Dae Gon Ha: Two for me as well. One, with regards to Bison, your remark on total hemoglobin as being a differentiation. I guess at what point do you kind of draw the line in the sand and look at that as a differentiator from potential competitors? And then as a follow-up to that, Vertex last night announced that there will be an AdCom for XL. I guess what are you kind of thinking about in terms of point of contention or debate or discussion as we approach that? And how would you see the AsCas-12a targeting HPG promoter as potentially raising another ADCOM when you guys go down that line?
Baisong Mei: Thanks for the question. Regarding the total hemoglobin and related differentiation, we are in the current protocol, we’re already actively looking to that. And as I outlined previously, we are looking for 3 category of things. One is come from hematological and other lab values. The other one and the second is the end organ function. The third would be patient report outcome and part life. And maybe a few words on the last two. We — in the current protocol, we monitor key organ functions such as cardiovascular, hormonary and renal function; we have multiple measures to measure the function. So we believe that the total hemoglobin increase would impact the quality of life and organ health. So that’s why we focus on the end organ function.
And then regarding reported patient reported outcomes, it could be a very important part of that for differentiation. For example, fatigue is the main — one of the main complaints by sickle cell patients. And that — and already data to show that fatigue can really relate to the anemia on that, too. And similarly, for pain, that’s also another the complaint that the patients have and we also have a close monitoring of those patient reported outcome. — main other things we can share more on [ph].
Dae Gon Ha: Yes. Do you want to add for the initiation?
Baisong Mei: Then your second question is about AdCom. And yes, we heard the news about the AdCom which, of course, this is a novel area that FDA which is not a surprise. And we feel that will help us to learn more about how their data look like and how the expert committee is new about or additionally how the FDA feel as well. And then related to our own mechanism of action, we do not believe the target of ASK 12a caused additional concern from a mechanism of action perspective. As I mentioned before, we actually — our targeting of HBG1 promoter is mimicking the nature mechanism of persistent the relator perineal on that. So that’s kind of the nature of mutation we are targeting too. And so — but we’re looking forward to see the outcome and the information from that come from the excess sales.
Operator: Our next question comes from Phil [ph] with Cowen & Company.
Unidentified Analyst: Two for me as well. First, in terms of the year-end update on RUBY and EDITHAL, what is your most recent thinking about the number of patients that will be disclosed for both trials and the follow-up for the patients in the disclosures?
Baisong Mei: Yes. Thanks for the question. Yes, we are on track those total of 20 patients by year-end. We are not disclosing the specific data to be released at the year-end but we are on track to provide a clinical update for 4 studies at the year-end.
Unidentified Analyst: Great. And then second question on the interference proceedings that you referenced in the prepared remarks. Can you remind us where are the next steps in those proceedings and when they could conclude.
Gilmore O’Neill: Yes. Thanks, Phil. The oral really is the scheduling of oral presentations is the next step. Those — our presentations have yet to be scheduled. And then what we’d anticipate is a judgment in early to mid-2024. — it’s worth stating that we are confident that we will prevail as we have before, both in front of the Federal Circuit Appeals Court as well as with the U.S. PTO.
Operator: Our next question comes from Yanan Zhu with Wells Fargo.
Yanan Zhu: I wanted to ask about your FDA interaction in the second half of the year. What will be the focus there? Do you think you have enough data to inquire about pivotal path? Do you think the kind of treatment afforded to the competitor in terms of 17 patients forming the basis for a pivotal cohort and the length of follow-up could be similarly afforded to your — to added 301 as well? And also, lastly, do you think you have enough differentiation on the total hemoglobin to request a breakthrough designation?
Gilmore O’Neill: Thanks very much, Yanan, for that detailed question. I’ll start. With regard to the FDA interactions that we are planning for this year or this half of the year, we will be talking about multiple elements, including our CMC, as I’ve said, as well as having a clinical interaction. With regard to the clinical data, I’m glad that you highlighted where we see Vertex’s BLA and the acceptance of an efficacy cohort of 17 patients with about 18 months of follow-up data which I think is a helpful precedent and certainly an element of guidance that we can actually use. And then as Basin has said, the AdCom that will be scheduled towards the end of this year by the FDA, I think, will actually also be very illuminating as we continue in our continuous process of aligning with the agency and understanding how we can come to agreement on what will be ultimately our pivotal path and BLA filing strategy.
With regard to differentiation, based on, I don’t know if you want to add anything.
Baisong Mei: Yes, thanks. I think your question about differentiation is related to the eligibility for fact designation. We are carefully looking into the regulatory designations and multiple different things in there. And certainly, we are excited by the data we have seen so far and we’ll evaluate very carefully and on this path. — related to your earlier question about 17 patients from the XL as Gilmore mentioned that we will know more, especially after the AdCom but it’s a good reference for us and that we still require the final alignment with the FDA on whether the package is required.
Gilmore O’Neill: And I think the good thing that I should have, of course, highlighted was that we are on track to dose 20 patients by the end of this year. And so that number is a helpful number for lining up with what we see with the BLA acceptance for excel [ph].
Yanan Zhu: Thank you.
Operator: Our next question comes from Rick Bienkowski with Cantor Fitzgerald.
