Q1 2020 Earnings Call
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Ladies and gentlemen, thank you for standing by and welcome to the Orchard Therapeutics first quarter 2020 Investor Conference call.
Fine all participants are in listen only mode I couldn't speaker presentation. There will be a question answer session asked the question during especially when you read the press star one on your telephone if you acquire any further system. Please press Star then Daryl I would now like the hand the conference over to your speaker for today, where they like the director of Investor Relations. Please.
Let's go ahead ma'am.
Thanks, Sonia good morning, everyone and welcome to Orchard first quarter 2020, Investor call you can access the slides for today's call by going to the Investor section of our web site Orchard T X dotcom.
Before we get started I'd like to remind everyone that statements. We make on this call will include forward looking statements.
Actual events in results could differ materially from those expressed or implied by any forward looking statements. As a result, a very risk factors and uncertainties, including those set forth in our annual 10 keep 10-K filed with the FCC and any other filings. We may make in addition, any forward looking statements made on the.
This call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date, we specifically disclaim any obligation to update or revise any forward looking statements.
And with that I'll turn the call over to our CEO Bobby gap SAR.
Thanks Ray.
Hello, everyone and welcome.
But like stock or Fuas acknowledging the tremendous efforts of our organization and apartments, the healthcare feels to ensure patients in need continue to receive cash during this difficult time. Thank you everyone.
Last few weeks have been an important period for which it.
Since taking all the leadership Franken <unk> together with the executive team for school very carefully about what to do you watch it could become.
How are we can ensure that orchard can fulfill its true potential what we need to do to make that happen.
Well, we think about how strategic vision as a company, it's really well based on the potential of the have nots poetics stem cell gene therapy thoughtful.
Where it can take us on the benefit it can provide for many patient populations, even beyond our current portfolio of ultra rare diseases.
We have taken some bolt and decisive actions, we believe will allow which goes to achieve long term growth and focus the company on sustainable value creation.
This vision is supported by new strategic plan that we have developed and would you still to run full pillars.
Each of these forms of chapter in our remarks this morning.
First operating efficiencies.
We've made a series of important changes to our operations the will enable us to sharpen our focus on more efficiently executing our strategy, which I will detail in a moment.
Second is our commercial build.
We are focused on establishing the white model for the diagnosis and treatment to patients undergoing HSC gene therapy and see the true value of this approach over a series of ultra rare products.
First one of the most exciting areas a gene therapy right now is the innovation taking place in manufacturing technologies that have the potential to deliver economies of scale.
We want to be leaders and invest in this space doing that on knits and capacity needs a covered by our experience CDMO network.
Finally central to this strategy is prioritizing our portfolio to enable the expansion of watches pipeline beyond the ultra rare to lessray indications.
We're not disclosing two new research programs for the first time today. These are such a genetic subset of Frontotemporal dementia, FTD and the genetic subset of Crohns disease.
We believe that the biological and clinical validation. So there's already been shown in our ultra indications allow us to expand with confidence to these larger indications.
Turning to the first chapter in our new strategic plan, we're focused on him proving.
The operational efficiency throughout the organization.
This started with an extensive evaluation of the politics weeks of each program in our portfolio using several criteria that as shown here on the left hand side that slide five.
We undertook an objective analysis that involve financial metrics and strategic considerations in identifying those programs, where there was high need for patients and high value creation for shareholders.
As you can imagine these with difficult decisions given the potentially transformative nature of many of these programs each has value.
And we intend to realize that in different ways and over different time horizons.
Today, However, we believe our resources, our best focused on that's a chromatic leukodystrophies.
Let's go to older syndrome, the MPS programs and our research programs.
It's also means that we have a balanced portfolio with late mid an early stage programs.
The programs I haven't mentioned such as OTO 101 in 88, good and the transfusion dependent beta Thalassemia program OTO 300, we'll have a reduced investment moving forward.
We will look for alternative ways to revert to realize value with those programs including through partnerships.
So smart six brings together a summary of the operational changes that we've announced today.
We believe these changes were important unnecessary to enable orchard to execute its mission and objectives, the highest level by matching our attention and resources to a set of core imperatives for the business.
I summarized here, we'd expect realized cash savings of approximately $15 billion from the prioritization about portfolio.
Another 60 million savings results from the decision to consolidate our R&D seems to one side and the further investment in the manufacturing facility.
Finally, the most staged approach to the commercial Buildout I, 25% reduction to our existing workforce and future head count planning will each yield another $25 million in savings.
All of these cost savings are expected to be realized over 20 to 20 and 2021 and result in total expected savings of $125 million over that period.
With the revised plan, we now have cash runway into Twentytwenty too I know near term the to finance.
It's worth mentioning.
It's $125 million in savings is off to making investments in the following key areas to supports our new strategy shown on slide seven.
In commercial.
Diagnostic and screening initiatives, including no charge testing programs to help identify patients with MLT and other neurodegenerative conditions in time for treatment.
In manufacturing the technology process innovation and efficiencies to drive scalability.
In R&D initiatives and that's rare diseases that has the potential to fuel the company's future growth in a substantial way.
This wasn't just an exercise to reduce expenses.
An important decision making to ensure our capital is deployed in a disciplined manner, while building a pipeline the can leverage our success across all phases of our business.
Now, let me turn the call over to Frank to discuss additional key elements of the new plan.
Thanks, Bobby and good morning, everyone.
As you can talk in this mornings press release, we have carefully examine each aspect of our business.
You heard that a moment ago from Bobby with the way, we are creating operational efficiency.
And I think you will see additional evidence in the next two section as we summarize our latest thinking around commercial deployment and manufacturing.
Starting with commercial we understand the importance of developing a commercial model that will demonstrate our ability to execute and bring these therapies to the market successfully.
This model and the infrastructure that we build will also be leveraged for any future product launches.
As you'll know from a bottom acquired nine each rare disease has certain dynamic that will impact the launch trajectory and speed with which we can penetrate the market.
In fact, we anticipate our first two potential watches and wall and M.L.D., having this thing, but complimentary launch curve as you can see from the illustrative diagram.
Let me start with M.L.D. and allow where we expect the launch first in the E U.
Followed by the U.S.
And then other countries around the world.
We think an important inflection point on the revenue curve with MLT will come later when newborn screening is established providing an opportunity for an acceleration in growth rate.
Disease progression in the second important dynamic that was dark market penetration.
Because MLB advanced so rapidly it will be important to diagnose patients early and get them treated.
But what's the older syndrome. The dynamics are very different that's reflected in the shape of the curve on the right.
Unlike in L.D. This disease is slower progressing and more readily diagnosed.
We believe that walk will provide an opportunity to treat a number of crumlin patients from the outset and also give us additional long term revenue stream.
Well this program the delay and M&A filings are on track with 2021.
Turning back to M.L.D. for an update on the regulatory timeline, we are on track to get a decision from the European Medicines Agency later this year and never crew launch in the you in the first half a point 21.
In the U.S., we recently engaged with the FDA on our plan BLE submission, both yell coupon grid for the treatment of MLP.
Yeah, FDA provided written feedback on the sufficiency of the company data package, including the clinical endpoint.
The natural history comparator and the CMT data package.
As a result of this feedback we intend to file an R&D later this year and also see our map designation.
Both of which we believe will facilitate a more comprehensive dialogue to discuss the data more fully and resolve the open matters before submitting a b away.
We're committed to working closely with the agency and will provide updated guidance on the new filing timeline for the BLE after further regulatory interactions.
On Slide 10, you can see that we're tracking nicely for the long Oh T. L 200 in you in the first after 2021, if approved with Germany being the first country, where we expect to treat commercial patients.
Many of the pre launch activities are underway and the team has been able to keep up momentum during the pandemic work with T. centre in progress with tight qualification.
We intend to set up a network of treatment centers, where MLB patients are often referred and who also have transplant expertise.
These same centers can be leveraged in future launches.
Absolutely for program in the neural metabolic franchise.
I previously mentioned the importance of diagnosis in M.L.D. to identify patients at early stages of disease, and we're taking the necessary steps to achieve long term success.
Beyond typical disease awareness efforts. We're also looking at it initiatives such as no charge diagnostic testing with partners such as in VJ.
And we're looking to facilitate newborn screening for MLP with funding of upcoming pilot in New York State and Italy that are designed to validate the assay and provide the data for wider implementation.
Except me he initiative will support early and they'll be patient identification.
Coming up quickly behind MLP and the neuro metabolic franchise, our two proof of concept program in MTF disorders, where we have made recent progress even during this challenging period with covert 19.
Right, yes, one over the past year, we've shown promising preliminary proof of concept data with positive in Grafman.
Biomarker correction and encouraging early clinical outcomes.
And we're excited to announce or plan to be in a registrational trial next year.
Bringing this program one step closer to commercialization.
For MPS three we announced late last month since the first patient was treated in a proof of concept trial at Royal Manchester Children's Hospital with enrollment plan to continue this year and interim data to group to be released in 2021.
You can see graphically I'm quite well clearly aggregation of these commercial market leads to sustainable revenue growth.
In addition, the infrastructure Bill is designed <unk> provides a necessary commercial capability to realize the potential of the portfolio.
On this slide we've included the incidents figures for MLP.
And the integration problem figures for walk to help you understand each opportunity opportunity as we see it today.
Given the dynamics at play for MLP that I described the flight flight nine we believe this opportunity should largely be tied to the incident patient population, which we believe ranges from 200 to 600 patients per year in countries, where rare diseases are often reimbursed.
We've taken a more conservative view than previously on the addressable patient and market opportunity in countries such as those in the middle East in Turkey, where the literature has a wide range of deferring incident figures.
Also overtime with improved disease awareness, there may be prevalent patients identified who also could benefit from therapy.
Our commercial strategy has always been continues to be based not only on one product, but rather the aggregation of multiple potential product launching off one HST gene therapy platform and infrastructure.
Turning to manufacturing. We've also made some key changes to our approach in manufacturing and how we allocate capital in the short and mid term.
On slide 14, you'll see the main tenets of our new manufacturing strategy.
First in the near term, we plan to focus on innovative technology to enable commercial scalability.
Second to ensure the appropriate focused on those technologies, we made a decision to consolidate R&D to a single site in London, which brings together or our organization in a more efficient way.
This will allow efforts made to improve our manufacturing processes to be quickly and easily share and then skilled commercial leaves the transfer to our third party manufacturers all of whom are currently located in Europe.
As part of this consolidation, we will close or California site, including the termination of the Fremont project and associated capital spend.
Third we have strong relationships with CDMO that will ensure supply clinical and commercial product to satisfy near term requirements.
And longer term, we intend to identify a new site in the U.S.. So we've actually bring manufacturing capability in house with the facility that is appropriately side and fitted for future technique and operation.
Slide 15 shows the three phases of our approach in manufacturing and that partner and Bill.
Today, we are investing will and we'll continue to invest in technology, such as transduction enhancers.
Stable producers cell line and closed automated processing of the drug product.
This will potentially reduce the amount of vector needed drive down costs and potentially change the way products are manufactured making it less labor intensive less expensive and more consistent.
In the near and midterm, we will continue to rely on our manufacturing partners for the early planned launches in MLP in walk.
For example, mold that has been with these programs since the beginning and they've been a reliable commercial partner withdrew umbrella.
In addition to our existing CDMO network, we have begun to search for a drug product partner in the U.S. to complete a tech transfer and served the U.S. smart market, thereby reducing scheduling challenges and creating some redundancy.
And finally overtime, we plan to Bill in house manufacturing capability closer to when Theres a need for additional capacity.
This enabled us to explore options that are more aligned with our business.
In terms of scale and time.
And with that I'll turn the call back over to body.
Thanks Frank.
In this section I'm going to briefly highlight the potential of HSC gene therapy to correct not only lovelady itself, but also how through natural mechanisms specific cell types may allow correction of disease specific organ systems clinics and enable expansion of our portfolio into new research indication.
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As many of you know and as shown on slide 17 to wait to see gene therapy, we are able to insert a working copy of the gene permanently into the genome of HSBC and these genetically modified cells can lead to multiple corrected cell types, and the bloodstream, including immune cells red blood cells and.
Platelets.
In addition agencies can differentiate itself of the monocytes in macrophages lineage that naturally migrate into various organ systems and this gives us an opportunity to the genes and proteins directly to those organs, including the brain and the Gi tract.
Within the newer metabolic space in particular, we have understood through a clinic preclinical and clinical programs in MLP MPS, one and MPS three a how HSC gene therapy can deliver genes and proteins to the CNS to correct you wrote degeneration.
Here's an example of this natural mechanism at work in slide 18.
Data shows that there are a population of gene mortified hsbcs that can not truly cross the blood brain barrier distribute throughout the brain and graph just like a clear and express enzyme that has taken up by neurons.
We have seen this approach will result in clinical benefit for patients with M.L.D. and we are also using the same approach for MTS, one and MPS three eight.
Beyond this we see that she HSC gene therapy approach could be used to deliver specific genes I'm proteins for other larger neuro degenerative condition, which have high unmet need.
One of the conditions were disclosing today and shown on slide 19 is a specific genetic subset of frontotemporal dementia, well the underlying pathogenesis has a number of parallels with the newer metabolic conditions that we are already addressing.
This program involves a broad strategic lines, we talk to other Thunder busy.
Boston Children's hospital, and how to a university in Italy to further explore the potential ex vivo HSC gene therapy.
And your metabolic and your degenerative conditions.
In other organ systems, such as the G. I tracked there are a similar mechanisms at work, which are illustrated on slide 20.
Tissue resident macrophages in the Comparables are required to respond to bacterin invasion from the got lumen and prevent infection.
Certain disorders, such as X linked chronic granulomatous disease or X CGD.
Defects and macrophage function resulted an abnormal immune response and severe collide says.
Moving on to slide 21.
We've already seen in our X CGD program that modification of agencies and migration of GE modified cells into the gun can lead to resolution of collapses.
Presumed reconstitution of the immune response.
Certain subsets of Crohns disease are also astute associated with mutations genes that affect the responsive macrophages to infection.
And so our clinical observations that nature see gene therapy for X CGD suggests that the same approach maybe applicable to this genetic subsets of credits disease.
This preclinical work is ongoing in our orchard recession departures.
As we advance I work in FTD, and Crohns disease, and assuming we show preclinical proof of concept.
These will become exciting opportunities for us to expand and address launch a patient populations either alone or in partnership.
We believe we have truly just begun to explore the potential for HSC gene therapy in diseases, such as fees and others.
We're excited to share more about the preclinical developments of these programs like this year.
So to summarize our path forward on slide 22.
The next 12 to 18 months office, many important milestones as we continue our evolution to a commercial stage company and advance our next wave clinical stage therapies.
We anticipate approval and launch Oh till 200 for MLP in that you.
Additional regulatory filings.
What's got older syndrome, an MLP.
Do you Registrational study next year in MPS one.
Multiple clinical data readout from on Euro metabolic franchise.
And further detail on progress on our research programs in FTD and Crohns disease.
To wrap up our prepared remarks.
We're confident that on new strategic plan and operational decisions announced they will set us on the write off to achieve long term growth build sustainable value.
So, but even larger number of patients who could benefit from them not to protect stem cell gene therapy.
Thank you very much and now we'll use the rest of the time to answer your question. So that's how the operator open up the line.
Thank you ladies and gentlemen, if you do have a question at this time. Please press Star then one on your telephone.
To withdraw your question. Please press the pound key.
Please limit yourself to one question and one follow up.
Please standby well, we compile acumen a roster.
And our first question comes from Whitney Ijem from Guggenheim. Your line is now open. Please go ahead.
Hey, guys. Thanks for the question. So first just wondering can you give us some more color maybe on the discussions you're having with the FDA on in and they'll be can what what are they looking for and I guess the I, Andy just sort of a tool to get our met or is there additional kind of clinical work you plan, you think you'll need to do.
Hi, Whitney Bobby hits, so thanks for that in general we can't go into all the details obviously you're off a the discussions with the with the Ftn, but I think in a in the release and then the scrip we've talked about the fact that that commented on a sudden endpoints the natural history, the CMC package et cetera.
Now I think I'd just like to.
Say this is a a you know obviously a very complex disease, a very ultra rare population. We have extensive data set and we have already filed with the I would be a may now for historical reasons, there hasn't been a and I N D. In the in the U.S. and so we haven't had the opportunity.
See to discuss that data in school, a with the FDA. What I can say is that we do have an extensive body of data we want to be able to talk to the FDA and have a comprehensive dialogue to be able to explain that full dataset, we feel confident but we have a the endpoints that they are looking for.
And that they said they are are they are asking for what we need to how about conversation with them in order to be explained to be able to do that a fully so that's why we're finding an R&D falling beyond that so we can have that dialogue and once we can terrify. Those issues. Then we could go ahead with submission of the Bailey.
Oh.
Okay got it and then just one quick follow ups on M.L.D. can you remind us where you are out with newborn screening I get those in Europe, and then in the U.S.
Yeah sure so newborn screening for for MLP I think as an important.
A very important issue because obviously that means that we'll be able to get earlier diagnosis and have more patients be able to access therapy. So it's very important part about kind of diagnostic initiatives in this disease. What we have so far is that we have worked with and the key scientists as well and I say has been developed.
Thats been published to show the isn't I say that we've done on it.
Drive blood spot.
To understand the the decrease in the enzyme activity and also the increase in the sulfur type levels and that I say is not going to be put into pilots. We're funding a pilot in in New York State and that will start late this year I. We're also looking at pilots in other states as well, but also try.
On spring that I say to Italy, and that and we're funding a program in Tuscany, and in Italy, where that will be rolled out and we're also looking for opportunities in other you states as well. So let's say we are ready to that are going start we are looking to fund others pilots as well and together that.
Dates that will allow us to validate the I say, but also allow why the implementation of newborn screening and also for nomination for example onto the rust panel for implementation in states in the U.S.. So I'd say, there's a lot of a lot of work going on in order to make sure that happens.
Great. Thanks.
Thank you and your next question comes from extra handler from Oppenheimer. Your line is now open. Please go ahead.
Hi, I come back when all the Kansas.
I guess my first question again on MLP and I'm trying to understand innovation between he looks cool and that Andy.
I don't know.
Not only that in fact graco fraud.
It looks like it's almost oh, yeah like from sites are cool, okay newborn screening.
Can you help us understand the timeline there.
You mean between you and U.S. or around newborn screening or both.
Around newborn screening generally between your approval in newborn screening.
Yeah sure as Bobby mentioned, there's there's a pretty active.
Program planned around newborn screening that I think we will expect will come over time, a in order to even apply for the Ross panel there are certain requirements that need to be Matt in terms of the number of patients or a number of children that has to be screen or identifying a positive patients and then and then you can apply on the Ross panel.
And then from there there's a process that you go through in the U.S. at least on a state by state basis to to get an AD itself. So I think there are a number of steps along the way, we haven't guided specifically or on the timeline, but but you know I think there are other president out there that that suggests that this could take you know.
Years or once we screen the once we apply for the Ross panel or to get sort of full reimbursement, but obviously will focus on.
Keep initially after that approval, but have the largest populations.
That's true night.
Got it.
I was just gonna say for the E. U obviously, we're looking for approval for MLT later this year as far as people screening in the he was concerned that some a country by country bases and sometimes even certain states, but you know I've worked on newborn screening for for Skid for example, in the EU and now there are.
Yes countries in the in the U.S that all screening a force good with number of pilots also in the pipeline as well and so would that kind of experience and we would be looking to kind of really facilitate that uptake.
Yeah and as in ended the U.S. as Frank as already mentioned.
[laughter] and then I'm the decision to to defer Capex is that related to the left that.
Hi.
Hi, nine coal at U.S., but did you approvals and the newborn screening or what really kind of went into that delay given you know you already have some costs into that facility.
Yeah, I can I can start body can add on a again I think.
Obviously, we continue to believe in house manufacturing is an important capability that we're going to want to have over some period of time. It really comes down to sort of when is the need for that capacity and capability relative to the various programs. We have you know we're working with the CDMO that we have today, we know that we have.
Capacity for the M.L.D. and WASC launches and for a period beyond the launch so there's not an imminent need to secure that capacity today, and we think that deferring. It makes the most sense, we'll continue to work with Citi Imos on those launches or we will look at bringing.
On a U.S. required for drug product to be able to more easily service. The U.S. market and then longer term look at potentially in house manufacturing at a site and location that we think is more fitted to what the the capacity needs will be.
So I wouldn't say, it's tied to any sort of.
Launch timelines because the plan always was to utilize CDMO school was and an M.L.D., but certainly as those launches rollout and demand grows our capacity needs will grow and that'll be the appropriate time, we think to make investments.
Understood. Thank you very much.
Thank you and your next question comes from I knew Panorama from JP Morgan. Your line is now open. Please go ahead.
Good morning, guys I guess to attack on the call. This morning, Sonys Ah Ah. Thanks for taking my question and trolley MPPR you pointed out that update interim data from the proof of concept child and for OTI out two or three and he asked why didn't expect it at a after.
Directional be it it's definitely not not easy to accomplish internally.
I have a a couple of questions on M.L.D. first relating to the the F.D.A. interactions Bobby if I can <unk> I mean, it sounds like there's two two elements one is sort of clinical data and endpoints men sorta C.M.C.. So I'm the clinical data and endpoints isn't that you need just clarification or.
The F.D.A.
Has a different philosophy as to what they want to see and do you think you'll need to conduct another study and then have a quick follow up on the Sim city five as well.
Yeah sure. Thanks, Thanks, Yeah, I mean again, you know it's difficult to go into all of the details and but in general you know this is a program that started really quite some time to go with that and and points. The F.D.A. have asked about whether those are the appropriate endpoints and even.
Guided us as to what other end points, we might want to look at and I think we can say that we have the ability to look at those are the endpoints and but we won't be able to do is too I say get in front of them have the dialogue showed the data that we have we do as you know have an extensive set of.
Updates now on 33, plus patients eight years plus follow up in some individuals and let's say shows that full data set to them to get the clarification and and talk about kind of fire fighting plants. So I say I think the the most important thing for us is to have that that dialogue and.
Submitting the i. empty and trying to get Ahmat designation would allow us to have that greater attraction.
Okay, and then and the C.M.C. side.
Any sense are they looking for essentially validation and new essays to characterize the drug products than the cell potency and maybe the vector expression.
We've seen that you know recently bluebird as well the visual you may have requested is vastly different than what F.D.L. requested yeah. No. It's not about that it'll so I think that's that's one thing. We can say is that you know we have an enzymatic essay for and multi looking at the office activity and that's the the button sassy and the C.M.C. issues almost.
Enroll rather than focused on starting to feel safe.
Okay.
<unk>.
So you're saying this is very central this is very specific to M.L.D.N. will not have an impact as much as a about what's or would you have a chance to essentially sort of take care of that on the west side before you file to be a late next year.
So are we talking about M.L.D. all <unk>.
Yeah, I'm I was talking about the C.M.C. issues relating to handle the cross correlation to your ability to then follow the B.L.A.'s for was next year on the C.M. right <unk> from a tendency perspective.
Yeah from a C.M.C. so since he perspective this <unk> the the issues that bad <unk> talking about well M.L.D. all kind of.
More related to for example comparison between fresh and Cry preserve formulation. So then 40, if they said that we have around that and so I put a note related specifically to be the potency I see.
No I think not kind of follow on full what are we are doing with <unk>.
Okay, great. Thanks, so much.
Thank you. Your next question comes from Channel Wang from Barclays. Sharon line is now a fancy just go ahead.
Hi, <unk>. Thanks for taking our question I guess another question on M.L.D. and I apologize if you have already talked about this.
I guess cause you give us maybe like the <unk>, how you're thinking about detention areas, but.
T.F.T.A. what would be like that's case.
And what will be like in terms of time now what will be.
Not so good case in terms of pain 19 stereo. Thank you very much.
Hi, Yeah, it's I think it's very difficult for us to give that kind of information without really getting the clarification from the from the F.D.A. as I said before on it you know the lost.
In other questions, we'd really just we'd need need to have this dialogue with them they've lost for I'd say I talked to us about a certain endpoints natural history data. We feel we have a significant body of information we that guided us in terms of looking at certain endpoint.
And we think we can we can meet that but obviously, we need to be able to talk to them in detail have a dialogue to to talk about the data that we have present that to them in its entirety and then think about the the best way for what so I don't think we could really guide to those kind of time lines until.
Hill, we've had those conversations and you know once we've been able to do that then obviously, we could go out you more accurately.
Well, maybe I can just add a few things I mean, I think this is obvious but just to put it in context. I mean this was a study that was started almost 10 years ago. So we have significant clinical data in the indication over a period of 10 years, we had intended with the strength of the clinical data to to go directly to a file.
Without the need for an I.M.D. I think based on the written feedback that we recently got it's clear to us that we're going to need to you know spend some time with the F.D.A. to familiarize them with the data so I'm not sure that they've actually spent as much time with the data per se as as much as you know I think having questions and I think we need to her.
A dialogue with them. So the purpose of the I.M.D. and seeking arm at designation of course as Bobby said earlier is to get in front of them have the discussion and I think we we hope that there are many parallels with the F.D.A. that we had with the M.A., whereas we had more dialogue with the May I think the the strength of the clinical data and our ability to provide.
I didn't answer questions helped in that process and and we feel like we're on a good path with the M.A. right now, but but I think we're in a similar place now with F.D.A. and and need to have a dialogue and we want to work closely with the agency to make sure that we meet the requirements and we we hope with the existing data package that we'll be able to do that.
Yeah.
<unk> just follow up on that because I was involved in those discussions with B.M.A. So the M- <unk> Hot we had the day 120 questions on them a number of points. They raised about the the clinical package on some you know and <unk> four to us and we were able to have a clarification meeting with them, where again presenting the entire I'd say.
Set the the magnitude of the fact that we are having on most of function and called it's a function I think we got to a very good place on because as a possible with two two answer those questions effectively. So I think that dialogue is very important in such a complex disease and say well, we do have launched 40 of data.
Thank you.
Thank you and that concludes today's chianese session I would not like the channel called back to Bobby gas five for closing remarks.
Thank you. Thank you weren't very much. Thank you should have run for pasta spacing in today's cool will be available throughout the day for any follow I also wanted to provide remind that as I sat along that orchard, we'll have a significant virtual precedence next weeks and A.S.D.C.T. meeting.
<unk> eighth accepted abstracts will shine like on a number of our program. So stay tuned. Thank you very much everybody.
Well, ladies and gentlemen, thank you for today's conference that concludes today's call you may now disconnect.
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