Ashley Cordova: This is Ashley. Maybe I’ll start with a market sizing update with the data [indiscernible] and then I’ll pass it over to Frank to provide some additional clarity on the commercial opportunity METIS. I do for the avoidance of doubt, though, within pancreatic want to say that we have always had the PANOVA-4 trial ongoing. So that is part of our ongoing pipeline and one we’re very excited about and committed to as a part of our long-term strategy, but there’s no update there. That’s just a successful open and enrolling trial. With regards to the market size for METIS, this is a very significant opportunity. 25% of patients have a brain mets diagnosed — brain mets at diagnosis of non-small cell lung cancer, and approximately 50% of non-small cell lung cancer patients will develop brain mets at some point over the course of their disease journey.
So it is a very large population. But admittedly, it is also a very heterogeneous patient population, and a patient population who was having to focus on both treatment of the primary tumor and systemic therapies at the same time as managing the mets. So we are recommending that you take a conservative estimate, there’s not a lot of precedent for systemic therapy treatment and brain mets. And as we noted, there are few companies that go in this space. So we recommend you’re conservative. And in the K we are recommending that you model 16,000 patients annually in the U.S as an opportunity set. We’ll start there, and then I think we’ll be able to explore how that can grow. But that’s what we’re anchoring to for your expectations.
Frank Leonard: Yes, I will — this is Frank. I’ll add some color just in terms of what we’re hearing from our customers in reaction to the data. It’s been a very strong reaction. It’s positive in [indiscernible] and I think, highlight that it was accepted as a late breaker at ASCO. So we’ve seen the PIs who are part of the study, as well as some of our customers who treat glioblastoma reach out with engaged interest here and see this is an area of high unmet needs.
Operator: Thank you. One moment for our next question. Our next question comes from Vijay Kumar of Evercore ISI. Your line is open.
Unidentified Analyst: Hi, its Kevin, on for Vijay. Thanks for taking our question. Just a follow-up question on your meeting with the FDA. The FDA explicitly indicates the need for an ad hoc panel at these meetings and is there opportunity for the FDA to come back and [indiscernible].
Bill Doyle: Thank you for your question. So the FDA can do many things. But in principle, when there is a panel, we [indiscernible] state that we were supposed to know about it. And during the meeting the panel was not mentioned as an option. So we still believe that we will not have a panel.
Unidentified Analyst: Got it. And on [technical difficulty] it looks like the data is now expected in the second half of this year. What change versus the prior expectation of fourth quarter.
Bill Doyle: Yes, so nothing’s changed. So the — we are in the stage we announced when the trial — this was built by the way we announced when the last patient was in. This is a trial that’s designed to read out 18 months following the last patient in, we are still on track to read out after the data are cleaned. So there’s been no change in the expectations for PANOVA.
Unidentified Analyst: Thank you.
Operator: Thank you. One moment for the next question. And our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open.
Emily Bodnar: Hi, good morning. Thanks for taking the questions and congrats on the progress. I’m curious if you could provide any timing for potential PMA submission based on your METIS study. And then separately [ph] any potential new indications that you’re kind of looking to advance into later stage studies now that your major Phase 3 studies are kind of coming to an end? Thank you.
Ashley Cordova: Emily, I think transparently, it’s too soon on both of those points. So the METIS data is very fresh. We’re doing the analysis now looking at a range of options given our current indication footprint and where we would like to go with that disease. So it’s simply too soon to comment on timing. We will update you all as we have more news. And I would actually offer that same message on our pipeline, we are committed to executing the pipeline commitments that we shared last year, and that strategic prioritization that we shared in November. So that is clearly advancing the GBM opportunities to extend survival in GBM with our TRIDENT trial and our KEYNOTE D58 trial that is continuing to invest in lung and it is also focusing on pancreatic cancer. We know we won’t be done there. This is a platform therapy, we believe that has significant broad applicability, but that’s what we’re focused on today. And we’ll come back with further updates as we happen.
Emily Bodnar: It makes sense. Thanks.
Operator: Thank you. We have no further questions at this time. I’d like to turn it back to Bill Doyle for closing remarks.
Bill Doyle: So thank you, everyone, for joining this morning and your continued interest in NovoCure. Q1 was a quarter of real executional progress. We’re very pleased with the milestones achieved, including, of course, METIS hitting its primary endpoint and our acceptance as a late breaker to present the first analysis at ASCO. We are very pleased as Asaf described, with our 100-day meeting at the FDA, and where we stand in the regulatory process both in the U.S and Europe. TRIDENT is a very important study for us. And we’re pleased that enrollment is complete, and we’re now in the in the timing period to releasing those data. As always, working with the FDA when we achieve a milestone like the IND approval for D58, that’s a very important milestone in terms of getting that.
