And so this has been the subject of a lot of activity by us, and we are working very closely with them to put everything in place for a successful FDA inspection.
Pete Stavropoulos: Thank you for that. And can you also just sort of remind us, the patients with melodies approved for in the you know, when you think about a U.S. label, do you anticipate if approved, it’ll be a similar label, a broader or more restrictive label?
Bobby Gaspar: Well, let me start that, and then I can hand it over to Brain for any extra information. But essentially in the EU, in the EU Libmeldy is approved for pre symptomatic patients with either the late infantile or early juvenile form of the disease, and also for early symptomatic patients with the early juvenile form of the symptoms and by early symptomatic, it is defined as individuals, children who still have the ability to walk independently and who have normal IQ. We will be applying for a very similar label with the FDA. And so, Braden, I don’t know whether you want to add anything to what I’ve just said there.
Braden Parker: I think you’ve characterized it we’ll, Bobby.
Bobby Gaspar: Okay, thank you. Thanks, Pete. I hope that answers your question.
Pete Stavropoulos: It does indeed. And just one last question, if you don’t mind, so as you move forward in filing INDs for the larger indications like Crohn’s disease and the risk benefit may shift for those indications relative to MLD and other neurodevelopmental indications you’re currently focused on, what are some of the key findings from your platform that sort of give you confidence that the risk benefit profile will remain favorable for these larger indications?
Bobby Gaspar: Yeah. Thank you. This is an important question, one that we’ve considered very carefully as we’ve thought about selecting which diseases that we can target. So for Crohn’s disease, it is a specific genetic form of Crohn’s disease and these are individuals with biolemic mutations in a gene called NOD2. And the literature and our Kol outreach suggests that these individuals have the most severe form of Crohn’s disease. So these are individuals who are refractory to biologics and immunosuppressants they have a high rate of surgery, and they have the fistulizing or stricturing form of the disease. So despite what’s currently available, there is still a high unmet need. We also know that many individuals with this form of the disease, the severe form of the disease, are taking part in trials of autologous transplantation.
So where they need to have. Chemotherapy conditioning and where unmodified autoliger cells are reintroduced. So that kind of intervention is still something that is warranted for those individuals with this severe form of the disease. Now, obviously, we will be going one step further and providing gene modified, selecting individuals with nod two mutations and providing gene modified cells so we believe it is justified. In addition to that, we are also working on reduced intensity conditioning regimes, which again, may make this form of intervention more applicable to a wider population.
Operator: Thank you. [Operator instructions] Our next question comes from Yarn Werber with TD. Cowan. You may proceed.
Brendan Smith: Hi, this is Brendan on for Yarn. Thanks for taking the questions and congrats on the filing. Just a quick one from us. Can you maybe just walk us through what kind of learnings or synergies from the European launch at this point that would help expedite a potential U.S. Launch? We’re just really trying to understand your expectations for the cadence of potential U.S. Sales later next year and really into 2025? And then I have a follow up.
Bobby Gaspar: Okay, well, thanks for that and I’ll hand that one over to Braden, our Chief Commercial Officer.
