WEBVTT - New Hope for People Battling With Depression

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<v Speaker 1>Bloomberg Audio Studios, Podcasts, radio news. You're listening to Bloomberg

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<v Speaker 1>Business Week with Carol Masser and Tim Steneveek on Bloomberg Radio.

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<v Speaker 2>Remember when psychedelics were like all the raid.

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<v Speaker 1>Totally and then they talked to you about them for

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<v Speaker 1>a while.

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<v Speaker 2>And then they weren't because in twenty twenty two we

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<v Speaker 2>saw prices collapse, money was pulling out, trial results weren't

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<v Speaker 2>where they needed to be. It's having a resurgence. According

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<v Speaker 2>to Bloomberg Intelligence analysts, they're estimating that the psychedelic drug

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<v Speaker 2>market could go to seven billion dollars twenty thirty two.

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<v Speaker 1>That's a decent market.

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<v Speaker 2>Yeah, yeah, So the market potential here, they say, is clear,

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<v Speaker 2>but companies could still run into issues with regulators. This

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<v Speaker 2>we know and in upscaling the products. So back with

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<v Speaker 2>us here in studio, which we're so happy about, is

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<v Speaker 2>Kabeir Nath, chief executive officer of Compass Pathways, and so

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<v Speaker 2>great to have you back. You were here last in July.

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<v Speaker 3>Kaber, that's right, and it's great to be back. Thanks

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<v Speaker 3>for the invitation.

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<v Speaker 2>So tell us first off, just a little background for folks.

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<v Speaker 2>This is a your company, Compass Pathways, five hundred and

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<v Speaker 2>fifteen million dollar market cap, not too shabby. Stock is

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<v Speaker 2>up forty two percent year to date. We know there's

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<v Speaker 2>a lot of volatility in this industry too, but that's

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<v Speaker 2>not too shabby either. Tell us what's changed since you

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<v Speaker 2>were in our studios in July.

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<v Speaker 3>Thank you. So we're excited about the fact that we're

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<v Speaker 3>now in a position to potentially accelerate getting this medicine

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<v Speaker 3>to patients who so urgently needed. Let me remind you

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<v Speaker 3>that there are three million patients living with persistent depression

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<v Speaker 3>in the US. Fewer than five percent of them today

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<v Speaker 3>are treated with a medicine that was actually specifically studied

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<v Speaker 3>for or is approved for treatment resistant depression. And this

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<v Speaker 3>is depression that is chronic, it's refactory. Often people are

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<v Speaker 3>unable to work. It has dramatic direct healthcare costs in

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<v Speaker 3>terms of costs of emergency room admissions in psychiatric care,

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<v Speaker 3>but it also has real social costs for these people.

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<v Speaker 3>So what's changed is we've had a really excellent conversation

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<v Speaker 3>with the FDA about their desire to see subject to

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<v Speaker 3>us to continuing to produce really strong results in terms

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<v Speaker 3>of efficacy and safety. Their desire to see this moved

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<v Speaker 3>more quickly. We've completed the enrollment and our second final

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<v Speaker 3>stage study, which we did ahead of expectations, which is

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<v Speaker 3>really down to the phase three. This is a phase three.

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<v Speaker 3>This is the second of our final stage studies. We've

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<v Speaker 3>completed the enrollment of that. We expect to have the

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<v Speaker 3>primary data from that in first quarter of next year.

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<v Speaker 3>That will give us the second of our final stage studies.

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<v Speaker 3>And with that we are actually excited to be able

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<v Speaker 3>to submit that to the agency and look to an

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<v Speaker 3>accelerated approval.

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<v Speaker 1>Wow, that sounds like a really big move. I'm curious.

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<v Speaker 4>Just remind us, and we were talking with our healthcare team,

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<v Speaker 4>how you guys designed the trials or research program to

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<v Speaker 4>avoid some of the pitfalls that we've seen with I

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<v Speaker 4>think about the ecstasy and the mm MDMA drug application

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<v Speaker 4>theF that was for PTSD.

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<v Speaker 1>How did you guys avoid some of those pitfalls.

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<v Speaker 3>So first, we had the opportunity to learn from some

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<v Speaker 3>of the lessons. We've been in an excellent dialogue with

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<v Speaker 3>the FDA now for some six or seven years since

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<v Speaker 3>the first start of this, Since this process, Yeah, as

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<v Speaker 3>we know, drug developing new medicines takes a long time.

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<v Speaker 3>On a lot of commitment. We've done this in a

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<v Speaker 3>very robust and rigorous way. We are collecting full side

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<v Speaker 3>effect data. We're collecting all the issues, not just your

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<v Speaker 3>potential side effects such as headache and fatigue, which are transient,

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<v Speaker 3>but also things like liking and so on, to make

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<v Speaker 3>sure that there is really no abuse potential for this,

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<v Speaker 3>and we've been collecting that right from them.

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<v Speaker 1>Is there any abuse potential for this?

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<v Speaker 3>There is no history in psilocybin of people actually seeking

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<v Speaker 3>it out or of any abuse potential with psilocybin, which

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<v Speaker 3>is an important point.

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<v Speaker 2>I'm putting my investor hat on for a moment, and

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<v Speaker 2>I need to ask you about intellectual property and how

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<v Speaker 2>you handle something like that, because psychedelic compounds don't sort

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<v Speaker 2>of fit comfortably into that compound if you will, because

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<v Speaker 2>a lot of them are natural, they can't really be

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<v Speaker 2>patented if you will, So how do you deal with that?

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<v Speaker 2>And to what extent is your medicine you know, hold

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<v Speaker 2>patents or have intellectual property.

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<v Speaker 3>So our medicine comp three sixty is a fully synthetic

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<v Speaker 3>formulation of psilocybin. Okay, we have polypomorph patents that address that,

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<v Speaker 3>and therefore we have robust protection till twenty thirty eight,

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<v Speaker 3>with the potential for extension around that, because again we

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<v Speaker 3>went for a fully synthetic modern medicine.

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<v Speaker 4>Have you talked directly with the Health and Human Secretary

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<v Speaker 4>Secretary Robert F. Kennedy.

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<v Speaker 3>We are focused on an excellent relationship with the Psychiatry

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<v Speaker 3>division of the FDA. Okay, we've been working with the

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<v Speaker 3>same folks for seven years now, yeh.

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<v Speaker 4>I have certainly made some commentary around this that has given,

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<v Speaker 4>you know, hopes and expectations that this would move along

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<v Speaker 4>more rapidly.

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<v Speaker 3>We're happy that there are senior figures in the administration

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<v Speaker 3>who believe like us in the potential for psychedelic therapy.

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<v Speaker 3>But we're really focused on delivering the right efficacy and

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<v Speaker 3>safety through our studies and working directly with the division

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<v Speaker 3>that's going to approve.

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<v Speaker 2>Us SO trial three phase next year. Early next year,

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<v Speaker 2>give us an idea of a timeline, I mean, when

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<v Speaker 2>might we see something like this come to market.

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<v Speaker 3>We will get the primary data, as I said, in

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<v Speaker 3>first quarter of next year. We will need to submit

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<v Speaker 3>some more data later in the year, but we are

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<v Speaker 3>looking forward to being in a position to complete a

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<v Speaker 3>submission to the FDA in the latter part of next year,

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<v Speaker 3>and then we'll work with them as expeditionally as possible

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<v Speaker 3>and a potential regulatory approval.

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<v Speaker 4>So twenty six, twenty twenty seven, Like, what's I know,

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<v Speaker 4>this stuff all takes long, and I know we consante

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<v Speaker 4>am asking you, but I think because it's been so

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<v Speaker 4>much out there for a while, a decade and then

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<v Speaker 4>some right, I think we're all trying to do, certainly

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<v Speaker 4>for an investing audience, understand when this actually hits the market.

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<v Speaker 3>We are preparing to be ready for a commercial launch

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<v Speaker 3>from the end of twenty twenty six.

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<v Speaker 2>Ah, he said it, Well, thank you.

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<v Speaker 1>What is something like this? What is something like this cost?

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<v Speaker 2>That's the question.

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<v Speaker 3>So it's premature to discuss the pricing for this in

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<v Speaker 3>the moment. First, we actually still need to see some

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<v Speaker 3>of the longer term results from our studies. In particular,

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<v Speaker 3>we need to see over the course of the first

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<v Speaker 3>six months what the potential for a second dose is

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<v Speaker 3>and really therefore how many potential sessions that a patient

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<v Speaker 3>may need to have in a given year.

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<v Speaker 2>That's a great question. You're talking sessions. So this is

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<v Speaker 2>not a drug that someone would continue to take or

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<v Speaker 2>a lifelong sort of drug if you will.

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<v Speaker 3>Absolutely, and it's a really important point there. What we

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<v Speaker 3>have shown in our studies so far is that a

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<v Speaker 3>single session can produce a dramatic response that lasts for

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<v Speaker 3>six weeks today, either it's a daily oral or there

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<v Speaker 3>is a product esketomine, which you will need to take

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<v Speaker 3>maybe thirty to fifty times a year. What we are

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<v Speaker 3>showing is truly transformative therefore for these patients with this

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<v Speaker 3>infrequent session.

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<v Speaker 4>So we're talking with Kabir Notath. He's chief executive officer

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<v Speaker 4>of Compass Pathways. Ticker is CMPs. He's here in our

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<v Speaker 4>Bloomberg studio, Bloomberg Headquarters. Kabir, one of the things I

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<v Speaker 4>think about then is if all goes as you anticipate,

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<v Speaker 4>and you've talked about the market for like who this

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<v Speaker 4>is for specifically, then do you move on to other

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<v Speaker 4>uses and other treatments, whether it's PTSD, whether it's drug addiction,

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<v Speaker 4>Like I'm just curious how far you can go with this.

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<v Speaker 3>Yes, thank you, Carol, And we are designing, have in

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<v Speaker 3>fact already designed and finalized the design of a study

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<v Speaker 3>in PTSD. PTSD affects thirteen million people in America. And

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<v Speaker 3>while there's this view that it's prevalent among veterans and

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<v Speaker 3>so on, it absolutely is that's actually only around fifteen

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<v Speaker 3>percent of that population.

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<v Speaker 2>Only fifteen percent.

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<v Speaker 3>Fifteen percent, actually sixty percent of people suffering with PTSD

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<v Speaker 3>are women, and so this is a very large population.

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<v Speaker 3>The only two drugs medicines approved for PTSD were approved

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<v Speaker 3>in the last century, so this is something new, different,

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<v Speaker 3>and so we are very excited about that we have

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<v Speaker 3>designed a study and that we will be kicking that off.

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<v Speaker 2>I want to go back to the question of price.

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<v Speaker 2>So what about insurance and how does that play a

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<v Speaker 2>part in all of this.

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<v Speaker 3>From the get go, Compass was set up in order

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<v Speaker 3>to ensure broad and equitable access for patients, and that

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<v Speaker 3>means the ability to work with insurers, both commercial and government.

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<v Speaker 3>With the data we've already shown, as I say, a

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<v Speaker 3>single administration producing statistically significant result of reductions in depressive

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<v Speaker 3>symptoms after six weeks, we've already started to demonstrate the

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<v Speaker 3>value that this can bring to the healthcare system. Patients

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<v Speaker 3>living with persistent depression frequently end up in the emergency room.

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<v Speaker 3>They sometimes have in patient's psychiatric care. There are direct

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<v Speaker 3>costs to healthcare systems, and we have already started to

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<v Speaker 3>demonstrate the value.

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<v Speaker 4>You know, and forgive us, Kamir, we do you keep

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<v Speaker 4>going back to I know you can't talk about price

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<v Speaker 4>or your guys A just figuring that out. But we

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<v Speaker 4>kicked off saying, according to our Bloomberg intelligence team that

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<v Speaker 4>this market psychedelic drug development could go to seven billion

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<v Speaker 4>dollars in sales by twenty thirty two.

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<v Speaker 1>How much of that do you.

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<v Speaker 4>Think is or how much of that market size do

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<v Speaker 4>you think you could get?

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<v Speaker 1>And I'm just trying to I'm curious.

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<v Speaker 3>So we have the potential to be ahead of other

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<v Speaker 3>companies in this market by two to three years, and

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<v Speaker 3>we're excited about the opportunity to treat lots of patients.

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<v Speaker 3>So for us, this is about the ability to make

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<v Speaker 3>inroads into those three million patients that need a new

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<v Speaker 3>treatment option. The only medicine that's actually approved and is

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<v Speaker 3>being really promoted for this population today is treating maybe

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<v Speaker 3>seventy to one hundred thousand patients, so that that population

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<v Speaker 3>of three million, right, So what we're excited about is

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<v Speaker 3>the ability to bring this new medicine to those patients.

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<v Speaker 1>Is it a billion dollar dug drug. Would you anticipate

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<v Speaker 1>We would.

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<v Speaker 3>Hope that if we can successfully treat, if we can

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<v Speaker 3>treat a large number of.

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<v Speaker 4>Patients, especially if you get and you expand out, do

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<v Speaker 4>you go for other uses?

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<v Speaker 3>Yeah?

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<v Speaker 2>Do you go alone?

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<v Speaker 3>That's our intention. We've always said clearly that we believe

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<v Speaker 3>that we can do this on our own in the

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<v Speaker 3>US market, and that's our intention.

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<v Speaker 2>All right, what about side effects? I mean, folks are

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<v Speaker 2>listening to this, A lot of folks are hoping that

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<v Speaker 2>this is all going to work and come to market

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<v Speaker 2>sooner rather than later. What are some of the side

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<v Speaker 2>effects though?

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<v Speaker 3>So on the day of dosing, there's some headache, some nausea,

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<v Speaker 3>and that passes by the second day at most, because

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<v Speaker 3>this is a day in a treatment center. We have

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<v Speaker 3>a fully independent group of scientists and clinicians that reviews

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<v Speaker 3>all our safety data on a regular basis. They have

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<v Speaker 3>access to data from all arms of our studies and

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<v Speaker 3>they have seen no unexpected or concerning side effects that

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<v Speaker 3>have caused them to alter the course of the study

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<v Speaker 3>in any way.

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<v Speaker 1>And just remind everybody, and we just got about forty

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<v Speaker 1>seconds co here, right.

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<v Speaker 4>When it is given to a patient, there are folks

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<v Speaker 4>around to really watch the process, make sure things go.

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<v Speaker 2>You're not taking this into your bathroom by yourself.

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<v Speaker 3>This is very much delivered in a safe environment, in

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<v Speaker 3>a medical environment, with somebody in the room who is

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<v Speaker 3>medically trained, who's there just to a sure patient safety

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<v Speaker 3>and comfort.

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<v Speaker 1>Do you see the finish line?

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<v Speaker 3>I absolutely do. We're excited about that potential.

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<v Speaker 4>I just think how long we've been reporting on it

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<v Speaker 4>and talking about it. It's really fun to kind of

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<v Speaker 4>be on this journey.

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<v Speaker 3>I'm just with you.

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<v Speaker 2>I'm just wondering quickly regulatory hurdles in twenty twenty six.

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<v Speaker 2>Do you think that it's going to be a more

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<v Speaker 2>friendly regulatory environment.

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<v Speaker 3>With the Psychiatry Division. We have an excellent relationship and

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<v Speaker 3>that's been consistent over six seven years and we expat.

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<v Speaker 1>Yeah, it sounds like you've been talking to them for

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<v Speaker 1>a long long time. Kabir, thank you, Nice to have

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<v Speaker 1>you in studio.

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<v Speaker 4>Kabir not his chief executive officer of Compass Pathways, joining

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<v Speaker 4>us right here,