Again, it increases the market significantly. We’ve got more than 3,000 patients a year in Germany dying from melanoma right now and equally bad numbers in France and the U.K. and elsewhere. And then we’ve also got Canada in play here, and we’re going to look at Australia as well as we’ve mentioned, too, we’re well over 1,000 patients you’ve dying in Australia of melanoma. The demand for TIL therapy in these jurisdictions is very high. We have clinical sites there. We know the physicians very well, and we’re very comfortable with launching the product there. We think it can be successful just like the CAR-Ts are.
Operator: Our next question comes from Yanan Zhu with Wells Fargo.
Yanan Zhu: Could you give us a sense of how the review is going? Have you had the late cycle meeting? Have you had any labeling discussions? And also, could you talk about your perception of the agency’s resource — the resources allocated to the review and whether the previous constraint has improved? And then I have a follow-up.
Frederick Vogt: Raj, would you like to take Yanan’s question? I think, Raj, is on the line.
Raj Puri: Yes. I’ll take that question, Fred. Thank you, Yanan, and thank you for the question. The review is coming along very well. We have been getting IRs and providing all the responses to the agency. Our late cycle meeting is planned. We will announce when that has happened. There are no other additional issues currently that the resource issues seem to be have been under control, and we are expecting that our BLA would be approved perhaps before the PDUFA date in January, sometimes in January, the PDUFA date is February 2024.
Yanan Zhu: And could you elaborate on the estimate of January? Is there anything for us to further understand here?
Raj Puri: Yes. So the FDA likes to approve products with the unmet medical need, at least 4 to 6 weeks prior to PDUFA date, as they have done with — on all CAR-T products and other products as well. So with that, keeping that in mind FDA will like to — they like to approve the product sooner before the PDUFA date. So we are expecting the same for the Lifileucel.
Yanan Zhu: And then my follow-up is about the number of centers and manufacturing capacity. So great to hear that you have 30 centers virtually ready to go. And by the time of approval, I assume you might have additional centers ready to go. And the question is, would you have any capacity limit that you might place a cap on the number of manufacturing slots at each of these early centers? And my other question is whether you can foresee that you might onboard more than 50 by the time — by 90 days after the approval? And would your capacity allow that?
Frederick Vogt: Yes. Yanan, let me start then maybe Igor can help out here. Yes, obviously, you’re aware of our facility. It’s a very large facility. It’s got capacity as built today for the 2,000-plus patients. FDA is the final decider capacity with cell therapies. So we can’t really say what’s going on until we got the feedback from FDA as part of the approval process at the very end, we’ll find out more about that. We did announce, as you saw, that we anticipate 50 ATCs within 9 days of PDUFA date. It’s possible we can go beyond that. We have to see right now, that’s a pretty large launch. It’d be the largest launch ever for cell therapy. So it’s pretty aggressive. But let me turn it over to Igor for just some comments on the capacity and our ability to scale up between our own facilities as well as our contract manufacturer.
Igor Bilinsky: Yes. Thanks, Fred, Yan. Thanks for the question. So first of all, as I mentioned earlier, the FDA completed pre-license inspections at both sites at our ICTC facility and contract manufacturing facility, both went very, very well, and both were successful. So both sides, our ICTC site and the contract manufacturer site are preparing for the launch and also producing clinical material. The exact capacity, as Fred mentioned, will be determined by what capacity the FDA allows. We’ve been hiring and training the personnel at what we have been and our contract manufacturing partner has been as well in preparation for launch. But again, the exact capacity of launch we’ll know, hopefully, in the next several weeks as we get to approval.
