Nicholas Kadysh, CEO at PharmAla Biotech

Julio Martinez-Clark (00:02.334)
Welcome back to another episode of the Global Trial Accelerators podcast. Today we have Nick Karish. He's the founding CEO of Forma Ala Biotech, right? The first publicly traded company manufacturing clinically clinical grade MDMA, which is exciting. I'm board chair of Psychedelics Canada.

Nicholas Kadysh (00:16.984)
That's right.

Nicholas Kadysh (00:25.773)
Yeah.

Julio Martinez-Clark (00:30.164)
And Nick has regulatory experience from dual labs, General Electric and Red Bull Canada, plus government experience at parliament. You started your career in parliament or in politics, right? And Nick founded Formala in 2020 to address the global shortage of clinical grade MDMA for research while developing safer molecules.

Nicholas Kadysh (00:43.438)
Yeah. Yeah.

Julio Martinez-Clark (00:57.012)
for treating PTSD and mental health conditions. So Nick, welcome to the show.

Nicholas Kadysh (01:01.774)
That's right. Thanks so much, Julio. It's really good to be here.

Julio Martinez-Clark (01:06.235)
Excellent, Nick. you know, I read the news about the FDA rejecting MDMA a while ago, a few months ago, and I've tried MDMA at parties and stuff. Who hasn't? Yes, exactly.

Nicholas Kadysh (01:15.726)
Yeah.

Nicholas Kadysh (01:22.83)
Sure, sure. is a popular drug for sure. Yes, absolutely. Yeah.

Julio Martinez-Clark (01:29.798)
I was really, really glad when I got your email accepting my invitation to speak because it's a topic that I've always been curious about. I've been reading the research over the years, the last five years or so. I think Tim Ferriss, you know, he's...

Nicholas Kadysh (01:33.772)
Yeah. Yeah.

Yeah, absolutely.

Nicholas Kadysh (01:43.064)
Yeah.

Nicholas Kadysh (01:47.948)
Yeah, yeah, I actually, have a funny Tim Ferriss story that I can share with you if you'd like. But yeah, yeah, yeah.

Julio Martinez-Clark (01:53.573)
Okay, good, good, good. Please do in a while, in a minute. So yeah, so anyway, it's a topic that I've been in contact with for a while. I follow Tim Ferriss' podcast and I read his books and it's just a fascinating thing. and also, I'm sorry, what was that?

Nicholas Kadysh (02:11.98)
Yes, yeah, I couldn't agree with you more. Yeah. I said, I couldn't agree with you more. I mean, we based our entire company on this. Yeah, for sure. Yeah.

Julio Martinez-Clark (02:17.957)
Yes, yeah, exactly, exactly. It's a fascinating topic. So I'm really, really looking forward to what you have to say about it. So anyway, so let's start with your journey. How is it that you got to where you are? Tell us about your personal professional.

Nicholas Kadysh (02:30.478)
Yeah, for sure. So, I mean, you kind of touched on it earlier. I did get my start in the Canadian Parliament. I worked sort of as a political staffer. Ironically enough, I think when people hear that we produce MDMA for clinical purposes, everyone sort of assumes that I came from the left side of the political spectrum. I actually didn't. I came from the right side of the political spectrum. So, I worked in the government of Stephen Harper, who is

former Prime Minister of Canada. I still consider myself a conservative, at least in the Canadian context. I don't know if I would qualify myself as a conservative in the United States. But basically, think that this is actually a very interesting matter because it crosses political lines completely. It's not a left-wing issue, it's not a right-wing issue, which is good. I think in the modern day, we are too focused on what we know.

Julio Martinez-Clark (03:10.321)
In the US, exactly.

Nicholas Kadysh (03:29.826)
politically where things lie. And it's nice to have something like, you know, like novel mental health treatments that sort of everybody all across the spectrum can sort of support. But yeah, basically, I worked in parliament for a while, and then I became a lobbyist. And I focused specifically on, on regulatory issues, especially for, you know, things at the leading edge of what was permissible at the time. So, you know,

10, 15 years ago that was energy drinks and I worked for Red Bull. And that seems very, very quaint now by comparison. I mean, it's just caffeine in a can, but it was very, you know, it was really pushing the boundaries back then. Yeah, yeah, yeah. yeah, it had like a whole stigma. Yeah, it was very, yeah, very, very political. Yeah. And actually for a very long time in Canada, energy drinks were a pre-market approval product.

Julio Martinez-Clark (04:00.754)
Here are your drinks, yeah, yeah, yeah.

Julio Martinez-Clark (04:10.214)
Hmm, interesting. didn't know that. But only the drinks had some politics and polemic stigma. Wow. Okay.

Nicholas Kadysh (04:27.97)
meaning that you had to, it was like launching a new drug. Like you had to get approval from the regulator before you could sell them in Canada. So yeah, very challenging regulatory environment. My successor at Red Bull actually fixed, she's brilliant. But anyway, so I did a whole bunch of work in various sectors. So I worked in medical devices at General Electric. I worked for Red Bull, I worked for Jewel Labs, which is a nicotine product, vaping.

Julio Martinez-Clark (04:35.907)
Okay. Interesting, yeah.

Julio Martinez-Clark (04:43.459)
Okay.

Nicholas Kadysh (04:55.598)
But I always wanted to work on a product that was in the medical field, moving more into pharmaceuticals. And I definitely wanted to work more in mental health. mean, a lot of what we dealt with, a jewel, a general electric, a lot of it was based in these sort of principles of harm reduction that I think everyone...

kind of thinks that they understand, but I don't know that they actually do. But certainly, I started seeing all of this research coming out specifically about MDMA and how useful it could be for the treatment of post-traumatic stress disorder. And originally the company was basically formed just to develop novel molecules. It was just going to be a traditional drug discovery company, nothing fancy, make new molecules, patent them, and develop them.

Julio Martinez-Clark (05:26.745)
Okay.

Julio Martinez-Clark (05:52.218)
Yeah.

Nicholas Kadysh (05:52.407)
And we are still doing that. And actually, you know, that part of the business is growing very nicely. So we have a couple of patented molecules and we actually just, I can share with you, we just formed a new entity in Australia specifically to do clinical research. So Pharma La Australia. But what we realized as we were building the business is there was also this deep need for just GMP MDMA.

Julio Martinez-Clark (06:09.114)
Great.

Nicholas Kadysh (06:21.274)
just MDMA to sell to researchers. And we do a lot of that, know, with 25 clinical trials and counting. And then in two countries and growing now, we sell to doctors and patients, you know, for actual active treatment, because it's sort of this drug is being onboarded in the psychiatric community. The research is remarkably good. And so despite the fact that FDA said no to MDMA-assisted therapy last year,

Julio Martinez-Clark (06:29.444)
Hmm.

Nicholas Kadysh (06:50.904)
there are still countries like Australia where this is sort of moving forward in fairly rapid order. And so we're very proud to be a part of that.

Julio Martinez-Clark (07:00.538)
Wow, interesting. All right, so let's talk about trends, Nick. What do you see happening in general politically, economically? Yeah.

Nicholas Kadysh (07:06.136)
Yeah. Yeah, yeah. Yeah, I mean, look, I will say maybe I'll focus on three. I mean, there's a lot of trends out there, obviously. I think I'll focus on psychedelics just broadly as a drug class because we are sort of a leader in this drug class to a certain extent. I'll talk about AI and the role of AI in drug discovery because I think that's a growing trend for sure.

And then maybe I'll talk about sort of the politics. You know, cause that's my background. I love to talk about politics. Look, on psychedelics, I think that the most interesting thing is not what has happened in the past, which is fairly well known, know, like those, the decision by FDA, you all of these things. think what's actually really interesting is what's coming. So as I said earlier,

Julio Martinez-Clark (07:36.983)
Okay, good.

All right.

Nicholas Kadysh (07:59.489)
we ourselves are supplying around 25 clinical trials with MDMA. This is just generic MDMA, know, like nothing special, nothing patented, just generic. And so, and nobody else is doing it. Well, to be fair, Lycos is doing it. Lycos, which is the company that did the application to FDA last year, they are still doing it in the United States. Outside of the United States, it's basically just us. And so,

Julio Martinez-Clark (08:03.897)
Hmm.

Yeah. But nobody else is doing it. Okay.

Nicholas Kadysh (08:28.782)
I think the interesting thing is going to be, know, those trials are sort of in progress. Some are just starting. Some are already dosing patients. Some are completing their dosing protocols. And so what happens in the next two years when you have that weight of clinical evidence just landing on people's doorsteps, right? I think it becomes very, very like, again, assuming that all of these trials go the way that they have gone in the past. And this is just MDMA.

Julio Martinez-Clark (08:47.587)
Yeah.

Nicholas Kadysh (08:58.54)
You know, some of these trials are being put on by, you know, the US Veterans Affairs Administration. The US military is doing a trial with us. I mean, like, these are very serious sort of governmental bodies that are running these trials. I think it becomes very, very difficult to say these drugs have no efficacy when you have that many trials from that many different groups landing at the same time. So, yeah.

Julio Martinez-Clark (09:17.741)
Yeah.

Hmm. You need to overcome that stigma that people have in their head. think it's just...

Nicholas Kadysh (09:28.942)
Yeah, look, I don't know that it's stigma. You know what I think it is, honestly? I think there's this saying, science advances one funeral at a time. I think that this is a very different modality of care than what any psychiatrist is really used to. know, psychiatrists for the last 20 years, and I know I'm going to make some psychiatrists very angry when I say this, but.

Julio Martinez-Clark (09:55.639)
Yeah.

Nicholas Kadysh (09:56.139)
I think a lot of psychiatrists see their job as working within what is available in terms of medication, which is basically SSRIs, right? SNRIs, SSRIs, but serotonin modulating drugs, basically. And you come in and we say, well, I don't have a drug to treat PTSD. I have a depression drug. And so that's probably comorbid. If you have PTSD, you probably have some depression as well.

Julio Martinez-Clark (10:10.734)
Okay?

Julio Martinez-Clark (10:19.192)
Mm.

Nicholas Kadysh (10:25.58)
And so we'll treat what we can treat and it's depression. And I'll give you this drug and I'll modulate the dose. And maybe we'd get you on a different, like, you know, we tried SSRIs, maybe we try SNRIs, but you know, with MDMA assisted therapy, it's completely different. It's a three month protocol. It's very time limited. It's a very intensive protocol. You know, you have to work at it for three days a month, long days with psychotherapy support. It's not just seeing a patient.

once a month and modulating their drug dose. And so it's going to be, think, a challenge for a lot of psychiatrists who are currently very successful to integrate this into their practice because it's a different way of delivering care. It's just different. And so that takes time. It takes time for that to like onboard through the medical system.

Julio Martinez-Clark (11:10.701)
Hmm.

Julio Martinez-Clark (11:15.479)
Yeah. All right. So you said you were going to give us three trends. right.

Nicholas Kadysh (11:20.034)
yeah, yeah, yeah, yeah, that's right. That's right. The three trends. Okay. So the second trend is more on the AI side. what we still do, which is develop new drugs. So Pharma will actually launched its own AI drug discovery platform a few months ago. And look, honestly, I think this is a complete game changer for, especially for companies working in, know, the CNS, like central nervous system drugs, neuropsychiatry.

and small molecules, because now the two most challenging parts of the drug discovery process, which is modeling these drugs from a neurotransmitter perspective, which is very, very challenging. We had some software for it. This software's taken a dramatically, but it's gotten much better. And then two, modeling the chemistry to see how can you make these drugs. It's like a complete game changer.

It's also just changed the way we do business with our customers. And that's definitely true. But just the way that we find drugs now is just so much faster, so much cheaper, so much better than it was before. So that's the trend on the drug discovery side. And look, the political trend that I never thought I would see in my lifetime is I think that in the United States, psychedelics, broadly psychedelics, know, psilocybin, MDMA,

Julio Martinez-Clark (12:26.861)
Hmm.

Nicholas Kadysh (12:48.056)
DMT, Ibogaine, all this entire class of drugs has to a certain extent become like a right wing issue. The people driving this forward are, Rick Perry, the former government of Texas, not a left wing guy. The current secretary of health and human services, RFK Jr. talks about psychedelics. I mean, these are not the people that I thought when I started this business would be the

Julio Martinez-Clark (12:55.02)
Hmm.

Julio Martinez-Clark (13:03.181)
Yeah.

Julio Martinez-Clark (13:16.364)
Mmm, mmm.

Nicholas Kadysh (13:17.304)
primary people pushing these drugs through the system. But I think it comes from an honest place because a lot of the loudest voices asking for these new types of mental health therapies are, you know, veterans, first responders, police officers. Not in Canada, where I'm based, but in the United States. And that trend, I think has really, I think it's really confused a lot of people, to be honest with you. I don't think anybody sort of expected this.

Julio Martinez-Clark (13:43.659)
Yeah, yeah. Exactly. Fascinating. I guess it's because mental health is one of those diseases that, one of those type of diseases that are very prevalent, especially in older people. And a lot of these guys are just older and they're feeling the pain and they want something. Who knows?

Nicholas Kadysh (13:47.415)
Yeah, yeah, yeah.

Yeah.

Nicholas Kadysh (14:04.046)
Solid.

Nicholas Kadysh (14:08.11)
Yeah, yeah. And look, I think it's very, very human. Again, I think we've become too political. I don't think post-traumatic stress cares if you're a Republican or a Democrat. I think it hits everyone equally. Yeah, exactly.

Julio Martinez-Clark (14:13.578)
Yeah, exactly. It's very human.

Yeah.

Julio Martinez-Clark (14:21.502)
Exactly, yeah.

All right, so let's talk about your company today. is it that you guys are due? Why having this company? mean, what's your impact? What's the need to have something like this in the market? You touched upon those topics earlier, but let's...

Nicholas Kadysh (14:42.402)
Yeah.

Yeah. Yeah. Yeah.

Julio Martinez-Clark (14:51.596)
get down to into the details of what exciting things you guys are doing and where are you taking the company in the next few years?

Nicholas Kadysh (14:53.289)
Yeah.

Yeah, yeah, for sure. Well, look, think psychedelics are very, very unique. the broad, you know, and it's funny because MDMA is not even really a psychedelic. Like it's not a hallucinogen. It's not a classic psychedelic. It's only mildly serotonergic. But, you know, it gets sort of lumped in with psychedelics. So when people talk about it.

Julio Martinez-Clark (15:20.49)
Okay, oh, I didn't know that, interesting.

Nicholas Kadysh (15:23.052)
No, it's not. It's actually, internally we call it an intactogen, meaning that it is a drug that induces a pro-social response. It's very, very interesting. know, not pro-social. So yeah, it generates this feeling of having a very intense bond with other people. So you feel like you can speak more honestly with people.

Julio Martinez-Clark (15:36.022)
pro-social response.

Julio Martinez-Clark (15:45.631)
Yes.

Nicholas Kadysh (15:52.909)
you feel as if you can receive feedback more honestly. can really, you know, bare your soul to another person. And so if I was designing a drug to help with psychotherapy, this is like the perfect drug, right? Like this is ideal. But the interesting thing about this and the challenging thing is the majority of these drugs are generic drugs. And as you can imagine, the pharmaceutical world is just not designed to bring new

Julio Martinez-Clark (16:00.96)
Yeah.

Julio Martinez-Clark (16:06.911)
Yes, yeah, yeah, yeah, yeah.

Nicholas Kadysh (16:22.528)
novel generic drugs to market. This is not a thing. And so you have this very weird situation. So I mean, just this week, the Norwegian public health system made an announcement that they will now be reimbursing ketamine for depression. Now, ketamine is not indicated for depression, right? Ketamine is indicated as an anesthetic.

Julio Martinez-Clark (16:24.971)
you

Julio Martinez-Clark (16:43.435)
Okay.

Julio Martinez-Clark (16:47.563)
Hmm.

Nicholas Kadysh (16:49.518)
You know, is there's there's there's this is the first country on earth that is basically said I'm taking this drug and on the basis of functionally real-world evidence I'm going to pay for it to be used in a new indication that it is it is currently being prescribed off labeling Ketamine is the fastest growing, you know mental health treatment in America

Julio Martinez-Clark (17:03.839)
Mmm.

Julio Martinez-Clark (17:12.341)
Interesting, okay.

Nicholas Kadysh (17:14.208)
It's just because it's legal and it's as close as we can get to other psychedelic drugs, you know, and it does work. It has, it has a couple of drawbacks. Obviously it's addictive. Not great. No, there's, there's problems with ketamine for sure. The effect on time is relatively limited. It's only about a month, maybe two months. So you need to come back for more doses, which is not great. Great for the drug companies. Not great for the patients. Yeah.

Julio Martinez-Clark (17:21.045)
Okay. Okay.

Julio Martinez-Clark (17:27.231)
Yeah.

Julio Martinez-Clark (17:35.699)
Okay.

Julio Martinez-Clark (17:40.489)
Yes, of course.

Nicholas Kadysh (17:42.607)
But so you get these very dramatic shifts that are sort of, you this is not how the pharmaceutical world generally works, right? Pharmaceutical pathway is very simple. Patented drug, approval, five years to 10 years of exclusivity based on the patent. You make all your money and then the generics guys come in. We are trying to do something very strange and people are often confused by, which is launch a new generic drug into the market.

Julio Martinez-Clark (18:02.475)
Hmm. Hmm.

Nicholas Kadysh (18:11.886)
based on sort of the body of clinical data that is currently available. But obviously we have had some success in places like Australia, where the government took that clinical data and said, yes, this is appropriate for use in this specific instance, the treatment of post-traumatic stress in treatment resistant patients. And I think now on the generic side, on the MDMA side, our challenge is now to take those wins from Australia.

Julio Martinez-Clark (18:36.852)
Mm-hmm.

Nicholas Kadysh (18:41.152)
and to start launching them out into the world, past Australia, past Canada, past the United States, into the European Union, where we just signed a new distributor in the Netherlands, and then out into the rest of the world, basically.

Julio Martinez-Clark (18:58.108)
Interesting. All right. So what's your mode, Nick?

Nicholas Kadysh (19:02.062)
Well, look, a couple of things. Number one, it's still a very small market. So not a lot of competition for a very small market. Number two, it is still a controlled substance. So you have to build up a certain level of expertise in the manufacturing of controlled substances, in the shipment of controlled substances. And that regulatory expertise does provide us a little bit of a mount. And then the third thing is generally you get market exclusivity when you're the first one to launch a drug. And so for a brief period of time, you five years.

Julio Martinez-Clark (19:06.73)
Hmm. Okay.

Nicholas Kadysh (19:31.053)
you know, eight years in some markets, you get exclusivity into that market. But honestly, I think the biggest thing is just trust. Now everybody argues, like everybody who says, you know, you don't have a moat, you don't have a moat. The best moat of all is being the one to fulfill the needs of your customers, right? Like developing long-term relationships with clinics and doctors who are going to be prescribing your material. It's commercial.

Julio Martinez-Clark (19:35.69)
Sure.

Julio Martinez-Clark (19:56.564)
Yeah. Mm-hmm. Mm-hmm. Yeah. Yeah.

Nicholas Kadysh (19:59.799)
Ultimately, nobody goes to like 3M, like the maker of Scotch tape and says, you don't have a moat. You can't possibly win. First mover advantage is important. yeah, yeah. The building out a commercial organization. And that actually is one thing that no one can ever replicate. You can obviously go in and try to steal my customers and steal my relationships and...

Julio Martinez-Clark (20:09.403)
Yeah, exactly. First mover advantage, marketing, things, exclusivity.

Julio Martinez-Clark (20:25.769)
Hmm. Hmm.

Nicholas Kadysh (20:28.366)
make the drug for cheaper, of course you can, but this is a very different thing than going in and building it yourself at first. So I'm a big believer in that.

Julio Martinez-Clark (20:40.305)
Okay, okay. So let's talk about Australia. Why do you choose Australia? Any particular reason? Because of the tax rebate incentive? Yeah.

Nicholas Kadysh (20:47.552)
Yeah, So three reasons really. Number one, we already have a lot of experience in that market because we're commercially active there. We sell our generic MDMA there. That's one. Two, think, I went to a meeting with Marty McCary, the Dr. Marty McCary, the commissioner of FDA a little while ago. It was an open session. And I can tell you, I don't think I'm supposed to say all the things that went on in there, but the one thing I can tell you is Australia was mentioned quite often.

because in addition to having this tax incentive, they also have a very clear and simple regulatory pathway to get your clinical trials approved. So you get your ethics approval, your human research ethics approval by an HREC. Any committee in the country can approve. Actually, I think it's any committee in your state, but regardless. And then for the TGA, the regulator, it's a notification scene.

Julio Martinez-Clark (21:27.433)
Yes.

Julio Martinez-Clark (21:45.021)
Yes.

Nicholas Kadysh (21:45.1)
So you say, I've gotten HREC approval. I'm notifying you that I'm gonna be researching this drug in this patient group. Here's the protocol. If you have any problems, let me know. And within 30 days, you can start your

Julio Martinez-Clark (21:54.086)
Yes. Yes. All right. So they get notified and they have 30 days to reject or object. Yes.

Nicholas Kadysh (22:02.158)
To object, yes, to object. And so that's, that's, look, I'll be frank. That is a much like, we do a lot of work with FDA. I have a lot of time for FDA. I'm not, you know, look, they have, they have a very different burden. They're the premier regulator in the world. It's 50 % of every pharmaceutical dollar is made in America. So they have a different problem to solve. But for me as a, as a CEO of a small company, if I'm going to go and do research anywhere,

Julio Martinez-Clark (22:18.855)
Yes.

Nicholas Kadysh (22:32.278)
I want the clearest, simplest path to regulatory approval for that clinical trial. Because as you can imagine, time is money.

Julio Martinez-Clark (22:40.304)
Absolutely. And you know, I'm very familiar with the process in Australia so much that, well, I ask the question for listeners, but I've been in this first in human clinical research world or industry for many, many years. And a lot of my clients go to Australia and...

Nicholas Kadysh (22:50.231)
Yeah.

Julio Martinez-Clark (23:05.745)
And also come to Latin America for other reasons. Every country has its advantages. But Colombia, I was born and raised in Colombia, so I love my country, but Colombia became so complex with the way nuclear trials were being approved. It was taking too long and too many steps, et cetera, et cetera, that, what is the aside, I can say with a lot of pride that I push.

Nicholas Kadysh (23:07.564)
Yeah. Yeah. Yeah.

Nicholas Kadysh (23:15.34)
Yeah.

Yes. Yes.

Julio Martinez-Clark (23:34.724)
certain congressmen in Colombia, I didn't push, I mean, I love it. Exactly. Okay, yes, exactly. know exactly what I'm talking about. It was just regular conversation. I told, I mean, over the past 50 years, I've been telling

Nicholas Kadysh (23:40.312)
You lobby? Yeah, yeah, of course, of course. Yeah, yeah. I used to be a lobbyist. I don't view that as a bad thing. This is good. Yeah, yeah, yeah, yeah, exactly. Yeah, yeah.

Julio Martinez-Clark (23:55.026)
politicians in the country, hey, the law in Colombia for clinical research hasn't changed in 30 years, 33 years to be exact. And it's about time that somebody does something about it. Panama already passed a new law, Brazil, Ecuador, all the neighboring countries passed new laws, so Colombia is behind. And a lot of money is going into other countries and Colombia is not.

taking part of this huge clinical trial industry and patients are not benefiting from these advanced therapies. two of these congressmen accepted my pitch and I am proud to say that I wrote the draft for a new law.

Nicholas Kadysh (24:29.037)
Yeah, I

Nicholas Kadysh (24:44.162)
Good.

Nicholas Kadysh (24:51.127)
nice, very good. Very good.

Julio Martinez-Clark (24:51.889)
that was submitted to the Colombian Congress. But the reason I mention all this is because I wanted to emulate Australia, because it's one of the best success cases in the world of a country that has really, really attracted research because of the tax incentives, because of the approval process just described, et cetera, et cetera. And I'm getting, of course, pushbacks. I'm getting calls and emails and stuff.

Nicholas Kadysh (25:00.578)
Yes. Yeah.

Yes. Yes.

Nicholas Kadysh (25:14.232)
Tournament.

Julio Martinez-Clark (25:21.146)
People don't necessarily agree, especially the government in Colombia. So let's see how it goes. But it's going to be an interesting journey.

Nicholas Kadysh (25:25.846)
It's no, I wish you good luck. mean, look, I think it's very, very hard for regulators. I've worked with regulators. I've been a regulator. It's very, very difficult for regulators to give up control. Now, if you're a regulator, want to have control. That's your job. But the other side of it is I want control, but I don't want responsibility. Because if something goes wrong,

Julio Martinez-Clark (25:41.592)
Yes, exactly. Yes.

Yes!

Nicholas Kadysh (25:55.617)
I don't want it to be me. I don't want to get fired, but I want to have control. And so what the Australians did, which I think is very, very smart, is they made a realistic assessment of what can we control and what can't we control. And so phase three clinical trials, which will impact a lot of people and are going to be serious. we're going to have a lot. For those, the TGA wants to approve those. Makes a lot of sense to me. But for phase three.

Julio Martinez-Clark (25:58.862)
Yes. Yes.

Julio Martinez-Clark (26:21.286)
Okay. Phase 3.

Nicholas Kadysh (26:24.632)
Phase one, phase two, look, we have clinical trial practitioners whose reputation is on the line. We have human research ethics committees whose reputation and business is on the line. I mean, there's lots of people who care and can be trusted in this industry already. For phase one, for phase two, for small clinical trials, we don't need to interfere, we don't. And that is the right attitude, I think, in the modern day, when we're trying to get a lot of...

a lot of stuff over the line and we don't have the luxury of zero interest rate anymore. Money is no longer free for biotech. Money is very expensive. So please, please make our lives easier. Otherwise you're not going to get any innovation in healthcare.

Julio Martinez-Clark (26:57.327)
you

Julio Martinez-Clark (27:01.711)
Yeah.

Julio Martinez-Clark (27:06.502)
Yes, yes. Although it's important to also mention, Nick, that I don't know if you know this, but there are two countries in Latin America that have a very similar pathway, actually even faster than Australia or less complicated than Australia. In other words, what I really mean is that in Panama, for example, or in Chile, you don't have to go to a regulator at all.

Just notify them and that's it. They don't even have that 30 day window of opportunity to object. Just let them know, exactly. Unless you're dealing with, you know, very advanced stuff like, if I remember correctly, Panama, if you're doing a stem cell trial or something like that, then exactly, yes, yes, yes. Yes.

Nicholas Kadysh (27:37.72)
Yeah, no, it's great.

Nicholas Kadysh (27:42.062)
Yeah, yeah, yeah, yeah. Oh, you just let them know. Yeah, yeah.

Nicholas Kadysh (27:55.279)
Yeah, gene editing, stem cells, yeah, a viral research. I mean, look, there are clearly things that represent significant risk to patients and significant risk to the broader population, right? So, know, stem cells, gene editing, viral research, all those, yes, I can understand. But if I'm testing, you know, like, I have to be honest, MDMA, this is not new technology. It's a hundred-year-old molecule.

Julio Martinez-Clark (28:06.881)
Exactly. Yes.

Yes.

Julio Martinez-Clark (28:16.218)
Yeah.

Julio Martinez-Clark (28:22.319)
Exactly, yeah.

Nicholas Kadysh (28:23.904)
It's being taken by people at parties every day all over the world. And it's being made in not very sanitary conditions because it's black market drugs. so from my perspective, I think that if we did drug discovery in a logical and sane way, the drug that is being taken by a million people made in a bathtub and no one is dying,

Julio Martinez-Clark (28:28.261)
Yeah, yeah.

Nicholas Kadysh (28:51.342)
it's a really, really good drug. It's a safe drug. I feel very comfortable giving that drug to patients in a clinical trial, especially when it's a GMP drug. We have a large body of scientific evidence around it. But of course, that's not the way that people look at it. Regulators say, well, this is a controlled substance. Well, we have to be very careful about this, I think there's a difference between biology and law.

Julio Martinez-Clark (29:00.835)
Yeah.

Julio Martinez-Clark (29:10.745)
Yeah.

Julio Martinez-Clark (29:19.013)
No, I mean, I think eventually it's going to get accepted. It's probably similar to cannabis. Like 15, 20 years ago, the conversation started and the train is for psilocybin and all these substances to get approved.

Nicholas Kadysh (29:24.13)
Yeah. Yes, it's. Yeah, yeah.

Nicholas Kadysh (29:33.005)
Yeah. Well, actually, one of the reasons that I hate the... I think you're right. The trend is the same as cannabis. The reason I hate the comparison to cannabis is there's way more clinical evidence in favor of psilocybin or MDMA than there is in favor of cannabis, which is not to say that cannabis can't be useful, but there's tons of really, really great high quality research on the usefulness of these molecules from top universities.

Julio Martinez-Clark (29:47.467)
Okay

Okay.

Julio Martinez-Clark (29:56.9)
Okay. From top universities, by the way, I think it was one of those Tim Ferriss conversations where I heard him saying that, John Hopkins and all that. He's actually a founder, I'm sorry, he's funding companies. Yeah, exactly.

Nicholas Kadysh (30:03.8)
Yeah.

Nicholas Kadysh (30:07.702)
Yeah, yeah.

Nicholas Kadysh (30:12.672)
Use funding, yeah, use funding. this research, yeah, yeah, yeah. So, I did, and these are all of our clients, right? So like Johns Hopkins is a client, Harvard's a client, Yale's a client. These are all sort of the top universities in the world and they're the ones that we're sort of selling our MDMA to. I promised you a Tim Ferriss story and I don't think I've shared this one publicly before yet. So I will share this Tim Ferriss story publicly and hopefully he doesn't get angry at me. But so when I started the company, I didn't.

Julio Martinez-Clark (30:21.474)
Hey.

Julio Martinez-Clark (30:28.068)
Yes, yes, yes, you did, of course.

Nicholas Kadysh (30:40.428)
I didn't really know anyone in this world. I wasn't sort of deep into psychedelics before I started Farmola. And I was looking for people to invest in the company. And I have a very good relationship with Professor David Nutt from Imperial College, who's a very well-known luminary in this space. And he was actually, he was on my board when I started the business. And Dave is fantastic. I just saw him a couple of months ago. He's really, really great.

And so I reached out to him and I said, Dave, like, who do you know that might be interested in investing in a business like this? And Dave goes, I have a friend named Tim. Tim might be interested in this. And so I don't know who Tim is. Dave says Tim is a good guy. So basically I sent an email. He sends me this email and I received back a very polite reply from Tim Ferriss saying, thank you very much. But I don't invest in these companies. I see this as a...

Julio Martinez-Clark (31:14.318)
Hmm.

Julio Martinez-Clark (31:32.483)
Wow.

Nicholas Kadysh (31:37.711)
as purely a philanthropic initiative. So I want to just give money to charities, not invest in businesses. And also please don't share this email with anyone. It was like a secret email. So Tim, I haven't shared the email with anyone. I promise you, I've kept it strictly confidential.

Julio Martinez-Clark (31:40.675)
Yes.

Julio Martinez-Clark (31:45.088)
Yes, exactly, that's right.

Julio Martinez-Clark (31:55.427)
That's amazing.

Excellent, All right, Nick, we are at the end of the show. I mean, it's been a lovely conversation. Thank you so much for joining the show again. And I look forward to seeing your success and seeing your company move forward and look forward to seeing MDMA being commercially available everywhere, even in small countries like the ones in Latin America where I'm from. Because, yeah, exactly.

Nicholas Kadysh (32:09.304)
Thanks, Elio. Of course.

Nicholas Kadysh (32:15.064)
Thank you.

Nicholas Kadysh (32:26.698)
Absolutely, absolutely. We're working on it. We're working on it. Yeah, yeah, absolutely.

Julio Martinez-Clark (32:32.323)
Yeah, I love to see patients benefiting from these therapies all over the world. So thanks. All right.

Nicholas Kadysh (32:38.53)
Yeah, thank you. Thanks for your time.