Q3 2020 Cymabay Therapeutics Inc Earnings Call
On our primary composite endpoint.
And accepted regulatory approval endpoint when measured at 52 week versus.
Versus 12.5% for the 56 patients on placebo.
Almost 30% response on Altland fossett days normalization versus zero on placebo.
And a meaningful and significant placebo controlled effect on reducing pure righted.
Key clinical symptom of PVC in patients with moderate to severe pruritis that baseline measured by the numerical rating scale or NRF.
In addition, sell adult par appeared to be safe and well tolerated in this study.
We have been studying sell adult borrowing PVC since 2015.
Having completed four clinical trials with over 300 patients dosed with cell Adele bar and a subset of these treated for two years or longer.
We believe a profile has emerged from our program in which sell Adele par at 10 milligram.
Is an optimal dose having anti coal is static anti inflammatory and anti pruritic activities and good overall safety today.
This pattern of effects suggest the potential of self-help are to provide patients with improvements in biochemical markers of disease severity and progression and to reduce symptom burden.
Our ultimate goal is that these benefits translate into improved outcomes and quality of life for many patients with PBC.
Although enhance was halted early its results reinforce our near term priority of restarting self-help our development in PBC.
Its results are invaluable because they allowed us to optimize the design of our next phase three study.
They confirmed the endpoint.
Let us select the optimal dose.
And gave us confidence to properly size. The study so that it is overpowered on its key endpoints, while still enrolling as quickly as possible.
The study is named response.
And it is a 52 week placebo controlled randomized global phase three registration study evaluating the safety and efficacy of Philadelphia are in patients with PBC.
Responses intended to enroll 180 patients.
Who have an inadequate response to or intolerant to ursodeoxycholic acid in a two to one randomization to oral once daily sell Adele part 10 milligrams or placebo.
The primary outcome measure is the composite responder rate after 52 weeks.
A responder is defined as a patient who achieved in alkaline phosphatase taste level below 1.67 times, the upper limit of normal with at least a 15% decrease from baseline.
And has normal level of total bilirubin.
Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase A's at 52 weeks.
And the change in pure right is from baseline to six months for patients with a baseline NRF of four or greater or moderate to severe pure righted.
You are right. This will be assessed using the same numerical rating scale and daily at electronic diary as we used successfully in enhance.
Importantly response, we'll evaluate the same patient population the same 10 milligram optimal dose of sell it LPR.
And the same primary and key secondary endpoints as evaluated and enhance.
The targeted size of the study balances our two most important objective, including demonstrating efficacy on biochemical markers of disease and on reducing pure writer along with supporting overall safety with the goal of enrolling and completing the study in a timely fashion.
As we have done and enhance we will also encourage patients to volunteer for a baseline biopsy in response.
The key difference in response we.
We will be that these patients will also have the option of a 52 week biopsy instead of at three years as had been planned for enhance.
The 52 week biopsy will provide required additional safety information to support registration.
Based on our own dialogue with the FDA the incorporation of paired liver biopsies in PBC phase three studies as part of their new posture towards broader safety assessments in PVC.
And is unrelated to specific sponsor or compound issues.
I am pleased by the progress our internal team has made in startup activities for response.
And we will continue to offer a refined guidance as we make further progress.
We believe we will commence response in the first quarter of next year.
I want to caution that the impact of the Covance pandemic may introduce unknown risks to study startup and enrollment.
We will continue to provide updates as we progress and develop experience in the study.
In addition to respond we have also initiated study startup activities for assure in open label long term study of self-help are in patients with PBC intended to collect additional safety data to support registration.
Like response of this study is expected to begin enrolling patients in Q1 2021.
The study will first enrolled patients who have participated in our prior studies of self help our in PBC.
Including the open label Phase two study.
In hand.
And our prior long term safety study.
As patients complete response and potentially other future PBC studies would sell Adele bar. They will also have the opportunity to enroll in a sure.
For each of these studies, we also plan to incorporate necessary procedures to ensure patient safety in consideration of the current global pandemic involving COVID-19.
In addition to providing valuable input into design considerations for response.
The results from enhanced have formed the basis for raising awareness and excitement around the re initiation of the self help our development program in PBC among patients and physicians.
We believe the positive data from enhance has the potential to drive interest from investigators and their patients in enrolling response.
Earlier this week, we announced data from enhance will be featured in an oral late breaking presentation delivered by professor Gideon Hirschfield from the University of Toronto at the liver meeting sponsored by the American Association for the study of liver diseases on November 16th.
We are looking forward to having a significant presence once again at this important meetings.
Which will also include a poster of distinction featuring data from our phase two study of Philadelphia are in patients with nonalcoholic steatohepatitis or Nash given by Dr. Stephen Harrison.
As we have previously discussed we believe these data support the potential for sellers out bar to offer meaningful anti inflammatory and anti fibrotic effects.
While improving metabolic aspects of the disease in a combination approach to treating patients with Nash.
This poster presentation will offer us a platform to continue exploring opportunities to collaborate or partner with others that may have complementary mechanisms for Nash.
While our focus remains on completing development of self-help are in PBC, we continue to evaluate sell Adele par and our other early stage clinical assets.
For other indications and development opportunities.
Earlier today, we announced plans to conduct a study to evaluate the potential for MBX 29 82.
Our GPR 119 agonists.
To prevent hypoglycemia in patients with type one diabetes.
Insulin induced hypoglycemia in diabetics is a significant limiting factor in achieving the desired glucose control.
And is the cause of significant morbidity.
In recent preclinical studies GPR 119 agonists were shown to enhance glucagons accretion in response to low glucose level and were able to prevent hypoglycemia in animal models.
The phase two way proof of pharmacology study will assess whether MBX 29, 82 can enhance glucagons accretion during insulin induced hypoglycemia in subjects with type one diabetes.
It's a total of $161.3 million at September 30th 2020.
We believe our cash is sufficient to fund our current operating plants, including the Reinitiate <unk> of the full development program for cell adult barn PVC into 2022.
Turning now to a brief review of our operating results net loss for the three months ended September 30th 2022 was $11.4 million or 17 cents per diluted share compared to a net loss of $26.3 million or 38 cents per diluted share and the three months ended September 30th 2019.
Net loss for the nine months ended September 30th 2020 was $35 $2 million or 51 per diluted share compared to the net loss of $73.4 million or $1 10 per diluted share in the nine months ended September 30th 2019.
Net loss was lower in the three nine months of 2020 compared to the corresponding periods in 2019, primarily due to a decrease in operating expenses, including clinical trial and labor related expenses as a result of the early termination of our cell adult bar studies and our cost reduction efforts undertaken in response to the FDA.
Clinical hold that were placed on the cell adult our program in the fourth quarter of 2019.
Given the FCA subsequent lifting of the clinical hold and our restart of the <unk> program in further exploration of other clinical development opportunities are cash expenditures and losses are expected to increase in the future as we advance or restarted clinical development programs and activities.
Finally, I'd like to provide you with a brief update on our current operating environment.
Due to the ongoing impact of the global Corona virus pandemic, we continue to conduct operations remotely for all employees, which is allowed business activity to continue as seamlessly as possible.
To date. These developments have not had a significant impact on our financial condition for our ability to execute our business plan.
We will continue to closely monitor pandemic development and their associated risks to our business, including our restarted clinical development of Philadelphia, and PVC and we will continue to take actions available to mitigate these risks where possible.
Further all our actions will continue to be guided by commitment to ensuring the health and safety of our employees as well as patients enrolled in our clinical study neutral.
Thank you, Dan where now happy to take questions operator.
Thank you, ladies and gentlemen, we will now be conducting a question and answer session. If you'd like to ask a question you May press star one on your telephone keypad.
A confirmation tunnel indicate your line as in the question queue you.
You May crush star too if you would like to remove your question from the queue for a participant choosing sneaker equipment and may be necessary to pick up your handset before pressing the starkey.
Our first question comes from the line of you guys mean Rahimi with Piper Sandler. Please proceed with your question.
Hi team congratulations on that amazing accomplishment on on response and assurance at two quick question. The first question could you. All can you comment on the F. D. A has requested.
Percentage of patients that should get biopsy, a baseline that and at the end of 12 months and then the second one is just a quick clarification patient to where previously and then hand alright.
Are they eligible to be part of response or Judy.
Do they have to go onto that shy. So if you could just clarify that perhaps that would be very helpful. And thank you again for taking my question.
Yeah sure. Thanks for the questions. He asked me I'll I'll start off and answer your second question first.
And then as you know I have Clara Dickinson here Archie for regulatory and can discuss the biopsy implementation in response as well with respect to patients coming out and hand.
Fundamentally response is going to be a phase III registration study and so ensuring that we have patients that are sell Adele par naive is important to maintaining the integrity of this study response.
Of course in theory, we could allow for placebo patients from enhance to enroll into the response study we fundamentally made a decision on behalf of physicians as well as their patients to allow those patients to actually have the option. So.
Fundamentally response is going to be new patient.
As you know we have a tremendous amount of experience enrolling in Pbc's studies globally.
And enhance was in 20 plus countries over 100 plus sites. So we remain very confident will be able to get new patients into this study at.
And.
To address your first question just from a high level I'll just make a comment as I mentioned in some of the prepared remarks. The agency has really moved to a position across a number of chronic inflammatory diseases, certainly and Nash and PSD and now in PVC of having an interest in review.
<unk> biopsy data is part at least in PVC of an overall safety assessment I think the agency is quite aware that given biopsy is not part of medical practice.
That it would be incredibly challenging.
And harmful really for all for study development overall to require that fundamentally and all clinical studies, but we can talk to you a little bit about how we think about our ability to ensure that we get patient and get biopsy. In this study and how we feel confident clarity when I talk a little bit about our experienced.
Yeah. Thank you so you'll tell in our in the enhanced 30, Uhm and I also had a requirement for.
Asking patients to consent to.
Until biopsy and in that setting we had about approximately 15% of the Rams demise patient.
That did did consent Sudan, carrying having a biopsy and so we're pretty confident that we can get an adequate number of patients in response to me.
Addressable need for the submission allow FDA to to look at the.
The changes in histology over the course of the study.
Thank you so much for for answering my question I'll jump right back into the queue.
<unk> as in.
Our next question comes from the line of Steve Seed House with Raymond James. Please proceed with your question.
Good afternoon. Thank you I just want to follow up on the biopsy. So is there anything from an efficacy standpoint that you think you might be able to glean from the 52 rebuffs use that you could use.
For a label claimed given that this has just not been a requirement I guess.
For example.
Right. That's a that's a great question I think we're a little bit into unchartered territory here.
I think one can always be optimistic if you think about.
Billy area and carry biliary disease with a lot of inflammation in fibrosis. Those are certainly things that would be scored on histology I do think given the slow nature of the progression of the disease.
The population were enrolling that it would be a bit of a stretch and I'll point out that you may know that.
I think that it's not a.
Definite mandate for the NDA, but I think as most of you on the call probably know there is.
Requirement to have a robust overall drug safety database that that provides collect.
Collection and safety for a longer period of time. So the more patients. We can have that have longer exposures, especially beyond 12 months of treatment.
Would be ideal for the FDA. So I think in addition to just our commitment to patients to allow them to to come back to treatment because they would probably still be on treatment.
Today and also to allow us to.
To collect.
Have data that's longer than 12 months of treatment and also with the the intercept.
NDS filing for all caliber they have longer durations of exposure that were out to I think bleed three small subset of patients beyond three years. So more data we can have any application the stronger the filing will be.
And Steve ill, just remind you that although we're sure as the new protocol.
We of course, when we are still in development with enhance had an ongoing long term study.
As you know we had over a 100 about 106 patients in our open label Phase two study after 52 weeks elect to enroll in that long term studies. This is effectively that study that will allow for a return of those patients as well as patients out of enhances and future studies, including response.
Yes, thanks for the last one for me just.
The type one diabetes for analytics and ask that you guys.
For a while or other issue for a while so just wanted to understand the timing of.
Starting that program and just what it might reflect on your overall strategic thinking for stream are they in this new sort of reduced.
Page.
Yes. Thank you, Steve Yes, Thats, a home grown compound that came out of medicinal chemistry efforts.
And we were targeting at that time type two diabetes with what's very interesting about the target is it.
Its expressed in the pancreas invading cells and an alpha cells.
And in one case, it stimulates secretion of insulin and glucose dependent manner and the other glucagon and glucose dependent manner, which as you know for regulatory counter regulatory hormones that really.
Controlled control glucose levels.
So that that is actually.
Emerging science that came out of came out of Yale and Merck.
Identified that in fact, the the alpha sell aspect of glucagon with something new to us.
So it was really an opportunity that came to us that represented I think.
The way to leverage the considerable experience that compound.
Had been in five previous clinical studies that have been at a.
Phase two a type two diabetes study, where it showed some significant effects on biomarkers.
Effects as well on glucose, but was not really meeting a commercial profile. So it really been.
Sitting in our pipeline not really being advanced and so this really represented to us a significant and exciting opportunity.
As you know type one diabetes is also an auto immune disease like PVC like PSP.
It's a little bit in our wheelhouse in terms of science.
The program was advanced in terms of the Nonclinical toxicology program as well as the CMC program. So.
Question on cell Adele part in PVC.
Very good thanks, so much for the questions.
And Q.
Our next question comes from the line of Alithia Young with Cantor Fitzgerald. Please proceed with your question.
Lucian with minimal effects and fibrosis one could.
Could wander weather either combining the anti fibrotic effect with the Nash and metabolic effect might might be very valuable.
Other mechanisms that contribute to either hepatic fat reduction.
Or to weight loss in general.
Or even improvement and insulin resistance, a paddock insulin resistance would be ones that come to mind for us.
Oh, Hey, thanks for taking the question and congrats on all the progress.
Uhm.
You had any panel of experts that you convene to review.
Particularly in PVC as we advanced they'll Adele power back into the clinic.
Is frankly well accepted.
And so there's really no change in how experts we've discussed.
Would would view the use of cell Adele par in clinical studies and if we're successful even beyond I'd also offer up that in fact through this review we have even greater confidence in the safety profile of cell Adele par to date given given the work that was that was done in.
This area and so I think really what excites folks in the area of PVC as the fact that we do believe we have a drug that's been safe and well tolerated to date.
The second follow up biopsy for those that volunteered to have a baseline wouldnt have actually occurred until two to three years into treatment again into a long term extension.
With the idea being that the assessment for a subsequent biopsy would have really been around trying to glean from an exploratory perspective, whether or not you could see any benefits around histological changes.
Here again.
Oral studies conducted.
Okay.
Our next question comes from the line of Patrick Dibble with lifestyle capital. Please proceed with your question.
Hi, Thanks for taking my question.
Could you please provide us with the rationale for moving forward with the 10 mcdaris exclusively verses incorporating the the five to 10 Meg penetration arm that was used it in the hands.
Statistically significant.
Decrease of 3.12 units on the NRF against the baseline of over six and a moderate to severe ishares.
As we really Didnt get stat Sig on the five milligram.
And then I think that so it just makes sense that dose is well tolerated.
Clearly shines across all of the endpoints of interest.
And then the last consideration is just.
This idea that having a single dose that that's very well tolerated and effective is actually an important convenience for four.
Patients, but also positions not to have to come back and adjust that dose it's potentially a commercial.
Differentiator you know.
Okay leave it has to start at five many of those patients. We know from script data never go to 10. So this notion you often hear from our commercial colleagues to have a.
The medication that you can set it and forget it.
As long as it's safe and as long as it does the job and avoids real world disappointment, where the lower dose really doesnt believe deliver the efficacy you'd like to have that's all part of the story. So does not actually really a compelling reason to have the five milligram at least for most patients.
Need to normalize.
And then to begin to build the message is we get a lower is better.
That's also something that you can develop with appropriate supporting clinical data and the probably the highest hurdle is really getting getting regulators to agree that there is a reason theres a reason to it.
To give you an something in the label along that so that that remains to be seen but I do think that that trend I would agree.
Great. Thank you.
Thank you.
Our next question comes from the line of ever seen with H.C. Wainwright. Please proceed with your question.
Hi, good afternoon, everyone business, Thomas Yip asking about options.
Congratulations on all the progress through price I will go back in the clinic.
First question for numerous past study in PBC.
Okay goal over some major distinctions or is this an answer other than the smaller patient size.
Also the primary focus on the 10 milligram dose.
Yes happy to Tom and thank you for the question you know there's there's much more that similar with response then enhance then then is really different.
As you highlighted here that we're really isolating and focusing in on the 10 milligram dose. The randomization here is two to one.
As opposed to one to one to one as we had in enhance as well outside.
Outside of trying to collect a subset of patients with biopsy data paired biopsy data for safety assessment.
The program is.
Is one in which we have an app or do we would have an opportunity with another party to combine.
Very promising complimentary target and assets and Chuck talked already a little bit about some of those that we think could in fact be combined with cell Adele par to drive an even greater response than what we've seen across other studies from other sponsors today.
And we think there is an opportunity with the target like people are delta and sell Adele par, specifically, where we do see very significant anti inflammatory and anti fibrotic effect.
Along with seeing improvement and metabolic elements of the disease VLDL triglycerides.
Of course, we know we drive fatty acid oxidation and although total liver fat.
Reduction has not seen to the level of seeing with the other targets that therein lies the opportunity really to combine and start to drive towards much more meaningful responses and Nash I'd make an argument that I think the entire field.
Is somewhat earning to see datasets.
That are driving towards 345 times the kinds of responses you see on placebo or with lifestyle modification on their own so with respect to our own process, absolutely whether or not we move forward and Nash will be dependent on how this dialogue progressive.
I think Asl D gives us the opportunity of platform. If you will to re engage in that dialogue, while maintaining again, our internal operating focus on getting back in the clinic and PVC.
It's really a nice platform for us to be able to share. These data with the medical community broadly and then to continue these kinds of discussions and so from an optimal perspective I think it is one in which the third party bring the right complimentary asset obviously has resources to bear.
But again allows us to do some development work here before we have to think about relinquishing any sort of rights to the overall program.
Thank you for sharing a few throw up on your lap dog first one last question about 20.
Two.
We're partnership under the details on the new Yorkers tourists turvy.
Should we expect a severe and and your primary endpoint.
Will be the right group.
For patients to gain entry into response without agreeing to the paired biopsies and then I guess, if so you mentioned the 15% of patients and enhanced volunteered for biopsy.
What proportion of patients are you assuming will consent to this in response.
Yes, they're good questions and comments. So first of all it is not mandatory for patients to have to agree to a baseline or paired biopsy in response.
Commitment to regulators is to try to encourage as many patients as possible of course to agree its.
Frankly, partially why.
Wouldn't argue that there is some minimal threshold. If you will we absolutely based on our prior experience when it's been fully voluntary in the setting of enhance.
Without a 52 week period biopsy were able to get 15%. So we believe and are encouraged by our discussions with the agency that we'll be able to meet us.
Subset to allow them to have appropriate review of additional safety assessment, but you know.
At the end of the day, we want to make sure and encourage as many patients to get the biopsy as as we can in this study. There is no question that although it's not part of medical practice. There is value of course to the patients and having some of this additional data set to understand stage of their disease and even progression.
And so we think it's simply allows for an even more robust assessment for the patients involved in our study and again want to do our part to ensure that the agency has a sufficient set of data to evaluate at the time, we would be looking to file an NDA should response be successful yet.
Okay got it thanks, Nigel it that's really helpful color and then maybe just one other question on PBC.
You have a competitor out there. There is also actively enrolling their phase III PBC study and they posted their travels on patrol suck up can you maybe just compare their design versus how you're thinking about response, and then any sense for the amount of overlap in clinical trial sites and how that might impact enrollment.
Yes, no I'm happy to I think what I'd first say his response fundamentally mirrors, what we did and enhance so even even before.
Really making any sort of comparison to Genfit study design I'd simply say that the experience we've had the ongoing dialogue we've had with the agency.
Really are the key parameters and which we think responses is.
Designed and really reflects as weve already talked about in detail what we've done in enhance.
Certainly having observed what they've put out in terms of their study design on claim trials. It's also a two to one randomization single dose versus placebo. So those things are shared in common.
Both.
The study for Alastair Brunner as well as response with cell Adele par both really mirror again, what we did and enhance same patient populations.
In fact, the same primary and same two key secondary endpoints that we had in enhance as well.
[music].
Okay, Great got it. Thank you will appreciate appreciate the insights.
Yes, sorry, Chuck just reminded me you also asked a little bit about overlap of sites.
We don't know.
Genfit very specific sites that we would expect that there would be some overlap that.
Calm and centers that.
Or are seeing patients with PBC common as we conducted our studies in Nash.
I think we are anchored around the fact that.
Enhance was in 20 plus countries across a 100 plus sites and so I think our experience in PBC has been more significant and more global.
Then than than the experience with LSW everywhere in the setting of PBC at least in phase two.
Even from the days that have better cholic acid was still in development.
This is in fact, a consideration again not dissimilar from how they've thought about development of therapies for patients with Nash or even PSC I think what's unique to PBC here is that it's not really part of medical practice. So the agency's always recognized that it would be quite challenging.
To implement certainly for every patient in any clinical study for PVC without really hindering overall development and of course he.
Here again, we are gratified to have breakthrough therapy designation I think underscoring even the agency's support to see new and novel treatment alternatives for patients with PBC, but fundamentally I think this is something that they've considered for quite some time, perhaps even well before any of the challenges.
More recent potential challenges seem with a better cholic acid from a safety perspective in PBC now I wouldn't.
Be able to necessarily tell you or argue that some of what they may be observing doesnt put them in a position of wanting to now going forward see at least some level of biopsy data to provide some additional safety assessment I think thats very logical.
That as a regulatory agency they recognize that they are in a position of wanting to again see development, but ensure overall patient safety. So.
I can't tell you whether or not you. Some of these recent events haven't necessarily influence them, but but I can tell you that.
Our understanding it is something that they have long since a thought about very similar to other chronic inflammatory liver diseases.
Oh on always forgetting the second question, Joe and then Nash sorry.
Again here I would just say Derek I don't we.
Were all up into the dialogue at the end of the day. If there is a meaningful opportunity to advance the program in Nash I think the details of any sort of arrangement would have would of course be important but.
But I don't set any specific threshold.
Irrespective I'd simply say that we think even if there isn't any sort of near term advancement and this is something that we will continue to explore without question.
It's not fundamental for our strategy to progress Philadelphia, our NPV see perhaps at some point in time again in PSC and continue to establish a very significant opportunity for cell Adele par in colas static rare orphan liver disease that we think can be quite significant.
Got it okay. Thanks, guys. Congrats again on the progress.
Thank you Derek.
Our next question is a follow up question from the line of Yasmeen Rahimi from Piper Sutherland. Please proceed with your question.
Hey team timeframe last an additional question.
So I think you provided color in terms of timeline on when do you expect for enrollment, but if you could just help size.
Sort of decided then that exists now versus maybe two years ago. When you just began the process you have more data as you go to investigators to you have already turned on many of the sites to just simply maybe summarize to me like three or four key.
Let's turn to trick that you found that you believe is going to sort of help with enrollment timelines that would be just helpful or even just a settlement on physicians with the additional data from many years of being part of this.
This new study.
Thank you you guys may now I'll take a start and then maybe clarify might have some some comments.
If she does if I Miss anything.
So I think you kind of touch on or alluded to at least several important considerations.
First of all the value of having it goes over 300 patients with PBC, having an open label data with strong datasets that.
52 weeks of even beyond to two years, having data in compensated cirrhotics and non cirrhotics.
Having placebo controlled data at 12 weeks showing.
Really the concordance with the open label data and now finally, having.
Data and provide us is it can only help and I think that our experience is very enthusiastically received.
Both by kind of wells, but also by investigators just kind of the bread and butter.
Folks who help help enroll the study weve been very active and outreach.
We talked with investigators and sites all over the world, It's not really our style. We work in close partnership with our COO, there and global clinical Cerro very effective, but we really are a hands on team.
And we believe that the relationship in a rare disease setting.
Setting is very important to it just makes it so much easier.
To arrange those calls to be able to discuss the data.
About what's coming next.
They're just really easy conversations to have.
The second thing I'd point to is how.
Having been through this before.
Things that we know about how to trade and Hello Hello.
Outside define patients who are going to qualify.
You know how to avoid goes screen failure. So that's really kind of tactical internal knowledge that we've been able to develop and even through phase two it into enhanced as we move through the year.
Recruitment program, we were able to improve and so we're able to share and leverage that took second place.
I think the third point is.
Knowing which countries performed well, what's the regulatory timeline like how can we avoid issues that kind of slowed us down a little bit before that we know how to move more quickly through whatever regulators asking questions on.
You kind of can get in front of us.
And then.
We had many sites who did so well it had enrolled so well and those are the sites that we know to bring back.
But it's not like every every relationship was a success story we had.
The sites that we activated and for a variety of reasons, maybe sometimes they just didnt have the patience maybe they were distracted with other.
Maybe they didnt have the staff to supported Frode lotteries as we know now were not to go back to and we know where to go back to if you. If you follow my may need. So I think those are all the kinds of experiences that are just invaluable some of them are kind of in tangible.
But they really they are really I think position us.
I guess, some significant challenges that the central who will acknowledge with respect to code and we are competitive but I think it can only help us going forward.
Thank you track down was absolutely excellent turnout very granular detail.
Thank you again.
There are no further questions I'd like to end the call back to Mr. schall for closing remarks.