With the recent headlines touting the FDA rejection of Lykos (MAPS), MDMA treatment application as a major blow to psychedelics and now the announcement that the company has cut 75% of its staff, you’d think investors would be running for the hills.
In fact the opposite is true, so dig into this informative webinar to expand on how the situation is actually a net benefit to the advancement of psychedelic treatments.
Full Replay
Chapter Quick Links
00:00 | Introduction and Overview
02:30 | Meet the Experts: Mike and Michael
04:34 | Recap of the FDA’s Decision on Lycos MDMA Application
11:04 | Scientific Insights: MDMA vs. Psychedelics
27:52 | The Natural Origins of Pharmaceuticals
28:49 | The Pathway to Market for New Treatments
29:09 | FDA’s Role and Approval Process
30:16 | The Importance of Assistive Therapy
31:56 | Legal and Regulatory Challenges
36:33 | The Role of Chemists in Drug Development
39:24 | Political Influences on Drug Approval
45:52 | Future Directions and Optimism
47:55 | Final Thoughts
Teasers
[0:56] Ross O’Brien on BVE and the topics they’re tracking in this entirely new frontier of pharmaceutical investingPlay
[1:04] Michael Werner on the importance of listening to FDA guidance for regulatory success in such situationsPlay
[1:22] Mike McCormick with the science and an academic perspective on clinical trials involving MDMAPlay
Show Notes and Transcript
Note: Elements of these show notes, including the transcript, were automatically generated and, as such, may contain errors.
Title
FDA & The Collapse of Lykos | The Opportunity for Psychedelics
Description
In this Bonaventure Equity live stream webinar, hosted by Ross O’Brien, founder and managing partner, the focus is on the recent FDA decision regarding Lycos’ MDMA application, intended for treating PTSD. Ross is joined by experts Mike McCormick, a PhD chemist, and Michael Werner, a partner at the law firm Holland and Knight.
They discuss the significance of the FDA’s rejection, the scientific and therapeutic implications of MDMA versus classical psychedelics, and potential steps forward.
They discuss how the situation is actually a net benefit to the advancement of psychedelic treatments.
The session includes insights on the FDA’s evaluation process, the ethical issues discovered during clinical trials, and the broader political landscape affecting the approval of controlled substances. The conversation concludes by encouraging continued research and development in the field of psychedelics, emphasizing that the journey towards FDA-approved psychedelic treatments is far from over.
Guests
The webinar features three speakers:
- Ross O’Brien, Founder & Managing Partner at BVE
- Mike McCormick, PhD, Venture Partner at BVE
- Michael Werner, Head of the Healthcare & Life Sciences Practice at Holland & Knight
Full Transcript
[00:00:00] Ross O’Brien: Okay. Welcome, everybody. We’re going to start exactly on time today. Welcome to another Bonaventure Equity Live stream webinar with thought leaders and experts from our team and our partners in the space as we advance the therapeutic potential of controlled substances. I’m your host, Ross O’Brien, founder and managing partner of Bonaventure Equity.
[00:00:21] Ross O’Brien: You can find us at bve. vc. We consider ourselves to be one of the leading investors in very early stage development and advancement of controlled substances. What that means for us is that we believe we’re on an entirely new paradigm with an opportunity to develop a whole new class of small molecules for treating healthcare’s biggest needs.
[00:00:41] Ross O’Brien: And that encapsulated in controlled substances is a treasure trove of assets that are proving with early science and early research to be highly efficacious and really profoundly powerful. We are a hands on team and we work very closely with the companies that we’re investing in. And as entrepreneurs ourselves, we roll up our sleeves and get involved.
[00:01:02] Ross O’Brien: So part of our mandate, our mission is to share with you the conversations that we have in our boardrooms and conference rooms. And the important topics that we’re tracking to at this entirely new frontier. So I’m really pleased to introduce to you a couple of really close colleagues and partners of ours for several years now who are helping us lead the way.
[00:01:26] Ross O’Brien: I will have Mike and Michael introduce themselves in a moment, but the focus of today’s conversation and why you’re all here is to talk about the recent FDA decision regarding the Lycos MDMA. Application. And according to the news, the psychedelic sky is falling. So we don’t think so at all. We think that actually this is a really important moment for the advancement of psychedelics into viable, real FDA approved treatments.
[00:01:55] Ross O’Brien: And we think if you strip back away from the headlines that the information that we can get from, and what we can learn from this process is only going to fuel. The research teams all over the country and all over the world that are continuing to do some really important work. The whole webinar will be about 35 40 minutes and then we will leave time for Q and a afterwards.
[00:02:17] Ross O’Brien: If there is a question that you would like to have discussed, please drop it in the chat. My colleague Alex will be managing the chat as well, and if you have any questions, etc., you can join us there. We will be recording this, so if anybody missed it they can visit this afterwards, and we’re always happy to talk to anybody.
[00:02:34] Ross O’Brien: You know, who shares or has an alternate view on how we’re looking at things and overall help us move this mission forward. So I’m going to start with my colleague Mr. Mike McCormick who works with us and leading our scientific and IP team. So Mike, why don’t you take it away with your intro?
[00:02:50] Mike McCormick: Sure thing. Thanks, Ross. Hi, everybody. I’m Mike McCormick. I’m a PhD chemist by training. Lots of experience in structural biology as well, with focus on the cannabinoid receptors and serotonin receptors. That whole realm of of science. I’m also an entrepreneur. I’ve been working with BB for a few years now as venture partner, and I’m excited to speak with everyone today about this.
[00:03:16] Ross O’Brien: Thanks, Mike is always glad to have you and glad. We’re lucky to have you as a thinking partner. And Another thinking partner of ours and mine personally is Michael Werner from Holland and Knight. Michael, if you would introduce yourself.
[00:03:30] Michael Werner: Sure. Thanks, Ross. Hello, everybody. I’m Michael Werner. I am a partner at the international law firm of Holland and Knight.
[00:03:37] Michael Werner: I’m based in Washington, D. C., where I head up our life sciences practice, which is a multidisciplinary practice of 80 lawyers across the firm. My practice is an FDA practice, so I help companies that are regulated by the FDA or whose products are regulated by the FDA. drugs or biologics or medical devices or food and supplements.
[00:04:04] Michael Werner: I help them navigate FDA regulations and processes to help them develop their products and bring them to market. I work with them on compliance issues so that they can stay on the market. I’m also a registered lobbyist, so I represent those entities on Capitol Hill. And with the political appointees at the white house and across the federal government.
[00:04:27] Michael Werner: And I have particular expertise, not only in new technologies, but in particular in controlled substances like we’re talking about today.
[00:04:39] Ross O’Brien: Awesome. Well, as always, we’re very fortunate and lucky to have you both as part of the team. Let’s start with jumping right in with you, Michael. Why don’t we just recap what just happened right for those of people that are just kind of catching up with this this process?
[00:04:54] Ross O’Brien: Lycos had an MDMA application and went through, you know, years of development and They’ve had this, this, what seems to be a conclusive decision by the FDA. So maybe you can share with us what happened.
[00:05:07] Michael Werner: Sure. So Lycos, which by the way, is the for profit arm of what the nonprofit organization, which was known previously as maps Lycos had been taken over the project of developing an MDMA drug.
[00:05:25] Michael Werner: for the indication of post traumatic stress disorder. And they had done been working with the FDA and had done a series of clinical trials with the objective of getting approval from the agency in order to market their product. And the big news that happened recently was that essentially the FDA.
[00:05:47] Michael Werner: So, so in order to do that, For those who don’t know, you have to, the company has to file a so called new drug application to the FDA where the company puts all their safety and efficacy data in and that sort of starts the process of FDA kind of formally reviewing their final application to make that decision.
[00:06:10] Michael Werner: Determination. We can, we can talk a little bit later about the fact that there was an advisory committee for this particular product. But the gist of it is that companies provide this new drug application. And the hope of a company, of course, is that FDA says, yeah, you know, great. You did everything we thought you were going to do.
[00:06:30] Michael Werner: You’ve demonstrated that your product is safe and effective, so we’re going to give you the license to market the product for the approved indication. Unfortunately for Lycos, what happened here is that FDA basically said it had completed its review of their new drug application, but determined that in fact they could not approve it based on the data that was submitted.
[00:06:56] Michael Werner: And so they basically said that they didn’t shut the door completely on Lycos. They just said, you know what, we’re gonna, we’re gonna need you to do additional research. Basically, they asked for an additional phase three trial in order to so they get more information about the safety and efficacy of their, of their product.
[00:07:20] Michael Werner: So a couple of things, right? That number one, The company certainly can and probably will go about, you know, developing this new phase three trial and they can come back to the agency. And if their data shows safety and effectiveness to the agency satisfaction, the agency will approve the drug. It’s not as if.
[00:07:41] Michael Werner: You get a negative, you know, response from FDA and then you’re forever banned from coming forward. They just said you haven’t, you haven’t met the standards at this time. Lycos also announced that they plan to have a meeting with the FDA to try to get what they refer to as a reconsideration of the, of the decision and to kind of further discuss this idea that the agency wants.
[00:08:09] Michael Werner: So I don’t have any inside information. Perhaps none of us do, but presumably Lycos is going to go in there. They’re going to say, Hey, we did you FDA knew what we were going to do. You, you had approved our clinical trials. You knew what we were going to do. We did it. So we’re now a little bit taken aback by your decision.
[00:08:33] Michael Werner: So if you’re not gonna just reverse your decision, which would be unlikely, tell us how, where we came up short. Because from the company’s perspective, if they have to go back and do an additional phase three trial, it takes a long time. relatively speaking and costs a lot of money. So they’re looking at a few years probably before they can get their drug to the market.
[00:09:01] Michael Werner: So they’re going to try to go back to FDA and say, Hey, you know we have a mullion here, right? Can we either reconsider this or if you want us to gather more data, Because, you know, you’re not satisfied, you know, tell us how we can do that in the most expeditious way possible. And of course, from the company’s perspective, and from the patients that they’re hoping to treat time is always of the essence of the essence, certainly for a business.
[00:09:33] Michael Werner: But there are millions and millions of people who suffer from PTSD. And certainly earlier, your earlier clinical trials had shown that there was you know, safety and, and certainly efficacy with, with the MDMA product. So there are patients who are kind of anxiously waiting for this as a treatment option.
[00:09:54] Michael Werner: And so undoubtedly Lycos is going to go to the FDA and kind of, that’s going to be a big part of their argument. They’re going to respond. They’re going to try to respond to what they see as FDA’s concerns. And they’re also undoubtedly going to say, Hey, even if you have concerns, what’s the fastest way we can resolve them?
[00:10:15] Michael Werner: Because there’s a lot of people who are suffering out there, so it’s not, it’s not the end. It’s certainly a big setback, certainly a setback for MDMA and for the company. But it’s not the end for that product and something you raised at the beginning, Ross, it’s by no means the even close to the end for psychedelics.
[00:10:39] Michael Werner: The FDA has has continuously expressed that there’s a way to do trials for psychedelics. They have been supportive. So. This is a situation where we have a new, it’s a new technology. It’s a new drug. FDA makes decisions on a case by case basis based on the data in front of them. So they’re not making kind of, you know, a political statement about psychedelics.
[00:11:06] Michael Werner: They’re saying, This application didn’t meet the standards that we wanted in order to approve the job.
[00:11:15] Ross O’Brien: So, I want to take a couple of those points just in reverse and then, Mike, I want to jump into a little bit of the, you know, MDMA versus psychedelics and that component to it. Yeah, Michael, first of all look, and I, I want to be clear, I mean, from our vantage points, I think collectively, but certainly from our firm.
[00:11:31] Ross O’Brien: FDA is an essential necessary. And you know, we respect, you know, the organization institution and think that it’s really critical. So by no means should anybody be looking at this as FDA doing something that they’re not otherwise mandated to do, which is there is a set of criteria that every product needs to meet in order to get through that for a public for our public safety.
[00:11:56] Ross O’Brien: And we think that that’s critical and One of the key components to what you just said is the treatment of patients, and I said in our, in our introduction, I mean, we are actively looking at treating health care’s biggest needs. I personally, though, and I’d like your perspectives on this. I want to caution everybody in in looking at the patient group and saying, you know, well, there’s people suffering, because that’s the case for every drug that the FDA,
[00:12:24] Speaker 2: you
[00:12:24] Ross O’Brien: know, cancer patients, Alzheimer patients.
[00:12:26] Ross O’Brien: Right. So 100 percent of, of the drugs that don’t make it through have patients that are theoretically waiting for them. I would like to know is there a precedent for companies going back and, you know, having a negotiation with the FDA? That’s what it sounds to me. Like the, you know, FDA meeting is saying, Hey, we think we need a Mulligan.
[00:12:47] Ross O’Brien: As you said you know, we always approach it. We coach our companies that, When the FDA tells you something, they tell you something, right? It’s not for you to try to convince them to come off of their perspective, but rather to understand what your culpability is in the process. If you mismanaged your clinical trials or if you didn’t have the right, you know, scientific team, et cetera.
[00:13:05] Ross O’Brien: So is there a precedent? Is that at all really likely? And has that ever happened before? Yeah,
[00:13:10] Michael Werner: I think the, the So first to your first point, 100%, right? There’s every, not every, but a lot of drugs that are out there for, are out there to treat a currently unmet medical need. And the Lycos drug, like many, received a breakthrough therapy designation, which is specifically designed to try to expedite FDA review of products for unmet medical needs.
[00:13:42] Michael Werner: So. I was parse, I was trying to parse my words. I’ll be a little bit more direct, which is to say that’s what li I think Lycos will argue is, Hey, there are patients out there who need this. We need to move quickly. I think FDA’s perspective is, we agree there are people who need this, we wanna move quickly, but our job is to make sure that the sign, our scientific standards are met and, and.
[00:14:11] Michael Werner: Let’s say just because there are patients who need the drug does not mean that we’re going to short circuit those those questions. In terms of, in terms of what, I think what, what the company is going to do is they’re going to go, they’re going to go back to FDA and have that conversation about, okay we’re, what they’re going to say is we’re a little confused.
[00:14:36] Michael Werner: And they’re going to say that because their argument is that we did everything that we thought you wanted us to do. So your point is exactly right, Ross, which is that, you know, FDA, right? Companies do better when they listen to their customers. I always advise clients, when you go meet with FDA, say what you want to say, but really spend most of your time listening, because they, you, you know, you need to listen to what they say, and then try to do it, or try to incorporate it, or try to, they’re telling you what they want.
[00:15:21] Michael Werner: They’re probably, you know, I haven’t been in any of the meetings with Lycos, but they’re not usually trying to hide the ball, right? They’re trying, you do this and then you’ll be okay. And so
[00:15:33] Ross O’Brien: Michael, it seems like the FDA is always on their, in their participation. I don’t want to say size, but in their, you know, involvement in these processes, it seems like they’re always sort of have an uphill battle in the sense of they’re this big amorphous nebulous kind of government agency.
[00:15:49] Ross O’Brien: And then you’d have these patient groups. You have. Identifiable founders, management teams that have PR campaigns. Like it’s sort of easy to say it’s a David and Goliath, that kind of thing, but it doesn’t, When you’re actually in it, it doesn’t feel like that at all to me.
[00:16:04] Michael Werner: No, it’s not that I do think there’s often either an orchestrated effort by a sponsor, or it kind of organically happens that when products move through, there’s, you know, sort of constituency of patients that could be helped, for example.
[00:16:21] Michael Werner: Or perhaps investors and they try. to sort of let FDA know. And look, one of the reasons I mentioned the beginning, there’s a public advisory committee meeting that FDA held prior to making its decision. And that was certainly the opportunity for stakeholders to come in and talk about the importance of this drug or why they thought FDA should do what they do.
[00:16:48] Michael Werner: And FDA Was in this case, certainly, and most of the time was very respectful and careful to listen to those views. It’s not that. The people who work at FDA don’t understand that. It’s just that from their perspective, that doesn’t justify allowing a product to get to the market that they don’t think has proven to be safe and effective.
[00:17:13] Michael Werner: And that’s, that’s what they, that’s the thing that they will. Now, like us may say, Hey, we thought we did listen. We thought we did what you wanted us to do. And that’s where the conversation will happen. So I suspect what will come out of it is some kind of agreement where the company has to go back and do some work.
[00:17:39] Michael Werner: Um, how much will, that’s what they’ll negotiate.
[00:17:44] Ross O’Brien: So I think we’re going to, let’s come back to the advisory piece because I think we can learn a lot from that. Mike, I’d like to turn it over to you to take us down the scientific rabbit hole. One of the important things, I mean, this is a, this is fundamentally based on science and research and data.
[00:18:00] Ross O’Brien: Yes. If you could start kind of just take us back to the beginning as well, like what Michael did. Sure. What’s really important here is I think that people understand sort of the process but also MDMA specifically the choice to choose that the choice to use that as their base. how it does and doesn’t compare to psychedelics.
[00:18:20] Ross O’Brien: Just, I think that foundation is really important to understand.
[00:18:23] Mike McCormick: Yeah, definitely. I mean, first of all, I want to say, that’s what we’re talking about, right? It’s the product, you know, in reference to what Michael was saying earlier, it’s the product. And in this case, it’s not just MDMA, it’s MDMA assisted psychotherapy.
[00:18:37] Mike McCormick: And that’s a huge crutch that the FDA had took issue with. because it’s one thing to scientifically evaluate a drug, a chemical compound and its effects on animals and people and research behind that. But it’s another thing to say, we have that plus the the involvement of a psychotherapist. And I mean, this is what, this is actually where they ran into this ethical issue that ended up leading to some of their papers being pulled.
[00:19:00] Mike McCormick: So they had publications that were associated with each of these six different clinical trials that were associated with this effort to get this approval. And a few days after the FDA’s announcement, the journal pulled three of their papers saying you didn’t tell us about these ethical violations and therefore you’re lying to us and we’re pulling your papers.
[00:19:19] Mike McCormick: And so it was kind of a double blow and one on the scientific front because, you know, here they were, they’re, you know, they’re already, sort of limping from the FDA’s. And then they had this journal pull a bunch of publications. And their reason was that, you know, it related to the therapy. There was some misconduct with at one of the sites where somebody was like sexually abused or was accused of sexually abusing somebody who was involved in the study.
[00:19:42] Mike McCormick: And so this became an issue. On various fronts with the company and also eventually even to their publications. And so, but, but that’s, it does kind of link back to what the product is. It’s not just MDMA and I’ll get to what you’re, you’re talking about in a second here, Ross, about the actual nature of the compound.
[00:19:58] Mike McCormick: But I just want to talk first about the product that’s being evaluated here. It’s not just MDMA, it’s not just ecstasy or whatever, any of the, any of these, you know, terms you would want to use for it. It’s, it’s this assisted therapy. And so that’s one of the things that the FDA came back and said. It’s like, Hey, we don’t evaluate talk therapy.
[00:20:14] Mike McCormick: That’s, it’s, it’s one thing to have consistency in a drug that you’re giving to someone which is even still sometimes difficult to achieve, but to also add in, you know, the idea that you’re having a therapist there. And that’s part of the, of the, the therapy. the treatment that’s, that’s seeking approval.
[00:20:29] Mike McCormick: It really makes it difficult for them. Now, it kind of again, goes back to what Michael was saying is that they, they, this isn’t like the day one of the process here. They had been going back and forth with the FDA for a long time and that had led them to this, to, you know, to, to do that, to make this big step.
[00:20:45] Mike McCormick: And then they get hit super hard like this. So it certainly does raise an eyebrow. And again, I’m not, Accusing the FDA or anyone of any misconduct or any foul play or anything like that. But it certainly does raise an eyebrow because it’s like, oh, we’re having this professional back and forth. We’re spending a ton of money.
[00:20:59] Mike McCormick: There’s lots of people involved, you know, there’s a lot of media attention to this. So, you know, it almost seems in a way if you step back like they kind of got set up maybe to fail. That’s, you know, might be a stretch. But it certainly in the least raises an eyebrow. But yeah, so, so one of the things that, that I guess I keep seeing that bothers me a little bit in media attention surrounding this is that people are calling MDMA a psychedelic and, and we can, you know, we can debate that at its core MDMA is an amphetamine.
[00:21:28] Mike McCormick: That’s what the A part of MDMA is, amphetamine. And so unlike things like LSD and psilocybin and some of the other, the classical psychedelics where people are, you know, associate those psychedelic experiences with those compounds, it’s, it’s not one of those. Those are tryptamines. Okay. And so here we’re dealing with, with essentially an amphetamine and it has a different profile for becoming dependent on it.
[00:21:52] Mike McCormick: It’s the type of thing that you can take every single day if you chose to, whereas that’s really not possible with classical psychedelics like LSD and psilocybin. After a few days, they lose so much efficacy that one has to take a break before they can return to that. And so they’re sort of naturally preventing them from becoming addictive.
[00:22:09] Mike McCormick: And so there is sort of a, I mean, just from, from where I stand as a, As a scientist, there’s sort of a safety issue already with the fact that, you know, we’re talking about an amphetamine, not a classical psychedelic. And also it’s something that yes, there could be a dependency to. Now, in terms of the actual, you know, the, the idea behind, let’s combine this with therapy that goes way, way back into the seventies when MDMA was first sort of making its rounds.
[00:22:34] Mike McCormick: And there were people synthesizing it and sharing the synthesis and it was sort of spreading into the. various parts of the country. It started with psychotherapists who are saying, Hey, we tried this. We had this core group of people who had this experience with this and some scientists brought it to us.
[00:22:50] Mike McCormick: And wow, this could be really advanced speed up therapy. And so all the way back into the seventies, there were people who were. giving this kind of therapy out, obviously underground. But this had built up into and, and reached into, of course, to the point where in the eighties and nineties, it was all over the place and you could get this recreationally.
[00:23:08] Mike McCormick: And so people were having these experiences and, and feeling this, this benefit. And so in a way it’s interesting because it’s like the anecdotal benefit that is this therapeutic elements that goes, that’s associated comes from people who are on their own or with their friends. They’re not laying on a bed with a psychologist.
[00:23:28] Mike McCormick: And so, you know, it’s, it’s, there’s kind of a disconnect as to, you know, what, what the, the therapeutic value could be and how they took it to the FDA, you know, which was, of course, sort of fostered by this back and forth with the FDA. And so that’s sort of my overall two cents on it.
[00:23:43] Ross O’Brien: I want to just double click on a couple of things you said, Mike.
[00:23:47] Ross O’Brien: So I think it’s important to understand MDMA and the landscape of psychedelics. You’re, you, you spoke about effectiveness and winning effectiveness over time. What are the fundamental, so why psychedelics as we think about what is the class of psychedelics and what is the spectrum and sort of where does MDMA fit versus some of the other things that we’re looking at?
[00:24:10] Mike McCormick: Yeah. So, so again, you know, structurally the scaffold that, that, that MDMA is is, is an amphetamine. And so like other amphetamines, it has a lot of the same measurable effects in people and in animals. And so you get a reduction in serotonin reuptake. So all of the pharmaceutical depression drugs are typically SSRIs or some analog of that.
[00:24:34] Mike McCormick: That means Selective Serotonin Reuptake Inhibitor. And so in the sense that that those drugs will, can help someone feel better, it has that same kind of effect physiologically on the body, which is the serotonin reuptake inhibition. It also it has a similar effect with some other neurotransmitters that also basically give it this sort of energizing effect.
[00:24:55] Mike McCormick: And so this is where you, where you get a difference from powerful serotonin receptor agonists like psilocybin and LSD that have this profound effect on specific receptors that cause what people believe that the hallucinations and the psychedelic part of it. That’s not, that’s not so much the case with NDMA.
[00:25:13] Mike McCormick: it’s more of the stimulatory effect. And so yes, there is a, you know, sort of a dilation in time that people experience, which they would say, Oh, that’s a psychedelic drug. You see this alteration in time that makes it psychedelic. You see that with MDMA. And so it’s sort of, in a way I view it as a, you know, sort of a, the, the, the amphetamine that’s as close as you can be to a psychedelic.
[00:25:34] Mike McCormick: But
[00:25:34] Ross O’Brien: MD, MDMA is what it synthesized. Right. Yes. Produced through synthesis.
[00:25:41] Mike McCormick: It’s lab synthesized. Yes.
[00:25:42] Ross O’Brien: Lab synthesized. It’s what’s otherwise known as ecstasy or mom. That’s right. Exactly. So we’ve got that sort of in one, you know, category now for people that are, you know, thinking about and trying to understand the landscape.
[00:25:56] Ross O’Brien: Everything kind of gets lumped in on psychedelics, but most people, when they refer to psychedelics, they’re thinking of psilocybin and the naturally occurring fungi that produces them.
[00:26:05] Mike McCormick: Yes, yeah, yeah, I think so. And You know, and that’s, it’s like, if we look at animal models you can’t really distinguish MDMA from regular amphetamines in a mouse, for example, there’s not a lot of, there’s as far as I know of no studies that really show any difference there.
[00:26:20] Mike McCormick: It takes, it takes to getting it into a person to see that kind of difference. But my point with it is that, you know, instead of saying, Oh, this is a real strike to psychedelics. I look back at it and I like, this is, this is a therapeutic amphetamines. And yes, there could be tons of uses for them. People have been doing it for 40 plus years already underground and will continue to, I’m sure.
[00:26:42] Mike McCormick: But you know, for, for this to translate into something that can be over the counter or prescribed by a doctor, I think for one, it needs to sever its connection with this therapy. We, I mean, it’s, are we really going to be able to have a talk therapist available for every single person out there that has PTSD and one that’s willing to do psychedelic therapy or MDMA assisted therapy.
[00:27:03] Mike McCormick: It seems like that’s almost would be would be a very difficult hurdle once it’s already available. And so the fact that it’s tied to that is, I think, an issue. And the reason that I think they did that, and people do that in general when studying the effects of of you know, these type of substances on people is for safety.
[00:27:21] Mike McCormick: They want somebody there in case the person loses it. You know, if somebody has a bad trip and they start flipping out, they want a therapist there to make sure that it’s not going to let things aren’t going to hit the fan basically. And I get that. But that’s the other thing is that the reason that we’re even doing this kind of study and looking into these drugs is because a ton of people went out and did it on their own.
[00:27:39] Mike McCormick: and got better and felt better and moved on or did something, you know, improve their relationship, whatever it was, they didn’t need the therapist. And so, yes, there is a risk associated with it. But there’s a risk associated with, with taking all kinds of drugs even things. So
[00:27:53] Ross O’Brien: I think what’s important to tie this all together and like, I’d like to come back to you on some of the, you know, the phases and the next steps here.
[00:28:02] Ross O’Brien: What I think is really important to frame this with is that everything that we consume in pharmaceuticals originates in nature and it originates in nature is either a plant plant base, but 74 percent of our top drugs consumers originating plants as a compound or molecule, but 18 percent of fungi, bacteria, soils.
[00:28:26] Ross O’Brien: This is how our pharmaceutical industry for generations has been developed and why we have drugs on the market that are highly efficacious that we have today. I, I, I won’t, I think it’s important for people to understand when something works in its natural form. From our vantage point anyway, yes, that’s, it’s great and exciting.
[00:28:47] Ross O’Brien: Yes, people are feeling better and getting positive benefits from it. Yes, there is a ton of risk to it because it’s essentially unregulated. Right. And, and, you know, how are we going to deliver health care, right. With, you know, some of these compounds, but in order to really bring them into the patient population as real treatments, real drugs, you know, there is a pathway for that as everything else that has come before it.
[00:29:13] Ross O’Brien: And this pathway does not have a hundred percent failure or a hundred percent success rate. There is some ratio for everything that comes through FDA. FDA does not approve everything that’s before them. This is the first step, right. It happens to be for these for MDMA, we’re certainly excited and looking forward to what’s happening on the more psilocybin front which also has a lot of potential for treating PTSD.
[00:29:38] Ross O’Brien: So, Michael, when we look at this landscape, and again, really leaning into FDA, You’d mentioned earlier on. So essentially, there is a playbook for moving forward for like us. And I think any entrepreneurs that are listening should be paying close attention to this this process because there’s a lot of really interesting and I think important data and signals to gather from the next steps are expensive and timely and redoing phase three as well.
[00:30:07] Ross O’Brien: If we look at that advisory committee meeting, Michael there were some key things that came out of that. Can you just revisit that for a moment for us? First of all, it’s not always common when it, when it does happen, you know, why does the FDA use that and what did we learn specifically? Not just about Lycos, but about the FDA’s thinking and the scientific community’s thinking.
[00:30:27] Ross O’Brien: Michael, Mike brought up a great point on the assistive therapy component. That is only one of a multitude of models that are emerging in this space.
[00:30:37] Michael Werner: Yes. So first of all, yes, there’s 100 percent a pathway to market for you know, drugs, biologics you know molecules that are studied. You know, extensively by by companies sometimes in universities and then spun out.
[00:30:56] Michael Werner: What? Right? We can have all conversation about that. But the point is that 100 percent there’s a pathway. And in fact, arguably, it’s it might be the there’s, you know, there’s two ways you can go, right? You can decide, Hey, we’re just going to have this product and we’re going to sell it. in local stores and we’re gonna say, Hey, this is a, you know, psilocybin product or what have you, and people have had great experience with it.
[00:31:30] Michael Werner: And you should too.
[00:31:32] Ross O’Brien: Michael, I want to, I want to really explore that because this is really important. This is putting mushrooms in the chocolate bars and selling them at Circle K in Oregon, right?
[00:31:42] Michael Werner: Sure. And I mean, look, I mean, people are doing this with cannabis, right? I mean, a hundred
[00:31:46] Ross O’Brien: percent,
[00:31:47] Michael Werner: right. I mean, so there are people who, who want to do this.
[00:31:51] Michael Werner: who for any number of reasons, right? There might be a business reason that
[00:31:56] Ross O’Brien: well,
[00:31:58] Michael Werner: I want
[00:31:58] Ross O’Brien: to, I want to jump in again, Michael, because we, the analogy with cannabis is really important. We consider that to be a recreational intoxication market. Talk to us about if somebody is, first of all, is it legal, right?
[00:32:11] Ross O’Brien: Like generally when you’ve got stuff, I see stuff on Facebook and there’s things that, so are people operating in the fringe here? Is there a gray area? Yeah, exactly. That’s my question. And,
[00:32:22] Michael Werner: and, but, but when we say, is there a path to market? I don’t want to suggest that. people don’t do that and think of that as their path to market, so to speak.
[00:32:33] Michael Werner: However, it is not legal and we can’t. The reason for going through the NFDA process, aside from the legality, which, you know, is a thing is that, of course, Going through the FDA process does a couple of things. Number one, it forces a company or an innovator to actually have to develop the product in a way that it can be consist, that it can be characterized, it can be studied and through a scientific method, it can be manufactured over and over and over In the same way, all of that is designed to protect, frankly, to protect patients so that when, just like with any drug you take, you go to CVS, you have confidence that, you know, you get drug X, whether it’s over the counter prescription, it was manufactured to certain standards.
[00:33:28] Michael Werner: If I pick up this bottle or this bottle, it’s the same. And right. And that’s maybe it’s covered by insurance.
[00:33:36] Ross O’Brien: And so, oh, I’d love to come back to that in a second. I just want to be mindful of time, but this is, I get asked this all the time, so I know people are thinking about this. When you look at the alternative to going to the FDA, so an ingredient, a nutraceutical, you know, what are the regulatory requirements for that?
[00:33:55] Ross O’Brien: Things like labeling, toxicity testing, et cetera, because People seem to think, I’m finding anyway, that it’s like, oh, we’re not going the FDA, so I’m just going to start selling this online and, you know, selling my brownies and my chocolate.
[00:34:08] Michael Werner: Right. And, and no, that’s not legal. And by the way, you know, FDA rules around what we refer to colloquially as nutraceuticals or, you know, food as medicine are not really defined terms in FDA regular regulations.
[00:34:29] Michael Werner: So if you are marketing those products or you want to do a clinical trial with a product like that, FDA is going to say, Hey, wait a minute, we’ve got a process for that. This is the, you have to go through, we don’t create special rules for you. We create, we have a process which has over time made sure that people get safe and effective drugs.
[00:34:53] Michael Werner: And if, especially if we’re talking about controlled substances or products that have The kind of properties that we’re talking about here or that have that effect on people. The FDA is going to be particularly concerned. So you, you cannot avoid issues like demonstrating safety and manufacturing and all of those things.
[00:35:23] Michael Werner: And I, and I’m not, and you shouldn’t, you can, this is. The FDA regulations are not designed to be prohibitive. They are designed to make sure that a product is proven to be safe and effective before it can be sold. It’s obviously not prohibitive because there’s lots and lots of people who make drugs and who can market them.
[00:35:48] Michael Werner: What we see is we see this over and over when you’re talking about kind of a new class of products. Sometimes at the beginning, it can be a little bit bumpy as the FDA gets their hands around the science and the impact of these chemicals on people and as product developers kind of learn, also learn about what the impact is going to be on someone and what, how FDA thinks about these things.
[00:36:22] Michael Werner: So it’s not, it’s not unusual that when you have a new class of products, sometimes the first product through isn’t the product. That was the first product.
[00:36:34] Ross O’Brien: I would assume it’s right. I’m assuming it’s rarely the first product. Now, Mike, I want to, I want to tie in something with you. Sorry. I want to tie in something here because this is really important as well is this we’ve talked a lot about the role of chemists and chemistry as we’re advancing this.
[00:36:53] Ross O’Brien: Can you pick that up as you think about in this process of taking things to FDA or, or not?
[00:37:00] Mike McCormick: Yeah, I mean, it’s, I mean, one of the, we, we’ve been talking about these different classical compounds, okay? LSD, like MDMA, was first synthesized by a chemist working for a pharmaceutical company. Okay. The person who first synthesized MDMA was working at Pfizer.
[00:37:17] Mike McCormick: And so, you know, that’s, it was some, it was a long time ago, but I mean, here we are, there was a chemist here was exploring, trying to make derivatives of natural things and things that occur in people, you know, things like serotonin and amphetamines that occur naturally in making derivatives, looking for some kind of new medication, not necessarily with an eye to exactly what it was going to be or a thought as to this is This could be recreational or this could be abused or anything like that.
[00:37:42] Mike McCormick: Just let’s, I’m, I’m making compounds and, and that’s, you know, that’s, that’s the older way of doing things is to go ahead and say, let’s just start rolling the dice with, with chemical structures and then start putting them into, you know, experiments and mice and people eventually and see how they do.
[00:37:57] Mike McCormick: And so that’s how these compounds got arrived at. Psilocybin is a different story. It comes from mushrooms that occurs in 80 different varieties of fungi and stuff like that. And it’s, that’s how it’s typically. consumed. It is also synthesized in a lab today for experimental uses. And so, so that’s how that’s done now.
[00:38:14] Mike McCormick: But but yeah, I mean, that’s, it’s, it’s like somebody was having a similar conversation probably about this 50 years ago, but under a different context. I mean, you can go back and look at the 1912 patent for MDMA or something. It was 1912, something around that distant past where you have somebody who was working at a pharmaceutical company trying to make a drug to treat somebody’s illness.
[00:38:34] Mike McCormick: And here we are, you know, with, with the same kind of question marks surrounding this. And, you know, there’s been this, all this long history of known effects and benefits. And here we are, we still don’t have a treatment and it’s not because it’s not there. It’s just because these, these things are incredibly complex and FDA and other organizations are looking to protect people at the end of the day.
[00:38:55] Mike McCormick: They’re not looking to Screw over, you know, somebody or something like that. It’s it’s it’s about having to have the right set of experiments and the right people and the right collection of stuff at the right time, too, because there is a political element to this, and we don’t know exactly what that is.
[00:39:11] Mike McCormick: But it does kind of makes you wonder if there is something underlying there. When you see this, you know, like we were discussing earlier, where it’s like it seems like they kind of got set up to fail. You know, that seems a little odd. That could just be Miscommunication competency issues. There could be a bunch of things there, but it also kind of looks like that.
[00:39:27] Mike McCormick: And it’s, you know, here we are again, this is a farm MDMA as a pharmaceutical product, it already, it always has been. And so, and
[00:39:34] Ross O’Brien: I think this is a really important and Michael, I want to hand it back to you and take a few more minutes here before we get to Q and a let’s talk about the political, put on your lobbyist for us and let’s talk about the political aspect of this.
[00:39:46] Ross O’Brien: Because. I personally don’t believe, you know, here’s the questions we get a lot is big pharma trying to stop this and subdue it is, you know, are they set up to fail? I personally don’t believe so. I think, you know, you, you should look at, you know, the sort of culture and leadership team and they’ve approached it the way they’ve approached it because that’s the company that they’ve built.
[00:40:08] Ross O’Brien: I feel very strongly, and this is not to be an indictment, but you know, advocacy acumen does not translate to. Business acumen, which does not translate scientific acumen, you know, they’re, they’re distinct and different. So Michael, when we look at political acumen as part of the basket of, you know, centers of influence around this, what has been the reaction, what’s happening, what are the conversations or things coming under scrutiny differently?
[00:40:36] Michael Werner: So, so a couple of things, first of all, my view of. of FDA. You know, let’s put aside, let’s put aside, say, Mr. Person, right? Let’s put aside like a really political question right around the portion. Generally speaking, I think, you know, um, politics with the FDA can have an impact, but it’s, you, you shouldn’t overstate it.
[00:41:05] Michael Werner: Right. It’s not like Congress can pick up the phone or lobbies can pick up the phone and get FDA to approve or not approve a drug. That’s just not going to happen. And in fact, during the COVID pandemic, there were lots of folks, lots of companies who had, you know, treatments or tests or all kinds of products that were used during the pandemic that tried to get political support for getting FDA to approve their applications.
[00:41:38] Michael Werner: And there were in fact, times when politicians did support certain applications. And then it was, they found out that, you know, maybe the company had misstated what their product really did. And so there were a lot of members of Congress who felt kind of burned that they, that they did this and kind of stuck their neck out and.
[00:41:59] Michael Werner: You know, turns out inappropriately. So I think even in that situation, politics, I think, is overstated. I’m not saying that having a member of Congress sort of weigh in on something Is ignored.
[00:42:16] Speaker 2: I’m
[00:42:17] Michael Werner: saying it’s not gonna if your side if their science isn’t good enough, it’s not gonna, it’s not gonna push you over the edge.
[00:42:24] Michael Werner: It’s just not. I think that a couple of things about the response. The first part of the response is it have the decision happened sort of right before Congress went out, or, you know, right for, you know, there’s the political conventions. I mean, it was all sorts of other stuff happening. So it kind of.
[00:42:46] Michael Werner: From a timing perspective, it kind of happened in a little bit of a dead zone. So there wasn’t this sort of, you know, human cry. And frankly, in talking to folks on Capitol Hill now, I haven’t heard it. People have said, you know, yeah, we read about that kind of interesting. What do you think? But nobody has said that I know, Oh my God, this is outrageous.
[00:43:08] Michael Werner: You know, There were two letters that were sent to the FDA, one by 61 bipartisan, a bipartisan group of 61 House members, and another one of, I think, 19 senators to the FDA. Now what’s interesting about them is they do not say approve this drug. It was about the Lycos drug. They don’t say approve the drug.
[00:43:34] Michael Werner: What they say is, you know, a lot of people suffer from PTSD. And it seems that MDMA has potential to, to help these people. So if a company were to bring forward a product that proves to be safe and effective, we hope that, you know, you’ll give it a you know you’ll look at that application carefully.
[00:44:00] Michael Werner: So they say they say if it if it meets your rigor, they’re not going out on a limb and saying, Hey, FDA, you need to approve this Lycos product. And I have not seen now, you know, it’s still right after Labor Day and all that. But I’ve not seen, for example, any of those members of Congress or senators subsequently sort of write letters saying, Hey, what the heck?
[00:44:25] Michael Werner: Right? Yeah. So I think the politics are, are there for sure. PTSD is, is, you know, the, frankly, The biggest political part of this is the fact that for for I don’t know about for the most part But in many situations we’re talking about veterans And so the fact that it’s veterans As much as anything else is what triggers the political reaction.
[00:44:52] Speaker 2: Yeah,
[00:44:52] Michael Werner: because there are people who say Rightfully, right? These are people who and they served they defended our country or Our principles and now they’re suffering. We need to help them And I don’t think anybody has an argument with that. But I think the politics of this now is more around. Okay, well, the FDA had problems with that drug, but, but, so what do we need to do?
[00:45:20] Michael Werner: What’s the research agenda that needs to happen? Federal government funds a lot of research, right? What’s the research agenda? If we’re going to make this product available, this product, these products available to the veterans, what’s the role of the VA? What kind of infrastructure needs to be in place at the VA or the DOD for that matter?
[00:45:43] Michael Werner: Right? I think those are kind of the policy questions that that Congress and the agencies are thinking about. Now, the FDA will think about applications as they come forward. The other agents, I think, are trying to think about these issues a little more broadly.
[00:46:02] Ross O’Brien: So one of the things that we’ve talked about in Mike, you and I have had a lot of internal conversations with Mike is that it feels like, and this is why we are even more bullish on the advancement of.
[00:46:13] Ross O’Brien: Of these new technologies is it feels like a moment where there’s becoming clear distinction between what I called earlier the recreational intoxication market and the health care medical, right? And the more those diverge, the better we think it is ultimately for treating patients and working with these organizations, including real science and real drugs.
[00:46:33] Ross O’Brien: That’s fine that there’s a recreational market that exists out there, but you know, some of the things that I’m reading about are. You know, a lot of the cannabis regulation coming back under scrutiny of things like, you know, the delta eight, delta nine and the farm bill and these types of things. And, you know, I think this, I’m optimistic that this, although it appeared like an, you know, an immediate setback is actually going to open up and help support more research funding, which is critical for us.
[00:47:02] Ross O’Brien: Clearly, the FDA is open for business to do what they do. And they’ve set guidelines on. how companies based on psychedelics can approach them and how they should conduct state research. I would recommend that everybody in this space take a hard look at the comments. They’re very informative you know, through this process, what Mike, you brought up about the assisted therapy component.
[00:47:23] Ross O’Brien: The, and it was more than just one instance. There was a lot of, you know, abuse reported and things that were happening in that, and kind of look at the landscape and say, well, you know, is this a company that was set up internally, right, with their own leadership team, their own infrastructure, where they.
[00:47:41] Ross O’Brien: Well suited to advance this, right? And I think that’s a really important question because we’re finding there are so many groups of researchers that really research institutions and universities, et cetera that are out there really moving these things forward that are not in the headlines because they aren’t, you know, sort of flashy and things like that.
[00:48:00] Ross O’Brien: And, you know, You know, that’s where we like to go. Yeah. We’ve taken up a little bit of time. Thank you. Right. We take up a little bit of time here for the Q& A. I do want to invite one of our partners Alicia Bullock who is on this call with us. Alicia contributed. Are you there, Alicia? I think Alex her in.
[00:48:19] Ross O’Brien: I wanted to kick off the Q and A. She and everybody can read this on our website as well as both Mike and Michael have contributed a number of articles historically to the BDE Insights, which are all up on our website. All on our website. Oh, it looks like we’re struggling with. So, so I’ll tell you what, with the time that we have left, I will direct you to her very thoughtful article.
[00:48:41] Ross O’Brien: We had a conversation on look you know, Lycos immediately laid off 75 percent of their staff right after this decision. And. Clearly a smart business decision and necessary given, you know, what happened with the FDA, but I think it’s a really important article as well for people to read and think about, you know so I’m just getting a text from Alicia, Alex I don’t know if there’s a way to bring it.
[00:49:09] Ross O’Brien: So Alex just put the article in the comments as well. So go read the article. It’s really important. The conversation we had was you don’t just lay off 75 percent of your staff within three days without having a contingency plan in place. And there has to be some thoughtfulness around that and how to do it properly.
[00:49:25] Ross O’Brien: And at the end of the day, You know, collectively with the help of Michael with Mike on our team, you know, our job is to help founders and founder teams build companies around something that doesn’t exist previously. And that comes from science. It comes from intellectual property. It comes from entrepreneurial energy.
[00:49:43] Ross O’Brien: And critical to the space is having a view on the regulatory landscape, the political landscape, and being able to understand the legacy and the history of these institutions, the important role that they play and how to design your company from an early stage in order to be as successful as possible.
[00:49:59] Ross O’Brien: Ultimately, when we work with researchers, we always say, You know, we’re comfortable funding research that fails because what we learned from that is only going to add to, you know, our ability to bring things forward beyond there. But as capital partners, we should not be directing the research. That’s the role of the researchers, right?
[00:50:17] Ross O’Brien: So I think this is a great place to sort of wrap up today, guys. Mike, do you do you have any other comments or thoughts on sort of where, where we go from here? And, and I know we have a lot of founders on the call today. Any, any directionally, any things that we should be thinking about?
[00:50:32] Mike McCormick: Oh, I just want to say that.
[00:50:33] Mike McCormick: I mean, it’s, I don’t think this should be a discouraging time at all. I mean, what we’re seeing right now is the, you know, the FDA. Is, is, is playing a ball with companies that are, are trying to push forth these kind of advanced treatments that are, you know, start with controlled substances. And so, you know, where it’s, instead of it being like, anybody who touched this is going to jail now, it’s like, you know, we’re actually having these conversations with the FDA and so.
[00:50:57] Mike McCormick: I, I really see this as a continued step forward and just like anything there, you know, there’s, there’s, there are things that happen that, that are unfortunate. And there also could just the, it’s a perfect storm of the wrong things. You know what I mean? That, that happened that, you know, that, that could have set this thing back, but I don’t view it in any way as a setback.
[00:51:13] Mike McCormick: It’s a, it’s a process. There are many things that go forward and try to become drugs and fail. And so that’s just part of the process. We just need to keep doing it. We need more compounds. We need, we need more studies on these and more access wherever that’s possible. And so what we should do is forge ahead and remember what happened here and think about that as entrepreneurs and as investors and every, every, all, all the involved aspects, politics and everything and say, what do we really want here?
[00:51:41] Mike McCormick: Do we want the first thing to just blast through or because this is the. The person who’s been at this the longest at maps or whatever should, should, should, should be the champion. Let’s, let’s find the best. And, you know, and so I think that we’re getting there.
[00:51:56] Michael Werner: Yeah. Well, well said, well said, and I totally agree. And, and just also something that you said, Ross, I think companies or, or investors in the space there’s a, there’s already, and there will be more activity from. The VA, the DOD, the certainly the DEA, we haven’t even talked about the FDA Congress, a research agenda.
[00:52:20] Michael Werner: So all of those things are, it’s important to pay attention to those things as you’re either putting together your company or as you’re advancing your research and your clinical program, both from a perspective of resources. And I think right now the policy makers that I talked to They’re thirsty for information.
[00:52:41] Michael Werner: They’ve read about this stuff. They’ve heard about it. But they don’t know, right? Like, what’s the difference, right? What’s the difference between these drugs? What can your thing do? Why is that better? How are you doing it? What can we do to help you? So there really is a a great opportunity now for you to think about.
[00:53:01] Ross O’Brien: Well as venture capitalists, we have to pretend that we have a crystal ball and largely we push the crystal ball forward by being optimists. Now, you know, we typically look at over 300 companies before we make a single investment, which is consistent with early stage venture, which means we have to see a lot out there and get comfortable with things that are the right fits for us.
[00:53:23] Ross O’Brien: Companies we’ve discussed on this call are ones that we’ve passed on for reasons that we have to stay true to our knitting on, which is, you know, core foundational science, large patient groups that have, you know, uncertain unmet needs or have needs that we can do a better job with entrepreneurial teams and a perspective on the broader landscape.
[00:53:45] Ross O’Brien: That’s what’s happening, which is why. I find these conversations so invigorating. Love our discussions. Michael where can people find you at all on the night?
[00:53:54] Michael Werner: All the night. Yeah. My email is michael.werner@hklaw.com. Can also always give me a call [at the number in the video]. Can always reach me or Ross knows how to get ahold of me too.
[00:54:10] Michael Werner: Happy to happy to chat at any time.
[00:54:13] Ross O’Brien: Another great conversation and I think we’ve just teed up episode three, which will be our DEA discussion. Yeah. Dr. Mike it’s, it’s a pleasure working with both of you, but also the work that we’re doing. Thank you so much for the thoughtful comments today.
[00:54:27] Ross O’Brien: Where can people find you?
[00:54:29] Mike McCormick: Oh, you can find me. BVE michael@bve.vc would be a way to reach me. But yeah. Great, great, great conversation. Thanks Ross And Michael. Awesome.
[00:54:40] Ross O’Brien: Thank you everybody for joining us. We’ll be posting this on our website. You can visit us at bbe. vc and you can email me directly at ross at bbe.
[00:54:47] Ross O’Brien: vc. We look forward to talking with all of you and this is a mission that’s too important to fail at so let’s keep keep plugging away. Thanks everyone. Appreciate it.
[00:54:56] Michael Werner: Thank you.