Q2 2020 Albireo Pharma Inc Earnings Call
Greetings, ladies and gentlemen, and welcome to the Alberta as far as <unk> second quarter 20, <unk> earnings Conference call. At this time, all participants are no listen only mode. It question answer session will follow the almost administration if anyone should be quite operator systems. Please press star zero under telephone keypad.
Well you to introduce your host all aren't like side library. Thank you you may begin.
Thank you operator, and good morning, everyone. Thank you for joining today's call.
This morning, Alberto issued a press release, highlighting its recent business accomplishments and reporting its financial results for the second quarter ended June 30 2020.
Press releases accessible via the company's website at Www Dot El Dorado pharma Dot com.
Before proceeding we would like to note that management's comments today may include forward looking statements regarding the company's plans and expectations.
These statements are being made under the private Securities Litigation Reform Act of 1995, and they are subject to various risks and uncertainties actual results may differ materially due to various important factors, including those described in the risk factor section of our most recent form 10-K, and our subsequent FCC filings.
These filings can be accessed can be accessed from the media and investors section of our website at www Dot Albert rail pharma dot com or on the Fccs website <unk>.
Any forward looking statements represent our views as of today Thursday August 620, 20, and should not be relied upon as representing our views as of any subsequent date.
We undertake no obligation to publicly update these statements.
Now it is my pleasure to turn the call over to run Cooper, Alberici, President and Chief Executive Officer Ron.
Great. Thank you Paula Thank you everybody for joining us this morning.
With me today, our Dr Pepper Horn, our Chief Medical Officer, Pamela Stevenson, our Chief commercial officer, and Simon Harford, Our Chief Financial Officer.
So before I dive into an update on each of our programs I wanted to give my heartfelt thanks to our hard working and tremendous team here at El Dorado, who show an extraordinary commitment and moving each of our programs forward in the face the covert 19 global pandemic.
Executing upon our strategy and keeping our programs on truck is no small feat even in the best times. Despite these challenges. We're pleased to report that last patient last visit has been achieved for the older VIX about P. FICC phase three study and the Olympics about Nash speaks to study.
The first patients have been enrolled in the OTA VIX about don't worry a treat a phase three study and we've come to agreement with the U.S. and European regulatory agencies on the design of a third or the VIX about pivotal program and that would yield syndrome.
We've continued to execute and build upon our plans for commercialization as we prepare for topline data.
Following our topline data announcements, we have a rich second half with key milestones to deliver on which as possible because of our team's focus and quality of execution with our strong balance sheet supporting our activity since the beginning of 2022, we feel optimistic about our position as a company.
Now for a closer look at each of our programs.
You know what it takes about for progressive familial interpreted coleus basis or piece that we were fortunate to have our phase three trial fully enrolled when many of the cobot 19 restrictions were first put in place.
We have now with cheap last patient visit and expect topline results in the coming weeks aligned to our mid Twentytwenty guidance.
I'm really pleased the data will include 62 out of a plan 60 enroll patients with no patients last fall, but due to cope with 19.
We anticipate approval issuance of a priority review voucher and commercial launch in the second half a 2021.
At Albert Rail, we continue to be fiercely dedicated supporting patients and we've committed to two important programs.
First we announced the launch of an expanded access program or EAP for patients with PC in the U.S., Canada, Australia and Europe.
Through our open label heads pick two trial and now our EAP, we hope to increased access to all the VIX about for all eligible patients to the greatest extent possible until OTA VIX about is commercially available.
We're pleased to launch the program in these first countries and we're working closely with local regulators in other countries to offer access and continue to provide hope for Pete pick families worldwide.
Second.
Genetics testing.
We're happy to be supporters of a free genetic testing program for P for canal Jill syndrome in patients in the U.S. with other industry partners.
Both programs demonstrated strong movement towards planned commercialization, but more importantly, our commitment to helping to provide support for patients who are in need.
We're confident that our pet pick one study has been carefully designed to incorporate F.D.A. input into the parade. His primary endpoint, we hosted a key opinion leader event earlier this quarter to provide background on the design and implementation.
Clinical outcome assessments, including patient reported an observer reported outcomes in pad pick one into.
Our precision measurement tools were designed using best practices for clinical outcome assessments in consultation with patients and caregivers expert clinicians and the FDA, who provide a considerable feedback through the development process to the design to the tools, including the interview study draft items.
In response scales.
Based on the continent validity work that we have done we believe it will provide the quality measurements. The F.D.A. requires born in the submission OTA VIX about four p. thick.
No plans for commercialization during high year, we've been very active on that front, our supply chain in manufacturing plants are taking shape with packaging partner selected for the U.S., Andy you and our patient support program partner is in place as well.
The ability testing for our registration bashes is well underway and we are executing on the CMC plan with input receive from the FDA in the fall of 2018.
As our commercialization plans begins to take shape, we're convinced today more than ever have the opportunity in people with a clear need for better treatment options for patients and an orphan drug designation offering market exclusivity. We believe that we are well position with our once the.
Today oral dosing with minimal systemic exposure.
And a favorable safety profile.
We'll have much more to say on this as we get closer to watch.
Moving onto our phase three program with OTA VIX about billerica trees young we fulfilled our one age 20 guidance and initiated our bolt pivotal study last quarter and we're delighted to have randomize the first patients.
I in the trial. Despite the challenges of covert 19 mold is the largest perspective intervention trial ever conducted in Delaware atresia, expanding the development order VIX about to a second rare cost static liver disease indication.
This study is a double blind randomized placebo controlled study in approximately 200 instance, designed to evaluate the efficacy and safety about a VIX about compared with placebo in children with Bill Maria Torija, who have undergone a cost side procedure. The primary endpoint is the proportion of patients who were alive.
Have not undergone a liver transplant after two years of treatment.
There are no approved pharmacological treatments for Hillary Teresa, which is the most common pediatric coal static liver disease, and the leading indication for pediatric liver transplant.
Clinical sites in United States are currently active for patient enrollment.
We have received orphan drug designation for Doria trees in the U.S. and you.
Rounding out aerobics about program is eligible syndrome, where we plan to initiate our third pivotal phase three trial by the end of year.
We've come to agreement with regulatory authorities in the U.S. you on the design of a protocol for a single study necessary for approval and have received orphan drug designation in both regions.
[noise] [noise], let me now move to our pipeline products.
It is estimated there are approximately 16 million people in the U.S. with with Nash with a 10 fold greater risk of liver related mortality compared to the general population. This presents a massive market opportunity no approved treatments, while many of the products in current development are struggling.
But the balance of efficacy and safety. It is our thesis that a non systemic drug could have the right balance of efficacy and safety in our Ela picks about program. We have two ongoing phase two trials in Nash and NAFLD deep.
For the U.S. Elagolix about five milligrams study, we completed last patient last visit and are expecting topline data in the coming weeks fulfilling our mid Twentytwenty guidance.
This study will read out ahead of the OTA VIX, but had big one phase three study.
We will have data on 43 of the 47 patients randomized as for loss.
To follow up primarily due to cope with 19.
For the second Elagolix about 10 milligram trial being conducted through our partner EA farm in Japan, We read reiterate our guidance and anticipate topline data at the end of this year or early next year.
We're eagerly anticipating these important need as both studies are designed to provide a proof of concept of I bedinan inhibitors in Nash Snapple deep.
There are no biopsy endpoints in this study for both studies the primary endpoint this change in LDL C.
And important secondary endpoints, such as reduction the liver fat measured by MRI Pdfs and reduction of liver enzymes with this combination or parameters. We are working for positive trends in lowering LDL liver health potentially with at least 10% to 20% improvement in liver fat and stabilization.
Liver enzymes and positive trends in cardiovascular disease factors with good Gi tolerability.
Meaning a manageable rate of diarrhea.
Our intent is to accumulate this data from both studies and seek a partnership further development for Ebix about and potentially one of our emerging preclinical assets.
So in summary, we are very excited by the opportunities before us in each of our programs. We truly believe we are building something very special with our focus on progressing our late stage programs and validating our pipeline with our best in class product gases and look forward to increased momentum in the.
Second half the year, starting with OTA VIX about peak topline data anticipated in the coming weeks Elagolix about data from one of our two phase two trials in Nash anticipated ahead of the OTA VIX about data and data from our Japanese partners.
By the end of the year early next year bolt phase three trial, which will continue to enroll patients with billerica trees, yet as well as a third phase three trial and knowledgeable syndrome to be initiated by yearend.
Additional milestones for auto VIX into 2021, including completion of a study initiation for the billerica trees your trial and the anticipated approval issuance of a priority review voucher and commercial launch in P. Fig next year.
We are truly on the cost of a very an exciting meaningful period for alber rail.
We're certain of the potential and opportunity that lies ahead and really appreciate your support.
So with that my pleasure now to turn the call over to Simon for a financial update Simon.
Thank you Rob.
Revenue was 1.9 million for the quarter. Yeah ended June 30 of Twentytwenty compared to 1.3 million in the same period last year.
The increase was due primarily to royalty revenue received from EA pharma in Japan, which is passed on to the healthcare royalty partners as part of an agreement to monetize the royalty stream.
Research and development expenses were 18.4 million for the second quarter 2020 up from 11 million for the same period last year.
The increase for the quarter was primarily the result of program expenses.
To fix of that as well as people costs as we continue to build out indications for our lead acid and expand headcount.
General and administrative expenses were 8.5 million for the second quarter compared to five into Hoffman and then the same period last year.
The increase was primarily due to additional headcount as we continue to put path for commercialization.
Net loss for the quarter ended June Thirtyth, Twentytwenty was $20.6 million or a loss of $1.38 a share compared to a net loss of 16 point sixmillion or a loss of $1.35 a shaft the second quarter of 2019.
As of June Thirtyth 2020, we had a cash balance of 152 million.
During the quarter, we restructured our royalty agreement with healthcare royalty partners, netting an additional 15 million in non dilutive capital. Additionally, we established an 18 million dollar debt facility with Hercules capital drawing down an initial amount of $10 million as a result of.
These two financings our cash runway now extends into the beginning of Twentytwenty too.
With that let me turn the call back over to run for closing remarks.
Great. Thanks, very much Simon.
So we're moving forward towards our vision of becoming a fully integrated biotechnology company with an act of commercial organization and a pipeline of therapies under development. We believe OTA VIX about has the potential to be a meaningful therapy in pediatric we anticipate much more to come.
Thanks, everybody for joining us we're now please open the call for questions operator.
Thank you, ladies and gentlemen, if you'd like to ask your question. Please press star one on your telephone keypad confirmation total indicate your line is my question Q.
Let's start to if you're able to if you'd like to remove your question from the Q participants using speaker equipment. It may be necessary to pick up the handset before pressing the star Keith one moment. Please.
Pull for questions.
Our first question comes from the line of Yasmeen Rahimi with Piper Jaffray. Please proceed with your question.
Hi team. Thank you so much for the grade updates on very excited for all the results that we will be since June two questions for you. The first question regards generics can you.
Care with.
What data you hope to see to give you confidence or make the decision to go further in development and warrants and then the second question is.
Have you had a chance to speak with <unk> of the a on the potential use about assets at the regulatory endpoints and thank you again for taking your questions.
Good morning asked me thanks for joining us I think we're very excited about the upcoming Nash data our program with Elagolix about has always been designed as a proof of concept program. The study were doing here in the U.S. and the study that our partners farmer are doing.
Our theses for Ela mix about in Nash is a theses of where we believe we can do multiple things that can help with the disease. So what we're looking for is that is the is the combination right youve improvements of liver help parameters in production of cardiovascular risk.
Parameters.
And doing that with good tolerability, namely, making sure there is a reasonable level of diarrhea. So that's what we're looking for between those two studies and as we've talked to potential partners. They said, they're they're looking for.
That type of information, we're pleased to provide that data.
And the to your second question as it relates to the to the to the regulatory question about using serum bile acids as an endpoint we had very good discussions with both regulators in the U.S. and ended in Europe about the design of the at fixed study.
Originally we had proposed serum bile acid in both regions and within Europe. They agreed that that would be a good primary endpoint in the U.S. Their focus is much more on a clinical endpoints and they wanted a brightest implied that being said both regulatory agency accumulated to us into the totality of day.
It is very important for approval and that there are looking for all the parameters to be swimming in the right direction and we hope to provide that information to them.
Thank you so much and the best of luck.
Thank you as me appreciate it.
Thank you next question comes from the line of Ritu Baral with Cowen. Please proceed with your question.
Good morning, guys. Thanks for taking the question.
Can you comment on any.
Any becomes a missing data that you guys.
Yes.
Said.
Given the conduct of the trial overcome David.
And at least at this point high level, how are you thinking about the commercial scores.
For a four key Frank.
Now how many reps do you think you would need are you going to be focusing on centers of excellence.
Right.
Marketing campaigns.
Yes, so high rate you this is Pat.
So in regards to the first question missing data. So we have been very fortunate that we had a clinical operations team.
Our own that we're able to put into into play and now.
Different majors and Billy handle these patient that we're remaining in the study on a patient by patient basis. So looking at the data we will have no missing bile acid data for the primary endpoint may be missing data at one or two of the intermediate endpoints for primary endpoint, which has that changed.
From baseline to that into the study there will be no missing data.
And for our commercial question I'll turn it to Pamela.
Hi read too.
Thanks for the question. So we are planning.
In terms of your first part of the question.
For about 15 to 25 field facing individuals as as you well no. This is a concentrated prescriber base and we will be deploying sort of a center of excellence model focused on 60 relative centers across the U.S. and we have spent a fair amount of time first half this year profiling those accounts. So we have adaptive understand.
One of those accounts alone, we feel confident in being able to cover them with the 15 to 25 field pacing personnel and take a final part of the question certainly there are important influencers and potential prescribers beyond those centers of excellence.
You're doing a lot of research now to better understand them, but we don't believe will build need more in terms of number perhaps to cover any additional prescribers.
Great. Thanks, Lynn Squeak in one less yeah, I mean, if we can one last question. Please forgive me.
Secondary analyses that we should be lucky outflow topline release.
And thanks for answering the question.
So for topline release.
Again, we haven't had the final internal discussions on my expectation is will only be releasing the primary analysis and top line.
Secondary analyses will be presented.
Meeting publication, you have to remember read too that the pet fix study will probably be the largest prospective study ever conducted.
In P. FICC and when we speak with the scientific community, they're very excited about that data because that's going to provide a huge bank of information on not only OTA VIX about but the treatment of the disease. So we'll be trying to preserve as much as a possible for for upcoming scientific meetings.
And publications.
Fair enough. Thanks for taking all the question.
Thank you.
Thank you. Our next question comes from the line of E and young Yang with Jefferies.
Thanks for taking my question.
Thank you so look forward to the data in coming weeks. So when you are pretty then PC Crazy say data at the San Juan.
I'll use the preventing some interim data from.
Q.
So for the topline rights you will be focused on just had pets pick one we will be doing some analysis and think too but that will be part of our regulatory submission.
Hi, Thanks, and then on the nation data there we have that.
I think the you mentioned briefly but can you talk about what.
We should have been looking for a with a high beta here. My question is what do you think or would that be the.
Benefit.
Compared to other products, so we've seen in mass.
Yes, Thanks, I think our theses in Nash is a little bit different than the other agents. So we don't when you think about the transition from from NAFLD and Nash what are the things that changed cholesterol changes glucose changes liver information and liver fibrosis.
And increasing that information that theres, an increase in bile acids. So our thesis is if we can affect multiple parameters by removing toxic bile acids and the body and toxic cholesterol taking out of the bought the body. We believe that we could have some really interesting.
Efficacy.
That efficacy, though is combined without up but right. If you look at many of the current agents that are being developed there is we are getting efficacy, but there are some side effects for convenience issues that make it difficult given this medicine to a largely asymptomatic population.
And so with Elagolix about in particular, you think about the convenience of this drug it's an oral drugs. So it's not injectable. It's once a day, it's not multiple times a day and it's a drug that is not systemic so we do not anticipate.
Much in a way of off target effects like we've seen in some of our other studies. So therefore, you can be combined quite nicely with our to cardiovascular drugs are combined with other Nash drugs. So for that from that perspective, we believe that the safety convenience tolerability is attractive for I VAT inhibition.
Now what we'd like to show is efficacy against multiple parameters of liver held in cardiovascular health to help with Nash patients. So we're pretty excited about the upcoming data to be able to demonstrate that.
Thank you.
Thanks you.
Thank you Sir our next question comes from the line up Brian Skorney with Baird. Please proceed with your question.
Hey, good morning, everyone. Thanks for taking my questions I know you've talked a bit about the powering our rent per right and point in the Pete pick study and do something that there is a sizable placebo effect there.
I was wondering how should we think about us for the serum bile acid endpoint, though the cut off with 70% reduction or less than 70.
Hello.
Pretty high threshold is there an assumption that any placebo patients.
This installed younger powering and maybe you could just kind of.
Characterize what would reasonable variability Iran.
Be for placebo and if you're looking at this over the leading periods in first stability before putting patients on on treatment and placebo and and have you seen any blinded serum bile acid. The study so far in as a consistent with expectations.
Oh so.
Let me if I can address Albert fried if I can remember so we did there were multiple bile acid attained the screening period and that was to confirm that the bile acids far above 100, because now it an inclusion criteria they had to be above 100, and so there was a little variability in outpatient relative it was relatively constant.
After screening after the first dose bile acid have been draw I've got this study, but always remain blinded. So we have not seen any of the bile acid data after the first dose.
70% is a high bar.
Yes.
I would agree it doesn't seem unlikely that placebo patients act reach that.
There is one other kind of component to the responder definition, though is getting below 70. So you might not have to be a 70% reduction to to be a responder, but even so yes.
The thinking it is unlikely that input Tivo, one region, but during our power assumption. We included a fairly significant response in the placebo arm.
To allow for any any variation that we might be seen so that was that with accounted for in our powering assumptions.
The Brian just said said differently.
Our powering subs are really driven around the parade. This endpoint because we recognize there's more variability in that so in the brightest endpoint, we where powered at well over 80%.
Just to show to show a difference in serum bile acids, there's there's just less variability overtime and and as Pat indicated we what we've done as we picked a number where we believe we will knock out a placebo effect. So think about this we need to show in the treaty.
Through the there is a reduction of 70% or reaching 70 versus the placebo group right and so that's the big difference the versus part. So you may recall that from our phase two study that within the Piecyk group within a four week timeframe, we had a mean reduction of over.
Were 70%, so we feel pretty confident our ability to reach the serum bile acid endpoint.
Great. Thanks, that's helpful.
Thanks, Brian.
Thank you. Our next question comes from the line of Alan Carr with Needham and company. Please proceed with your question.
Good morning, Thanks, taking my questions.
Can you talk more about this about the genetic testing program John highlighted earlier today and the scale of the extent expanded access.
Program trying to get a sense.
Of.
Where you stand in terms of.
Identifying patients.
A number of identify patients.
I had a launch next year.
So.
And we're not hear you really well, but just to make sure I think you asked some questions around the genetic testing program and a little more information around the expanded access program kind of where we are without Pamela maybe you can address those sure yes.
Yes, the other element to that was just understanding or where are you all stand in terms of understanding that the number of.
By patients as you get closer to launch.
Right.
Thanks, Alan So on your first question on the genetic testing program. This is that program that sponsored by multiple industry partners to provide financial support for free genetic testing program in the U.S. So as we understand it from what we hear from physicians that this is a really valuable program for physicians and patients and families.
Until we are providing financial support to support to continue this program and we're really happy that we're going to be able to continue to support the key fact community in this way.
On your on your second question on the EAP program that we announced on launch on July 20-F.
I'm very pleased with the response, thus far from physicians and parents.
We're getting requests we are processing those requests and it's certainly that will be one mechanism to sort of identify patients on but into the latter part of your question. We have other efforts ongoing to better understand the number of patients out there so through centric help mapping and.
The other research that we're doing continued to kind of hone our understanding we will continue to hold our understanding of those numbers prior to watch.
Okay. Thanks for taking my questions.
Thanks Alan.
Thank you Sir our next question comes from line of Ed Arce with H.C. Wainwright. Please proceed with your question.
Hi, Good morning, everyone. This is Thomas Yip asking the couple of questions for.
Congratulations on a very busy second quarter.
So first first question.
Regarding your upcoming eligible syndrome pivotal study that's expected to kick off before yearend.
So while you're still figuring though.
See you told US I studies as that starts study designs can you give us a rough idea off the urban size sermon duration.
Also the primary endpoint, whether it be the same for both yeah, yeah yeah.
Thomas Sam Good morning, Thanks, very much yet for the for the for the question where were really pleased.
To have come to agreement with regulatory authorities in the U.S. in Europe on a single pivotal program for four Algeo eligible syndrome, as we're pleased with that and the team is up and going and try to execute on that when you think about the Algeo study.
Think about it kind of like our Patrick one study upscale like that and we'll provide more details on that as as we work our way through sort of the IR BS and the various sites, but as I said Oh, we're excited to have a single pivotal that should be sufficient for approval for eligible syndrome in both the U.S. in Europe.
And we anticipate.
Moving up and going by the end of this year.
Okay. Thanks, Thanks for Thats for Europe.
Corporate vision and then for.
No cash corporate costs up study.
Assuming.
We'll see positive.
Liver and cardio grown and as you mentioned.
What are the next steps.
For you guys with the.
Okay.
Before the end of every though from a farmer or.
Hey, guys breathing for that data sets your back.
I got this session.
Yes, Thanks, Tom as our business development discussions.
For for an asset says our ongoing act activities. So we continue to have dialogue with potential partners I think we need to see the data from the phase two study in the U.S. first of all and we'll be sharing that with our potential partners.
And we'll kind of take it from there then we'll look forward to our Japanese data, which will be a larger studies as 100 patients. It's at a higher dose is also in combination with cost are being so that will be part of the ongoing dialogue that we will have with potential partners, but we're pretty excited to be delivering.
To that because when we spoke to potential partners.
Before they said look really like this concept of I bet inhibition in Nash.
Like the little bits of data that you out, but we'd like to see data in national NAFLD patients and so we're going to be delivering that data very soon.
Okay that makes sense one final question from us.
For your hair occurring clinical candidate.
Well for a period area you have in mind for now whether that be.
More along the line.
Yes.
These or would it be a broader professional market right Nash.
We have a lot of expertise and our organization bile acid modulation Neal the history of our company goes back kids Astra Zeneca in multiple decades, and so our understanding of these mechanisms is really strong we'd love I bet inhibitors, because as I've said before.
Sure.
The safety profile, the convenience and the efficacy that we've been able to demonstrate in both in disease like chronic constipation and children's pediatric cost static liver disease that just great, but we are limited in the therapeutic window with the with these ages right and so.
Well, we're trying to do is to widen that therapeutic window that the balance between you being able to drive down bile acids and have good tolerability and we're pretty excited that our team in Sweden as has come up with some really interesting approaches that at this time weve not disclosed.
The mechanism of action and we've not to schools, where we're going other than to say, we're looking at add adult diseases, but we have filed for path is we have I'd, enabling studies ongoing and we're looking forward to sharing more data with you as the year progresses and as we get into next year.
Okay.
It's got a little before today. Thank you once again no questions again, we look forward to tier two data readouts in the next two weeks.
Thank you Thomas.
Thank you. Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question.
Hi team. This is John on for Tim. Thanks for the question just two from US. So just with regards to Bill Eritrea and just wondering if you guys are seeing any issues that getting in the trial fully up and running.
Given the ongoing pandemic and if you're seeing any issues with enrollment cadence or any issues specific to a specific regions.
And then just to follow quick follow up on a prior question on the Alec Yeltsin Dumb trial I. Just wondering if you have any timeline for when you will share some more details on that trial side. Thanks.
Thanks, very much John I'd say, I'm really proud of pads clinical team in his Clin ops team you think about trying to get a trial up and going during this cope with crisis and really is something else. So we've been able to get that at trial sites up and going in the U.S. Theyre actively recruiting we actually.
We have patients.
Enroll pretty excited about that.
We've given guidance that we should complete having all the sites up and going in the first half of next year and I know that pad and his team are working really hard not.
A key factor in that will be our ability to actually get onsite in the hospital right. So in some some circumstances from the cope with cobot. It is difficult for us to get into those hospitals, we're hopeful than our ability to get into those hospitals and get trial sites up and going give as I said earlier.
Hillary a treasury is the number one caused a pediatric liver transplant the unmet medical need is super high and there are a number of children that could pension potentially benefit from from our study. So we're working very hard to do that as in regards to timelines for outlets Yeltsin from.
I will give more guidance on that as time goes on but I think the way to think about it is we're going to be delivering a perfect data in the coming weeks allergy ill syndrome data should be should be next and then bill or trended data overtime.
Alright. Thanks.
Congrats again on the productive quarter.
Thanks very much on.
Thank you ladies and gentlemen, our next question comes from the line of Liana Moussatos with Wedbush. Please proceed with your question.
Thank you for taking my questions. So I see three ways to win on had Vic.
You can either wynnewood, both endpoints or either endpoint.
Yes, serum bile acids hit, but greatest doesn't I'm would you pursue European commercialization European approval and commercialization.
Without a partner or with a partner and how long if both endpoint to how long will it take for you to submit the regulatory documents.
Thanks. The question now the and I think we remain really confident in the outcome of the pad FICC a study and in both are both endpoints.
I think the realize your question as we got to see what the datasets rise and once we see with the data with what we do have then then we will proceed from there. Our current plans are to commercialize in the U.S. and in Europe as Pamela's said.
This this is a key account approach there is about 100 key pediatric hepatologist in the U.S. The same in Europe. So we think that is quite manageable. So that did the answer your question really is dependent.
On the data and then your second question.
I timing of filing a timing of timing right, yes, right now.
Yeah, right now, we've not given guidance and that our guidance has been that we expect.
In the second half a 2021, we expect approval issuance of a priority review voucher and launch during that timeframe.
Thank you.
Thank you again.
Thank you, ladies and gentlemen at this time there no further questions I'd like turn it back to management for closing comments.
Great. Thank you operator first of all I'd like to express my Thanks to everybody that has joined us for todays call hopefully what you see this that we have made tremendous progress during this quarter. Despite the challenges of cope with 19, and we eagerly anticipate seeing topline data for OTA Vic.
It's about NP fig as well as Ela VIX about.
In Nash, Thanks again for tuning in.
Thank you ladies and gentlemen. This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.