Unidentified Analyst: Got it. That makes sense. Thanks for the answer. Another one on commercial. We heard recently that Krystal reported about half of their scripts are actually from community doctors versus centers of excellence, are you thinking about reaching maybe to some community doctors and get the initial steps done before patients are treated at centers of excellence? Or how does that report or sort of surprising update change how you’re thinking about your launch?
Madhav Vasanthavada: Yes. So there are centers of excellence as well as community centers where these patients are present or as at the time of launch, we believe that patients who are at the centers of excellence will be ideal candidates to get this therapy. And over a period of time, we will look to expand outwards from centers of excellence, which are pz-cel trained centers to the centers of excellence that don’t necessarily have the ability to surgically apply with pz-cel and then finally to the community centers. There are some 23 centers of excellence that we know of that see a lot of EB RDEB patients. And so clearly, we will look to educate these centers so that they are aware of the therapy, and we could have the referral in place.
So that’s our approach. And we continue to work with patient occupancy group. We have a strong partnership with multiple adequacy groups, DEBRA in particular. And given the nature of this patient community, we also anticipate a vast majority of these patient will be self referral if we understand where these centers are that apply pz-cel procedures. So that’s going to be our approach. And so even though the patients are in the community setting, for the treatment like this, which is a onetime procedure for those wounds that they are suffering from, there is a strong appetite and there is a strong pull versus if this were to be a chronically applied treatment, then yes, I think we would have to think hard here is where we feel the value proposition is very strong.
Unidentified Analyst: Okay. Got it. Just one last quick question. The Phase III trial enrolled patients, 6-year old or older, do you think the label is going to have a minimum age of 6? Or how do you think about unmet needs in patients under 6-year old?
Madhav Vasanthavada: Yes. That’s a fantastic question. Thanks for that. It’s going to be a dialogue that we will have to have with the FDA. So if you look at body surface area, so this is a topically applied epidermal sheet so dose is something that is differently viewed here as a percentage of body surface area that we are applying these sheets. So if you look at a small stature patient, let’s say, close to the 6-year old mark, and we’ve applied 6 to 8 sheets. In fact, we have applied 14 sheet across the 2 studies on the same patients that a 7-year-old and so as a proportion of their body surface area, that’s a huge percentage of coverage. So how the agency is going to view dosage is going to impact how they view a minimal age because the reason why the 6-year age was selected as a minimum in our study was primarily the ability to report pain endpoints, understanding the Wong-Baker scale, which is validated for ages 6 and above.
So because we had an end point, we had that restriction. Now that, that mean you couldn’t apply as therapy on a patient that is 4 years or 3 years old, that is up to the negotiation. And we believe that with the currently ongoing Phase IIIb study dropping that age limit below that 6 years is also going to help build that experience. So by the time we get approval, this is something that’s going to be locked in the late stages of review with the FDA. Our anticipation is that it’s going to be beneficial for patients even younger than 6 years of age. But this is where the dialogue that’s currently happening among various types of physicians, plastic surgeons as well as the EV specialists says, what is the age of a patient where we can safely have them follow best practices after application in order to immobilize these sheets because if patients move too much, the graph needs to take optimally and how do we manage those patients that are younger than, let’s say, 12 months old, I think these are all the types of questions we’re currently answering to say what is that age, but we believe that it’s definitely applicable to much lower than 6 years of age.
So more to come in the coming months on that topic.
Operator: [Operator Instructions] Our next question is coming from James Molloy with Alliance Global Partners.
Unidentified Analyst: This is Laura on for Jim. So with the working on building out commercial organization for pz-cel, have you also started the sales team hiring process yet? And have there been any challenges on getting numbers to join?
Madhav Vasanthavada: Thanks, Laura. I have to address your second question, actually, we have had no issues at all in bringing on talent so far. We’ve got the leadership team in place from a commercial side. We have the head of marketing, the medical operations person, market access and key account management so we look to continue to scale the organization. Not — we don’t need a whole lot of team, right? Because what we have been saying early on is that this is a therapy where a limited commercial infrastructure is what we required given the pull. So that leads me to your first part of the question with regards to sales per se. We don’t anticipate having a sales team or a major sales team at launch because of the initial level of interest that exists in these centers.
