Geoff Meacham: I had one clinical and one commercial on ROCTAVIAN. I guess, Hank, for the three-year data, is it just having to go through the details, for example, in all the case reports or was there any real new information at the three-year time point? I guess I’m trying to figure out on what the hurdle is that constitutes a major amendment in your view. And then commercially, just a follow up on the last question. When you think about testing being a gating factor in Germany. Is there a strategy to maybe to streamline this? And are there lessons to be learned in Germany that you can roll across the big five and broadly across EU that may help onboard patients a little bit more efficiently? Thank you.
Hank Fuchs: Yes. Hi. Geoff, it’s really a subjective assessment as to whether any submission constitutes a major amendment. And I can’t really give you any kind of guidance one way or the other about how to interpret any action they do or don’t take at this point, it would be all speculative. I mean it’s — we’ll let you know if we hear that it’s going to be amended and otherwise, we’re going to stay preferably quiet.
Jeff Ajer: And over to the companion diagnostic question, this was certainly a learning set for us in Germany. In fact, optimally, we would have preferred to see patients coming through for companion diagnostic testing faster and in more numbers. And had that happened, we would have used that to put as a point of leverage to put pressure on the insurers to get these outcomes-based agreements signed. The logic of the German physicians to say, well, we want to make sure that patients have access to commercial ROCTAVIAN before we push them through for companion diagnostic testing and the reality, which we knew was that German physicians would bear some financial responsibility potentially if they were prescribing and treating with ROCTAVIAN before these outcomes-based agreements supporting reimbursement were completed.
It makes logical sense but it reduces the pressure on the health insurers to act. So, how could that apply to other key markets in Europe? Probably not very much because if we took France and Italy as our priority other strategic markets in Europe that we’re really focused on, the reimbursement process takes about a year to get through. So, we’re anticipating we could have reimbursement approved in Q4 of this year. And really, in those markets, we have to have the reimbursement in place before we can start promoting and moving on patients. So, it’s a different environment that we will be working through in other markets in Europe.
Operator: And our next question comes from Phil Nadeau from Cowen and Company.
Phil Nadeau: A couple of follow-up questions on German reimbursement and then one on the U.S. for ROCTAVIAN. In terms of the outcomes-based agreements, Jeff, it sounds like what you’re saying is anything that is negotiated now will sort of be almost invalidated when there’s federal reimbursement that will be retroactive to March 15th. So I guess we’re kind of curious why would one of these bureaucratic insurers spend the time and effort to negotiate something if it’s not going to be relevant for them much longer? And what implications would that have on patients starting on therapy in Germany over the next couple of quarters before you are within a short period of time from federal reimbursement being clear? That’s the German question.
Then in terms of the U.S., Hank, are there any guidelines as to when the FDA needs to let you know whether the submission is deemed a major amendment? Can they go right up to the PDUFA and send you a letter than that before, or is there a certain amount of time before PDUFA they have to let you know? And then also in the U.S., when you guys know when you’re labeling discussions?
JJ Bienaimé: Now we start with Jeff.
