Q1 2023 DURECT Corporation Earnings Call
Greetings and welcome to the Durect Corporation first quarter 2023 earnings call.
This time, all participants are in a listen only mode.
Question and answer session will follow the formal presentation, if anyone should require operator assistance during the conference. Please proceed.
Zero on your telephone keypad, although model, which conference is being recorded.
Now my pleasure to introduce your host <unk> Chief Finance officer. Thank you Tim you may begin.
Good afternoon, and welcome to direct Corporation's first quarter 2023 earnings Conference call. This is Tim <unk>, Chief financial officer of direct.
Before we begin I would like to remind you of our safe Harbor statement. During the course of this call. We may make forward looking statements regarding direct products and development expected product benefits, our development plans future clinical trials or projected financial results.
These forward looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements further information regarding these and other risks can be found in our SEC filings, including our 10-K and 10-Qs under the heading risk factors.
To begin I would like to review, our first quarter 'twenty 2023 financial results.
Our total revenues in the first quarter were $2 1 million compared to $1 9 million for the prior year.
This increase was due primarily to an increase in collaborative R&D revenue.
R&D expense was $8 $6 million for the first quarter compared with $8 2 million for the prior year.
The increases were primarily due to higher clinical trial expenses for our ongoing affirmed trial and contract manufacturing expenses for luxury goods Darryl.
For the first quarter SG&A expenses were $4 $1 million compared with $3 7 million for the prior year. This increase was primarily due to higher market research expenses higher audit related expenses as well as higher employee expenses.
As of March 31, 2023, we had cash and investments of $44 $4 million as compared to $43 6 million at December 31 2022.
We completed a registered direct offering in February 2023, raising $8 8 million in net proceeds excluding the proceeds from the financing our cash burn in the first quarter was approximately $8 million.
We believe our cash on hand is sufficient to fund operations into the first quarter of 2024.
Lastly, I would like to highlight that we will be hosting a K O L event in New York City on May 16.
We are pleased to be hosting Dr. Paul Gaglio from the Columbia University Department of Medicine, and Dr. Brett Fortune from the Albert Einstein College of Medicine Department of Medicine Division of Herpetology.
Doctor Gaglio Doctor Fortune are both running now hepatology, just with a wealth of experience treating alcohol associated hepatitis or H.
We look forward to hearing her insight about the current treatment paradigm for H and the unmet medical need in this highly lethal disease.
Several members of our leadership team will join doctors Gaglio unfortunate you discussed the ongoing development and commercial landscape for less because they're all NIH and advance up the top line readout from our firm.
You can find the details for the webcast of the event in our press release from April 27 on our website.
Now I would like to turn the call over to our CEO Jim Brown.
Date uncertain of our programs.
Thank you Tim.
Hello, everyone. Thank you for joining us today for our first quarter 2023 update we're excited about the continued progress for our lead clinical program.
CECO sterile for the treatment of alcohol associated hepatitis.
2023 is poised to be a significant year for direct as we look forward to completing our phone trial and reporting topline data by the end of the year.
If successful we believe our firm has the potential to support an NDA filing.
Our primary focus of the company remained gain you.
[noise] approval Polish sequester, all in a H and bringing this potentially lifesaving therapeutic to patients with no effective treatment options today.
We are nearing our enrollment target of 300 patients in our phase two be affirmed trial with more than 285 patients dosed to date.
We continue to expect completion of enrollment by the end of this quarter.
As a reminder, our firm is a 300 patient placebo controlled double blind multinational study with two active dosing arms and a placebo arm 100 patients each.
We're enrolling patients with severe a H, which are patients with meld scores ranging from 21 to 230 <unk>.
Baidu discriminates function scores greater than or equal to 32.
The primary endpoint for a firm is reduction in mortality or liver transplant at 90 days.
We've enrolled patients and affirmed through a global network of clinical sites, including leading hospitals in the U S. Australia, EU and the U K are so I think we'd be now liver centers and we are working with some of the world's preeminent thought leaders and a H.
The FDA has granted our luxury called sterile H program fast track designation and we are hopeful that a positive result in the firm could support an NDA filing.
With this in mind, let's sequester all has the potential to be the first FDA approved treatment for a H, where there is a substantial unmet need for these patients.
We designed it for them to be a potentially pivotal trial based on our phase Iia data.
And our open label Phase Iia trial, all 19 patients survived the 28 days, an encouraging result, given that approximately 26% of hospitalized a H patients die within 28 days based on historical data.
In April we announced that our phase Iia data had been published online by the American Journal of Gastroenterology.
This peer reviewed article includes cross study comparisons with well matched severe a H patients from the contemporaneous trial conducted by the defeat alcohol, Seattle hepatitis or Dash consortium.
While the sample sizes are small and these patients were not part of a controlled study. These comparisons indicate that severe a H patients treated with either 30 milligrams or 90 milligrams about chico's Darryl had statistically significantly lower Lille scores compared to the patients treated with the standard of care, including steroids.
In addition, liver enzyme levels decreased rapidly in the last few calls to all treated patients, including statistically significant reductions in a L. T.
We believe these results provide further evidence of the potential for the Stukel sterile as a treatment for a H.
Our confidence that the trial will be successful is driven by.
Our compelling phase Iia study data, including the recently published comparisons.
The mechanism of action of lifecycle, sterile, which ties directly into the biology of age.
And our multiple preclinical animal study, where we observed a profound survival benefit in multiple relevant acute organ injury models.
I'd like to briefly turn to the market opportunity for H.
In addition to the high mortality rate a H represents a significant cost to the U S health care system with over 150000 hospital adjacent attributed to age at a cost of between 50 to $150000 each.
As a result of XI cluster all represents a potential multibillion dollar opportunity in the United States alone and could simultaneously.
<unk> substantial overall cost savings to the health care system.
We will discuss the economic opportunity for electrical sterile further during our upcoming K O all of it.
We've begun to lay the groundwork for potentially commercial I think last year called sterile and the U S and believe we can effectively launch the product to a modestly sized hospital focused sales force.
We are also continuing to build awareness around the role of epigenetic regulators and acute diseases like H.
Hey, H, it's also a global concern, allowing class newco stir all the potential to serve ex U S. A H patients and their health care system.
These ex U S markets represent additional attractive market opportunities.
Because we enrolled patients from our global site network.
We believe a positive result from a firm may support regulatory filings in the EMEA and other regions.
In summary, we continue to make great strides with affirm and have enrolled more than 285 patients to date.
We are on track to complete dosing the last patient in the affirmed trial this quarter.
Which would enable reporting topline results in the second half of this year.
If successful we believe our firm has the potential to support an NDA filing.
With that we'd now like to take any questions you may have.
Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment and they'd be necessary to pick up the press.
May be necessary to pick up your handset before pressing the pocket one moment, please while we poll for questions.
Thank you. Our first question is from Christopher cluster with Cantor Fitzgerald. Please proceed with your question.
Hi, good afternoon, everybody. Thanks, so much for taking my question. The first one I had is if you could break down for us the 50000 to $100000 cost that you cited in your prepared remarks, I guess, how much of this is just driven by the fact that patients are often.
In the hospital for a couple of days and obviously I respect and understand the 90 day endpoint related to the FDA, but you know time times of hospital, especially because when the number of your patients didn't even need that second Kevin I guess like how important are those statistics going to be for payer conversation.
Should these jobs can be successful.
The great question Christian Thank you.
It's good to hear from you I'll I'll start it and then I'd like Keith maybe speak a little further on this issue as well I think we've seen from.
Most of the literature that I've seen is the typical patient stay in the hospitals around six days for those that live and longer for those adult and for those that live it's about a 50000 cost so those that die in the hospital. It's a 150 and then good the majority of patients that they're gonna pathway actually they moved them out on the hospital to hospice care.
Keith you want to maybe sneak some to the farmer economic drivers need to be hospitalization costs.
Sure. Thanks for the question, Chris and I think it's a good observation I mean, the folks that are driving the higher end of that $150000 cost.
Of course, those are the ones that unfortunately expire and dial in hospital from this is taken from the high the age cut N I S dataset.
And our belief and we're doing our continued research and this is that those are the patients that are unfortunately take up the most amount of health care utilization as far as diagnostics more intensive care unit Tine and hospital length of stay.
And you had cited our.
Our phase Iia study that showed that yeah. Two thirds of these severe patients only required one dose however that not maybe different in their firm trials. So it will be interpreting all of those results length of stay time in ICU time, there's a step down unit overall length of stay.
And all of that will be important as we put together our value prop and budget impact models for the market access and payer environment.
Thank you I appreciate your thoughts there and a question we've been getting is just.
Why do you believe that other mechanisms have failed in this space and what is it about those do go sterile mechanism that might be more appropriate in the setting, especially with the recent paper and some of the deeper diligence she's conducted.
That's a great question as well and.
I'll address it and then and then we'll see if we have some more because we have both way T enrollment on the line as well I think first off it's a complex disease a H.
Unfortunately, these to the breakdown of the number of assistant. The these patients are eventually dying of multi organ failure. So it's not just the liver eventually they most of them die actually from kidney disease, and we've shown with marsico still that we protect against multi organ failure protect the kidneys or liver, the lungs, and and and and numerous numerous models and.
We've shown shoring.
Showing up as it were and protection of of these organ systems in humans, who have chronic kidney disease or chronic liver disease won't be dosed, whose team reductions Cytokeratin 18. These markets you sell that.
If we look at the drugs that have been tested against the H in the past.
The two main areas of focus and one was in trying.
Trying to do say pop Kocis and in a couple of drugs have been tested there and unfortunately didn't work and then there's also been drugs looking to block certain a cascade of a of the <unk>.
Planetary system with monoclonal antibodies you know Ali.
So we're more one note and really couldn't address the breadth of the disease with a simple sterile we have a molecule that that changes what we know is gone wrong. We know that there are elevations in D. N M. T O DNA methyl transferase levels in these patients so we know.
From patient data that they that there there is hyper methylation ongoing and we know.
Most of the different systems within the cells are damaged we know a lot of people still protect against.
Mitochondrial membrane damage until we've got that component of it we know it is.
Reduces liver toxicity reduces inflammation.
Cancer cell survival and regeneration of the sales increase is on top of G. There's just a host of different components.
Components.
That are that have gone wrong that our dress, but maybe I'd give it to maybe wait till you can start and then maybe finish on this as well any additional thoughts.
No I think again, you'll have a covered quite well.
I'll also just add one more thing because of alcohol, particularly I'll call. It a I'll call. It associated hepatitis subjects, they do have impaired liver regeneration.
Regeneration is very important to our company.
The acute liver injury and then there's algae the mother say itself.
Lots of called sterile Silicon Lane promoting.
That's also important Jim mentioned that are a little bit as well.
Thank you enrollment.
Yeah.
[noise] pardon me too much.
He's doing press release mitochondrial stabilization because.
Mitochondrial dysfunction is a big part of the apoptosis pathway. So.
That was important and the quite you know steroids.
[laughter] inflammation, but they also probably interview with liver regeneration is really cheap point, Scott you need sort of this broad improvement.
Inhibiting the new generation in order to recover from this.
I feel as if prior treatments have retraced one thing at a time.
And what you need is something much much broader than that.
And the.
The mechanism of action.
Is really impressive but even more impressive is the empiric data that we saw in the phase Iia trial.
Great well. Thank you Barry Yeah, I think it's it is interesting when you see the histology of these patients they aren't off from biopsy, but sometimes there you do see Mega mitochondria. So you know that there's a there's a stress and that's Oregon now anyway.
Okay. Thanks, and then for the second half of the year read out just because we're getting really clear now do you anticipate that you would share certain endpoints first through our press release, and then maybe see more detailed data from medical presentation what.
Are you kind of preliminary thoughts on this assuming that plan goes to place, but with timing.
Yeah, It will depend on the timing but.
This is too important to wait and we wouldn't so when we had the last patient enrolled which we're getting close obviously, we know we're now over 285. So we just have a few patients to go.
A dozen or so left and so.
When we enroll that last patient we will announce that and then people can start the countdown. So then it would be three months from then to last patient last visit in Norman and the team have done a great job of keeping up with the patients as we've gone through we've been closing out our centers as we can include patients as we can and so our hope is that we'll just have the.
Last you know 10 or so patients.
Do you know to clean up as we get to the last few months. So the team is hoping to have data within two months or so after the last patient last visit I that would be wonderful it happy when whenever it comes but one that.
That day comes when we unblinded.
The the trial, we hope to report out with just a few days and so that.
That would be our objective I'm sure. It will we'll have a press release and I'm sure a conference call I don't know about the timing of that versus meetings, we certainly wouldn't hold anything back at that point I think what we'll talk about it and then eventually what we'll present the data in more than a.
Broader fashion.
And you know through the publication of the meetings. They normally do you want to add anything to that.
No I think that's that's correct Jim clearly we are as excited as anyone to.
To underline and see what to see what the topline data on the most important things.
And then decide on a on a publication and presentation strategy.
Great. Thanks look forward to seeing in New York next week.
Yes, absolutely that's right. Thank you for reminding me that we do have.
Oh cable event next Tuesday in New York So.
Happy to have you guys okra, and that's not online would be great.
Thank you. Our next question is from Ed Arce with H C. Wainwright. Please proceed with your question.
Hi, Jim how everyone stands for.
Hi, Thanks for taking my questions. It's great to see you last week and I also look forward to seeing you next week at your event.
Beyond the timing of the trial that just had a couple more.
Questions.
Hum.
I think this would be important as investors start sharpening their pencils on this on this readout.
Is to just go over and explain why there were actually two there are two dose arms in the study.
And ultimately if.
If both are positive in both of our.
Power for.
For statistical significance.
You would seek to get both of them unbelievable.
And then separately the other question I had was just around <unk>.
Commercialization.
Given that this is a potentially a pivotal study and you could be looking at.
An approval in the not too distant future. We just wanted to get your thoughts on the hospitalization Salesforce. The MSL sales force, how you expect that to enroll given that there there is a fairly.
Concentrated a targeted set of call points. Thanks, so much.
Okay sure.
And I'll I'll start off and then I'll, let you.
Speak to a little more to the doses and then and then we'll certainly have key speak to the commercialization with that so with.
To the doses, we are looking at it at two different doses, which allows us to get gain a little more insight.
And its.
Basically we've seen pretty exciting results are already.
Already in the phase two a with both of these doses and we've seen in various other human experiences Oh.
Variety of doses tested and oftentimes the low dose looks every bid good if not better than the hiring and that's also been the case with some of the non clinical so it's a but we certainly are excited to see what will come from this but as far as.
Dosing lychee any additional thoughts there.
Yeah. Those two doses were selected based on our understanding of the dose response relationship in.
Yes, Uh-huh mechanistic studies.
Also based on the a T M E. They taught impulse in animals and in human.
On top of that that was based on the PK data we obtained phase two study.
So that's how we determine that these two doses.
Should be in the optimum dose of.
Uh huh off the clock exposure to that level, because a H and so that's why I never centric Dizzy.
So that's how we selected these two doses, although we know that the hungry assistant milligram dose.
That's the one we also used in the phase Iia study.
That's the highest adult it's also face in these subject now, but that last Saturday and the mandate medical and we sell off and moving to a place to be.
We believe the optimal slate.
Yeah, I think that's a good point from a safety standpoint, we've in the Nash patients we dosed for a month, a 600 600 milligrams a day. So we certainly have given a huge amount more than that then these doses and pretty much more extended period of time.
So maybe then Oh I'll handle over the commercialization question to Keith who doesn't who don't know has tremendous commercial experience.
And in particular of late.
Before coming to directed at both Genentech, Pharmacyclics and sold a number of oncology products and and is dealt with lethal disease before so we're we're excited yeah.
For Keith and his team to to take this on.
Yeah. Thanks Jan on on your question of potential hospitalization Salesforce, we had been doing some preliminary work on just understanding the hepatology and gastroenterology gastroenterology marketplace and the various hospitals and their discharge volumes and H are working with big data.
It houses that are well known like <unk> and others, but we know that there's a.
Russ.
Population of Hep Syngas rose and advanced practice providers in the U S of about five to 6000.
We know there is around 4000 hospital accounts, but only about half of those had had H discharging over 10 per year. So we're starting to get down through the funnel on what that concentrated target list may look like.
We're still pretty early in the analysis, Yeah, I think we've talked about on previous calls our sales force roughly somewhere between 50 and 100.
It would be ample to cover the United States.
For a rare disease, a hospital based disease like a H <unk>.
And we continue to work through on pace of what our commercial planning looks like we'll talk a little bit more about that.
Next to take care of all events as well, but we are we do have a pretty good understanding of where the targets may be and where those high volume tertiary liver transplant sites may be and start to think about cheering structures and how that might influence the construction of our field sales force and commercial organization, but look like.
Great Keith Thanks for that I appreciate it I look forward to more details on Tuesday.
One additional question if I may is just around the primary endpoint obviously.
90 day mortality and reduction in transplant we.
We know as as you mentioned, Jim that H natural history is about 26% mortality rate at 28 days do you have any.
Any measures forwards for the rate of transplants for age patients.
It's a great question and I'll, let normally speak to a little bit after I'm done. Unfortunately, there just the bottom line is there aren't enough levers to go around there are about 9000 livers available for transplant in the United States across the entire country.
We know there are 150000 hospitalizations in 2024 for a H and we then we estimate that about 120000 patients represent a 150000 hospitalizations without coming back again to 120000 patients 9000 transplants well they don't they don't all go to H in fact, it's estimated that about.
Half of those 9000 transplanted livers go to people with alcohol associated liver disease. The other half go to people who are remaining.
Viral Ah patients and inherited diseases like Wilsons and M O M.
P S C and some obviously to Nash patients as well so you've got about half of it was about 4500 going to patients with alcohol associated liver disease and somewhere between a half and the third of that remaining <unk> 4500 go to a H patients, which means you're talking about.
But more around 2000 patients being having livers available for them out of 120000. So it's just the numbers aren't there and and I don't know I can speak much more eloquently than I can with regard to this.
Oh I didn't know about eloquently.
Got it.
As you know, it's a moving target because transplanting people for age is a fairly recent development sort of gaining popularity.
And.
Previously people didn't want to admit they were transplanting them because they were sort of this general feel.
Feeling that you need in six months, it's a variety and so it was in <unk>.
Mendes underreporting of metrics shown in a very nice paper by Brian .
Brian Lee.
Since then these be.
In general acceptance is growing actually you noticed has now created a special category for alcohol associated hepatitis. So we'll give more accurate numbers going forward, but for right now we don't know.
No.
And as Jim said, we think.
I think speaking to my colleagues.
Approximately.
So to a half of the people who truly attributed to alcohol and alcohol makes up about half of the transplant quality goes like 9000 patients transplanted.
So.
Getting to the end point is it does obscure and.
To the 26% and 30% you mentioned, it's sort of an all comer. So you just take a general population of a H.
You should expect to see.
And that's been shown in multiple studies.
When you deal with a transplant center they tend to see people in the higher ranges and so the mortality of patients with the milk of say 25, and it's more like 40%. So.
You see high them higher mortality as you go.
Admission meld score.
Yeah.
Yeah, I would add also put my father or economic standpoint, so if we if.
If we take a rough guesstimate.
Normally just gave us it's close to 2000 and.
We know transplants cost close to a million dollars. Each so you're talking about somewhere in the range of about a 2 billion dollar check that's been written for that piece and then the the other components of hospitalization, we think represents probably.
Seven maybe eight.
And as well so it's a substantial cost to the health care system for sure.
That's very helpful I am not much.
Sure.
Thank you. Our next question is from Francois Brisbois with.
Please proceed with your question.
Alright, Thanks for taking the question just a just a couple here just in terms of the inclusion criteria just to touch on the meld score and the severity can you remind us the.
Difference between the phase Iia and phase two b in terms of severity of patients and also you know from the cross comparison Saturday with Louisville or Dash I can you also touch on the severity of those patients and I guess the implications of the changes in severity and the need and the phase III.
Yeah sure and.
Just straight up but we are we're taking severe patients. So these are patients in their firm trial, but they range in meld from the 21 to 30.
Match exactly with the severe patients we had in our phase Iia trial.
And to put that into some perspective, we've got another 21, you got about a 20.
Let's say 25, 26% maybe to a 30% chance of dying in the next 90 days and if you go to meld, a 30 or 60 per cent and Theres enrolment says in the mid range of that 24 to 25, it's 40%.
And so it's.
It's.
Obviously, a huge problem and.
As far as the consortium goes what we tried to do is pick patients who would have matched for our study that was that was the objective there to get like and like and then we had to have patients who.
We're doing a 28 day comparisons they had to be alive at 28 days. So we had to not count the dash patient that died and there were a number that unfortunately died before 28 days that aren't counted in there because they don't have 28 day data or you know score data at all and what we saw with their survivors versus ours and all of our survive.
We still thought.
To my eye improvements in liver function and they liked it looked like we had patients who are in a better space.
I don't know Norman or or way Chi.
Anything to add.
[laughter] accurately speech at the.
When you look at the at the paper.
Remember that the patients in the dash trial the subject in the Geis consortium actually survived the 28 day, so any patients who died prior to that question.
Even with that you still see tremendous you'll see better better survival.
You bet.
What's really impressive is how much they have biochemistry was better including markers of liver injury.
Ruben and meld scores well kept milks clause.
It's it's a bit more complicated but.
So, but survival believe who'd been with significantly better.
Okay.
Great. Thank you and if I could just ask one last one so in terms of the comment to the previous answer about the doses used.
Is it fair to assume that you don't necessarily expect a dose response here correct.
Yes.
I mean, we were doing the study in order to determine that we couldnt say and that we couldnt get enough information out of the small number of patients in the phase Iia. So we're doing this trial to understand dose.
And I certainly hope we can distinguish we tended to do two doses, but I think it remains to be seen I dunno wait see what would what would you say to that.
Oh.
Yeah.
Actually I think that that's a M.
And so it's probably it sounds like well, we'll have to see that the phase two that was sold.
Yeah, we just don't know.
Yeah understood.
Alright, I think happy if either either one when I'm really happy so I don't think either one or both.
Yeah.
Yeah. Thank you.
Thank you. Our next question is from Sean Kim with Jones trading. Please proceed with your question.
Hello, everyone and thank you for taking my questions Hi, I just have a few questions that one with science and a couple on commercial so I guess my first question is that.
You know based on your and a further analysis of the phase two study I'm just curious to hear your thoughts around some patients requiring second do it yourself are still stable.
To see if there was any differences in terms of demographic characteristics of these patients are what their ultimate clinical outcomes versus those who received one here one there was.
And kind of tying that into the commercial if you think about potential of commercializing the product.
You know what your thoughts are on potential pricing, whether it'll be hurt those spaces or per treatment.
Sure.
I'll take the first one is certainly that's the way she just to comment as well and then obviously Keith on the second.
I think the first thing is important to note that.
It's just that we didn't have very many second doses.
Even in the severe patients just a small number and because it was the first.
Testing of this drug in a H patients I think early on we had some physicians who are keeping their patients in the hospital two to enable a second dose just thinking they wouldn't give the drug its best chance not really kind of kind of considering the way it works.
This isn't a.
Outside of oncology is the first epigenetic.
Modulator to be being developed in medicine, and so the whole concept is that only a single dose.
Mike reset my epigenome and allow my Oregon's to improve.
It is a very different way of approaching and thinking about medicine. The way I think about it for what it's worth I think about it.
Like a heart attack for the liver you've got the liver under.
James sat stress, but if one can get it over that acute stress circumstance to live it doesn't look great great regenerative capacity infrastructure AIDS in that regard, but I think it's all about shoring about showing you the Oregon yet so.
Nobody can begin to repair itself.
But wuxi what are your thoughts around.
Yeah.
Yeah, just like Oh, Jim mentioned that the epigenetic modulation typically as we know that the.
Yeah.
It's a relatively long lasting especially for N P and M. Two one that you have.
It shouldn't.
In fact, theoretically would be even longer lasting.
Yeah Keith.
Sleepy inhibition.
Logical sterile inhibits awfully yourself.
We expect what the Mustang relatively longer lasting than and tightens laboratory at Gainesville, and Pi felt that AR agings or just the same play promoting never reach out unless you're now talking about the liver regeneration.
The fact of what that one or 2011.
Nicole.
We generate.
And what about otherwise when T O helped.
<unk> doesn't have that to Oh that comes out of kilter episode, They what we generally now hopefully with a mea culpa I can't to.
Episode, that's awesome.
The reasons why.
Only sell off at the one or two doses, but this particular indication.
Thank you Wei Qing then they'll keep maybe some thoughts around the one or two doses and commercialization I know at this point, but we're a ways away from pricing, but maybe you can just give some general thoughts.
Yes sure.
Good question I would say at this point I would corroborate what Jim was saying, it's probably too early to say, although in our market access strategy meetings. This is certainly a topic of discussion obviously the final decision is gonna be influenced heavily by the affirm results and looking at the cohort of patients and their outcomes that.
I had one or two doses.
But hasn't run a similar analysis on previous drugs prelaunch drugs that I've worked on.
I will say that it is challenging for the for pricing on a per treatment course basis as opposed to on a per dose basis, you run into various issues like Asps best pricing and what have you government discounts and.
And alike. So well we have not made any kind of determined decisions on that it is something that will take into effect the affirm results.
And that will strongly.
I haven't had a heavy influence like I said on on how we think about overall pricing and on a per cup per per treatment course versus protos pricing arrangement.
Yeah.
Okay. That's that's helpful and just one more question on the commercial side so.
So I guess, you've mentioned about five to six sponsor and hepatology Castro's I'm just wondering how many of those doctors are currently aware of large coastal and I presented the rider program in general and how much effort.
You did too.
Bringing our discussions up to date on the unwashed cholesterol.
That's a great question and I think I'll, let me start and then I'll, let Keith finish because I think it might have thought he didn't perspective, so I loved it loved to hear this so nominal right.
His data so I'm just going to say, yes.
Among my colleagues.
I have lived in the academic Herpetology route which is at least 10 per se transplant centers.
And.
Among among those colleagues there is practically uniform.
Knowledge of it.
Trial.
Keith has done a much more thorough job of looking at people sort of even what I'm not.
Not meaning to sound for Georgia, but in.
It's sort of the mixed here.
Keith I would like to like you to take it from there.
Yeah, we've we've conducted some market research in the U S.
Looking at unaided recall.
<unk> products NIH, and obviously there aren't too many that are underdevelopment and certainly alert superstar all program is furthest along and to be development.
But I I would corroborate what normal was saying and in those hospitals.
That are typically transplant centers or academic.
Referral centers with multiple.
Happened gastro specialist that have a particular interest in alcohol I think the recall or you know that.
The the knowledge of our trial and our superstar hours is high.
However, when you look at the entire population of about five to 6000 that I quoted earlier.
That's inclusive of anybody because this is not.
A disease that is.
Yeah, typically referred to only a handful of sites are only a handful of sites have H specialists if any.
Cytologist or gastroenterologist.
They would have the training to treat a H and so it is fairly spread out to our knowledge right now and when you get out of those tertiary care centers and specialty sites that are still seen age patients. The recall is going to be a little bit lower but therein lies the commercial opportunity and why we're trying to understand.
The baseline of that now, particularly that that's not a that's not too surprising given that there is nothing approved for H and having worked in disease areas that have had little or no standard of care and other fatal diseases like in oncology hematology.
Yeah.
There's a lot there may be a number of things under development, but until you you hit a.
Randomized controlled clinical trial study endpoint and that doesn't really raise a flag for most people to start paying attention.
If a firm hits.
Later this year as we've talked about.
We certainly will have a big flag trays with that whole population of type syngas froze and advanced practice providers.
And bring a lot of value to patients and to the the age community.
Great. Thank you very much.
Thank you there are no further questions at this time I'd like to hand, the floor back over to Jim Brown for any closing comments.
Okay, and I just want to.
Thank you all for participating today and as always if you.
You have any further questions. Please follow up.
And we look forward to seeing hopefully a number of you.
In New York next Tuesday.
See you soon bye.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.