Fred Vogt: No, we haven’t had any additional interactions with them. We do expect to have priority review for this and we will know more about in AdCom at some point. We have spoken before about whether an AdCom is likely here, it’s possible we may not get an AdCom, because it is familiar with T-cell therapies at this point. Raj has talked about that a few times on calls like this. With respect to the work and a little bit more color on the work, it’s, like I said earlier, it’s largely validation activities leading to some of the CMC stuff that we do, that’s part of our filings. I can tell you the bulk of the work for the BLA is done and submitted. So we are on the homestretch now and we are just completing some of these key tasks that takes a lot of effort from the company.
We have a lot of people here working very hard to get this done and really, it’s not the kind of thing where it’s extremely technical in nature, it will be very difficult to communicate with the Street on this, but it’s basically a lot of additional CMC validation activities, like we have spoken about before.
Unidentified Analyst: Okay, thank you.
Operator: Thank you. Our next question comes from the line of Ben Burnett from Stifel.
Ben Burnett: Great, thank you. I want to just ask about the launch preparations for lifileucel. Can you remind us just how many melanoma treatment centers in the U.S. you have already sort of onboarded, wherein sort of you feel that you have sufficiently trained all the necessary stakeholders at a particular clinical site? Like how many clinical sites have you onboarded as per all of your clinical trial activities to-date?
Jim Ziegler: Thanks, Ben. This is Jim.
Fred Vogt: Go ahead, Jim.
Jim Ziegler: Great. So the onboarding process is exactly that it’s a process. We have engaged a number of key types across the country to ensure that we have sufficient geographic coverage as well as access. I won’t give you the specific numbers, but what we have stated in the past is, based upon our own assessment, looking at analogues like CAR-Ts, we know that there is a heavy concentration of care at these top centers. In the CAR-T market, about 10 centers drive about 50% of all the treated patients and the top 40 about 80% of all the treated patients. So we are focused on getting the right sites up into our targeted and up ready for launch. We want to train them in the final phases of launch. If we train them too soon, there could be staff turnover, there could be the recency.
So what we are really doing is lining everyone up now? And as soon as we have the BLA acceptance, well BLA filing and acceptance, then we will start to really accelerate that final onboarding process.
Ben Burnett: Okay, understood. That makes sense. And then I want to ask just another question about the timing of data from the CRC program, in particular, the expanded CRC program in the post-chemo post-pembro setting. I guess, number one, do you have line of sight as to where we can get data? And then have you said how many additional patients needed to be enrolled there to kind of support BLA in that setting?
Fred Vogt: I think, Ben, you are not talking about colorectal, you are talking about non-small-cell lung, right, you said CRC right. Yes, you meant CRC right. So I assume you meant non-small-cell lung, you got cut off there.
Ben Burnett: My apologies. I said the wrong indication.
Fred Vogt: Yes, we don’t have an ovarian indication at Iovance right now, although it’s certainly something we are very interested in and we have explored through IFPs.
Ben Burnett: Okay, my bad. I mistook that for a different program?
