Q3 2019 Earnings Call
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A question and answer session will follow the formal presentation.
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I'll now turn the call I get your first Mr., Brian Ritchie from my side I said. Please go ahead.
Thank you operator, thank you all for joining US just yesterday with me on today's call, our Chief Executive Officer, Dr., Stephen Hart, Chief Financial Officer, Michael Smith. In addition, Dr. Gail Farfel Chief Development Officer. She said, we're all the car Chief commercial officer and Dr. Joe.
<unk> Chief Medical Officer, Genesis subsidiary motorists Therapeutics, well also be available during the Q and a recession.
Good afternoon, Synergetics issued a news release attaching financial results and providing it business update for the third quarter ended September Thirtyth 2019.
Please note that certain information discussed on the call Tonight is covered under the Safe Harbor provision of the private Securities Litigation Reform Act, we caution listeners that during this call. So genex management will be making forward looking statements.
Actual results could differ materially from no stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.
These forward looking statements are qualified by the cautionary statements contained in Synergetics. This press release issued today and the company's actually see funds, including in the annual report on Form 10-K , and subsequent filings. This conference. This conference call also contains time sensitive information that is accurate.
Only adds up to date of Thislife broadcast November seven 2019.
So generally undertakes no obligation to revise or update any forward looking statements to reflect that's just circumstances. After the date of this conference call now I'd like to turn the call over to Steve.
Thank you Brian good afternoon to everybody, who is joining us on todays call.
Thanks in the third quarter on September 26, we were pleased to announce that we got resubmitted R&D rifle shot for our lead product candidate for the treatment of seizures associated with Dravet syndrome to the FDIC.
Accordingly, we expect to where it always acceptance for filing body yesterday.
Early to mid December timeframe.
Assuming if itself what Andy day, it's accepted for review.
If the FDA granted priority review offer different topics I could be as soon as any and all the first quarter when she's worked.
In Colorado.
Hey, footprints happens the treatment procedures associated with everybody syndrome, which was submitted an accepted in 30 trend she'd like to remain subject to review by the European right makes your cards.
Over the last several quarters, where you have been actively engaged with reviews in Europe to assist in that assessment or application.
The process towards a final tenure in trends you to work.
[noise] review of these important regulatory submissions advances we continue to collaborate with leading experts to further finalize all clinical dataset in order to expand the body of evidence in support of in top line.
<unk> drilling syndrome.
In October we presented fine posters at the child and royalties and only Jay highlighting you take that demonstrating long term clinically meaningful reduction convulsive seizure frequency and some of the most vulnerable to raise syndrome patients, but we spend a major sets as well as opposed to analysis about two phase three.
Pinnacle trials, but show clinically meaningful profile reductions internalize tonic clonic seizures.
Type of seizure often cause its digital injury to the child as they come fall during the seizure.
I mean, there's also a recognize risk factors for sudden unexplained SAPIEN epilepsy, well see that.
Also the CNS meeting we share the results are in phase one study.
Recently conducted to assess the potential drug drug interaction offering Tesla I'm kinda die all CBD.
Hey studies show that the basketball Intrexons CBD entre into a minimal.
Like me to require a dose adjustment to concept, but if the drug so co administered.
This information will be on importance to positions when considering concomitant use of things happen I'm CBD to treat speeches in patients. It's been tough part is ultimately approved.
Looking ahead to the rest of the here we were once again have a strong presence at the upcoming Americans Aframaxes inside your pay you asked me back.
Which will take place December the sex with the tests in Baltimore.
A total of eight abstracts, including three late breaking presentations with new takes analyses from a choppy syndrome clinical program are being accepted for presentation.
Yes.
In addition, we'll be sponsoring she got me Symposium conference and what it can host a scientific exhibit room on the voting or Sunday December the ice.
Like many other takes a presentation generated from off in type one program.
We'll also be holding an investor lunch on Monday December nine the I guess meter.
The events will include discussion of the new data presented at EEI Conference.
Like the evolving evidence of long term neurocognitive improvements associated with seizure reductions demonstrated in the first half what kind of a studies.
So turning his team will provide an update on U.S. commercial activities in anticipation of the approval in the old trucks can tap on Interbody syndrome.
Also discuss progress on that front SAP I kind of a programs.
Meanwhile, we're taking advantage over time, we have anything extra potential product launch two study can assess the emerging dynamics told me taking place in the Drabik community through interactions with key stakeholders.
We have been participated in targeted discussions with Cinryze advocacy groups key opinion leaders on treating coming to see possessions in order to obtain a complete review of the important unmet needs and challenges patients and that's probably stay stable.
In addition, we continue to hold positive constructive meeting because there's a bunch of my syndrome underfund template clinical efficacy.
Outcomes data generated to date.
I was communicated previously we've also established our specialty pharmacy capabilities.
Sure a high level of access and especially if experience for patients to initiate himself with therapy.
Importantly, we continue to experience strong interest and engagement from the drop in community in both the open label extension studies on the early access program.
Total there are over 420 purvey patients currently being treated with fintech across these programs.
More than 350 of these patients not be don't concept for at least one you're an approximately 130 for at least two years.
We remain encouraged by the efficacy and safety profile being demonstrated he finds itself in these patients over the long term.
Moving to a program for open topic for the treatment of seizures associated with LG, Yes, Lennox Gastaut syndrome refinancing this third quarter.
Seated enrollment for studies 60, no one the company's phase three clinical trial.
Study 60, no one is a global double blind placebo control three on trial in 263 subjects between two and 35 years of age.
We're on track to report topline safety efficacy data from this trial in the first quarter 2020 .
I'd now like to briefly discuss the new phase two exploratory randomized double blind placebo controlled clinical trial offering SAP, but we intend to initiate in subjects with rest seizure disorders.
This would be an international multicenter multi cohort study in subjects with doses syndrome Super Sclerosis complex to 15, Q syndrome, CBL takes five deficiency.
Patients in the P.H. 19 gene.
Got it takes you into sodium troubled gene that does not meet the diagnostic criteria for everybody syndrome.
Finally patients between one in three years of age, which Rami syndrome.
The study will benchmark seizure types in each indication for four weeks, followed by short term placebo control here that our long term open label extension.
We expect to enroll the first patient into this phase two study into first quarter Oh 2020 .
In addition to achieving further progress, but at least in separate pro program on September nine So Terminix tour. Another major step and its commitments are becoming a leader in developing and commercializing transformative therapies for rare disease patients, let's find ways, where we completed the acquisition of.
Just a few days.
What does it lead investigational therapeutic candidate M. T 16, 21, it's a late stage. It didn't late stage development for the treatment of a devastating mitochondrial DNA diffusion disorder, finding trying these two deficiency or teekay to D.
Well this disease can affect patients of old age is this more prevalent in infants and young children presenting on progressive, Pennsylvania muscle weakness, so profoundly impairs movements breathing eating and other normal functions. The disease is often fatal although not currently no approved.
However, please.
M.T. 16, 21 isn't only fixed dose combination treatment of the oxycyte today.
The oxycyte redeem it serves a substrate in husband therapy to restore mitochondrial DNA to overcome deficits caused by the disease.
As a reminder, this investigational therapy has received breakthrough therapy on rare pediatric disease designations from the FDA I'm trying to resignation from the European Medicines agency, a cold orphan drug designations for treatment of she takes routine in the U.S. and in Europe .
In early October at the annual World Muscle Society Congress in Copenhagen.
We presented key efficacy and safety data from a global retrospective study trimmed retro Oh, the oxycyte to Dean on Deoxi signed to date, and 38, pediatric and adult patients with Teekay to deficiency.
Oh comes from treated patients in this study when compared to a compiled dataset of the natural history outcomes of 68 untreated patients.
The most important results reported from the retro study, what a survival analysis, which demonstrated that the difference in probability of survival between treated patients.
Treated natural history control patients was highly statistically significant that's a P value of less than 2.0006.
Okay and T 16, 21 treated patients remain alive.
In addition, 95% to treated patients either improved will stabilize responses in the major functional motor respiratory and feeding demands.
A subset of treated patients demonstrated profile advocacy responses in some cases, requiring previously lost motor milestones, including population on the ability to walk.
Breathing independently without mechanical ventilation, all other respiratory support on the ability to nourished without feeding support.
[noise] safety findings from the retro study indicated the M. T 16, 21, with Germany safe well tolerated.
The majority of serious adverse events related to the underlying disease.
Two patients discontinued trait treatment due to asymptomatic increases and liver enzymes that reverse stop the study just consideration.
We intend to meet with the after gains during the first talk to try to 20 to discuss next steps for this exciting programs.
I would anticipate providing an update regarding future development plans and regulatory submission timeline.
Once we have attained feedback from these discussions.
In conclusion, while we wait acceptance variety right force Fintech put intravase syndrome umbrella empty and they remain said to review in Europe . We're focused on key commercial preparations for launch in broke the United States in Europe .
We also look forward to the availability or phase three data in L. She asked in the first quarter of next year onto initiating the phase two study Fulton template and multiple rigs seizure disorders.
We're also very pleased with the recently announced retro study results.
While preparing to meet with the rent utilities on Mt 16, 21, and the first talk next year.
With that I'll now turn the call when somebody for his review the financials Mike.
Thanks, Steve and good afternoon, everyone. Today, we issued a press release summarizing our business and financial results for the quarter ended Septemberthirty 2019, which I'll now summarize.
We recognize point 6 million in revenue in the third quarter of 2019, and this revenue as a result of our March 2019, strategic distribution partnership or thing Tesla and Japan wouldn't upon it shouldn't yacov.
For which we received upfront payment in the second quarter of $15.5 million. The development activities related to have been dealt with for the treatment of Gerais syndrome, and LG, yes.
Total operating expenses for the third quarter were 294 million important to know that 249.5 million or 85% of this amount was recorded.
Acquired in process.
Research and development expense related to the Motors acquisition NMTC in 21.
That's DNA expenses for the third quarter ended Septemberthirty 2019 totaled $15.8 million, which reflects a 43% increase over the third quarter of 2018, our SGN expense increase was driven by continued investment in preparation to prospectively launch been tough love for the treatment of debate.
In general in the United States and in various countries in Europe in the coming years.
Net loss for the quarter ended September 32019 was 290.5 million or $6 in 75 cents per share and this compares with a net loss of 42.3 million or dollar eight per share in the third quarter ended September 32018, again, keeping in mind that are recorded 249.5.
Million dollar in process R&D expense related to the acquisition of Motors and then T. 16, 21 is the primary component of those lost a mouse.
And the first nine months of 2019 net loss was 363.4 million or net loss of eight to $8.54 per share.
David the net loss of 101.5 million or net loss $2.78 per share in the nine month ended September 30 in the prior year was again $249.5 million in process R&D charge related to mode as being the primary factor in the medical loss.
We ended the third quarter with cash cash equivalents in marketable securities totaled $255 million.
Falling lease of 175.5 million for the most acquisition, which occurred on September 16 2019.
We remain well capitalized and positioned to execute on our strategic plan bring fintech brought to market has the potential new treatment option for duration gel and L.L.D.S. patients and their families and then successfully expanded our late stage pipeline through the acquisition of bonus and T. 16, 21, I'll now turn the call over to the operator to.
In the queue any session operator can you please provide instructions.
Thank you.
I'd like to ask a question. Please press star one on your telephone keypad.
Confirmation triangle indicate that your line is in the question Q.
Chris Dodd too if you would like to <unk> question from the Q.
<unk>.
Necessary to pick up the headset before pricing.
Your first question comes from pull Matthews with Stifel. Please go ahead.
Great.
Congrats on the progress and thank you for taking my questions. I was wondering if there's anything you can tell us about the you May review.
And Ah and whether or not there been any surprises and whether or not you you discussed the preclinical animal model a conversation that it came up with Ftn yard yeah.
And then just a couple other quick other ones I was wondering if you've given any additional fintech well long term safety data you may and if you commented on that and whether or not it's aligned with last year's A.S. presentations and then lastly, I just have one follow up at all or I'll stop talking for a second thanks.
Hey, Paul.
Thanks for your questions with respect to our interactions with anyway.
Clearly we have received a I'd say one's going to questions on we're working towards I'm getting all responses to a they review as a by the end this year with respect to the questions are perceived they were right across the comments all the sections of the old BT submission clinical.
Non clinical and a and C M C, but nothing that whereas pertain to us having to generate more data. So really nothing surprising I would say in an hour and our interactions.
Today, Gail anything you'd like to answer that oney that any data that we presented to the I mean are to your question about long term safety is the same said.
I've talked about I believe it Ain't yes, it would have provided to the FDA.
Well just a gain on the long term safety, we will we won't see moved forward with and analysis all that open label extension data to satisfy the day 120 safety requirements. So that will be a larger dataset with more patients and overseas longer durations exposure.
We will be Oh, probably reporting on our publicly at once it's been submitted to the so do you have to yet.
Okay. Okay. Thanks, and then on the err on the is key.
If that's something we could see some data from next year, how many how many patients do you think might be in that I'm, referring to the the study and do send TSC. Thanks.
Okay.
That is a company sponsored trial and we're also were enrolling across seven different indications and the indications when we analyze individually. So our hope is that we get enough patients at least one of the seven indications if not more to be able to give an analysis of one on them.
More of the indication latent 2020.
Okay, great. Thanks, so much.
Thanks Bill.
Thank you. Your next question comes from Marc Goodman with.
Please go ahead.
Yes. Good afternoon. So first of all can you talk about the CBD trial that you Chris ended at the meeting that's just recently.
And you know what type of feedback you got from the physicians do they feel like they understand how to use the products together you mentioned.
Something about you know having to adjust dosing <unk> what exactly do you think are the learnings that we've got there.
That's number one and then second of all you talked about commercial preparations, but would you mind just going through like World, where we are what exactly you've done with respect to preparing commercially for for the U.S. and then and then also talk about some of the payer interactions and whether the pricing that you.
Kind of hinted out to everybody is is okay. You know what the payers and they're kind of giving you positive feedback that that can work. Thank you.
Thank you Mark I'll address the CBD trial or first and then ask Ashish through a comments on all commercial preparations. So the CBD try was at its a it was a phase one study in healthy volunteers. He was we conducted its in order to I've been able to get it back.
<unk> perspective on rather not there was a plausible drug drug interaction between can tell plug on CBD recognizing that there are CBD and there's a hefty improved safety protocols market as well as or the use of autism CBD by this patient population.
Hi, I'm going to be conducted this particular studied I'm happy deluxe is not available for us to use as part of the trial. So we actually used I once and I'm going to study in kinda using a government approved form or CBD and used out in our trial.
We didn't even take home from out is that.
The CBD well speed holiday plausible in vitro effect on the metabolism of fenfluramine open tough, but it didnt raised to the level in our phase one trial when somebody to worry about with respect to a dose adjustments open top with those who previously used together.
So the bottom line for US is that if we had a question from physician about using the two products together I'm working on it would be quite a dose adjustment we could go back and basically say they wouldn't noexit dose adjustment required spoken topline and become with the concomitant use Oh CBD.
We think it's very worthwhile and appropriate study the due to provide that information to physicians, who maybe [laughter].
[laughter] prescribed concept, but once its approved.
Ashish Yep.
So mark on the Okay few minutes go through.
Some of the teams.
From a couple of some fresh perspective, let's start with your question on the bad interaction, we continued to having a very constructive conversation with payers.
Have you started from the rising down with the clinical efficacy and safety profile.
We have received very positive reception to the outcomes data, but that's not showing the trials.
Oh, yes, the if we did in this year.
The outcome models with input from customers, which includes Fas and on a constant deals here.
We hope to continue having that dialogue in Q4 as well as in Q1 as we prepare for lunch.
Oh, probably population perspective, as we said earlier this specialty pharmacy operations is up and running yeah I'm kind of early access program is being dropped to about Soviet beginning a phenomenal experience off how do we fulfill the orders and how do we manage the interactions that we launched.
Let me get approval and launch.
We also.
Yeah, Hi, Ed individuals in market access function, which includes in the national accounts, well, calling on pay US obviously at this point in time yeah.
It's probably shop.
Being ready once you get to closer to launch to put all the other infrastructure in Macau, which includes the reimbursement support and Oh I'm disappointed that the patients need.
We did highest since most of your media they do have come by more than 40 years of experience in epilepsy market.
One so high and a couple of key account managers, yes, we have continued to higher than you Tvs.
Because as you recall, we undertook a very extensive exercise of profiling that got us when I made patients actually currently being treated and Vietnam, introducing ourselves and then getting to know what the processes.
So that we see a lot on when we launched a we even have a cliff bought and E file it kind of process to manage.
Finally on pricing.
Not yet finalized the pricing for has jumped up and that we've been talking about disclosing back towards the approval and launch timeframe, but as we have come to me pricing. We carefully review a few factors first is optimizing based backs as a second decides on premise robot.
They should think about indications and we'll be launching at first.
Profile the Tony as these outcomes that we have seen the political times, what we do believe that it will deliver to patients and finally, the ability for us zogenix to make they stand.
Yeah based on the outcome specs and definitely has demonstrated we do believe that it will deliver value based on spares and the healthcare system relative to other therapies.
I mean, just lastly on the pricing I realize that you haven't set pricing, yet, but I'm sure your interactions with the payers or in a range of pricing and I was just curious if the feedback from them and given the outcome data you've set them is relatively okay. You still feel good about the range that we've been talking about for the past.
At this point in time, we do feel good about the range, but as you know we will have the haven't really happy as detailed conversations that bounce out specific pricing because.
As I said earlier, we will not be disclosing it that tell me they seem to be up or whatever around the time of up to one at lunch.
Okay. Thanks.
Your next question comes from Janney.
Jaffray. Please go ahead.
Hi, good afternoon, everyone listening arrive on for Danielle.
Thanks for taking my questions I, just had a couple or the first one was Oh I was wondering if you've heard any feedback from doctors about any sort of burden that you kg monitoring might cause.
And if you've done some analysis to see how many of your target prescribers have in house capabilities.
Yeah, I'll ask Ashish to a.
Address that one for you.
Yep so.
We cannot advisory boards and the conversations with the physicians what we have discovered is that.
Doing monitoring eons for patients with various syndrome is a fairly common yeah. There's a lot of testing that goes on.
We do realize that when approved if we have to do the monitoring we are putting together infrastructure. The time specialty pharmacy, but also hub to help them for the process and to that effect.
We have conducted multiple workshops and satellites Rico.
Things with.
Families bands as well as physicians to really thinking through how we can help that but how we can make systems much more easier to manage so we feel very comfortable in that we now have a plan that we cannot Chris.
You can easily beat your second question about target prescribers.
Yes, I was just wondering how many of your target prescribers would have in house capabilities to do the monitor monitoring in house.
It will depend on bad they are located is data the institute our hospital. They will have back in house capability, where they can just take down about a.
On.
The floor.
But what we feel comfortable is have you done south deep.
The data get population of bad who have epilepsy centers I would say almost 30% to 40% off them would have that's fun and capability in the initial stages and as we get into the community settings, we will be.
Working to tell how do we have minus the at that process.
Got it. Thank you last question. It's just a quick follow up on a previous questions. I was asked a in regards to pricing specifically in your interactions with pairs or any market research you've got have you seen.
Any indication Oh, one way or another of how adoption might be impacted if it is it's off in top line is a price at a significant premium to epidiolex.
All right now given the sensitivity has been the what becomes 20, Bryce I can be difficult to comment on that at this point.
But when we look at the overall value the feedback we have got them on the value that people away from the clinic Alaskan I've outcome perspective has been made positive and I think that's what I would be comfortable saying at this point in time.
Okay. Great. Thanks, that's helpful. Thank you actually a question for the questions. Thank you.
Thank you.
Your next question comes from Jason Butler with JMP Securities. Please go ahead.
Hi, <unk> on for Jason. Thanks for taking my question, we had a few about them. The modus acquisition I think when you now see acquisition, you're still detailing the commercial opportunity do you have any updates you can share on that.
And then.
Single escalating dose PK trial anything you've learned from that trial and then.
Last question can you share any timing about plans for discussions with the regulators for <unk> 16 21. Thanks.
Well that's your questions I could have Astro answer address those for you.
So could you repeat that the first glad you had several questions yeah sorry.
Quickly the commercial opportunity you guys were still working on it I think when you announced the acquisition anything you can share around that.
Yeah, I'll keep aren't just yeah.
That's not what I'm, John I think you ought to clinical questions that you want that we're still obviously working on that right now with respect to the commercial opportunity look we have data that shows that.
Looking at epidemiological data, there's anywhere between 650 into and a half times in patients United States that could suffer from this disorder are we doing work now from a bottoms up approach to gas and that's a number on that I've got work is ongoing we continue to two we'll do that next year.
As we conclude the clinical development. So we do think that this is one of these disorders, where as a drug becomes available is more awareness about drug.
The disease itself, we likely to see I know an increasing the number of patients who are diagnosed with Teekay June deficiency.
Sure I haven't actually went up.
Right right.
PK trial anything you've learned from that that you can share with US and then just plans on timing for discussions with the regulators.
Oh, so that the PK trying to think completed although we are still analyzing the data. So we've not released that just yet.
In terms of discussions with regulators I think Steve mentioned earlier that we're planning to meet with the FDA in the first half 2020, and then any discussions to follow that so a bit later than that.
Okay. Thank you.
Thank you. Thank you once again, if you wish to ask a question. Please press star one.
Fine and wait for <unk>.
Your next question comes from yes.
With Guggenheim. Please go ahead.
Hey, guys. Thanks for taking my question question on the commercial friend would you anticipate any sort of the dealer and MRI.
Confirmation for the diagnosis for Jeremy and or do you think just the clinical diagnosis is enough for the dropped to the prescribed and could you maybe remind us if that was a one of the requirement for that kind of talked that you syndicate.
Just screen patients.
Thank you question, though it's it's simply a clinical diagnosis and that's exactly what we use it all phase three trial. So really no difference is doing what we do know phase three trial relative to the way, which everybody diagnosed in the broader patient population.
Got it. Thank you and then just another question on the face on the new phase two trials.
In a rare disorder or is he just that you are going after can you maybe help us understand like how are you sort of trying to prioritize the indications what indications are there particular type of seizures that you did you go no go off.
And how can you expedite the the development in other art epilepsy outside drill them then okay.
Yeah, I think the purpose of the phase two trial is a signal seeking studies where we.
Well the drug homes in a variety of from receded disorders, and well into him. It was in individual studies is doing more of a basket approach. So it's really that the the outcome. We're looking for work in this study is to see where the draw works effectively and then consider what the next steps would be.
The thereafter.
Got it and final question I'm on the Pan out and maybe if you can help us modeled the expenses going forward or how do you think the R&D is going to ship off given that you know both the Leno gastro trial will sort of conclude some time I'm already next year.
Thank you Mike.
Like the drugs My question, Mike I'm sure I'm so nothing.
If you're speaking for the need for future and give you some qualitative color on that but.
And specifically at yet for financials for next year, but the.
One thing to keep in mind is that.
Our Oh.
Probably our most expensive study right now is a combined says studies where were.
We're allowing patients to continue on therapy in our open like people program, where we have over 400.
Patients.
Being treated.
On an ongoing basis now some of those patients are going to shipped out.
As the.
We are able to get approval, but elds, yes program will not be eligible they get approval next year. So we'll have some of those expenses continuing in some Simpson bashing, but we are going to have a drop off of our currently.
Operating.
Global Phase three and the run out of some of the duration. So don't see going up too much or down next year, it's kind of the qualitative guidance you at this point.
Okay and can you quantify the exact cash that you have a I mean I see an entity in the balance sheet. There is about 25 million in escrow each that money going to go away or is that just a part right now.
So that's related to some true up of related to the transaction. So it could stay or go away. It all depends there's a currently and often liability with respect to that on our balance sheet. So you know from an accounting perspective worsening, it's not going to go into our pocket we have 200.
In 50 plus million dollars as of 932019.
Got it thank you I'm Oh.
Yep.
Thank you. Your next question comes from scratch.
And then company. Please go ahead.
Hey, Thanks for the question does this Chen on for search so I just had a couple so in terms of Fintech.
Submissions are coming they.
Are you that the FDA acceptance by mid December and getting a priority review.
Has there been any feedback software updates from the FDA, whether you still need to conduct the.
Tox study I think was from the <unk>.
And then.
In terms of the quality of life benefits that you saw in study more than 15 Ofour.
India stations. So given these data is there any plan to perhaps potentially target a narrow behavior indications in the future.
For example, ASCII and things like that thank you.
Oh, Hi, this is deal.
So we have we did resubmit in late September and we are.
Looking forward to hearing shortly if the FDA is going to you except the filing we expect that to be made note or very early December we are hopeful that we will be eligible for priority review with regard to the toxicology study that was requested any refusal to file letter we met with the FDA typing.
Adding several months ago and I came to agreement that that study was not firecrest resubmission.
And your last question about quality of life Tina our current focus is to look at other epileptic encephalopathy U.S., we talked about the signal seeking things to study that we are beginning to look for a signal wasn't strong efficacy in one of those diseases. We currently don't have target up looking in the broader.
Your old behavioral landscape, but you bring up a good question.
Okay. Thank you.
Thank you.
Thank you. Your next question comes from Tim Lugo with William Blair. Please go ahead.
Hi, This is loughlin thanks for taking my questions.
You mentioned that in some of your sort of pre commercialization work you'd be doing you you'd be looking at the changing dynamics in the draw they market could you provide anymore color on that and then second of all.
You mentioned that you've got I think it was 130 patients that have been on.
Bluff greater than two years.
Can you provide any any update.
Yeah, what what you're saying those patients the durability of efficacy.
And is there.
I guess, all that plans to publish that daughter or lease it in some capacity.
Yeah, we will certainly be publishing more data.
Oh, right now where our focus clearly is in supporting the idea in every area applications.
I haven't checked where providing more safety data to the idea is probably the day onetwenty up there. So we will in time of course are moving forward or publishing the the data with respect to Brooks long term advocacy.
Well as long term safety in the future I think.
Hi level now we were very pleased with what we're seeing coming out of a long Tim's I'm studies, there's really no change in conclusions from what we've already discussed and presented at the U.S. conferences, so yet, but we will certainly been running those updates are ones that are available.
And she shows a husband drops the commercial question Yeah. Let me you. Okay well. Thank you pointed out but that is a lot of by changes in the drove a lock it and the probably community is undergoing significant dynamic.
Two years I would never know indicated tend to be now there are too and then I definitely is absolutely thatll be treated by middle of next year.
And we do expect that that has more kind of these are coming in the market I think physicians will have more.
Confidence, but also.
Even with the controls the seizures with either of the product on the combination products.
I see the what underlying fact here is that would be P.T. therapies coming up and what you're hearing from not only the physicians.
Patients and the community is that is a significant unmet need or even having two products in the market at this point in time and done so having a satisfactory to just control.
That said he's a need for different kind of piece because as you know doesn't work.
So we do feel pretty confident back when we launch it up I think we will have a good reception and I'm, sorry file helping patients or something.
Hope that answers your question.
Yeah, Yeah. Thank you.
Thank you.
Your next question is a follow up question from pull Nazis. The stifled. Please go ahead.
Hey, Thank you so much you're taking the follow up I just wanted to ask one quick question on the on the long term safety data during the past calls you you've reiterated that through just center I'm Lux, you haven't seen any instances of Bobby off of the or pulmonary hypertension.
Hypertension I I was wondering if you work in a position to reiterate that this evening RF or if the next kind of look or data analysis is being typically done for regulators. So youre more reluctant or any color would be great. Thanks.
Yeah, we're happy to reiterate what we've said all along so.
No incidents, so ababa health disease or pulmonary arterial hypertension.
That's asset actually.
[noise]. Thank you we've reached the end of the question answer session and I'll now turn the call that you talked to stay on fossil closing remark.
Thank you very much off Raisa I'm glad you all for joining us on todays call. We're extremely pleased with progress made this quarter, but since our IPO.
In both survey syndrome, as well as onto your <expletive> I'd also M. T 16 is running on programming seeps into deficiency.
Looking forward to the end of ending this year with a successful yes meeting and we hope many of you will be able to its hands and see our post has been a home see attended our investor lets say funds as well. So thank you again for joining just on todays call enjoy the rest of the day bye.
This concludes today's conference and you May now disconnect. Your lines at this time. Thank you for your participation.
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