I think we are really dealing with very aggressive and very sick patients, but we are hoping for the best. So I’ll stop here and take any questions if there’s any additional ones from you, Hartaj.
Hartaj Singh: That’s really good. And then just on 534, how do we — what do you expect to see? I mean, you’ve got all the way can go to 600 milligram oral daily, right? It seems like. Where do you think you could get to how you’d expect the , do you need to go all the way to 600? Do you think it could be before that? And that’s the question.
Salim Yazji: I think it is also — it all depends on the dose escalation and how fast we can go there. But we will actually believe that a therapeutic dose or the efficacy dose maybe start from the 300 above, which is that would be the fourth cohort. We may start seeing things earlier than that. And we hope to do that. But I think time will actually will be on our side to see if we will be able to see any early responses in earlier cohorts.
James Breitmeyer: Let me add something. There was a very interesting panel discussion at the Citi conference last week where several members of the FDA addressed Project Optimus, and what they made clear and emphasizing what’s in the FDA guidance here is that FDA is looking for developers to establish a balance between efficacy and safety. And they are not — they’re in oncology in particular, they’re encouraging early development to learn more than just the maximum tolerated dose and to explore doses below MTD to look for that perfect balance between efficacy and safety. And so this was — what was particularly helpful about this panel was that it was being discussed in the context of cell therapy such as 808, but the same principles will apply to the choice of dose for ONCT-534 as well.
Hartaj Singh: Yeah. And Jim, I guess I was just thinking, I know you’ve probably mentioned this before, just remind us again, why do you have to dose levels, dose level A and dose level B when you move forward from the dose escalation part of the study?
James Breitmeyer: It’s exactly for that reason, Hartaj, it’s what FDA is looking for in this Project Optimus. And they make clear that whenever possible, they expect to see randomization between the two dose levels. So that before you start a registration intent study, FDA will have the opportunity to examine efficacy and safety and risk benefit ratio for more than one dose.
Hartaj Singh: Yeah. That is all very helpful. Thank you for the question.
James Breitmeyer: Thank you.
Operator: Next question comes from Kemp Dolliver with Brookline Capital Markets.
Kemp Dolliver: Great. Thank you. The question relates to 534 and Novartis recently presented the data from (PSMA)4, which is the pre taxane setting and we’re expecting data any day now from the splash trial, which is also in that same patient population. Based on what you’ve seen so far and the commentary regarding how these drugs would be used in that setting, how are you thinking about the opportunity for 534?
James Breitmeyer: Yeah. Good question, Kemp. The challenge from the (PSMA)4 study is that there is a slightly worse overall survival in the active treatment group in the intent to treat analysis. So we know that FDA will be looking at their safety data in a very close manner. And what we believe is that there is still a very high desire for both the patients with prostate cancer and their physicians to have another treatment option available — an oral treatment option available that doesn’t require referral to a different specialist to treat after resistance to enzalutamide or abiraterone develop. So we’re remaining confident that we have a commercially viable and clinically important indication here in the prostate cancer continuum.
