forthcoming and they've been very, very transparent [00:42:27] in their interest in seeing solutions to address the public the sexual dysfunction, public health issue in America.

So they, they've got their sleeves rolled up. I

think if we ever find ourselves. Misaligned with the FDA, it's a healthy and welcome misalignment.

[00:42:42] What

are you seeing ? What are we not seeing and

help us And then let's, bite the bullet and let's proceed. And we'll always make sure that is it's reasonable it's within scope we're not redoing stuff that doesn't need to be redone. That's our personal [00:42:57] philosophy.

So no points of contention today. Obviously we expect for there to be, this is a new horizon and whenever new horizons come to play individuals that say, wait a minute, that concerns me.

But they have not come to, to, to light today. I think everybody

we've talked to, everybody we've engaged with [00:43:12] has been open and ready and engaged. I'll say if I had to put one area. Of issue. It's with time. It's with time.

How much

time will it take for us to make this case? How much time and investment and resources will it take for us to [00:43:27] achieve this climb?

And we're racing against the clock. We want, we, we have ambitions and we have advisors and experts telling us you're moving in the right direction. Here's what you, here's what you can expect. But time will always be in our minds, [00:43:42] recruitment is an issue. So as you recruit, especially spouse, sub populations, sometimes recruitment can be significant delays, which against points to the factor of time. So

[00:43:51] Mike Koelzer: Recruitment of,

[00:43:53] Fady Boctor: patients 

[00:43:53] Mike Koelzer: Patients.

[00:43:54] Fady Boctor: consumers, yeah. For that, for our studies. So we,

[00:43:56] Mike Koelzer: for your studies. 

[00:43:56] Fady Boctor: [00:43:57] yeah. In the development path, we have to achieve certain studies, label

comprehension, self-selection, actual use, and with each, you have to select a new and naive patient population to clinical

studies. And as you do so, you're subject to [00:44:12] time. Sometimes it, it could prolong the matter just a couple weeks. Sometimes it could prolong the matter a couple months.

So it's us trying to move as swiftly, as efficiently as possible to get as many engagements with the FDA to take as [00:44:27] many necessary developmental steps to make the story and to submit for an I and D, which is our goal.

[00:44:33] Mike Koelzer: That question, what you said about the FDA, about any friction that comes is usually good because you're doing it on behalf of the patient. It makes me think that [00:44:42] when we built our house 20 years ago or so our builder was kind of pissed because where he usually built next door city he usually built would do a fireplace mantle.

And so on a certain way, when he [00:44:57] was in our city, the inspector came and said, well, this part's not this for our area and this and that. So I told my wife, I'm like, golly, if you want someone to fight about something. Fight about the safety [00:45:12] of a fireplace, . 

[00:45:13] Fady Boctor: This is true. 

[00:45:14] Mike Koelzer: of all the things people can fight about, fight about that or fight about what I like best for dinner and go back and, and forth on that.

You These are important things, [00:45:27] but like you say, if there is any friction it's a good thing if everybody's working in the same direction.

[00:45:33] Fady Boctor: Agreed. Agreed. And I think that the ultimate output of that becomes improved patient safety.

And if that's the consequence and that's [00:45:42] the result, that's the fruit of the discussion in the process. Then I think

we've all won. 

[00:45:47] Mike Koelzer: So fatty, what is the actual status of this drug right now? 

[00:45:51] Fady Boctor: So in terms of the product today, we enjoy a fully [00:45:57] commercialized footprint. We're in roughly 15,000 or more pharmacies across the country.

 already partner with telemedicine providers such as for himss. So from a prescription commercialization perspective we're present and ready to go.

[00:46:10] Mike Koelzer: And Fadi, we're [00:46:12] a little bit of unique pharmacy 'cause we don't carry brand name drugs. And so forgive me for not knowing enough of this, but is your product, is that a brand name sitting on pharmacy shelves across the country 

[00:46:24] Fady Boctor: That's correct. That's correct. And so the brand [00:46:27] name is , generic

molecule is Avanafil and it's not as well known obviously as the big players, Viagra

and cis. It's been around since 2012. It is available today for prescription use available at all major [00:46:42] wholesalers across the country,

 and as I dive into it, I'm gonna quickly just make a quick disclosure because I'm talking about the brand, so I wanna make sure that your audience knows  Currently it's a prescription medication indicated for the treatment of erectile dysfunction for men 18 years and over. So [00:46:57] it's not for use in women and children.

That's obvious.

Men who may be interested in using stra should consult with their doctor to assess if is right for them. As men who have been advised that sexual activity is not safe for them, should not be using 

for reasons such as cardiovascular [00:47:12] conditions or

any other reason in

perspective. And again, contraindication is nitrates. Men with on nitrates should never use entra, so I wanted to make sure that was known. And

entra.com will have more important safety information.

But yes, it is commercially [00:47:27] available today available across a multitude of pharmacies. It is expensive. We do have an automated ve voucher coupon that helps bring it to a more affordable cost per tablet.

And we hope to also work down that price in the coming future. 

[00:47:41] Mike Koelzer: And [00:47:42] what is the generic status on that? Is that chasing you down, or 

[00:47:46] Fady Boctor: so we're fortunate that we're the last standing patent protected, branded

prescription. PDE five inhibitor. We do lose patent in May of 2025.

 and then we'll [00:47:57] probably see generic entrant at that time. I will say that if we're able to achieve over-the-counter designation, that'll give us another three years of market exclusivity

as an OTC brand.

So that is something to look forward to if we're able to achieve OTC switch.[00:48:12] 

[00:48:12] Mike Koelzer: and it could be the case where you switch . and that's now in its class, but the other ones don't necessarily get to come along for the ride because they would have to do this all themselves too.

[00:48:25] Fady Boctor: That's right. That's correct.

Every brand [00:48:27] has to make the switch. So Viagra by way of Pfizer has what we think perhaps sunsetted their efforts towards OTC. I think they've outsourced or off shot their Viagra pursuit for OTC to another company. We're not sure what that status is yet. [00:48:42] Lily has licensed the OTC rights to Cialis, to Sanofi, and Sanofi is currently pursuing over the counter switch as well.

So it's a bit of a race to see who's the first

mover in this space.

And we believe we will be for [00:48:57] our own personal

reasons, but we think we're fighting for it.

[00:49:00] Mike Koelzer: so 10 years from now, do you picture that each of these is gonna have their own app, their own website or will there be a, I'm sure the anything's possible, [00:49:12] or will it be more like, I'm just gonna throw it out again, Amazon kind of thing, where, you know, instead of picking through their 20 different disease states, you're maybe looking at 15 or 20 different brand names in the [00:49:27] category you're talking about.

I know you can't predict this, but do you see each of these being like their own app, their own home front kind of thing? 

[00:49:34] Fady Boctor: that's right. That's right. So, so right now the intended, platform will be every pharmaceutical, , will have its own [00:49:42] app engagement with the consumer to ensure the consumer appropriately. Self-selects and that's the drug device approval process. So it becomes a part of your drug application.

It becomes a part of your brand.

[00:49:52] Mike Koelzer: Oh, I see. 

[00:49:53] Fady Boctor: Yes.

[00:49:53] Mike Koelzer: That's part of it.

[00:49:54] Fady Boctor: It's a part of it, and that's, the FDA governs it. [00:49:57] They wanna know every element, every component, every line item, every behavior around it. So that, yes, every pharmaceutical that's prescription that seeks to switch OTC by way of technology will be a drug device combination and will be unique to that particular [00:50:12] pharmaceutical.

[00:50:13] Mike Koelzer: I see. And so let me throw this out, Fadi. So the FDA be looking as deeply as at your app to make sure that you're not, uh, speaking too highly of this [00:50:27] side and downplaying something else ? they're actually looking at that app for that.

[00:50:31] Fady Boctor: Absolutely. Every line item, every word. In fact, they wanna see behavior studies around the language used. They wanna see behavior studies as well as how well comprehended are your drug facts, labeled [00:50:42] elements and

metrics. They're very, very thorough and proficient in making sure that everything we say to the consumer by way of this technology is fully aligned with label, but also comprehended and leads to appropriate self-selection, which is the beautiful art that the [00:50:57] FDA practices in this matter. I respect what they do. It's, It's not an easy task, but they do look at every line item, every period, every comma every piece.

 One thing that we're looking to, um, to kind of produce out of this is pers perhaps [00:51:12] establishing a platform that's applicable to different medications. 'cause

then the FDA says yes to, to this platform for this erectile dysfunction medication. Well then all the controls around it and all the elements around it, and hopefully the backend mechanisms point to, well then let's just [00:51:27] plug the next pharmaceutical for approval and the next pharmaceutical for approval. So if there's sort of a common nomenclature or a common app ecosystem,

some familiarity there, we hope to achieve that platform applicable to multiple assets. So, so look for that. Petros [00:51:42] is working on some unique, unprecedented technology to help it become that platform technology for multiple pharmaceuticals in the future, but each of them approved individually.

[00:51:50] Mike Koelzer: so it might be under, like for example, the Petros logo that's gonna have four [00:51:57] tie-in apps somehow. Four quarters of the screen or something like that.

[00:52:00] Fady Boctor: That's right. It'll be interesting to see if the FD will allow future integrations from one product to another.

So if, for example, I'm there to get my ED medication, but then I'd

also like to get my migraine medication,

can [00:52:12] I switch to this new app all in a single work stream or

experience stream?

That'll be interesting to see if that happens in the future. Today that is not in discussion and is not under review.

[00:52:21] Mike Koelzer: Back in the day, 30 years ago when the internet came out, it was all like, [00:52:27] Internet's great. Everybody can have their own business, and you can have a socks dot and coffee mugs.com the world's gonna be split apart.

Everybody's gonna do their thing. And then you'd have guys marketing guys like Al Reese and Jack Trout, these [00:52:42] guys that wrote like the 22 Immutable Laws of Marketing. And they would say don't ever combine stuff. Everything is a separate thing and people's minds have to be focused on one product and all that. Then you read these [00:52:57] books. Now they're so dated because 10 years later it's like, there's one company, you know, Amazon, maybe Walmart, you like all this stuff they were saying about you don't wanna sell books lawnmowers and, camping stuff that's never gonna go. And now here [00:53:12] we're down to one.com. So you don't know what the right way to go is. 

[00:53:15] Fady Boctor: This is true. This is true. It changes constantly today.

Today it's a race from Mindshare. Today it's mind equity. Once you've captured a share of a consumer's mind, [00:53:27] build trust, let them trust you. And if they, and when they do, and that causes you to be accountable for everything you say do and how you handle that consumer.

But if you built their trust, you could now be a trusted person at their table to help them sell things that they need. [00:53:42] Because they now trust you. You're at their door. So that's a responsibility. It's a it's a stewardship of sorts, but it

has changed completely the previous learnings.

[00:53:51] Mike Koelzer: I've done that with the show here, and I'm just starting to monetize it and bring it on an advertiser but right now [00:53:57] I'm just building, I'm just building eyes and building trust because it's so 

divided, The attention. And then you bring in stuff like AI where you don't know what, whom to trust anymore. You think you're looking at somebody you think it's a company [00:54:12] and it's not so trust and eyes are gonna be important going forward. More important going forward.

[00:54:18] Fady Boctor: Absolutely. And I think a big one also is relatability we have two faces. We have our public face and we have our private face. And even as entrepreneurs for those who own their own [00:54:27] pharmacies or own their businesses, the way you engage with your consumer, your vendors even your industries one way.

But when you go home at night, you look at your books and you look at your business and you're scratching your head, what am I doing right? What am I not doing right? And in my fears and my concerns you have [00:54:42] somebody then that begins to relate to you to say, here's my fear. Here's what I confronted, here's what I faced, here's how I handled it.

And that's relatability. And that is

true treasure. And I think there's very few that are vulnerable that way. There are very few that share those underpinnings that [00:54:57] we all struggle with in the dark, behind closed doors.

[00:54:59] Mike Koelzer: Fadi, as your company goes along here, I imagine like, 

Financial wise, I imagine there's different levels. Certainly if the FDA tomorrow were to say, Hey, [00:55:12] go ahead, you've gotta get some tremendous growth, I'm assuming overnight kind how is that all planned out with investing and how do you take that forward at different levels of your business?

[00:55:26] Fady Boctor: I think [00:55:27] there are a few prospects. I think one hand we're in the company of some pretty large players that are in this space. And those players, I bring them up because we've spoken to many of them. We continue to compare notes with many of them and many of them have indicated an [00:55:42] interest to partner with us in the future, it will take a big player and big dollars to launch this commercially And many are looking to be a first mover in this space. And when I would say this space, I mean a prescription grade ed medication switch to [00:55:57] over the counter readily available to consumers that are appropriate for its use. So I'm talking about players such as Pergo, Sanofi, Halon, Ken, view, Bayer, these are large players. So to your point, if FDA gave us the green light and said, okay, you're approved. [00:56:12] We would've hopefully have had lengthy discussions, ongoing discussions with these partners, foundation, consumer Healthcare among them, where we're say, what needs to happen. Now these are all successful commercializers of prescription OTC switches, and we hope to have the right partner at bay.

We [00:56:27] wanna do all the work necessary to disrupt the marketplace by becoming the first ever approved. And then once we've done that, we're gonna look for another specialty player that can help us bring it to commercial success in

unprecedented ways. 

[00:56:40] Mike Koelzer: Fadi, let me get this straight. [00:56:42] So. I know you'd be the first ED drug to do this. Are there drugs out there now though that have this model of needing a middleman of an app? I'm not talking ones that have gone from just RX to OTC, [00:56:57] but are there any that have this model going already?

[00:57:00] Fady Boctor: None, none exist today.

[00:57:01] Mike Koelzer: what I thought.

[00:57:02] Fady Boctor: And none are prescription grade, let alone with technology guidance. The only products available over the counter today are supplements, [00:57:12] nutraceuticals none of them FDA guided or governed or approved, per se as the prescription grade would be. And so this would be the first of its kind to ever bring this great of medication to the fingertips of male consumers out there who are suffering from ED and [00:57:27] are looking for a solution. I.

[00:57:28] Mike Koelzer: But as far as other drugs, 

are there any drugs out there that are doing the same thing in front of the FDA, showing them their app and having to get the app and the drugs synced and you have to show it to the pharmacist and all that? Is that already going in certain [00:57:42] drugs

[00:57:42] Fady Boctor: It is it's, it's currently uh, Cialis by way of Sanofi is currently attempting to get the same approval

with FDA. 

[00:57:49] Mike Koelzer: attempting. They don't have it yet.

[00:57:50] Fady Boctor: That's correct.

[00:57:51] Mike Koelzer: Gotcha, gotcha. Other. Disease ones, either. Those are [00:57:57] not out there yet. They might be trying, but there's not one for asthma. There's not one for hair loss, there's not one for ear infections. They're not out there yet. There's nobody that has that app in sync with their drug.

[00:58:10] Fady Boctor: That's correct. [00:58:12] Nobody's been approved yet. However, this is public. Crestor by way

of AstraZeneca is the furthest along in terms

of 

that technology. Yes. they've gone through their final stage study, which is an actual use study, and that's currently being [00:58:27] reviewed by the FDA. We don't know yet when the approval date would be, but that they're the furthest along as far as we know publicly. 

[00:58:34] Mike Koelzer: fadi picture out like five years would you go past this 

[00:58:40] Fady Boctor: the dream and the ambition [00:58:42] is to develop a platform that can accommodate a number of key and critical pharmaceutical prescription grade pharmaceuticals that can be accessed without a prescription for vital conditions such as the ones we talked about, depression, anxiety, migraine,

[00:58:57] hypertension, UTIs, and to be able to build a platform that's been well known by the FDA. And it includes, it begins to incorporate elements of, and I know this is a scary term, artificial intelligence, but by

way of algorithm, by

way of reasoning. And we integrate potentially with big data. [00:59:12] So the idea, the vision is like this. If I'm feeling a certain symptom, I know what I have, I need to get this non-prescription medication. I go to the retail pharmacy, I fill out their information, my vital signs are taken immediately. I've been informed if I have [00:59:27] borderline diabetes or diabetes, I've been informed if I have hypertension, I've been told, keep in mind your vital signs indicate such and according to your medical history, we think this is a, this is sufficient.

But be sure to follow up with your physician on such and such matters in the future. It al almost [00:59:42] becomes a transient quick primary care engagement, giving me the

access to the therapeutic I need real time,

but also informing me that I should follow up on certain metrics. All in all, improving my health and my knowledge of my health and awareness of my health. That is the vision and ambition over the next five [00:59:57] years. That would be a tremendous, and we would be the foremost platform in this marketplace that then becomes the destination for many colleague companies that are looking to switch their prescription medications to OTC or non-prescription. That would be [01:00:12] exciting.

[01:00:12] Mike Koelzer: Do you see your company as, let's say you get this running off the ground and then another two or three products. Come on. Petros do you see ? Ever shifting your company that instead of, [01:00:27] these are your products, 

[01:00:33] Fady Boctor: I think dual. I think it's both. I think it's, we can take on our own assets and decide to switch them for ourself, but we could also accommodate and host and license with other

larger players. [01:00:42] So I could see us playing both. Now, the moment one seems to be predominant and the other seems to be distracting, then we'll

probably

standardize.

But yeah, I could see us being applicable to both, concepts.

[01:00:53] Mike Koelzer: Fadi, thanks for coming on. That was fun to talk [01:00:57] about. It's always fun to talk about the future. getting technology into people's hands and having that health in people's hands. I don't think there's really anything better than that. Instead So, very cool stuff. Thanks for joining us.

[01:01:09] Fady Boctor: Thanks, Mike. It's been fun dialoguing with you. Thank [01:01:12] you. 

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