DBV Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. I would now like to turn the call over to Katie Matthews, Investor Relations. Please go ahead.
Thank you. This afternoon, DBV Technologies issued a press release on recent FDA feedback on its Viaskin Peanut Program for toddlers and the regulatory path forward. This press release is available in the press releases section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements, including but not limited to comments regarding our clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, our plans and expectations with respect to our clinical trials, plans with respect to submission of BLAs to FDA, expectations with respect to any action or regulatory pathways, including an accelerated approval pathway, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies.
These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company discloses any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Daniel Tassé, Chief Executive Officer of DBV, and Dr. Pharis Mohideen, DBV's Chief Medical Officer. I will now pass the call over to Daniel. Daniel?
Thank you, Katie, and thank you, everyone, for joining our call this evening. As we discussed the most recent communication DBV received from the FDA during our last call, approximately six weeks ago, I shared that we had made significant progress in establishing clear and straightforward regulatory pathways for the Viaskin Peanut patch in the EU and in the US. As we have previously announced, in Europe, EMA confirmed via scientific advice that the VITESSE study conducted in four to seven-year-olds with the modified patch, plus EPITOPE in one to three-year-olds with the original patch, could constitute an MAA in one to seven with the modified patch, subject to running a safety trial in one to three-year-olds with the said modified patch.
For peanut-allergic children ages four to seven in the US, we have aligned with the FDA that the COMFORT Children study will enroll approximately 250 patients, randomized three to one, and will complement VITESSE, which fully enrolled in August and is on track for top-line results a year from now, Q4 2025. We expect to file a BLA in the second half of 2026. For peanut-allergic toddlers ages one to three in the US, in October, we announced that FDA had offered DBV an accelerated approval pathway in one- to three-year-olds and toddlers with the original patch, subject to finalizing two things. One was the intermediate clinical endpoint that would support licensure, and two, the key elements of the confirmatory study. Next slide. As you have seen today, we announced that we have received a written response from FDA confirming alignment on the AA pathway.
I'll use that acronym for Accelerated Approval for the toddler indication and alignment on those two points. Our press release of today highlights FDA has confirmed key criteria for post-marketing confirmatory study in toddlers one to three years old. DBV and FDA have also aligned on key study design elements for the COMFORT Toddlers study in one- to- three-year-olds, including study size and wear time collection methodology and analysis. We expect to screen the first subject in Q2 of 2025. The Viaskin Peanut patch BLA submission for the toddler's indication is anticipated to be submitted in the second half of 2026. We are delighted with the pathway aligned with FDA, and Pharis will go into further details in a few minutes. But before we get to that, there are questions that we sometimes get.
One is, why did it take so long to reach alignment with the FDA on the toddler program? The other we often get, or get on occasion, is that we know that the accelerated approval is an attractive pathway for many breakthrough medications and that CBER, the Center for Biologics Evaluation and Research, as you know, DBV Viaskin has reviewed at CBER. We know that CBER's leadership has been vocal that it should be used more often to accelerate access to novel products within the biological division. But the question is, how does it fit Viaskin Peanut under our circumstances quite exactly? Let me answer those two questions. Go to slide five. Although this may be a repetition of what we've already shared, we think it is helpful to summarize again here. Let's start.
The slide here gives the regulatory history of Viaskin Peanut, and although it has been longer and more complex than we had all wished, it's helpful to think of it as playing out in three chapters. The first was the CRL of August 2020. At its core was the FDA's concern, and I quote, about the intersection of adhesion and efficacy. As you know, PEPITES, our pivotal trial in four to 11-year-olds narrowly missed the statistical test but did miss its primary endpoint, and FDA had identified adhesion as the likely culprit. They asked DBV to modify the patch. To be clear, the adequate characterization by DBV of the expected patch wear experience was not a design element of the PEPITES trial at the time.
DBV chose to modify the patch, as you know, is the modified patch that is larger and round, as requested, and committed to executing the VITESSE trial to generate additional data that could support approval in children four to seven. The second chapter was a discussion with the FDA on how to capture data about patch wear time and how it would be analyzed as part of the VITESSE trial. From the moment we made the decision to conduct VITESSE, we began discussing the design of an efficacy, safety, and adhesion study with the agency. The discussion they welcomed. As I'm sure you remember, these discussions in 2020, 2021, and 2022 took place mid-pandemic while the Office of Vaccines Research and Review, OVRR, that reviews Viaskin Peanut obviously had to deal with COVID-19 treatments and vaccines, which were consuming all of their time.
We certainly understood when Viaskin Peanut-related reviews missed regulatory review-defined timelines. In December of 2022, in the process which included the lifting of a partial clinical hold, we came to agreement on key VITESSE study elements, including the assessment of adhesion and wear time. So adhesion assessment, as defined in VITESSE protocol, is satisfactory to FDA. The third chapter on this slide focuses on our toddler program. As we announced in April of 2023, FDA agreed that EPITOPE met the pre-specified criteria for success for the primary endpoint and did not request additional efficacy studies. But FDA stated that additional safety data would be required to support a BLA, that is, the genesis of study we refer to as COMFORT Toddlers. In the ongoing dialogue with the agency on the design of COMFORT Toddlers, a key question was how to assess adhesion and wear time in COMFORT Toddlers.
DBV offered to assess adhesion in COMFORT Toddlers using the same methodology as we do in VITESSE, and as was announced in October of 2023, the FDA agreed with our proposed approach. Therefore, DBV included the proposed methodology of VITESSE in the COMFORT Toddler protocol, which we submit to FDA in November of 2023, and as previously disclosed, we received comments from FDA on the COMFORT Toddlers protocol in March of 2024. Excuse me. Following the March 2024 feedback from FDA, we engaged in ongoing discussions with FDA to seek clarity for certain deviations from methodology included in the COMFORT Toddlers protocol that FDA had previously agreed with. We believe that the deviations from previously agreed methodology would greatly complicate recruitment, lead to significant missing data and protocol deviations, and risk investing considerable time and money to run a study that would have uninterpretable results.
Much of the ongoing dialogue between DBV and FDA was focused on patch wear time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time, and here, I want to pause and stress one thing I think we have always been aligned on by we, DBV and FDA, the importance of instructing prescribers and parents with clear data-driven instructions in the Viaskin Peanut patch label and how to manage variability in daily patch wear time and its potential impact on treatment effectiveness, if any. Because we are a novel therapy, it took those ongoing discussions to align on how to collect wear time data, how to analyze it, and how to translate it into meaningful guidance to allergists and families. We have always agreed if Viaskin Peanut is approved, questions will be asked by some parents.
Can my child benefit from Viaskin Peanut therapy if he or she cannot wear it or wear the patch for 24 hours every day? It's a question that must be answered in a fulsome and data-driven way. Patients certainly deserve that clarity. Next slide. After we shared our concerns about the absence of alignment between DBV and FDA on the issues of adhesion and wear time with comfort, we essentially brought that to the attention of the Office of Vaccines Research and Review Director at FDA, Dr. David Kaslow, and to his office. The engagement and solution orientation with FDA was noteworthy, and I very much wish to acknowledge it. The pandemic was also behind us. OVR had more bandwidth. And after that point, the discussions, video conferences, phone calls, email exchange were exactly what a sponsor wishes in interacting with FDA.
Viaskin is a novel technology that has no analogs. We have breakthrough designation, and that scientific dialogue was key. Now, obviously, we did not always agree, but we had a dialogue and a good discussion. And those ongoing discussions were focused on clinical data and regulatory science, which we believe was long overdue in our regulatory process. I will tell you more about the outcomes from those discussions, which we're very pleased with, which I think balanced nicely the needs of DBV and FDA in providing Viaskin Peanut as a treatment option for patients with peanut allergies.
So yes, we believe, to come back to the question, we believe that the ongoing discussions with FDA were essential to not only de-risk Viaskin Peanut in one- to three-year-olds and, in doing so, be responsible stewards of your money, but also build a mutual understanding of EPIT and the Viaskin platform between DBV and FDA that we hope will benefit all our future programs and, more importantly, benefit patients. Now, the other question we often get is, how is accelerated approval a solution for Viaskin Peanut in toddlers? By bringing back to the CRL, let's not forget that it is the intersection of efficacy and adhesion that was the question. EPITOPE showed significant efficacy but was not designed as is VITESSE assessed efficacy, safety, and adhesion wear time simultaneously. There's no intersection.
The EPITOPE protocol, to remind you, was written at the same time as the PEPITES protocol before the CRL. To FDA, there was a real clinical question that needed to be answered, and in answering it, helped with the product label. Moreover, I bring you to the slide in front of you here that has a lot of information on it, but let me walk you through it in a second here. Moreover, in preparation for potential commercialization, DBV made slight modifications to the Viaskin Peanut patch using EPITOPE to increase the simplicity of application for the caregiver and provide product identification on each patch.
As you see the top of the slide on the left-hand side, that is the patch that gets touched by mommy, daddy, or the caregiver, and we've made changes to the paper liner that's pulled off to help apply the patch, and we've provided a place to print the product name and the NDC code. The bottom part, the part that touches the skin where the allergen and the API or product is provided, is absolutely unchanged. Same vacuum film, same adhesive foam, same dose, same release liner, literally, what touches the patient is unchanged. But those changes that were made to increase the simplicity of application to the caregiver and provide identification on each patch, as I said, no changes, including patch shape or size, were made to the device components that are in contact with the patient's skin.
Further, to increase the volume of patch production for potential commercialization, changes need to be made to the manufacturing process and location. Although the intended commercial Viaskin Peanut patch is currently being used widely, about 304 patients have used the product in over 296,000 patch days of therapy in the placebo crossover of EPITOPE and in the ongoing three-year open-label extension EPITOPE. The collective changes to the intended commercial Viaskin Peanut patch were viewed by the FDA as constituting a different product relative to the clinical patch used in the EPITOPE study. Here, and again, hats off to the agency, the FDA was creative in making use of existing regulations to accelerate Viaskin Peanut's potential availability to patients if approved, and at the core of the solution they provided are the following observations. One, Viaskin Peanut has breakthrough designation. I don't think DBV's talked about that enough.
It's clear to the agency, which means that Viaskin Peanut treats a serious condition and generally provides a meaningful advantage over available therapies. Viaskin Peanut has shown convincing efficacy with EPITOPE chemical patch that is certainly predictive of efficacy with the commercial patch to be launched. FDA has confirmed that there is no need to generate safety data in 600 patients with the commercial patch. Instead, they're asking DBV to generate safety data with approximately 360 patients with the commercial patch as part of toddler, and that data will be pooled with the safety data in about 240 patients from EPITOPE using the chemical patch to satisfy the safety requirement of 600 patients on EPITOPE. Thus, the accelerated or through the accelerated approval pathway, Viaskin Peanut may be approvable and made available to patients through a clear regulatory pathway by way of a six-month safety study.
Adhesion data in COMFORT Toddlers, some of it will be somewhat lighter than what is assessed in VITESSE, making for a study that we're quite confident can be executed with ease. A confirmatory study will be done post-approval and will validate if FDA made the right decisions. And importantly, that confirmatory study provides DBV a large pool of patients on therapy to explore all the important questions about long-term benefits that we explore in all our Open-Label Extension, in all of our studies, including, obviously, the OLE and VITESSE. We believe that the Accelerated Approval is an elegant solution and a true win for all the stakeholders here. It answers questions that matter to the FDA. It's a very reasonable pathway for DBV, and most importantly, it's a win for patients that allows us to bring the product to the market as quickly as possible.
Here again, I wish to thank OVRR and its senior leadership. They proposed the accelerated approval pathway to us after stating to DBV that VP, Viaskin Peanut had met the first two criteria. One, that the product treats a serious condition, and two, that the product candidate, which is Viaskin Peanut, generally provides a meaningful advantage over available therapies, and then in discussion between DBV and FDA, the FDA also proposed an efficacy with a chemical patch to be the clinical endpoint, like to predict efficacy with a commercial patch. Obviously, many details remain to be discussed and finalized following the verbal agreement, which we have now completed, received in writing, and the confirmation was received just recently. I will now pass the mic on to Pharis for him to walk you through the critical details of this accelerated approval pathway in toddlers. Pharis?
Thank you, Daniel. Before diving into the details of today's press release, let's quickly recap the clinical development pathway for Viaskin Peanut in toddlers and in children. Recall that we have two Viaskin Peanut patches: the original square patch for toddlers, ages 1 to 3 years old, and the modified circular patch for children, ages 4 to 7 years old.
Each patch is regarded as a separate product by the FDA and hence follows its own regulatory path, meaning that two BLAs will be submitted, one for each age group. I recall that there's symmetry, where each BLA will be supported by a 12-month phase 3 efficacy and safety study: EPITOPE in toddlers, published in the New England Journal of Medicine in May 2023, and VITESSE in children, the largest peanut allergy study in this age range, respectively. Each will be coupled with supplemental safety studies: COMFORT Toddlers and COMFORT Children.
As Daniel highlighted earlier, it was imperative that we aligned on the COMFORT Toddlers protocol with the agency to ensure that it was a study that we could execute. I would like to highlight three positive outcomes achieved from our exchanges with the agency. The first positive outcome was that the FDA agreed that adhesion would not be a co-objective of a safety study and would be an exploratory assessment. The second was that adhesion would be assessed in the overall totality of benefit to risk in the context of efficacy and safety. The third is that we have aligned on what we believe is a very feasible approach to collecting adhesion, not only reasonable to parents and subjects, but also reasonable for clinical sites, so you can see these are really big issues, and we are thrilled with the outcome and the collaboration with the FDA.
As you read in the press release issued today, FDA recently provided written communication confirming the accelerated approval pathway for the Viaskin Peanut patch in toddlers one to three years old. It may be helpful to start by providing a quick overview on the FDA's accelerated approval pathway, since it is more often used in CDER at the FDA and not CBER. However, senior leadership at CBER has made it public that they believe accelerated approval is a regulatory approach that should be used more often with biologic products. And we're happy that Viaskin Peanut has been included in that vision. The FDA instituted its accelerated approval program to allow for faster approval of treatments. This approach can considerably shorten the time required to receive FDA approval and make new products available to patients sooner. The FDA guidance for accelerated approval includes three qualifying criteria.
One, that the product treats a serious condition. Two, that the product candidate generally provides a meaningful advantage over available therapies. And three, that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. As we announced in October of this year, the FDA confirmed by written communication that the Viaskin Peanut patch already meets criteria one and two. Since then, we have been actively engaged in ongoing robust discussions with the agency regarding the intermediate clinical endpoint necessary to meet the third criterion. In the recently received written communication, the FDA confirmed that the efficacy data from the phase 3 EPITOPE study can serve as an intermediate clinical endpoint, which is highly likely to be predictive of the efficacy to be demonstrated in the post-marketing confirmatory study.
The intended commercial Viaskin Peanut patch was not used in EPITOPE but is being used in the ongoing three-year open-label extension of the EPITOPE study and will be used in both the COMFORT Toddlers study and the post-marketing confirmatory study. In the recently received written communication, FDA also confirmed the criteria for a post-marketing confirmatory study in toddlers ages one to three years old. DBV and FDA agreed that the confirmatory study would demonstrate the effectiveness of the Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. The confirmatory study will include a double-blind placebo-controlled food challenge and will use the same statistical criteria for success used in the EPITOPE phase 3 efficacy study, which was the lower bound of the 95% confidence interval being greater than or equal to 15%.
Adhesion will be collected in a similar manner to the COMFORT Toddlers study. This study will also seek to further support the importance of average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and labeling. As you recall, COMFORT Toddlers is a phase three double-blind placebo-controlled study that intends to generate supplemental safety data and adhesion data in peanut allergic toddlers ages one to three years old. This study plans to generate six months of placebo-controlled safety data to support a BLA submission per the accelerated approval pathway. We anticipate enrolling approximately 480 subjects, randomized three to one, active to placebo, at around 80 to 90 sites across the US, Canada, Australia, and Europe.
The planned 360 subjects on active treatment can be combined with the 244 subjects from EPITOPE to meet the FDA guideline of close to 600 subjects on active treatment. The FDA has been very consistent with this number for applicable regulatory guidelines. We will include an optional Open-Label Extension so subjects and their families have the choice to continue to receive Viaskin Peanut for a longer duration. As we previously announced, we have alignment with the FDA on patch wear time collection methodology, analysis, and study objective hierarchy in the COMFORT Toddlers study. Importantly, the agreed-upon adhesion data collection methodology provides a practical approach for subjects, families, and investigators and is intended to generate sufficient data to support a BLA submission under the Accelerated Approval pathway. Collection methodology will focus on daily wear time at relevant time points, which should not be overly burdensome.
As we previously communicated, we have already initiated study startup activities, and we anticipate screening the first subject in the second quarter of 2025. So let me recap. For our toddler program using the original square patch, we will submit a BLA under the accelerated approval pathway, which we anticipate taking place in the second half of 2026. At that time, we will have completed two phase 3 studies, Epitope, which has already completed, and the COMFORT Toddlers supplemental safety study. The post-marketing confirmatory study will be initiated at the time of BLA submission, as agreed to with the agency. Okay, let me turn now to our four to seven-year-old indication. As you know, this is a separate development program, which will have its own BLA submission. This program uses the modified circular patch.
In September this year, we announced that screening had been completed for the VITESSE phase 3 efficacy trial in 4- to 7-year-olds. We were thrilled that a total of 654 subjects were enrolled, and we anticipate top-line data in the fourth quarter of 2025. VITESSE will not only be the largest peanut allergy registration trial ever conducted in this age range. It will also be the most comprehensive assessment of safety, efficacy, and adhesion DBV has conducted in a single study. The FDA has commented positively on the comprehensive evaluation being done in this study. The COMFORT Children safety study is on track to initiate in the second quarter of 2025. The company anticipates that this study will enroll approximately 250 subjects to raise the total number of 4- to 7-year-olds on active treatments across the development program to close to 600, consistent with prior FDA guidance.
The VITESSE and COMFORT Children studies will constitute the core studies for a BLA submission in four to seven-year-olds anticipated to occur in the second half of 2026. At this point, I'll turn the call back to Daniel for closing remarks. Daniel?
Thanks, Pharis. Before opening the floor to your questions, I would like to take a moment to express our excitement about reaching this milestone and establishing a formalized accelerated approval pathway for our toddler program in one to three-year-olds. We believe this provides a clear and reasonable path forward towards accelerated approval for the patch in this age group. Additionally, we have aligned on the details supporting our separate BLA in four to seven. I would also like to sincerely thank the agency for its engagement and responsiveness over the past few months as we worked through the specifics.
These discussions always take longer than expected, but we discuss science, interpretation of data, and labeling needs, discussion with benefit DBV, FDA, and certainly patients moving forward. This is particularly important given that the Viaskin platform holds promise for other indications in our pipeline besides the peanut indication. We remain confident that Viaskin Peanut is approved as a potential to be a game changer not only for children with peanut allergies but also for the broader food allergy community, which faces the daily challenges of living with peanut allergy. While the landscape has evolved with the approval of new treatments, providing families with much-needed options, it's clear that more progress is still needed. Here at DBV, we're proudly going to be working on generating data that will richly benefit families.
We are 100% committed to doing these studies and need to get to that approval, but they're not just to satisfy FDA. They're first and foremost to satisfy our patients. 2025 will be a pivotal year for us. We'll have the initiation of our two comfort studies in Q2, while we anticipate a top line from Vitesse in Q4. In short, we believe we have decreased the regulatory pathway risk for both programs. We're now in full execution mode here at DBV with exciting developments ahead as we work to bring this innovative therapy to patients and their families as swiftly as possible. Thank everyone on the phone and webcast for joining us today. Now, ask Pharis to join me for the Q&A.
If you would like to ask a question, please press star one on your telephone keypad now. You'll be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you have a question, please press star one on your phone now. And our first question will come from Shushila Hernandez with VLK.
Yes, thank you for taking my questions. I have a few.
Pleasure. Pleasure.
Just to clarify, so the collective changes to the patch that you mentioned makes the patch a different patch than used in the EPITOPE study, but the FDA doesn't require a new phase 3 study, so the supplemental safety study and post-marketing study will be sufficient?
That's exactly it. That's exactly it, Shushila. Okay. An elegant way to get the product without having to generate efficacy data given the implied carryover of the development, the clinical patch to the commercial patch.
Okay, that's great to hear. And also, you believe that the safety study will be sufficient to support the average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and safety, also relating to labeling?
Yes, absolutely. That's been the core of the discussions with the agency. As I said, it started with VITESSE many years ago. So yes, we have clear alignment with the agency in generating data that is relevant to them to inform labeling.
Okay, that's clear. So these are really the last items that you need to agree upon before starting the safety studies, or are there any other steps still remaining?
Pharis, you want to take that one? I know the answer, but you should be the one answering it.
It's already agreed upon, so we're ready to roll. It's been great communication with the FDA, as Daniel said, and I believe we have everything ready to go.
Okay, that's great to hear. Those were my questions. Thank you.
Thanks, Shushila.
And our next question will come from Jon Wolleben with JMP Securities.
Hi, this is Katherine on for John. Just a couple of questions. Just want to clarify once again, the reason why you guys are required to pursue accelerated approval versus like Xolair that got full approval. It's because of the differences between the commercial and clinical product, or was there kind of something else in discussion? And how does that affect the actual label once the drug is approved?
You mean how does accelerated approval affect the label? Is that your second question?
How does the accelerated approval affect the label?
Yes. Okay, I'll answer both, and Pharis can add some comments to it. Xolair is a supplemental BLA, which, as you know, is a more straightforward regulatory pathway than your first approval. The product's been around for 20 years, and it's also reviewed within the drug division within CDER. Monoclonal antibodies are reviewed within the division of pulmonary allergy and critical care, which is another same division that reviews our product, and as you know, there are differences in how different divisions look at dosing, so let's start with that, so ours is a first approval.
Theirs is an approval as a supplemental, and the product has been around for a long time in different divisions, so that's the best way I can describe the difference between the two. The difference is not a function of data or clinical profile, but simply of the maturity of data given BLA versus supplemental BLA. When it comes to the label, no.
The labeling of the product, and as we can surmise not only from what the regs show, but also the discussion we had with the agency, we expect the labeling of our product when approved through the accelerated approval pathway to be quite similar to the one that will be confirmed achieved through the supplemental study. Obviously, the agency and us have every latitude to revise that as a function of the data being generated. So the data might bring that change. We don't expect that. We know our product well. There is nothing at the core of what's being offered to us that is meant to put any sort of a difference in the approval language within the accelerated pathway or the confirmatory study. If that answers your question. That doesn't.
Just a quick follow-up on. Sure. You said that the TG data is going to be collected in a feasible way. Can you just kind of provide a little bit of color on how you collect data in COMFORT Toddlers?
Important question. Yeah, Pharis.
Yeah, so as we've dialogued with the FDA, we focused on average daily wear time, and time points that are relevant to what we had presented as our label and label out proposal a few months ago. So rather than more of a maybe shotgun's not quite the right word, but this is much more focused and aligned to what the potential label could look like. So it's really targeting more relevant time points that are of interest to both FDA and to us. That's a lot more focused in based on this proposed label and label out approach. Does that help?
It does. Thank you so much.
Yeah. I would also add another element to Pharis's answer. The window is also around those time points are reasonable to accommodate the real life having a toddler at home. So that's also something that's progressed quite a bit in our discussion with the agency here. We have precise time points and reasonable windows around it to capture the data as to have obviously skewed deviation and a rich data set.
Thank you so much.
You're welcome.
And there are no further questions at this time. I'd like to turn the conference back to our moderators for any additional or closing remarks.
No, my closing remark would be a big thank you for everybody attending the call today. Again, to everybody, investigators and parents and patient advocacy groups and investigators and experts who have all been very much involved in helping essentially articulate the need for this product to the agency and to the agency again for their responsiveness now that the pandemic is behind them to engage in a spirit breakthrough designation and discussions that were important to have about our product. I'm very, very satisfied with the progress we've shown in understanding we, DBV, understanding the agency's regulatory needs, the agency understanding better our product.
I think much has been achieved on that front, which is echoed through the alignment of regulatory pathway, but most importantly, is also much more profound than that. I want that to be clearly acknowledged. So I thank you all for your time. Wish you a wonderful holiday season. And as always, reach out if you have any questions, thoughts, or comments.
And this concludes today's conference call. Thank you for attending.