We add physicians, new physicians, and it does get back to what Jeff said earlier around finding the patients. Again, there’s 6,000 to 7,000 of these patients being treated by 10,000 physicians. So it’s always a matter of being in the doctor’s office at the time that they identify that patient. But thanks for your question. I hope that helps.
Matt Kaplan: No, that’s helpful. And then just a question on 102, given the expectation for top line data in the middle of this year, 2023, can you elaborate more on the regulatory timeline for the product and the rate limiting step, whether it’s CMC or long-term follow up? What’s going to €“ what’s the rate limit step as to apply it for you?
Liz Barrett: It really is durability. Waiting for durability, the agency was very clear and we’ve talked about that as well, that durability is very important. So even though complete responses are primary endpoint, a key secondary endpoint is durability. And the FDA wants to see some strong durability data. So we have to wait until, remember, we look at CR after three months from the time they started therapy, and then we need all of those patients to have a minimum of 12 months. The good news is, obviously some of them will have more than that. And that was the strategy we used with JELMYTO is we didn’t wait for everybody to have long-term follow up, but we were able to go in there with the majority of them. For 102, we’ll wait for everybody to have 12 months post their CR and that will give us some strong data in which to go forward to the FDA.
So that’s really what’s driving the timing. CMC knock on wood in this case, because it is so similar to JELMYTO, we don’t really foresee any issues there. We think that will go very smoothly. And so it really is just a matter of the clinical data and getting that the database cleaned, once we get the durability and having that data to go forward. So we haven’t given a time exactly of when we’re going to file. And I’ll let you know, it is also an event driven study, right. So in addition, we have to know, we have a certain number of events as well. And so that’s what will drive it. So we’re comfortable saying 2024 and we’re comfortable saying that, if given priority review, we could potentially get at the end of 2024 or beginning of 2025.
Matt Kaplan: So durability data, first half of 2024, is that the expectation?
Liz Barrett: Well, yes, exactly. Absolutely.
Matt Kaplan: Okay. Thank you. And last question in terms of 301, what will you be looking for on the data 301 when that reports out later this year?
Liz Barrett: Yes. Mark, you want to talk about 301?
Mark Schoenberg: Yes, sure. Thanks, Matt. So what we’re currently doing is dose escalating 301, and that obviously is predominantly a safety experience for the appropriate dose. So the initial finding is going to be the appropriate dose. Subsequently our plan is, I think and others do is to combine this with other immunomodulators and chemotherapeutics. So ultimately though, those data will not be forthcoming this year, hopefully in the near-term we’ll be able to share combination data that would provide evidence of efficacy in this high grade population, which is obviously different than the JELMYTO and UGN-102 populations we’ve been focusing on. But for right now what we’re focusing on is finding the appropriate dose and demonstrating safety.
Matt Kaplan: Thanks a lot guys.
Operator: And thank you. And one moment for our next question. And our next question comes from €ªAJ Velasquez Mao€¬ from Jefferies. Your line is now open.
