Jeff Ajer: Yes. Thanks for the question, Phil, about the contracting process in Germany. Having these outcomes-based agreements provide a framework for CDx testing and other aspects of patients gaining access to therapy. So, there’s still value in these agreements coming together even after March 15th. The terms of the federal reimbursement will supersede but there are other aspects that add value. But you’re absolutely right. I mean, the urgency to act was probably higher in Q4 of last year when there was a substantial gap in time between then and the end of the free pricing period as we’re approaching March 15th, the urgency around those outcomes-based agreements goes down. But similarly, the risk for the insurers also goes down.
So, they’ll have the benefit of retroactively applying whatever we wind up with for federal reimbursement, which a reminder, that takes about a year in Germany to get to. So, there will be the six-month period where it will be helpful to have those agreements in place to treat patients and the risk for those insurers on the financial terms is markedly reduced.
JJ Bienaimé: If I may add, I think having also these discussions on outcome of these agreements should help in terms of the final reimbursement price for Germany in general, because if we believe that the likelihood you have a better reimbursement price at the federal level in Germany is higher if we have outcome-based agreements in place than if we don’t. So, that’s why they are…
Hank Fuchs: And then the second part of your questions, Phil, there are guidelines or desk constructions, I guess the agency might call them, around time to process submissions. But bear in mind that these guidelines are kind of lower in enforcement and visibility than, say, PDUFA. And they don’t always hit their PDUFA. So, I don’t know that there’s any real enforcement or tracking around guidelines. So, I would plan that it’s possible that they could notify us at any time. And as far as our communication, back to you of the coming milestones, we don’t plan to inform yet about when we enter — when or if we enter labeling conversations. There’s a lot of back and forth. I think the thing that everybody is trying to figure out is what the action that the agency is going to take.
We won’t know what that action is until they tell us, and then we’ll share it with you. But I do want to commend the agency around their diligence. I mean, they’re clearly working very hard on this application. We’re almost in daily contact with them. And we, like you, look forward to their decision on or before the PDUFA date.
Phil Nadeau: That’s very helpful. Thanks again for taking our questions.
Hank Fuchs: And hopefully, they don’t delay the PDUFA.
Operator: Our next question comes from Jessica Fye from JPMorgan Chase.
Jessica Fye: A couple more, sticking with ROCTAVIAN. First, how many U.S. centers do you expect to be ready to go on day one? And second, when you say the FDA’s findings of the — on the ROCTAVIAN manufacturing site are addressable, can you comment on whether they have been addressed at this point? And if not, when you expect them to have been addressed by? Thank you.
JJ Bienaimé: Maybe we can start with that, Greg, our Head of Technical Operations, can answer the question.
Greg Guyer: So thanks for the question, Jessica. So yes, we responded pretty closely after the inspection in December. There was one additional clarification which they wanted, which we gave them. And since then, it’s basically been radio silent. So, we — as Hank said, we’re in communications with the agency a lot. But we have heard nothing more since several weeks from — ago, probably late in December. So, we believe almost all the issues have been resolved. Most of them are procedural. Those SOPs and things have been updated, and we are preparing for launch.
