Ed White: Okay, great. Thanks for taking my question.
Operator: Our next question comes from the line of John Thome with TD Cowen. Please go ahead.
Unidentified Analyst: It’s Joe. Thank you for taking my questions. Maybe the first one, just on the overall geographic differences, I guess, is there a — when you think about expanding new sites, do different regions kind of handle the care of these patients differently so that, that might be a potential risk when expanding to new territories? Or is the enrollment criteria sufficient enough that kind of streamline things? And then second, patients aren’t allowed to have bevacizumab before entering the study. I guess over portion of patients do have bevacizumab in the overall population, I guess, is this a headwind for enrollment? And when you think about the commercial opportunity what does that sort of shake out like? Thank you.
Mike Andriole: Thanks. Allen, do you want to talk about how we’re assessing sites and different standards of care in harmonizing that?
Allen Melemed: Absolutely. Thanks, Mike. That is definitely one of the consideration and look out at the center that we’re picking. We’re only picking centers that have the ability to do the proper neurosurgical approach the proper radiation therapy and then a proper follow-up. As you know, the standard of care in this patient population is that surgery and radiation, and that’s it. However, we need to make sure these are qualified centers that can actually follow these patients and have appropriate care. And that is a very critical assessment that we use to that, whether the center we want that we will choose. We will not choose center that we do not think have that kind of standard. In regards to bevacizumab, most of these patients don’t come off of that. Actually beva is not allowed on this. We do allow for a concurrent Temozolomide, though there is a washout we know that patients need to be off of that prior to starting the ACTION study.
Unidentified Analyst: Great. Thank you very much.
Operator: Our next question comes from the line of Soumit Roy with Jones Research. Please go ahead.
Soumit Roy: Good morning, everyone, and thank you for providing the details on that progress. One question on the ONC201. Are you seeing the screening versus from the screening versus enrollment data, still at 30% of the midline glioma to be H3 K27M mutation? And in U.S. versus ex U.S., are you seeing any difference in the treatment regimen prior to enrollment or they’re fairly similar?
Mike Andriole: Allen, do you want to talk about those geographic differences, if any?
Allen Melemed: Yes. So one of the main difference that we do see is there is a higher utilization Temozolomide outside the U.S. In the U.S. population Temozolomide is used more in the adult population and not as much in the pediatric. It’s used a little more frequently in outside the U.S. However, there has been very little concerns about stopping this after they receive the current radiation therapy.
Soumit Roy: Okay. You are still seeing from the screening versus enrollment like about the mutation person mutation rate is still in line with your prior expectations?
Allen Melemed: Yes. So the — what we’re seeing is on part of what our expectations are.
Soumit Roy: Okay. Prior to the top line data next year, would you be giving us following full enrollment, would you be giving us some baseline characteristics of these patients enrolled, like tumor size, size of the tumor, any co-mutational status?
Mike Andriole: Allen?
Allen Melemed: Can you repeat your question? I’m not following what you’re asking here.
Soumit Roy: Prior to the data update next year, the top line data, would you be providing us any granular details on the patient characteristics being treated like size, tumor size, the size of the tumor, or mutational status? Or will these all come out after the top line data is announced?
Allen Melemed: Thank you, Soumit. I think that will all depend on how we plan to release this. So as you know, since this is a double-blind study. The only thing we’ll be able to look at would be aggregate data, which would be all three arms combined. And that data, we could potentially discuss so that is something we have to discuss internally how best to share those results. But we will not be able to look at a per arm evaluation until we actually share the results.
Mike Andriole: Yes. I’d just reiterate Allen’s commentary that we won’t know that in advance at the ARM level, Soumit. And so it’s likely a level of detail that would come out when full data is disclosed following top line data, we’ve had a chance to analyze it.
Soumit Roy: Totally understand. And one last question. So much interest in the ex U.S. territories. Would you be considering any business development or partnership activities in the near future?
Mike Andriole: Tom?
