Q1 2021 Provention Bio Inc Earnings Call
[music].
Good morning, My name is Kelly and I'll be your conference operator today.
At this time I would like to welcome everyone to prevention bio call. This will be a question and answer session to follow please be advised that this call is being recorded at the company's request I would now like to hand, the conference over to Mr. Robert duty, Vice President of Investor Relations for the prevention by it.
Thank you operator, and thank you all for joining us on preventing volume first quarter 2021 financial results Conference call.
Joining today's call for the prevention by the team is Ashleigh Palmer, Chief Executive Officer, and Coke out of there Andrew.
Andrew Drechsler, Chief Financial Officer on the other members of the prevention by our leadership team.
Before we begin let me remind you that the various remarks, we will make today constitute forward looking statements.
These include statements about our future expectations clinical results regulatory and other developments of timelines related to our product candidate.
Including for the Daclizumab BLA.
Such as our plans to work with the FDA to resolve their PK comparability concerns and expectations for the upcoming Advisory Committee meeting.
The potential safety efficacy and commercial success in support of the map and our other product candidates.
The potential COVID-19 impact on our clinical studies and business plans for.
Financial projections, including our anticipated use of cash and our cash runway.
And our business plans and prospects, including planned pre commercial activities across the company in preparation for the potential approval of <unk>.
Cause the mab and protect the timing for the thing.
Actual results may differ materially from those indicated by these forward looking statements.
The result of various important factors, including those discussed in the risk factors section of our most recent quarterly report on form 10-Q.
Which we filed with the SEC of this morning.
And in other filings that we may make with the SEC in the future.
Any forward looking statements represent our views as of today only.
While we may elect to update these forward looking statements at some point in the future.
We specifically disclaim any obligation to do so even if our views change except as required by law.
Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today.
There is more complete information regarding forward looking statements risks and uncertainties in the reports prevention filed with the SEC.
These documents are available on prevention of the website at Www prevention bio dot com under the investors section we.
We encourage you to review these documents carefully.
With that I will now turn the call over to Ashley.
Thank you Bob and good morning to all of you joining us today.
We greatly appreciate your support and the tension as.
As we continue our mission to develop and commercialize pioneering therapeutic options to intercept will prevent serious life, threatening and life impacting autoimmune diseases.
In founding prevention bio just four years ago.
Our intention was to disrupt how the biopharma industry and healthcare systems around the world typically wait for patients with autoimmune disease.
Hence the clinicians with symptoms.
Often by this time.
Reversible tissue damage has already taken place.
Precious sales in Oregon have been damaged or destroyed.
It's simply too late it is not good enough.
And we believe the patients and their families deserve better in this modern world of medicine.
Yeah.
As with all pioneering endeavors, we recognize the path to accomplishing our mission is not without its obstacles hurdles and resistance.
As such we built our company from the ground up with like minded professionals and industry experts capable of addressing those challenges head on.
We have established the resilient and tenacious culture dedicated to improving the lives of patients and their loved ones.
Ultimately, we believe we will prevail.
My open our call. This morning with these comments to put into context. The current status of the ongoing review of our BLA for <unk> for the delay of progression to stage III clinical type one diabetes.
At risk individuals.
When we acquired <unk> of just three years ago.
We took on the challenge of reviving of potential therapeutic option.
Had been loans the prioritized by others.
On the original strategic intent was to do so by focusing on the preservation of beta cells in newly diagnosed patients by way of our phase III protect study.
But the time of acquiring touches the map in 2018.
The TM 10 trial conducted by the NIH sponsored academic consortium trial net.
<unk> had already been fully enrolled and.
And was waiting for the progression of the threshold number of patients to clinical stage disease before opening up the blind.
Yeah.
The drug product administered in the TM 10 study had been manufactured using drug substance produced by Eli Lilly more than seven years beforehand.
Now over a decade ago.
Building plans and certain processes that are no longer available.
Importantly, when prevention of acquired peptides. The map. We also acquired the original cell lines used to manufacture the original Lilly drug substance along with the original batch records.
Specifications and other knowhow necessary to transfer this process to our manufacturing partner and into the model of Biotechnology era.
We believe we have produced the quality and comparable capital as the map drug substance by way of an up to date, well controlled reproducible and validated commercial scale manufacturing process.
Additionally throughout 2020, all of the physical chemical testing and analyses required for our manufacturing partner AGC biologics to release that drug substance fulfilling.
Net of all the requisite specifications and parameters.
Thereby enabling the completion and submission of our BLA CMC module.
Before introducing new drug product containing AGC drug substance into a phase III protect trial in newly diagnosed <unk> patients.
We conducted a single low dose PK PD bridging study in healthy volunteers.
And we observed a PK area under the curve or AUC level below the target comparability range.
Indicating that in this particular study the.
For the new drug product might be clearing from the bloodstream faster and drug product manufactured from the old Lady drug substance.
Importantly in this study we believe the other relevant PK PD parameters.
Such as the peak concentration or C. Max the clinically relevant PD marker of transient lymphocyte drop.
Immunogenicity and the safety profile all fell within acceptable ranges of comparability.
As we stated previously.
Based upon very extensive PK PD modeling and taking into account the totality of the information available to us at this time.
It is our firm belief that the observed difference in PK AUC.
Is not clinically relevant and should not impact clinical efficacy or safety since the predicted exposure for the intended commercial product remains above the requisite thresholds for beta cell protection.
Based on its review to date.
The FDA is not comfortable with our conclusions the.
Of the agency has informed us that it does not yet consider the two drug products to be sufficiently comparable.
Cannot be certain of the PK AUC shortfall observed in a single low dose PK PD bridging study in healthy volunteers might not translate into clinical relevance.
Nevertheless.
Under our breakthrough therapy designation.
The FDA continues to be very engaged very helpful on very cooperative.
And has agreed to work closely with us to figure out the island next steps on the path forward to a solution.
Which we anticipate will likely require our provision of additional data to support PK PD comparability.
One potential pathway.
Maybe to access PK PD data from patients in our ongoing protect study.
Which has begun enrolling patients to receive either drug product using the original Lilly drug substance.
All of drug product intended for commercialization using AGC drug substance.
We have also stated that we expect the need to provide the agency with additional data will result in a delay of the expected timelines within which to please the mab has the potential to be approved and made available to patients.
We are continuing to discuss next steps with the FDA and we will keep you apprised and updated as to our progress.
These comparability discussions are occurring in parallel with preparations for the upcoming Advisory Committee meeting in three weeks' time.
On may 27th.
On the SBA notified us of its intention to mention the comparability considerations index briefing materials.
Along with an affirmative statement that the agency is actively working with us to find the solution.
We believe the Fda's intent is to focus the advisory Committee meeting all of the examination of type one diabetes unmet need.
From the safety and efficacy of <unk> <unk> from the TN tend trial supported by data from other historic studies in newly diagnosed patients.
Our understanding is that since the fda's comparability considerations do not bear on the benefit risk assessment of the TN 10 study clinical data package.
No comparability related questions or discussion topics are planning for the meeting.
We are also fully aligned with the Sba's recommendation to remove the term prevention from the wording of capitalism. The initial indication.
Instead focus exclusively on delaying the progression of disease.
We believe this will help to reinforce the fact that one of the pre symptomatic.
<unk> patients with two auto antibodies and this glycemia.
<unk> already have the disease and may benefit from therapeutic options targeting the preservation of functional beta cells.
Our team has been working diligently for quite some time now preparing for this advisory Committee meeting.
As we realize the pioneering importance of having an opportunity to present, the first disease modifying therapy for type one diabetes tipping.
To be reviewed by the committee.
We look forward to standing alongside scientific key opinion leaders endocrinologists immunologist and other treating physicians.
Diabetes nurse educators and other members of the <unk> the clinical community.
As well as the patient advocacy organizations patients from that families.
Who for so very loans have hoped and weighted for a disruptive innovation that has the potential.
Central to delay clinical stage disease, and the burden on risks of insulin dependent.
Such a therapeutic advance would be a critically important breakthrough.
Especially for younger patients otherwise facing a lifetime of continuous blood sugar monitoring and insulin therapy.
We understand that much of our investors focus on attention. This year is concentrated on the nearer term regulatory pathway to the potential commercialization of <unk>.
For the at risk patient population.
However that is certainly not all the prevention bio is the balance.
And I would now like to spend the few moments, providing you with an update on the progress and momentum that is taking place throughout our organization with our impressive pipeline of other immuno immunology therapeutic program.
Importantly, our previous guidance with respect to our programs remains on track.
Beginning with our protect phase III trial of <unk> in newly diagnosed patients as.
As you know randomization into this trial was caused for some time last year due to COVID-19.
However, upon resuming randomization enrollment has steadily increased the various sites and countries have come back online.
We are now on track to complete enrollment of this trial in the second half of this year.
Importantly, this will position us to have top line results available in mid 2023.
Now turning to <unk> $32 79.
This is on humanize, the Bispecific scaffold targeting both CD 32, B and C. The 79 B receptors.
Designed to inhibit b cell function.
On the suppress auto antibody production without causing b cell all platelet depletion.
In addition to the strategic collaboration agreement, we announced in the first quarter of this year with part of our medicine for development and commercialization in greater China.
We continue to progress preparations towards the initiation of our pre Vale phase Iia lupus trial in the second half of this year.
Also with respect to <unk> $32 79, we reported preclinical data and results from our model of Pompeii disease, showing improved efficiency of transfection of of gene therapy products by reducing its immunogenicity with the PR of the 32.
$2 79 surrogates.
<unk> five hour partnered fully human anti IL 15, monoclonal antibody program continues.
Of this enrollment in the phase two be proactive trial, and we expect top line results in 2022.
As a reminder, after this phase <unk> trial is completed.
<unk> has an option to take the asset back for phase III development and commercialization.
At which point if exercised we would receive a payment of $150 million along with subsequent milestone and royalty payments.
Lastly, we are excited to announce that we have completed the enrollment in the first in human phase one healthy volunteer trial for PR of the 101 hour.
Our vaccine against Coxsackie virus B.
We expect to have a top line results for this trial in quarter four of this year.
As discussed previously it is believed the Coxsackie virus B is one of the main triggers of the immune cascade.
That results in pancreatic beta cell destruction in type, one diabetes and gluten exposure driven gastro intestinal autoimmunity in celiac disease.
Overall, we continue to make significant progress advancing all of our autoimmune disease therapeutic programs, whilst at the same time concentrating on the tape lithium of regulatory pathway on potential commercialization preparation.
On.
I'm now going to turn the call over to Andy to provide you with details on our financial results for the first quarter.
Before returning for closing remarks and questions.
And the.
Thanks, Ashley and good morning, everyone.
Before I begin I would encourage you to read our 10-Q that was filed today.
10-Q includes our financial statements.
Risk factors as.
As well as management's discussion and analysis of our financial condition.
I would also like to call your attention to the earnings press release, which was issued prior to this call.
Let me start with the P&L.
We generated a net loss for the first quarter of 2021 of the 32 4 million or <unk> 52 per basic and diluted share.
The increase of net loss compared to the first quarter of 2020 as the result of increases in research and development expenses of $10 6 million driven primarily by cost for our to click on that program, including the protect phase III trial manufacturing.
Manufacturing and regulatory activities as.
As well as the build out of our medical affairs infrastructure to support the pose the Mab, which includes type one diabetes disease state awareness on screening education programs.
The increase in net loss also resulted from an increase in general and administrative costs of $9 million, which includes $5 1 million and pre commercial expenses.
Shifting now the cash.
As of March 31, 2021, our cash position was $207 2 million.
Our net cash based operating expenses were $29 5 million for the first quarter ended March 31 2021.
During the first quarter, we completed a follow on offering which generated approximately $102 3 million of net proceeds.
In addition, during the quarter. We also received a $6 million upfront payment related to our strategic collaboration with one down to develop and commercialize <unk> $302 79 in greater China.
Please note that from an accounting perspective, we expect to recognize the upfront payment and other R&D funding from this agreement on a proportional performance basis over the next three years as we conduct the development activities contemplated by the agreement.
Finally, we expect to use between 30% and $35 million of cash for operations in the second quarter of 2021.
We expect our current cash cash equivalents and marketable securities will be sufficient to fund projected operating requirements for at least the next 12 months.
<unk> will enable us to actively develop all four of our programs.
Was the mab for type one diabetes.
The <unk> $32 79 for lupus.
<unk> 015 for celiac and.
<unk> 101 of top Sackey virus the vaccine.
The plants provide additional cash guidance on each quarterly call as we continue to progress towards the potential regulatory approval and commercial launch of to play the math.
With that let me turn the call over to Ashley for closing comments Ashley.
Thank you Andy.
Before we open the call up to address any questions you may have.
I want to share my deep appreciation for all our colleagues here at prevention bio for their hard work.
Expertise and dedication.
You can demonstrate each and every day the highest levels of commitment tenacity and professionalism as together, we fulfill our mission of becoming the disruptive catalytic game changing industry pioneer we set out to create for years ago.
I am also thankful to the team of officers and review as of the FDA for.
Their level of collaboration they've shown a company as we strive to bring to please the map closer to becoming a disease modifying option for patients with stage II type one diabetes.
There will always be challenges along the path of innovation and change.
However, the cooperation we have witnessed to date provides us with optimism and confidence.
I, especially want to thank our shareholders, both new and those who have been with us from the very beginning.
Your support enables us to continue to progress our mission and make the significant strides we have witnessed over the past 12 months.
Sincerely thank you.
And finally, I want to acknowledge and thank the patient advocacy organizations clinicians patients and their family members impacted by type one diabetes and other serious autoimmune diseases.
We believe Youll calls goes beyond worthy and deserving it's essential.
And the has compelled us to create and found the prevention buyout for years ago.
It is your needs and your courage that inspires and propels us forward each and every day.
With that operator wed like to take any questions.
We will now begin the question and answer session.
Ask the question you May Press Star then one on your telephone keypad if the area.
He is on a speaker phone please pick up the handset before pressing the keys to the.
Draw. Your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
Your first question comes from Alethia Young with Cantor. Please go ahead.
Hey, guys. Thanks for taking my questions. Just a couple of just so on like this kind of pre specified 80% to 125% area under the curve range. I guess can you just kind of give us like background or walk us through how I'm you know like obviously it was prespecified. So it was kind of known just how did it become kind of you know.
The significant consideration for the F D. A and you know kind of why that happened now and then maybe.
Another question just on.
What do you what's your hypothesis on like why these comparing comparability issues exist you know basically in the first place.
And then maybe just the third one on the on the panel do you think that effectively that's kind of the now but a little bit more of significance on the panel because it seems like if you are a part of the panel you know there'll be a little bit more.
Focus on I'm trying to trying to sort this out thanks for taking my questions.
Thank you for the questions Alicia Let me ask let me answer the last one and then hand over to Francisco to answer the question regarding what I understand is a very typical of comparability range.
And address.
The question as to why.
Yes the.
Significance on the Advisory Committee meeting is now.
Exceptionally important at this at this juncture.
The positive Advisory Committee and <unk>.
Community support.
We'll create the context in which the.
The company on the agency.
The work together under our breakthrough therapy designation to find.
Our solution as quickly as possible.
And the Advisory Committee.
Is not positive then on essentially the comparability issue becomes a moot point, so you're exactly correct from Cisco could you speak to the 80 125 comparability range.
Any thoughts as to why.
It gives them on an alethia.
80% to 125% is the target that is typically the quiet for bio equivalence.
Even though we are not obviously.
Biosimilars and innovative products.
It was used to ask for a target as well in our study.
As to why we were.
Below the <unk>.
The target.
But on the sensitive we still don't know that goes for US a single low dose study in health of alone tiers.
And we do believe it.
Both.
Now clinical relevance.
Especially when you think of multiple higher doses in patients, which is our in terms of ideas. So we are working.
Trying to understand it and also working towards providing additional data and analysis pharmacodynamic endpoints et cetera that might ameliorate fda's questions on concerns.
But just as a follow up for effectively I guess, it's kind of like you know maybe perhaps like you guys didn't think that the low dose would be something that the F&B. So focused on our or I guess I'm trying to figure out how it kind of all came together that it was you know now on this like new photos from the past couple of months, you know versus like maybe like eight months ago.
Yeah.
We conducted the PK PD study specifically to bridge to the inclusion of the.
The Ah.
AGC originated drug product in our protect study.
All of the.
The physical chemical analysis and that includes assays potency assays and so on.
On <unk>.
The buying AGC biologics and ourselves that was submitted into the BLA.
<unk> comparability.
As did.
Many of the other parameters of the PK PD study itself. The reason that it has appeared.
On.
The same time as the BLA is being reviewed is because the PK PD studies results.
It came available at the beginning of the year.
So the first time.
Had the opportunity to discuss the study which has to be submitted to our R&D and our BLA.
We cannot disclose that to the agency was at the.
The mid cycle review in February and at that time, they had indicated to us that they were evaluating the results and doing their own modeling.
And as you know it was only in last month April, but we had meetings with the agency that indicated.
The conclusions that they were not.
Comfortable with.
The comparability.
And that's where we're at today.
Awesome, great. Thank you for that for all of it.
Your next question comes from Gregory <unk> with RBC capital.
Good morning, Ashley and team I. Thank you for the update and thanks for taking my questions on the App.
Maybe just to build on elite is a question of I'm. Just curious if you could comment a little bit.
On some of the dimension of.
The reliability of the analytical methods are one of the analytical methods to release type of pleasant that been your filing today as well as just some.
The commentary on the that form 480, threes are issued the AGC, which sounds like they would be required to be resolved prior to any.
The decision on to put them out of any additional color you have on those findings would be helpful. Thank you.
Please.
These appear to be the red.
Relatively straightforward way of working with a G C biologics too.
Answer the those and we believe that they will be able to do that.
Thank you that that's helpful. On maybe just one more ethics spoken.
About the possibility of using data from the protect the trial to address the the comparability question I'm just curious what would be the best protocol to conduct such an analysis without on blinding, maybe some of the more tactical steps and thinking about [noise] leveraging that study in order to fulfill some some of the.
The the the voids or the additional data would be great. Thank you very much again.
Thanks, Greg Yes, so we have not discuss the specifics of how we.
We can make that day to are available I can tell you that we are collecting P. K P. D date of from.
The protests study in anticipation of it's being able to assist the agency and its review and we intend to have a discussion with them in parallel with the continuing preparations of the outcome to get their input to ensure.
<unk>, we do evaluate that day tour and presented to them in the in the in the way that's useful to them without undermining the integrity of the protests study and we believe we can do that.
That's great I appreciate it if I may of maybe I'll sneak one more on perhaps for for for Jason just on on the commercial side, how should we think about some of these issues that of right now at the 11th hour impacting potentially any commercial receptivity of of to put on the app and how docs could could sort of the.
The the the the comparability issue, but just also some of the the proceedings along with has been sent certainly of of winding road for now thanks again Ashley.
Yeah that kind of stuff.
Sorry for the last night.
What would you do if I was gonna say I'll hang on for that but.
The efficacy and safety.
Have you asked the agency whether it would be possible to include a question for the AD com regarding whether they would consider it advisable to approve the drug even though all of the comparability of questions have not been fully answered simply because the.
The efficacy profile and the at risk study, what's so compelling and <unk> is such a significant unmet need.
But we have not discussed the questions specifically with the agency related to that.
Would not make sense to me in so far as the <unk>.
Comparable at the issue is a technicality.
C is fully.
Staffed and capable and qualified of addressing as it does with any comparability biosimilar change in the manufacturing facility.
Formulation et cetera.
And the members of the panel.
Do not typically have that background or expertise and wood.
Be able to provide the agency with any additional of box.
Okay with respect to Europe as you look towards the filing of the MAA.
For reporting of the top line data from the protect the study just wanted to to be reminded what what you're targeting now and if you could also just provide us with some additional granularity on how that trial is progressing overall in terms of the enrollment in terms of you know any logistical challenges you're encountering.
<unk>, there's been an absence of that and everything's going as smoothly as it might be expected to the.
Thanks around the yes, so uhm on guidance is still the second half of this year.
The completion of enrollment and then there is an 18 month follow up.
For the the the study to close and so the results of.
The top line results, we anticipate will be available in the middle of of 2023.
We've seen a state of the increase in enrollment right as a result of get the management of the COVID-19 pandemic in income Crazy sites and vaccination and so we are encouraged by that as we go into the summer months and believe that we will in fact.
The on track to complete the talking to the enrollment in the in the second of all I would just like to point out of it but we uhm, having discussions with the agency regarding P. K P D day to.
From the protests study and we do not yet know the details, but uhm, we shouldn't assume that we have to wait until the top line results to get that day to that day to can be accessed much more quickly then waiting for the final results of the study.
Great. Thank you very much.
Your next question.
Comes from Justin Kim with Oppenheimer N K.
Good morning. This is now on for Justin Thanks for taking the question can you just remind us of what we can expect from the findings of the prevent CVV study and the strategy to reach patients but for exposure of of the disease Uhm just from a regulatory perspective.
Three weeks out from the icon can you just talk to your interactions with the agency regarding the <unk> clinical data I guess whats your sense for the FDA comfort or.
Where there are areas of concern might be around the clinical dataset and where they plan on asking the panel for more input.
Thanks for the question Tom So.
We're very encouraged by the fact that the agency is continuing with the Advisory Committee meeting, we believe the perhaps an indication that the breakthrough therapy designation.
They find the TN Ken.
Study clinical data set in the context of the safety database from newly diagnosed and the supporting evidence of protection of beta cells of <unk>.
And by C peptide from Historic studies.
As.
A dataset that's worthy of this advisory panel.
Evaluating it and the timing and we.
We believe that the focus of the of.
The committee will be on understanding the unmet need on.
The relevance of the delay in the progression of the disease from stage two to stage three.
Then the efficacy and the strength of that signal from the <unk> study.
Although.
Modest study has a very powerful.
Value on.
Statistical significance and a very significant delay with the median of two years and in follow up.
Published data, indicating that that is now.
Approximately three years.
And then finally, the the safety profile of.
The safety profile of an immuno modulator of <unk> therapy.
The the potentially the first disease modifying therapy for type one diabetes.
And.
In the context of that.
There'll be concentrating on.
The potential risks of immuno modulator therapy, but again were.
Very well.
We're very keen to point out that this is the discrete exposure.
It is a resetting of the rebooting of the immune system. It is not chronic immunosuppression.
And after the conversion of the Autoreactive T cells, which destroy or attack the beat the cells.
Conversion to exhaust the regulatory T cells.
The cost of therapy is over.
That therefore reduces the.
The prospect of the risk of a opportunistic infections and malignancies that might be associated with a chronic immunosuppression. So that's the discussion that we're expecting and we believe.
But we will also have.
A lot of support from key opinion leaders and from patients and patient advocacy groups.
Really looking forward to two coming up in three weeks' time.
Got it got it Okay and then.
Also on the the manufacturing in the form for 80 threes for AGC biologics, where the where the issues cited the specific to the closing of I guess can you describe what the issues are specifically related to the chipotle them out and what's your level of confidence that these issues could be resolved. The ahead of the the current July 2nd City per day.
We believe they are.
They will be satisfactorily addressed by AGC and its response to the 480 threes.
The 480, threes, where a typical observations made from a pre approval site inspection.
All of them pertained to the general matters at the sites some of the pertain to.
Matches that were related to.
The products that were being manufactured and on a few pertained to the.
The process of facility associated with kept plays the map, but as I mentioned earlier, we're working with the AGC and we believe that they will be able to satisfactorily address the 480 threes.
For the agency to to not have those considered.
As an approval obstacle.
Yes.
Okay.
Okay, and then just on the Teekay TV comparability can you can you comment at this point that's the how many patients within the protect study ever since of the legacy of Lilly manufactured products versus the new AGC biologics product.
We've not disclosed that information yet.
Okay. Maybe can you just comment at a high level is your expectation that the majority of patients in the study would have received the legacy product or the new product.
Well the the.
The issue isn't necessarily how many patients received the legacy product for US is the new product, it's about bringing a PK PD sub study into a trial that was the phase III trial simply looking at the efficacy compared between active and placebo.
And as you may appreciate a PK PD studies of different protocol. It requires taking blood samples much more regularly.
The after the therapy has been administered.
In order to evaluate how it clears from the blood for example, and.
On the PD Biomarkers.
So what's important is whether we will be able to.
The initiate and complete a sub study.
Before the clinical trial.
Trial completed enrollment and we believe we will be able to do that and provide PK PD data to the agency to assist them in the ongoing considerations.
Okay got it that's very helpful. Thanks, Ashley I appreciate you taking the questions.
Thanks, Tom.
Your next question comes from David Wong with F N B C.
Hi, guys. Thanks for the update on taking my questions. So I just had one on the.
And then the follow up the first one on the Paducah date of July 2nd we know it still stands.
If that should need to revise the move is that something that youre going to wait for the agency to give you that guidance or is that something you could have the active conversation around.
Well, we've indicated that there is likely to be a delay based on.
Our understanding of the agency's position on comparability, we've not had discussions on how that the label.
Manifest itself, whether it will.
The within the current.
Review cycle with some expansion or after a formal response.
But we are we certainly indicated the potential for the delay.
I think a lot will depend on the outcome on the outcome.
Some of the anthem.
And I suspect that the agency will wait until the outcome of its taken place are.
Complete its clinical.
Review.
Take into consideration of the meetings that we hope to have with them concurrently.
In regards to additional data we can provide and then.
We will obviously update you on.
At the appropriate time, when we have material information.
Okay got it that's helpful. Thank you.
And then just on the the celiac disease assets.
So I understand there is the option for Amgen to take that asset back and pay you a milestone fee if if amgen elect not to take it back.
Are they still involved or are you still kind of splitting the cost of development of the phase III or where the old that developmental costs come back to you.
Okay.
Of the full control of that asset by way of an.
An arm's length of license arrangement that would continue after that decision.
It means that we would have the full benefit of the AR beyond the development and potential commercialization of Nevada assets, if merited, but it would also mean that we would have.
The full burden of of development costs.
We would have an opportunity to partner that with other parties interested in Sylvia.
Yeah.
I see okay, great. Thanks, Thanks, so much for taking the questions.
Thank you for the questions.
This concludes our question and answer session I would like to turn the conference back over to Ashleigh Palmer for any closing remarks.
What kinds of Kelly and thank you everybody.
Thank you for the questions.
Again like to thank you for your time.
And we hope that you all have a great day and look forward to speaking to you again soon.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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