Ep. 380 - AZ-BMS rumors, Replimune, psychedelics

Rumors flew this weekend about a mega-merger of AstraZeneca and Bristol Myers — but would such a deal make sense? On the latest BioCentury This Week podcast, BioCentury’s analysts explain why they aren’t buying it.
The team also discusses what lessons can be learned from the regulatory roller-coaster ride of Replimune’s RP1 vusolimogene oderparepvec and psychedelic therapies’ inflection point in treating depression.

View full story: https://www.biocentury.com/article/660376

#BiotechMA #FDA #Psychedelics #Depression #OncolyticVirus

00:00 - Introduction
00:51 - AZ-BMS Rumors
08:07 - Replimune
20:46 - Psychedelics

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

Transcript

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Jeff Cranmer: 0:02

Rumors fly about an AstraZeneca-Bristol Myers mega merger, but would such a deal make sense? We'll discuss on the latest BioCentury This Week podcast. Plus, Replimune's RP1 has had quite a biotech-style rollercoaster ride. What are the lessons from the advisory committee meeting from last week? And we'll map the psychedelics frontier in depression. Joining me today on the BioCentury This Week podcast, we have, of course, Editor-in-chief Simone Fishburn, today joining us from the best coast. For those who don't know, it, uh, starts with a W. my fellow Executive Editor, Selina Koch, our Washington Editor, Steve Usdin, and our jack-of-all-trades man in the UK, resident Minnesota Vikings fan, Stephen Hansen. Well, the Financial Times caused quite a stir over the weekend, reporting that AZ and BMS had been in talks about a mega merger, wow, that, that woke me up when I saw it. Stephen, what do you make of this?

Stephen Hansen: 1:16

Well, I saw this and I just found it a bit annoying, if I'm honest. Um, yeah, it's, uh, not a great idea in my opinion. I'm not sure if I can recall off the top of my head the last time that one of these mega mergers was a good idea to start with, but this one in particular, doesn't really strike me, as, as one that, that I would really expect to go anywhere. Part-- I mean, partly I think it's just because… So AstraZeneca has been one of the best performing pharma companies over the past five, plus years. They've-- I think I looked in five years, they've got fifty percent sort of share price appreciation, you know, not including, you know, increasing dividends and that sort of thing. Bristol has been one of the most underperforming pharmas. I think they were up like four percent, I think, over that same period. And, I know everyone's been sort of talking about each of them have their own sort of separate LOE sort of, uh, you know, loss of exclusivity challenges that they're facing. But AZ's already been through one. I mean, they lost quite a bit from their inhaled and their, cardiovascular portfolio that's, that's gone off patent, and they've made it through that and are still on a good growth trajectory. So and, and, and on top of that, they still have a lot of really good growth drivers that are, that are just coming, coming into the fore. So I just never would've, you know, singled them out as a company that needs something like this, sort of going forward. And, uh, that's why I was actually just quite shocked when I saw the headline, and I was like, " Okay, I can understand BMS being involved in a mega merger talk of some sort, but I would never have put AZ as the, party on the other side of that table."

Simone Fishburn: 2:53

Yeah. So Stephen, um, couple of points. First of all, on the whole, I do not comment on other media, um, and the, you know, Finan- Financial Times is obviously a, a very, very good, uh, newspaper. They did 100% get wrong their call-out on the Chancellor, of the Exchequer in the UK, for which I think they're still eating a little bit of crow and explaining that it was true at the time. And so maybe this is another one of these stories that is true at the time of reporting. the point is, I'm, I'm with you. Like, I think of all pharma CEOs in the last 10 years, you've got Dave Ricks, who's done a phenomenal thing at Lilly, no two ways about it. But actually, in terms of actually engineering the progress, Pascal Soriot probably rises above. I mean, um, noth- nothing against Ricks, and it's not a, a relevant thing, but he has really been a CEO that oversaw that turnaround. And you've … You're right. He's put them in this position that like, why do you want to go to BMS kind of thing. So there is this idea, and the reason I'm chan- what I'm channeling is here, there's a lot of nervousness in the U.K. even before, but, you know, with AstraZeneca saying it was gonna pull out its R&D or pull back, then they listed in the New York Stock Exchange. So I feel like this article by the FT taps this vibe of we might be losing one of our crown jewels to those dirty, you know, tax evader U- US people who, you know broke away from us all those years ago or something like that. Um, I don't know. I don't know if that'll go anywhere, and I don't think we have to spend too much. But I, I do think in a way, for me, the response of the UK and nervousness over losing AstraZeneca or even losing a lot of its influence, you know, that, that really speaks to, sort of where it is right now

Stephen Hansen: 4:42

Yeah.

Selina Koch: 4:43

Can we speculate on the other side? So, so if we think AZ has made a bunch of really good decisions and it's generally rational and logical, what's what's the argument for? Like, are there a set of technologies it would get from BMS that if you went out and bought every one of them separately, it would, like, cost more? Is there, is there any argument to be made?

Stephen Hansen: 5:03

I don't think so. I mean, so there are particular things that BMS has that, that might be a decent fit, like their partnership with BioNTech for the PD-L1 VEGF. But I can't believe that there aren't other PD-1 and VEGFs they could go get without having to do a hundred and forty billion merger. They have assets in cell therapy. BMS obviously has assets in cell therapy. Maybe combining them together might give them greater scale. But again, is that worth this larger, larger deal? It just-- There are individual assets within BMS that I think are attractive, but I don't know why you would spend this much money to, to do that. And to go back to the point that Simone was making about sort of the, the nervousness around being in the UK and stuff, and I know there's been maybe a little speculation, like have they, you know-- Did, someone leak this as a way of trying to, improve AZ's leverage or their, their positioning, you know, with the government? But I guess my pushback on that would be, uh, at, at the time that we're recording this, AZ stock is down almost eight percent, which equates to over twenty billion dollars in value. And so that seems like a f-- I mean, you can maybe argue that the moment this goes away, you know, that bounces right back, and maybe it doesn't actually cost them anything. But, it seems like a steep price to pay if, if this hangs on a little bit for, I don't know, manufacturing that leverage. yeah, it just-- Th-that was what struck me the most, I guess, was just the, the investor reaction spoke to how-- to m-my mind, spoke to how much AZ investors don't like this idea, don't think they need to bring on any of this. And, and I mean, frankly, I know everyone else will have already pointed this out, but, when BMS bought Celgene, they were so tied up in that integration that they were basically absent from the buyer's market for several years. I think when I looked in our database, it was like two or three years, I think, before they did another major acquisition. And so you would effectively be removing, you know, two buyers from the market effectively for the next couple of years if this were to go through. So,

Simone Fishburn: 7:01

I will just say, going back to Selina's point, there's, there's only one thing, which is I think we can agree Pascal Soriot is very smart guy and he's done a lot of good things. It's always a question with things like this is like, is there something up his sleeve that everybody else just isn't seeing, or did he just misread this? You know, um, you know, or is it true, or did he

Stephen Hansen: 7:21

Or is it complete, is it?

Simone Fishburn: 7:23

yeah. So we could, yeah

Selina Koch: 7:24

Yeah, yeah. The level of the talks may not be as advanced as they or they're making it out to be.

Jeff Cranmer: 7:28

Could have just been a cup of coffee, uh,

Selina Koch: 7:30

yeah

Stephen Hansen: 7:31

Exactly.

Jeff Cranmer: 7:32

somebody spotted him having espressos. excellent. Well, Stephen, look forward to reading your piece. Uh, we'll drop a, a link in the show notes. And, uh, get back to that pasta you're making, Stephen. Uh, you… Sounds delicious. Send, uh, send, send a little bit to

Simone Fishburn: 7:50

I think the listeners need to know that it's a Napolitano's sauce today, right?

Stephen Hansen: 7:55

Yeah, with lots of chili. So it's, it's a good spicy sauce

Jeff Cranmer: 7:58

Uh, food, food is often very top of mind here at, at BioCentury. Uh, it occupies at least, at least two Slack channels. All right, uh, let's head over to FDA and Replimune. Steve, wow, talk about rollercoaster rides. CRLs, setbacks, agreements with FDA that went poof. And then, uh, well, briefing documents came out last week. stock plummeted. Uh, advisory committee, the, uh, the experts on the advisory committee felt a little differently. Stock, uh, made a round trip, and here we are. What sense are you making of all this, Steve?

Steve Usdin: 8:38

So first we should say, look, we're recording this at one twenty PM on Monday, Washington time. There hasn't been a decision announced about, approval or not

Jeff Cranmer: 8:49

A good, good point. Yeah

Steve Usdin: 8:50

of RP1. the PDUFA date was actually, yesterday. So, you know, by the time people are listening to this, they may know more about it than we do now. So what do we know now? FDA Cellular Tissue and Gene Therapies Advisory Committee voted ten to three on July 30th that the efficacy results from Replimune's IGNYTE trial of, RP1 plus Opdivo are, uh, valuable and clinically meaningful. The panel was not asked whether to approve the drug. It voted against the written recommendation of the review team, which it concluded that IGNYTE was not an adequate and well-controlled trial, and that's the same finding that produced two complete response letters in roughly a year The dispute really, and this is what the AdCom was looking at, was about two issues, measurement of the systemic effect of RP1 and the relative contribution of RP1 and Opdivo to any systemic effect that was detected. it, it gets nerdy really quick here, but basically, one of the problems and that, and that the advisory committee pointed to is that the RECIST, criteria to assess systemic therapies, treats, lesions that have, been treated as non-measurable unless they grow. So the IGNYTE protocol specified that as many lesions as possible should be injected because the theory is that injection is the route of administration, and the injected tumor is the priming site for the immune response. So those rules are kind of incompatible, right? So 53% of Replimune's, responders didn't have any target lesions that weren't injected. So according to FDA, you couldn't really determine whether there was a systemic effect in those patients. So FDA's primary analysis said,"Okay, there's 140 patients. Remove 53% of them, from the numerator because you can't tell whether there was a, a systemic response according to the, RECIST criteria." and that changed the, response rate from Replimune's 33.6% to FDA's 15.7%, uh, and the duration of response from 24.8 months to 14.1 months. So that was a fundamental question. The secondary question was contribution of effect. If the responses are systemic, if there really are systemic responses, is that RP1 or is that the Opdivo re-challenge, right? This came to the advisory committee meeting, and as I said, they voted 10 to three, that the results were interpretable I think there's some lessons that came out of this for companies, and for patients. One is that, um, advisory committees, can serve as an appeals mechanism against, um, the judgment of, of an FDA, review division. that's happened in the past. It kind of, went away, under, former Commissioner Makary Vinay Prasad. It seems to be back. The other thing is, you know, if you look at who was on the committee and who was really decisive, it really came down to, the impact, I think, of, clinicians on the committee, versus statisticians. There was a lot of discussion, and I think this is something going forward that FDA is gonna talk about, about this issue of the, the target lesions and their impact on analysis. I suspect that one of the things going forward is gonna be a greater em-emphasis on companies having, a reserve of patients who don't have all of their, um, tumors injected so they can, look at systemic, effects, objectively. The alternative to that would be some kind of redefinition, of looking at systemic effects, in this kind of situation. One of the, panelists, said that FDA has a, a moral obligation, that was the term that he used, to kind of sort this out, to, to create, guidance because he said, you know, there, there are gonna be m-more, of these situations in the future. And finally, you know, I, I think, it's clear the panelists said it themselves that the, public commentary, uh, the public comments, swayed, their decisions, um, that they were impacted by it. And we've seen that before at advisory committee meetings. I think that if you have a situation where you have passionate patient advocates and, um, clinicians who, who really want to do something for their patients on the one side, and FDA making an argue about-- an argument about statistics and interpretability of clinical trial results, in the heat of the moment, in the heat of the advisory committee meeting, it's likely that the clinicians and the patients are gonna be more persuasive than the argument about, statistics and, clinical trial design and things like that.

Simone Fishburn: 13:39

So do you, w- maybe you and Selina, like, what is your opinion about FDA's … I don't want to call it gymnastics. F- FDA's operations on the mathematics, I mean, on the merits, is FDA right that if they injected all of those tumors, the consequence has to be to remove those people from the statistics?

Steve Usdin: 14:01

Well, look, you know, I, I'm not an oncologist, and I, I don't even play one on the podcast, you know? So I, I, I just… I think it's good enough for me to just to try to explain, you know, what the logic on both sides of it was. And, you know, it, it persuaded the clinicians who were on that advisory committee. I would leave it at that. I think, you know, time will tell, right? And this isn't the first time that this has happened, even with, with a very similar… There was a very similar, product to, to RP1, and an advisory committee that looked at very similar issues. Ultimately, FDA, granted accelerated approval to that product. It- it's not really being used very much now because in the real world, it turned out that it looked like it really doesn't provide much benefit. I think that we'll find out. You know, we'll find out, you know, in the months and years ahead who was right here.

Simone Fishburn: 14:47

let me just interrupt and, uh, let, let me just ask a question there. I think one thing that wasn't clear to me is what is the downside? There's always this idea, right, a sort of, of, of balancing risk and benefit. And you said, you know, and the sort of, you know, one argument will always be if it doesn't harm, let's put it out there and let it, let, let's find out. Is there, is there a lot of toxicity associated

Steve Usdin: 15:08

Yes, there, there to- there's toxicity associated with both elements, both arms of the, of the, combination and so, If it turns out that this doesn't work, patients will be subjected to, to a treatment that has, substantial, you know, or at least has some toxicity, some adverse effects. I don't think that it's really a viable standard to say, well, no, you know, this do- it looks like it's not gonna hurt anybody, so let's just go ahead and try. Let's go ahead and prove it and see, see if it hurts.

Simone Fishburn: 15:36

No, I, I agree. Although there are plenty of people who would-

Steve Usdin: 15:39

yeah. I d-

Simone Fishburn: 15:39

that is a lot of people who make that argument. It's almost a libertarian argument

Steve Usdin: 15:43

I, I don't hold that view, and also it happens to not be the law. The law doesn't say, you know, an Alfred E. Neuman "what me worry", kind of standard for approvals. The, the law says you have to demonstrate, um, safety and efficacy, and I, I think everybody would, who looks at it carefully, would… Not everybody, 'cause I, I'm sorry, 'cause there are people who, who think, well, if it doesn't hurt anybody, just go ahead and do it and, let's just approve everything. I don't think that's a viable, standard for FDA going forward, and it's certainly not what the advisory committee says is happening here. if it does get approved or if it does get accelerated approval, that's not what FDA is going to be saying. The critical thing will be to look at the confirmatory trial and the, and the experience going forward and to see, what happens and, and also to think about how to develop policy around these issues, around the two things. One about measuring systemic efficacy, and two about, measuring the contributions of two elements of a combination trial. because this isn't the last time this is gonna come up

Selina Koch: 16:43

Now, isn't there already data on Opdivo by itself in this population who's already experienced it before and progressed? And I thought the company's argument was that it was very, very low. So whether it's the efficacy of its therapy is FDA's number or its number, both of those are quite higher than Opdivo by itself. Did that-- Was that part of the discussion?

Steve Usdin: 17:04

Yeah, it is, but that all depends on the first question of whether you're using the company's thirty-three point six percent response rate or FDA's fifteen point seven percent response rate. So the delta between, um, re-challenge with, with Opdivo or, or an- another PD-1, and the effects that we're seeing in this trial are quite different depending on which response rate you're, you're using

Jeff Cranmer: 17:31

What do you expect, Steve?

Steve Usdin: 17:33

Well, I think we'll know soon enough. I think it would be difficult for FDA to reject it, to give another, complete response letter in the face of a 10 to three advisory committee vote, uh, in favor and, and also, you know, be honest, there's a, a lot of political and, um, and media pressure. I think I've talked about it on the podcast before. There's been… Besides extraordinary, uh, media attention to this, there was a, a meeting that was on the docket between, political, leadership at FDA, and it included an attorney from the White House, which was quite extraordinary, and, the CEO of, of Replimmun, prior to FDA's decision to have the advisory committee and to, to reconsider the application. So, you know, it's obvious that we're seeing, a lot of pressure from patients. We're seeing, political influence on this, and now there's the advisory committee meeting. So Anything could happen, but it seems to me most likely that, FDA will grant accelerated approval

Jeff Cranmer: 18:30

All right. Well, as you said, we'll, we'll know soon enough. Uh, we'll take a quick break, and we'll be back to talk psychedelics.

Voice Talent: 18:40

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Jeff Cranmer: 19:46

Okay, we're back on the BioCentury This Week podcast, and we do hope to see you at the China Healthcare Summit this November. It is part of Shanghai Life Sciences Week, for the China Summit. it is November 2nd through the 4th, but we have a limited number of spots, remaining for the pre-event excursions, which include a full-day tour at Suzhou's Industrial Park. Suzhou, of course, is home to such biotech names as Ascentage, Innovent, Harbour, and Ribo, and it's also where you'll find the campus of BioBay Park. we also have a few remaining, slots left for presenting companies. We're expecting record attendance from the West this year. A lot of very prominent VCs have signed up to join us, and we hope you will too. Okay Well, . Late stage wins pharma deals and a relevant commercial precedent have put psychedelics at an inflection point. Selina joining us now to talk about what is happening in the world of psychedelics for depression. What's up, Selina?

Selina Koch: 21:07

Well, I should say our colleague Tierney Baum has put together an analysis, a slide deck, which you will see coming out in BioCentury soon, on psychedelic therapies for depression, in which she, as Steph just mentioned, argues there's a number of factors sort of lining up to move that field toward an inflection point. when it comes to the deal, the deal's part of that. We saw Eli Lilly last month agree to buy AtaiBeckley for about $3 billion upfront. of course, last year we saw AbbVie buy, um, the lead candidate of Gilgamesh, and it's-- Utsuka had also done, an acquisition this year. So kind of pharmas are showing interest. The pipeline is maturing. So Compass Pathways has two positive Phase III trials and, expects to complete its rolling submission this year. So next year could bring the first approval of a classic psychedelic for depression. Behind it, there's an 11-member clinical pipeline.

Simone Fishburn: 22:11

Selina, you know, this space, it, it's one of those ones that was sort of, trundling along and then sort of, kind of has exploded in the last couple of years maybe, maybe less than that. you talk about an inflection point. What could the trajectory look like? I mean, it seems that obviously it's become very mainstream. We've got a number of pharmas, you said Eli Lilly, getting in the game as well. Although with Lilly, you don't know whether they just have so many resources now that they're just gonna cover every base just in case, and they can afford to do that and then win. So, so I'm not sure how much that means for the field that, that Eli Lilly has bought in. It's not like they spent their last dime on it, right?

Selina Koch: 22:47

I agree with that. Yeah. Yeah

Simone Fishburn: 22:49

so, so, but what would it look like? I mean, do you think from a treatment perspective, how big could this field be? Do, do you think it could really change the whole field of, of, of psych, or do you think it will always be sort of hampered by the constraints of how you can deliver it and, and, and its sort of negative, potential?

Selina Koch: 23:12

there's a couple pieces to that. One is effect size. What does it actually do for the patient? And then the other is the scalability issues, the commercial model, right? So on scalability, the, that precedent, the commercial precedent that Jeff alluded to, that's from Johnson & Johnson's Spravato, which is a S-enantiomer, a left-handed version of, of ketamine. So ketamine is not a classic psychedelic, but it's psychedelic adjacent in the sense that it's a highly psyc- psychoactive compound, and it requires, administration in a clinic and then monitoring during that psychoactive experience, before a, a discharge, right? And so psychedelics, psilocybin and LSD are gonna require that as well. So it's a very different model. It uses clinic resources that you would not use from like a Zoloft type, you know, take-at-home pill, right? Um, different kinds of billing models, staff, equipment, so on and so forth. But J&J, it had a very-- a fairly slow launch for, for Spravato, but it, is winning that battle. It's now a blockbuster drug. Might even reach two billion, in the near future. And to do that, it has got, I think it's over seven thousand now certified clinics that can deliver this care. And so the next generation companies, basically they plan to piggyback on this network that J&J has already built and then hopefully also build it out some more themselves. So that's on the scalability side. In terms of what it does for patients, I mean, we have-- there's a fair bit of early clinical stage data now, and there's starting to be some late-stage readouts. And so Compass Pathways, as I mentioned, is a leader. They've had two phase III trials they produced an effect. It w-- They both were positive, so it's reproducible, so it seems to be real. it's not an especially big effect. It's in the range of your conventional antidepressants, you know, and there's been so many trials in antidepressants over the decades. Sort of the, the effect on the primary endpoint, which is like the typical scale of depression symptoms, is called the MADRS. In its two phase III trials, it produced, you know, three point six, three point eight point changes on that sixty-point scale. so your classic psychedelics are around that. Spravato in its one, like, positive pivotal trial produced something similar to that, about four points. So it will be-- it's looking like they're gonna be another treatment option that's Effective that patients can turn to. Will they prefer it? It remains to be seen. There, there is this, um… From the trials we've seen, they do seem-- the effect seems to be, measurable quickly, within days, and then they're burdensome, right?'Cause you have to go into the clinic and take a day off work. but you don't have to get dosed very often. So these are the trade-offs that physicians, and patients will have to consider

Simone Fishburn: 26:18

Right. So do you, I mean, are we seeing, a growth of the pipeline in a, in a significant way? Are we sort of seeing it all the way down at the innovation end, the discovery end? Is it, is it sort of really filling out at lots of levels?

Selina Koch: 26:31

Well, here's the thing. Nobody really knows how psychedelics work, right? This is not hypothesis-driven science exactly. Um, like, like, like we've cracked brain science, so we know what causes depression, and now we have a very, you know, specific targeted therapy against that mechan- it's not like that. I always think of them as more

Jeff Cranmer: 26:50

despite a lot of research being done, uh, in San Francisco from the late '60s on

Selina Koch: 26:56

Yeah, right. A lot of research on, on themselves, people. But, um, so there is a, the, the leading hypothesis has to do with a certain type of serotonin receptor, 5-HT2A. for those in the camp who believe that the psychedelic experience itself, getting out of your mind, is key, they think that that mostly is driven through 5-HT2A. But these compounds from LSD and, and psilocybin, they, they bind a wide range of receptors. Um, the serotonin system, LSD also, and the dopamine system. It, it gets more complex from there, and these receptors can be found all over the brain, right? So you're having different effects in different places on different timescales, and sorting that all out is not at all trivial. so when you say on the innovation end, I mean, I think not included in Tierney's analysis here, but there is a set of companies who think they can achieve a similar sort of efficacy without the psychoactive piece. And I would say they're trying to get to a more specific targeted mechanism But, you know, that's a small, that's a small set of companies

Simone Fishburn: 28:11

I think it's just really difficult because, because, I don't know, they, um, it's just a difficult field. M- m- maybe because of what you said. It's like the science behind it is amorphous, shall we say.

Selina Koch: 28:24

Totally I mean, I think of it, the mechanistically, this is probably, they would probably reject this. I think of it like electroconvulsive shock

Simone Fishburn: 28:33

It is something like that. I

Selina Koch: 28:34

Like you just jolt the brain out of a local minima, you break a negative feedback loop, and when it settles back down, maybe you have a chance of, you know

Simone Fishburn: 28:42

No, I, I, I agree with you. And it's funny because, like… So I'm a molecular pharmacologist. I'm not a systems biologist, right? And so I tend to think in terms of pathways, right? Rather than, you know, rather than that sort of reset that you're just talking about. you were talking about there's all these inputs and whatever. You would really think that you could feed that in. That's the kind of information you'd imagine that AI should be able to pick through. If you actually could give it reliable information, I think one of the problems with psychedelics is there haven't been that many well-controlled studies, right? So as Jeff says, half of it is being done in, you know, Hey, Ashby, as opposed to ways that you can really get the data in the… So, but what I'm saying is that doesn't mean it's not real. It just means it's very hard for people who have got my training to get their head around,

Selina Koch: 29:34

Yeah. In some ways it's like back to an older school kind of medicine where you tried stuff and you don't, didn't know why it worked or whatever. But like the way that the industry is moving is, you know, targeted therapy, like understood, like, uh, causal biology. You know, this is very different

Simone Fishburn: 29:50

But like Bayer developed aspirin in something like 1915. It was like 80 years before they knew how aspirin worked, right? And nobody questions that aspirin works or even how it works now.

Jeff Cranmer: 30:03

Very interesting stuff. Tierney, uh, has definitely dug deep this time. The deck, uh, love the format. It, it just, uh, gets all the info, to the readers front and center. I guess one, one last thing that's probably worth mentioning, Selina, is, uh, psychedelics have, have been kind of championed by HHS, in recent years. Uh,

Simone Fishburn: 30:30

anyone in particular at HHS?

Jeff Cranmer: 30:32

Last seen with a whale on top of his car. Um, yeah, so any, any comments on the impact of, of this federal push by, uh, RFK Jr.?

Selina Koch: 30:46

Well, there's a few threads to it. I think there's an execu-- there was an executive order in April that instructed HHS to kind of accelerate access to these treatments. And then there were, back when Makary was still FDA commissioner, um, commissioners national priority review vouchers given to a few of the leaders in the space, which, you know, could m-move their reviews ahead, uh, shorten them. And then there's some-- That executive order also, is trying to lower barriers to research through rescheduling of these for research purposes. Now, there's still more to do on that front when one actually gets approved, in terms of, like, fully rescheduling. So that's still, that's still an overhang

Jeff Cranmer: 31:33

Okay. Well, thanks for that. look for the link in the show notes. And while you're there, subscribe to our podcast. Um, our sister podcast is on deck next, uh, the BioCentury Show. this week we'll have, Steve, our Washington editor, in conversation with Jeremy Levin, so should be a very fun conversation. Jeremy, of course, former BMS, former, Teva, uh, he's now executive chairman of Ovid Therapeutics. Uh, that will be out, later this week, and we'll be back next week with another installment of BioCentury This Week. thanks all for tuning in, and thanks to Kendall Square Orchestra for providing the music for our podcast