Roger Song: Great. Thanks for the update and taking our questions. A couple from us. In terms of the interim analysis now we have two. Maybe can you let us know, I understand you are not going to be providing the guidance right now. But at which interim analysis, if at all, you will contextualize the efficacy against the FDA statistical hurdle or the standard of care you have been providing to the FDA as the benchmark? So we can know in each interim analysis, the efficacy or the ORR will be reaching the goal you want to achieve?
Dave Lennon: Thanks for the question, Roger. I’ll take this one. It’s important to note that this interim that we’re presenting in December is based on one-third of patients enrolled and minimum of four and a half months of follow-up. It’s also investigator-assessed ORR, so this is not the primary endpoint of the study, which is independently assessed overall response rate. And the second interim is actually based on the primary endpoint, and it will be at that point, we would be testing against the statistics of the plan.
Roger Song: Got it. So, in the second – the interim analysis, you will do the primary endpoint analysis will be that at the point you will let us know what’s the hurdle for that? Or you would just let us know, okay, we are not stopping the trial and we’ll continue for the full data?
Dave Lennon: Yeah. We view the hurdle to be something that is a review issue, and we probably wouldn’t talk about that at that point in time, but rather give a sense of what the efficacy measures we’re seeing are and whether – where we are with the trial in terms of continuation.
Roger Song: Got it. Thank you. Maybe just a quick follow-up.
Dave Lennon: Yeah.
Roger Song: Yeah, a quick follow-up on this is that, you say you will complete the trial by the end of 2024. And when should we expect the full data from the trial? Thank you.
Dave Lennon: Yeah. It’s roughly at the end of 2024 or early 2025. We anticipate it’s probably more like the early 2025 at this point, but we’ll give a further update once we complete enrollment.
Roger Song: Excellent. Thank you. That’s it from us.
Operator: [Operator Instructions] Our next question comes from Ahu Demir with Ladenburg. Your line is open.
Ahu Demir: Good morning, team. Thank you so much for taking my questions. Two questions from us. First one is regarding the Triple Meeting Presentation. It looks like p53 is the most frequently observed comorbidity. Curious how that might impact deep comorbidity, how they might impact the trial activity? And during the interim analysis, will you disclose the other mutations in the patients? Or is it going to be more high level?
Dave Lennon: Yeah. So, I’ll take a first crack and Loretta back me up on this. TP53 is the most common co-mutation that you see in that analysis for patients across 440,000 cancers that we looked at. And our internal calculations when we look at those distributions indicate there’s potentially 16,000 new cancer patients each year with either TSC1 or TSC2 mutations. About 50% of those, if I recall, the data correctly, had co-mutations in p53 and although that while high overall is very consistent with what you see across all tumor types and all types of cancers. TP53 is the most common co-mutation in general for different types of tumors. And so, it’s not different from what you might expect overall. And given that we’ve seen responses to patients with TSC1 and TSC2 altered cancers in the past in the retrospective analysis that became the basis for PRECISION 1 and PRECISION 2.
We wouldn’t expect it to necessarily negatively impact the trial in any way, and we believe it would work within that context. And Loretta, I don’t know if you would add anything to that?
Loretta Itri: No, I think that’s entirely correct. I would have answered it the same way.
