Unidentified Analyst: Right, right. Okay. Understood. And the question regarding the Phase III registration potential registration trial, so yeah, FDA published recently and previously in PTCL, the FDA approved other drugs in this — in single arm trials. So do you think this is already sort of set in stone to have Phase III randomized trial design or the FDA may still kind of go with the precedent?
Richard Miller: I think that a randomized trial is better for us. I think this is a good thing. Here’s why. First of all, if you start a single arm trial, there’s no assurance you’re going to get the results that are going to be successful enough to achieve accelerated approval even by the old policies, number one. Number two, you still have to meet with them, and you have to commit to, or have to have the data already baked for a Phase III definitive trial. So you have to have all those activities going on previously. You got to have the data from your open label study. You have to have started and now fully enrolled your definitive trial. And so you put all that together, it’s actually more work and takes longer. What I think is better for us on this is we can now do a randomized trial, go up against chemotherapy, chemotherapy has, and we can make a dealer’s choice pick three or four drugs.
We’ve already been discussing that with our experts. The expected median PFS with those drugs is about three months, maybe less, and we have to beat that in our — in our single agent 818 arm. So the plan might be to look early, look at response rate. If you get a — meet a threshold for response rate, you get accelerated approval, but you’ve got your definitive trial already cooking, and then you wait for PFS. Now, in this case, I believe, and we have to do a little bit more work running these numbers. The PFS is so short in the chemotherapy arm. I’m not sure you would save much time by looking at response rate for accelerated approval when just a probably a few months longer and you’ve got the definitive PFS data, you follow that.
Unidentified Analyst: Got it. Yeah. Makes sense. So you don’t have to wait like 24 months — 28 months.
Richard Miller: Yeah. Right. The difference between — the difference between when you have your response rate and when you have your PFS, you know — enough PFS data is going to be pretty short,
Unidentified Analyst: Right? Yeah. You just have to beat that. Okay. That makes a lot of sense.
Richard Miller: And Aiden, the key here is that this is a definitive trial. You don’t have to then go do a confirmatory trial, obviously, if it’s positive.
Unidentified Analyst: Yeah, makes sense. And when do you think you can start the trial?
Richard Miller: We think we can start this trial before the end of the year.
Unidentified Analyst: Okay. Got it. All right. Thank you for taking my questions and congratulations with this biomarker. Thank you.
Operator: The next question comes from Mara Goldstein with Mizuho. Please go ahead.
Mara Goldstein: Oh, great. Thanks so much for taking the question. Hey, I wanted to just go back for a second to the biomarker, understanding that there’s a normal level for ALC, do you have a sort of sense of with these patients, I know you talked about a little bit with earlier line versus later line, but, what percentage of patients are likely indeed to have to meet the sort of 900 threshold that you’ve identified?
