Q2 2020 Reata Pharmaceuticals Inc Earnings Call
Hello, and welcome to <unk>.
Second quarter financial results, an update development programs call My name is <unk>.
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Well, we begin I'd like to go for a few housekeeping role in audio recording of today's webcast will be available shortly after the call's today I'm Riyadh its website at <unk> Riyadh pharma Dot com.
In the Investor section.
Before the company proceeds with his remarks. Please note the forward looking statements disclosure of the company's press release the company will make forward looking statements on today's call.
There are many factors there could called <unk> cause results to differ from expectations, including dose noted and the company's FCC filings.
Today's statements are not guarantees to the future outcome.
Also note that any comments made on today's call speak only as of today August 10th 2020, and May no longer be accurate at the time of any webcast replay are transcript.
Reading.
Are you prepared remarks, we will open the call up for questions. We ask that you. Please limit yourself to one question. So that we can't accommodate as many questions as possible.
Please now welcome.
Mr. Vinnie Jim Dolls, Vice President strategy, you may begin.
Thank you.
Good morning, welcome to reality management's called to discuss our financial results for the second quarter 2020.
To provide a review of our development programs.
This morning, we issued a press release with a summary of these results and the press release can be found on the Investor section of our website and Riyadh apartment outcome.
I'm joined today by our Chief Executive Officer weren't House, our Chief operating Officer, and Chief Financial Officer, Monday, Tony and our Chief Research and development Officer, calling Meyer.
Before I turn the call over to one I'd like to remind our callers that we're limiting questions to one per caller. Please during the Q1 day.
Well I'll now turn it over to you.
Thanks spending good morning, everyone and thank you for joining us on our quarterly call.
On today's call I'll provide an update on a regulatory path for our lead products paradox loan at no metal locks alone Collin will summarize the status of our ongoing clinical programs in my meet will review the company's financials.
I'll begin with an update on the status of a regulatory interactions with the FDA [noise].
Excuse me with respect to the potential approval up or docs long for the treatment of patients with Alport syndrome on slide five.
So following the announcement of your one data from the phase three Cardinal study in November of 2019, we've been engaged with the FDA to discuss the year, one efficacy and safety results. We've had a type C meeting, where the F.D.A. express concern with facing in India for accelerated approval on the year.
Sure one data alone and recommended that we consider submitting the NDA with the year two data.
We believe that their recommendation was based in part on their assumption that there would not be much delay in India submission by waiting for the year two data.
The FDA invited us to address their questions and has provided suggestions for additional analyses of the year one data.
Following the type C meeting, we've had a series of interactions including in formal meetings and written submissions to the high end D to address the F. da's questions and requested analyses raised at the meeting.
We delayed requesting a pre NDA meeting, while we address the FDA review questions. We recently requested and were granted a pre NDA meeting by the FDA to discuss the India submission content and plans.
One of the key questions to be resolved in the pre NDA meeting is how the year two data should be handled during the NDA review process. Our plan has been and continues to be to submit the NDA for products alone at Alport syndrome. During the fourth quarter of this year for accelerated approval based on the one year data.
The phase three portion of Cardinal.
The second year results are available during an acceptable timeframe, we maybe able to submit the second year data during the review process and before the FDA makes a determination about accelerated approval. This may extend the PDUFA date, but could also result in consideration of full approval rather than accelerated approval.
The F.D.A. could recommend that we wait for the second year data from Cardinal to file the NDA. This would permit us to file for full approval, but would delay the filing until the first quarter of 2021 compared to our current guidance a filing by the end of this year.
Of course, this timing assumes that the year to date are positive and that we can complete the activities necessary to provide the year two data to the F.D.A. on a timely basis.
Colin will be providing more details on the steps we've undertaken to maintain data integrity and ensure timely database lock like year to Cardinal data.
Moving to slide six I'll provide an update on the regulatory pathway for amount unlock Sullivan.
After the announcement of the data from Oxy part two study in October of 2019, we plan to subject to discussion with regulatory authorities to proceed with the submission this year for marketing approval of amount for the treatment of friedrichs attacks in the United States.
We've been engaged with the FDA to discuss our proposals to use the data from the Moxy part two study is a past Andy a submission.
Our proposals have been supported by the Friedreichs Ataxia research alliance or Farrah and key opinion leaders in the essay community.
We recently completed a type C meeting in which the FDA provided us with guidance that it does not have any concerns with the reliability of the M. Fars Prime or primary endpoint result in the Moxy part two study.
Nevertheless, they are not convinced that the moxy part two results will support approval based on a single study without additional evidenced that lends persuasiveness to the results in preliminary comments for the meeting FDA stated that will need to conduct a second pivotal trial that confirms the m. far as results of the Moxy part.
Two study with a similar magnitude of effect.
In response to the preliminary comments fair key essay clinicians and we explained that it would be difficult to conduct an additional perspective clinical trial in essay because of the very slow progression rate of EFI patients. The limited number of essay patients available for clinical research.
The small number of clinical trial investigators, who can conduct the emphasis exam and the impact of the coven 19 pandemic on the ability to conduct neuroscience clinical trials.
We pointed out the conducting an additional pivotal study would result in a long delay in the availability of the potentially effective therapy to patients with a progressive life threatening disease with no treatment options.
The FDA has acknowledged the unmet need of if they patients reiterated its commitment to facilitate the development of O'malley within the constraints of the regulatory standards and emphasized its willingness to consider all available options to meet the regulatory standards.
As an alternative to a second adequate and placebo controlled pivotal study Farrah key epay clinicians and we proposed a second study the crossover study that could serve as additional evidence of effectiveness.
Study would measure the effective Omar on M. farce in patients who were previously randomized to placebo in the Moxy part two study and are being treated with Omega of in the Moxy Open label extension study.
The FDA acknowledged that launching a new clinical trial would be difficult now because of the cobot 19 pandemic and that is study like the proposed crossover study could be a source of important additional information.
The FDA asked the company to submit a description of the proposed design that agree to review the proposal and determine whether the crossover study could provide additional evidence of effectiveness.
If the FDA accepts the proposal we could have the completed data from the crossover study as early as the fourth quarter of this year, assuming that the FDA views. The crossover study data is sufficiently positive to provide confirmatory evidence our plan would be to submitted in da during the first quarter of 2021.
If the FDA rejects the proposal or if the data are not supportive we will evaluate whether it's feasible to conduct a second pivotal study NFV patients as suggested by the FDA.
Regardless of the interacts with the FDA, we plan to pursue marketing approval outside of the United States.
I just like to add we only recently completed the type C meeting and we're providing details of it without the benefit of having received minutes of the meeting from the FDA yet.
I'll now turn the call over to Kolon to comment on the design of the proposed crossover study and to provide an update on the company's ongoing development programs.
Thanks, Martin as Warren mentioned, the crossover study would use patients as our own controls patients randomized to placebo group Moxy part to be used the analysis approximately 40 patients were randomized to placebo moxy part to enter the extension phase the trial, we would measure that are changing empire.
During moxy part two and compare it to their change in bars on the open label extension study.
After patients completed the 48 week treatment duration and Moxy part to the stock treatment for four weeks and had a safety visit at week 52 for the patients who continued in the extension phase the trial. The week 52 imparts value will be used as their baseline for analysis of the extension phase patients and investigators have remained.
Blinded to treatment assignments remoxy part two and therefore, they do not know if they were receiving a math or placebo.
Operationally the empires efficacy assessments have been conducted the same rigorous manner during the extension as during Moxy part two.
We would likely analysis to be the most informative it can be and would like to have agreement with the FDA before conducting the analysis. We are seeking guidance on the specific analysis methodology and many of the details will be finalized during discussions with the FDA.
Moving to our CKD programs on slide nine and as Warren mentioned earlier, we're in the process of completing the year to portion of our Cardinal Phase III study as cobot 19 emerged as a pandemic with serious public health implications. During the first quarter 2020, we undertook a series of measures protect.
Health and safety of patients in healthcare workers involved in our ongoing clinical studies.
Containing the conduct of risk studies in accordance with guidance provided by the FDA and the M&A.
For example, we have implemented the use of at home visits as an alternative to in clinic visits when necessary to collect blood draws and to assess patient safety. We also range for home delivery of the study drug to patients.
This time, approximately 60% of 157 patients randomized the Cardinal phase three cohorts have completed the year to final off treatment visit last study business are anticipated to occur during the fourth quarter of 2020, which is consistent with our pre koby 19 timeline Kurt.
Only almost all sites are allowing onside or remote monitoring as a result with the measures taken in response to pandemic and based on current operational metrics. At this time, we believe that the timeline for your two data availability is unlikely to be affected by koby 19.
In addition to the Cardinal study we are conducting the phase three Falcon study of box loan in 80 PKD as described on slide 10, similar to Cardinal Falcon because in international to use study enrolling patients with a wide range of kidney function and age with off treatment easier.
Assessments for one and two years or treatment that support approval.
In March 2020, we temporarily paas screening and enrollment of new patients and Falcon due to the emergence of Coca 19, we began to lift the screening hold in June 2020, and currently all sites are able to screen patients and approximately half are able to randomize patients. The first few patients have.
Reach the second year the trial the measures we implemented to the to the conduct of Falcon in response to cope with my team have been effective and we anticipate no meaningful impact on data integrity due to covert 19.
During our first quarter earnings call I described kidney code genetic testing program sponsored by Reatta in detail to help nephrologist identify the genetic basis various forms of CKD today I'd like to briefly provide some background for this initiative recent findings published and highly respected journals.
Our consistent and suggesting that Alport syndrome, maybe more prevalent and currently estimated and that patients with offers syndrome are often miss diagnosed.
In one study published last year, the new internal medicine over 3000 patients with CKD were genotyped and 10% hey, genetic form of CKD.
These 30% how mutations in the college and genes that cost upwards syndrome, which was nearly identical to the proportion of patients who tested positive for mutations in the genes that caused 80 PKD.
More recently the same research group assess patients with Egina frothy and found that 20% of patients with familial eyes unified apathy tested positive for the college and genes that cause our syndrome. Several other genetic studies have concluded that approximately 10% to 30% of patients with a clinical diagnosis of Fs G.
Yes also test positive for these mutations and therefore have alport syndrome as the underlying causes there can be disease.
Moving on to slide 12.
As we previously announced researchers and why you are initiating an investigator sponsored trial to study the effects of murdoch's alone in patients suffering from Koby 19.
Just complications of cobot 19 are caused by excessive systemic inflammation, which can result in dysfunction, the lungs kidneys and other organs acute kidney injury has been reported to occur in up to 28% of all hospitalized koby 19 patients and an up to 72% of patients who do not.
Survive cover 19, Murdoch's long and as analog have demonstrated anti inflammatory activity in animal models of acute long in kidney injury have increased survival and models. This is systemic inflammation. So.
Suppressed replication of several types of viruses and im showing improvements in kidney function and multiple clinical trials that enrolled over 3000 patients with various forms of chronic kidney disease.
The phase two of our Kona study is a randomized placebo controlled double blind trial that will enroll 40 patients with the primary endpoint of safety and treatment duration of up to 29 days and hospitalized patients major exclusion criteria include patients were intubated noninvasive mechanical ventilation.
For three or more days.
Higher hospitalization for heart failure.
We are easier far less than 30 mile per minute.
To further mitigate any safety risk enrollment will be paused after enrollment of the initial five patients to assess safety.
As with all trials conducted and why you the trial will be overseen by the data safety monitoring board that meets every other week.
Reorder was involved in the design of the trial has the representative on the studies executive steering Committee and is providing drug supplies requested by and why you.
Any further enrollment in a potential phase three trial will be gated besides assessment phase two safety and activity as well as feasibility of conducting a phase three trial.
I'll now turn the call over to many provide an update on the Companys financial results.
Thanks color and good morning, everyone. Thanks for joining us today.
Please refer to our press release issued earlier today for a summary of our financial results for the second quarter of 2020.
Before I walk through that summary.
Wanted to highlight a few key financial developments from the second quarter, which out on slide 14.
First we completed a $350 million static investment from Blackstone, that's fenton theaters balance sheet.
Comprised of 300 million dollar for future royalty payments and $50 million for common stock issued.
Regarding the accounting for Blackstone and that's been we accounted for future royalty payments as a liability due to a significant continued involvement we allocated the total investment based on that related to fair value of the two components, resulting in 294.2 million dollar and transaction concentration to the liability and.
55.5 million dollar to the common shares.
In connection to the payoff or done loans, we recorded a loss on extinguishment of debt up $11.2 million.
I would like to note that by paying off are done loans, we would save approximately $25 million of cash interest payments over next three years related to the dumb loans.
Moving to the financial results on Slide 15, we ended the second quarter of 2020, with approximately $610.4 million and cash and cash equivalents.
And we continue to expect or maybe cash to fund operations through 2023.
The decreases in revenue than the three months ended June Thirtyth 2020 were primarily due to the write off of our remaining deferred balance related to our agreement with Abbvie to reacquired licensed rights for our and I'd have to activity programs.
Rejected and last quarter of 2019, and which resulted in no revenue recorded during 2020.
Moving to expenses R&D expenses for the quarter were $36.8 million compared to $29.6 million for the second quarter of 2019.
Our year to date, R&D expenses were $84.4 million compared to $55.7 million and pointing 90.
Our DNA expenses for the quarter were $16.6 million compared to $11.7 million for the second quarter of 2019.
Year to date, DNA expenses, what $37.4 million compared to $21.7 million in 2019.
Our operating expenses for the quarter were $53.7 million compared to $41.5 million for the second quarter of 2019.
Our net loss for the quarter was $67.6 million ARPU dollars and three cents Porsche on both basic and diluted basis.
As compared to a net loss of $34.4 million or $1.14 cents per ship on both a basic and diluted basis for the second quarter of 2019.
Moving to non-GAAP measures on slide 16. These non-GAAP measures exclude stock based compensation expenses loss on extinguishment of debt and noncash interest expense from liability related to sale future royalties.
Our non-GAAP R&D expenses were $29.3 million for the quarter as compared to $27.9 million for the second quarter of 2019.
Our year to date, non-GAAP R&D expenses were $65.4 million compared to $52.3 million for 29 King.
Our non-GAAP gn expenses with $9.3 million for the quarter as compared to $8.9 billion for the second quarter of 2019.
Our year to date, non-GAAP operating expense, what $22.3 million compared to $16.4 million for 2019.
Our non-GAAP R&D engine expenses for the quarter increase primarily due to increased headcount to support the advancement in our pipeline to late stage clinical development programs, our year to date non-GAAP R&D expenses increased due to increased relevant costs, primarily clinical studies and manufacturing expenses and higher personnel cost.
As we increased our headcount to support our expanded at activities.
Our non-GAAP operating expenses also experienced increases in personnel to support growth in our development activities as well as increases and commercial readiness activities.
That concludes our prepared remarks, we will now open the line for cushions.
Thank you will now begin the question and answer session. If you would like to ask a question you could you tell by pressing Star then one on your Touchtone phone.
The speakerphone, please pick up your handset first before pricing any numbers once again, if you'd like to ask a question. Please press Star then one.
And your touched on pound.
Our first question comes from E call the chime event.
From Citigroup. Your line is now open.
Hi, guys. Good morning, Thanks for taking the questions at the two part question first on Allomap.
Regarding the FDA feedback emphasizing the willingness to consider all available options to meet regulatory standards as well as acknowledging I've been in new trial may not be possible given kogut.
With those comments.
In subsequent to the written comments or in writing or were those also verbal comments and then regarding Borgata alone warn you mentioned that based on the type C meeting that.
There were some additional analysis that we requested by the FDA on the upward study if you could potentially expand on what those additional analyses were thank you.
Yes, I'll take the first half the question, yes, the comments about their willingness to consider all options in the discussion about the crossover study all occurred after the preliminary comments.
Were sent to the meeting.
Happened during the meeting.
Okay. Thank you.
And your I'll answer your second question. So the FDA questions, primarily by efficacy they did not have questions about safety.
Responses your questions, we provided pre specified sensitive analyses as well as analyses. They suggested the review team was new to US the program and we also provide a preclinical mechanism of action data as well as data demonstrating the clinical pharmacodynamic profile.
And so we address these in Poland meetings as well as a formal I'd amendments.
We believe comprehensively address your questions and comments.
As we stated we waited to submit a pre NDA meeting request. We believe we had address after years questions and comments.
And as you know we were recently granted hit that PND meeting.
Got it thank you.
Thank you. Our next question comes from Maury Raycroft from Jefferies. Your line is now open.
Hi, good morning.
Thanks for taking my questions. Thank you are providing the clarity on the regulatory at today.
Or as a.
I would say more about why not convent might argue single study resolved as supportive of approval and when you'll find out into the public if they do the crossover study at the vision.
Sure morning, and so we believe the data are supportive of.
Of approval Moxy was the largest placebo controlled MPAR study conducted to date.
As you know what enrolled approximately 100 patients hit the pre specified primary endpoint with a P value of <unk> 0.01 for that it could have wanted a lower P value. Our lead investigators believe the treatment effect was maximal for this duration of treatment in the variability was much lower than observed and natural history study.
We therefore unsure if the P value could have been much lower.
Additional sensitivity analyses controlling for imbalances and baseline characteristics suggested that the primary analysis, maybe a conservative estimate the treatment effect importantly on that patients improved from baseline while placebos worsened the treatment effect improved versus placebo at every time point all four sections of the impart is an all pre specified in our.
So as populations favorite Omar major subgroups favorite, though Matt, including the pediatric patients and those with risk factors for the most rapid progression, including age of onset and Jay one revealing we review the data with all of them Oxy investigators who represent almost all of the global EFI clinical experts as well as fair.
And they agreed that the data should Merritt regulatory review the only real criticism at the data is that we missed the secondary endpoints in the pre specified Cherokee we knew part of conducting the trial. The secondary endpoints were not powered but included them to provide descriptive data to support the conclusions. The primary analysis the first secondary PJ.
I see approach significance in the primary analysis population with a P value of 0.1 in was significant across all randomize patients CG I see in frequency of false favorite OMAP, most important to us and investigators is the patient reported activities of daily living where HDL result, the LTL had a nominally signal.
It can P value point zero for all my questions favorite Omar and the different separate overtime. So for those reasons and we think the data should should support approval. We're engaged right now with the FDA.
To discuss the crossover trial.
Now as we stated we believe that we could conduct that analysis.
The fourth quarter of course pending FDA review of the design, we want to make sure that they're an agreement with.
With the design before we actually execute the analysis.
Got it thank you.
Thank you. Our next question comes from Joseph Schwartz from Leerink.
Leerink Your line is now open.
Thank you.
You just.
Into what you know the FDA.
Views are on all now could you walk us through what aspects of the one year Cardinal data the FDA questions. The merits of and the scenario goes for the two year data.
On the FDA would like to see this scenario or scenarios.
If you were cutting out some Jones was your first question about the questions that you had about the Cardinal one your data.
Yeah, it specifically like what aspects it was helpful. How you.
Laid them out for Omar So could you do the same thing for barge so that way we can understand.
What aspects of the one year data.
They're not convinced by specifically.
Yes, and then I mention what to your data would would.
You know.
Lead them to feel differently more positively.
Yes, so as I mentioned, we provided.
Specified sensitive.
Now sees as well as post hoc analysis, which they recommended to address their specific questions that was all.
Formally submitted in the idea amendment.
Now we have a pre NDA meeting, where we are scheduled to discuss the actual mechanics of submission and so as Warren mentioned our plan is to file based upon the one year data in the fourth quarter of this year.
I will discuss with FDA how to handle.
Year to data.
And your that could influence the timing.
Right, but what aspects of the one year data was it the G far or was it proteinuria was it something else.
There were just scanner questions. If you took we asked about.
The analysis.
Trial.
As well as Pharmacodynamic effects, so that they can you know better understand results.
And then what data at two years with the FDA I'd like to see did they give you any insight into that.
It's the same and so since our pre 90 meeting FDA stated that they wanted your two full years of data to support full approval.
Okay and that you commented in the in the context. They commented that they didn't see much delay and waiting for the year two data.
Yes that parts clear.
Okay.
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Thank you thanks again.
Thank you. Our next question comes from Annabel Samimy from Stifel. Your line is now open.
Hi.
Thanks for taking and question.
Just.
I guess.
But it sounds like.
Got it regardless.
The FDA is going to wait for that to your data because it seems like they had some questions around that one of your data. So can you can you. Please tell us.
First whether the black San Jos conducted before the type C meeting and if so how does the delayed impact the tiered royalties that that you might see from that and then separately in Oman.
It.
I guess I wasn't clear exactly when we might know whether the FDA accepts the crossover study will the 40 patients be sufficient to satisfy their their there needs to see additional.
Data there thank you.
I will take the first part of that the.
The Blackstone diligence was conducted after the reference type C meeting for Murdoch's loan.
And I haven't seen with the royalties that has no impact on the royalty from right.
Those yes.
Thanks data mainstay in the Blackstone royalties are stock back.
Mid single digit and they can tier down to low single digit are up high mid single digit thats. It thats it doesn't change because of this.
And just to address the first for your question. So our current plan is to file on the basis of the one your data not to wait until the two year due to our FDA in the previous meeting.
May provide additional guidance and so thats why our current plan is to file on the one your data for accelerated approval. We believe we address their questions that were raised in the initial meetings.
We when we made the I'd amendment submissions and the in da.
Pre NDA meeting request.
We made clear that our plan was to file before year end.
And then too.
The clarity on that.
Well what was the question.
It wasn't clear to me when we might hear what are the FDA is going to accept a crossover study design.
Oh, well there'll be a 10th of one of my there'll be a step process of working out the.
Most informative analysis plan with them.
Which they offered to do and formal meetings and make themselves available for that that will take some period of time here and then of course ultimately they'll want to see the actual data before they make a final decision I'm sure.
Okay, great. Thank you yes.
Thank you. Our next question comes from Bryan Garnier from Baird. Your line is now open.
Hey, good morning, guys. Thanks for taking my question on.
On the Omar regulatory update can you talk about wetware Deanne, one division that's coming down in terms of they want in a single study for approval I mean, it just seems like there's a lot of with little room here across divisions, and and it's unclear I mean, there through that they want it.
That they normally want to lower P value on a primary thats being sufficient that a matter of secondary analyses needing to support the primary with statistical significance or is it around an endpoint or a magnitude of endpoint and how did the agency consider the boxy part one data here would that not be considered sufficient confirmatory evidence.
So I think you know there they're just trying to follow the regulations. They have for single study approvals and so they told us that they wanted additional information and so.
Theres a few different ways to provide that then discussions.
The most receptive to the crossover design.
And so thats, how were proceeding to provide them with the additional information to provide for some additional persuasiveness.
And then in terms of the timing for the year two data from Cardinal can you just help me understand in terms of trial design why we wouldn't expect the data that you available pretty much one year. After the one year to date has announced last year on November 11.
Yes that is the expectation so our guidance is that we will have the year two data available in the fourth quarter of this year, we think it's unlikely now to be affected by cobot 19 for the reasons I mentioned and so obviously in order to provide dot to the India has to be analysis, we have to update the datasets and formerly summit.
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That being said and as we stated.
Our plan is to filing of by year end on the year, one data executive requires the year two data on the initial submission.
That would delay the filing until the first quarter and so there's potentially not large difference in time, there's other potential mechanisms to.
To provide the data and so we'll be discussing that with with the agency of the pre NDA meeting.
Great. Thanks, guys.
Thank you as a reminder for your question. Please press Star then one on your Touchtone phone again, if you'd like to ask your question. Please press Star then one on your Touchtone phone.
Our next question comes from take on half from BTG. Your line is now open.
Great. Thanks for taking our questions and I appreciate the update as well.
So just wondering this might be extremely naive, but given the sort of timeline you've outlined for alport the expectation or the second your data for Q and the planned submission for the end demand for Q.
Just wondering I mean at this point assuming positive data just comes out I guess why wouldn't you just go for the full approval in the first quarter of 21 since that's the timeline you've laid out and there is only seems to be a couple of months. If you do I guess supplement the second your date I guess the three month delay. It would also kind of puts you in that same timeline of.
Review period anyway, and the second part as if we kind of looked out into Youre talking trial.
Given the similar trial design I mean is there any read through as to what the FDA staying with regards to Alport requiring second your data for how we should think about the the Falcon and ATP Kt approval. Thank you.
Okay.
Yes, I think we agree with that it's.
The the options are too you know file and just seek accelerated.
Or with the data coming.
The two year data coming in the fourth quarter.
To supplement find a way too.
Submit that data to the India in there there are multiple options for that.
Just like to add that some of the thinking about this has evolved with the pandemic I mean, a few months ago. It was not clear to us that we would be able to for example, close the database.
On a timely basis, we didnt have concern about data integrity or the visits.
But the timing could have been impacted them.
Conceivably could still be impacted if the pandemic gotten much worse today, we don't see that so we are stuck with some complexity about timing just based on the environment that we're currently operating in.
But it would probably if things play out the way we believe today, we would have that data in time.
And we.
Should be able in the pre NDA meeting.
To have an open discussion with the FDA about how that data might be submitted if they let US proceed with the with the.
Submission on the basis of the year one data.
But of course, they may tell simply wait and submit on that year to data.
Thank you already I'm sorry go ahead Sir.
Did you want to continue Sir.
Okay.
Go ahead.
Oh no question about the Falcon trial go ahead of the John sorry.
Yeah I think.
Not necessarily so does it read through to 80 PKD I think is.
As all of you know this design was given to us by by the FDA.
Similar design with a one year treatment duration of treatment period.
Was given.
Two different company.
For the 12 apt and in the Reprised trial, which supported its approval and so this is the first time the FDA is going through.
Data, where there is one year data, but the trials two years and duration.
And so some of the questions once again as I mentioned all around analyses that that day recommended that we conduct.
Which we provided and they've granted the pre NDA meeting and so it's to determine if theres any potential read through on I'm not not exactly sure. What you would mean by read through to 80 PKD.
Yeah, Okay, well, thank you very much.
Sure presenters, we have no further questions in queue at this time I'd like to turn the call back to Mr. been Aegion Dol for closing comments.
Thank you so much thank you for joining us on today's call.
That would be the ended the call today. Thank you.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may now disconnect.
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Mhm.
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