Their enthusiasm, I think, will carry this. That having been said, there is a point at which we’ll be evaluating in the coming weeks and months, plans to, again, driven by data, potentially accelerate that, but certainly plans for the next phase of trials that would expedite a regulatory approval process. So that planning will happen here in the coming months. This response certainly triggers and puts us on our toes in that regard. I don’t know, Mike, if you have anything to add to that?
Mike Andriole: Not much, Mike. Just reinforce. Certainly, that response has us engaged significantly on the program, and we’re looking carefully at other measures of activity. And as Mike said, that certainly raises the bar as we look at external innovation as well. We continue to have a broad evaluation and search process for that. But clearly, this response, particularly in a patient without the H3 K27M-mutation is €“ raises the bar for that. In terms of capital allocation, in the near-term, probably no change in capital allocation in the near term. As Mike said, we continue to leverage external capital for the ongoing Phase I work and we’ll carefully evaluate the dose escalation and intensification during this year. And certainly, that could evolve into more capital allocation to this program and company-sponsored studies in the future. So €“ and we’ll be on the lookout for that, and we’ll update you accordingly.
Kevin Strang : Great. Thank you.
Operator: Joseph Thome with TD Cowen. Your line is open.
Joseph Thome: Hi there, good morning. Congrats on the news and thank you taking our questions. Maybe the first one on ONC201, just to kind of get a good handle on the expectations for the cadence of how we’re going to see some of these readouts. So, is it your expectation that, that PFS readout would come between the first and second OS interim look sometime in 2025? And maybe based on your conversations with the agency ahead of starting that Phase III study, what’s sort of your impression that you would be able to file for accelerated approval on this PFS endpoint, and then maybe wait for the second OS interim and final OS, either during the review or to be confirmatory? Thanks.
Mike Sherman: I’ll start that. And Allen, you can add on to it. First of all, you’re right about our expected time lines for the PFS would likely occur between the first OS and the second OS interim. And so, as we have not explicitly and frankly, intentionally have not asked the FDA about their view on progression-free survival as a basis for accelerated approval. And the reason is, you know what the answer is going to be, it will depend on the data. So, I think if it’s a positive outcome, we would plan on submitting it. And of course, they would, I imagine, take an early look at the overall survival status and at least look for supportive trends in that and then be part of their decision-making process. So, it’s our plan that we would move ahead with that submission based on the data we would see if it’s positive. Allen, if you want to add anything to that?
Allen Melemed: Hi. This is Allen Melemed. Just a couple of things. Just to reiterate, progression-free survival is in gating analysis that we intentionally did for this trial. So, if positive, it will be powered for a claim of significance. You’re correct on the timing, which is around 2025, obviously, depending on enrollment rates and event rate. I think the last thing I’ll mention is the ability to submit on PFS is very much aligned with Project Front Runner, which is a project that FDA has, which is looking at sponsors submitting based on an interim Phase III trial with the ability to convert to full approval based on the final results of the study. So, my interpretation is that this is entirely consistent with that project and has a good likelihood of meeting those requirements. Of course, we need to see when we have the data at the time if we’re able to move forward.
