Friedrich Finckenstein: Yes. So the projection of accomplishing the analyses is hard, particularly when you are in the early phases of startup. I think we will better understand that once we are in make progress on enrollment and site activations. Also keep in mind that ultimately the endpoint particularly the TSS endpoints are event driven and a true and exact projection is never really truly possible because of that. So stay posted on that. The repeat the second question about the study please. Yes, you were saying that this is an open label study, it’s actually not, it’s a blind study. So we are blinded to the treatment assignment as we would in any other study design, the assessments are done by a blinded independent radiology committee. So there is probably no update in between other than as the final decision is being made by the CMC.
Karina Rabayeva: Okay. And also, I have another question. You said that you did not expect to get REMS, is that probably the case?
Fred Vogt: Yes, that’s the €“ we don’t see any reason why we will get REMS, the total treatment regimen, Cy/Flu and IL-2 don’t have REMS today. So TILs don’t really carry any safety issues themselves. So we don’t see €“ we don’t have the issues that you see with some of the CAR-Ts that triggered the REMS in those cases.
Karina Rabayeva: Okay, thank you.
Operator: Thank you. Our next question comes from the line of Madhu Kumar from Goldman Sachs.
Unidentified Analyst: Hi. This is for Madhu. Thanks for taking our question. Just how should we think about the timing of data from cervical cancer cohort? And then on the genetically edited TIL products, what are you guys thinking in terms of efficacy or like where do you expect to be better?
Fred Vogt: Yes, genetically TIL products, to take that one first that combines the with a TIL product. So we are hoping to get something that would look like additive efficacy between the two modes, the TIL response and then the blockade of the inhibitory mechanism directly within the cell now. And then as we add additional immune checkpoint targets to our gene-editing, we can hopefully add on top of that too. So, that’s the basic theory behind it. We are testing that now in humans and we will know more about how that works. It’s similar in many respects to how you see a lot of people developing bispecific antibodies right now that blockade PD-1 and something else. I mean, this is the kind of thing that we want to do within the cell.
And so the first the PD-1 knockout is the first one that’s in humans right now. We will have more updates on that for you later on this year. Cervical, we just restarted enrollment in that study. And that’s a pivotal study. We intend that to be a pivotal study. And so we don’t have an update for you today on that. The post PD-1 cervical population is large enough that we think we can enroll it reasonably well, but we will know more later this year on that. Thank you.
Operator: Thank you. At this time, I would now like to turn the conference back to Fred Vogt for closing remarks.
Fred Vogt: Thank you again for joining the Iovance Biotherapeutics fourth quarter and full year 2022 financial results conference call. We have had an exciting start to 2023 with the Proleukin agreement and new clinical data. And we look forward to completing the BLA this quarter and delivering on our regulatory commercial manufacturing pipeline activities and milestones throughout the year. I am grateful for the patients, physicians and regulators as well as our employees and cross-functional teams who have worked in close collaboration to advance our mission to be the global leader in co-therapy. I’d also like to thank our shareholders and covering analysts for their support. Please feel free to reach out anytime to our Investor Relations team for any follow-up. Thank you.
