Harout Semerjian: Yeah. This is very exciting for us to be honest. I mean, the fact that this unmet medical need and we know this is a disease area where enrollment is difficult, enrollment takes time. And if you don’t do it right from the beginning with a good collaboration, it can lead to unfortunate outcomes from a clinical trial perspective. We’ve learned that the hard way with our previous generation asset. And as you know, if we had stayed true to the original design of having patients be exposed to our previous generation within the first 26 hours, there was a statistically significant benefit as we reported in our post hoc and blood last year. So this time, we really want to make sure we’re working hand in hand with people who are very much involved in the sickle cell community, be it on the patient level, be it on the investigator’s level so that we’re working together in tandem to co-create what would endpoints look like, which centers would we go so that we really are able to deliver a clinical trial that not only looks good on paper but we can actually get it done.
So I’m very excited about this collaboration. And hopefully, we will report on progress in months to come.
Naureen Quibria: That’s helpful. Okay. Sorry, one more question, and I guess just flipping back to the Phase III study, just final one for me. Just assuming everything positive, you plan to submit everything the NDA before year-end, do you have any clinpharm or CMC (ph) studies that you still need to complete before that?
Harout Semerjian: Yeah. I mean, as you know, this trial has been taking much longer than it’s — were supposed to do. So we’ve been really cleaning a lot of the — what’s needed being on the data side, but also on the clinpharm. Do you want to tackle the clinpharm particularly?
Edwin Rock: Yeah. Regarding clinical pharmacology, in agreement with the FDA, exposure response analysis and exposure toxicity analysis as well as population PK analysis are included in our Phase III trial and our program. This will accommodate FDA expectations and ensure that we have appropriate information for the product label to direct safe and effective use of the drug.
Harout Semerjian: Thank you, Ed.
Naureen Quibria: Okay. Thank you.
Harout Semerjian: Thank you.
Operator: [Operator Instructions] Our next question comes from Ed White with H.C. Wainwright. Your line is open.
Edward White: Good morning. Thanks for taking my questions. Perhaps I could just start with 1687. This collaboration, are there any financial stipulations in this? Does it save you money somehow? And then just if you can — reviewing your strategy for development, does this collaboration mean you’re going to go it alone? Will you be looking for a partner to further development?
Harout Semerjian: Yes. Thank you, Ed. Good to hear your voice. Yes. Of course, I mean, any collaboration for it to be effective, we got to make sure that we’re compensating people’s time and effort. So there is a financial component for their efforts. It’s modest but it’s there. And regarding your second part of the question, are we going to do it alone or not, I mean, that’s really an open conversation. What we would know is regardless if we’re doing it alone or not, we want to advance 1687 and we want to make sure that we’re learning more before we advance it and move forward into a full-on clinical development program. We want to make sure that we’re very in tune with the patient voice. We’re very much in tune with developing endpoints that can be delivered by physicians in the clinical trial setting, but also it’s relevant for the patient.
So we’re gathering a lot of insights. And regardless of how we forward the execution of those insights is going to be helpful anyway. So for us, this is a no regret move with a very credible group that really is aligned with us on the sickle cell patient outcome. So that’s why we’re very pleased with our collaboration with them. And then those highlights will be used in due course in a clinical development setting.
Edward White: Okay. Thanks, Harout. And then my other question for uproleselan is just can you give us your thoughts on your strategy for Europe, which is something you really haven’t discussed all that much in the past. But since you’re getting closer to a potential launch in the U.S., I think start — it’s relevant to start thinking about that and get your thoughts on that.
Harout Semerjian: Yeah. No, absolutely, Ed. Those plans are ongoing. They’re underway. Our plans are not just to work with the FDA but also from a European perspective. We haven’t guided on the European side, but the work is ongoing. As you know, our clinical trial, our Phase III is half U.S. and half globally, including many sites in Europe. So we have patients over there. We have medical experts who are exposed to uproleselan and know how to use it. And of course, we’re going to be working with the European agencies as well in due time. So the first focus is on FDA, but then we should be turning our attention to Europe as well, so that’s also underway.
