It’s fairly typical too in that situation, then go with a non-overall survival endpoint and we are particularly happy about having an agreement of being able to use ORR and PFS as dual endpoints in our discussion with the FDA. And that’s exactly the reason for it. The value of the crossover arm in this case is outweighing potential impact on the overall survival of the secondary endpoint.
Mara Goldstein: Okay, thank you very much.
Operator: Thank you. Our next question comes from the line of Kelsey Goodwin from Guggenheim Partners.
Kelsey Goodwin: Hey, guys. Thanks for taking my questions. I guess, first regarding manufacturing, I guess how do you think about kind of initial launch capacity and then the timing for step-ups if we are kind of thinking about it similarly to what we have been seeing with the autologous CAR-T therapies, to be just a bit more granular than kind of the Phase 1 Phase 2 that you lay out for the iCTC? And then secondly maybe just a quick one, are you able to provide anymore color on your plans for potentially expanding into Europe for melanoma? Great. Thank you so much.
Fred Vogt: Yes, let me take the last one and then Igor can give you some more color on the manufacturing. Yes, Europe is something we are very interested in. We haven’t publicly spoken much about Europe, but we are active there. Obviously, our trials have been run there and we continue to run them there. And TILVANCE-301 is going to have a significant European presence. We are engaged with the European regulators. And I think you’ll hear more from us in 2023 on that. But that is an important market, we think for melanoma as well as other markets around the world where we have a high incidence rate of melanoma. You already want to answer the manufacturing question?
Igor Bilinsky: Happy to, Kelsey. Thanks for the question. So as I mentioned earlier, we have built the capacity, because the facility is built, can support more than 2,000 patients per year. And we are now hiring the manufacturing team to meet the demand that we anticipate at launch. We are not sharing the exact demand numbers, but as Jim mentioned, actually, in response to an earlier question, we expect maybe a bolus. So we are taking that into consideration as we are planning the initial launch capacity. Beyond that, we can continue hiring the staff as needed and then also build out the shelf space that we have within the existing iCTC facility that can bring us to over 5,000 patients per year. To increase the capacity step wise, there is a process that’s similar across TIL therapies, similar to CAR T that requires capacity general submissions to the agency and we are planning those as well.
Kelsey Goodwin: Okay, great. Thank you so much.
Igor Bilinsky: Of course.
Operator: Thank you. Our next question comes from the line of Asthika Goonewardene from Truist.
Karina Rabayeva: Hi, this is Karina for Asthika. Question €“ my question is for TILVANCE-301 study, how long that will take for you to finish recruitment? And given that the study is open label, do you plan to report interim data and if so, at what point? Thank you.
Fred Vogt: Friedrich, do you want to take that?
