Hank Fuchs: Yes. So I think the first part of your question was about VOXZOGO requirements for full approval have clearly aligned. We have a very specific understanding what the agency as the requiring to full approval. And we haven’t really given specific time line guidance largely for competitive reasons, although we do think that we are meaningfully far down the road, having initiated this Phase 3 trial a while ago. To be able to follow patients to a final adult height that I think would scratch the agency’s itch to confirm their determination that AGV is an intermediate endpoint. So, feeling pretty good about that and feeling pretty good about the time line of that. On the prophylactic steroid study, I think a key reminder there is that this study is — so still underway, and we don’t have a precise date yet for when we’re going to share the information with you.
But the concept was twofold. One wants to evaluate weather starting corticosteroids therapy prior to the initiation of the liver inflammatory response, whether that could lead to a higher Factor VII expression initially — that was one key part that’s being tested. And just to remind you that as part of the story of the first bit of few patients we have treated trying to understand whether the difference in the Phase 1 results and the Phase 3 results has anything to do with the corticosteroid regimens. So one part of the study is to address that question. But the other most important part of that is to see if that in simplifying the corticosteroid regimen and evaluating overall durability, whether there’s an even simpler approach to take with corticosteroid management.
And I think it will take probably a few years actually for that story to really fully be understood. So, early days in the journey around prophylactic steroids.
Operator: And our last question comes from Josh Schimmer from Evercore ISI.
Josh Schimmer: For the patients in Germany who are undergoing the AAV antibody screening, do you have an estimate for how many will be eligible and how many would drop out? I think in the U.S., you’ve said it might be around 20 to 25% of patients who failed the screening criteria. And then for those patients who fail, are they going to be eligible for the AAV5 existing antibodies trial that you’re running? And when might we get those data?
Jeff Ajer: Hi Josh, I’ll start. We have published data on seroprevalence in our key markets, and that’s guiding our overall thinking. We are not allowed to get patient-level information in Europe due to GDPR. You’re aware of that. So we’re really blocked except from some aggregate data. With 10 patients going through the CDx testing process, that’s a small end. I don’t know how that’s going to line up against a larger population when we get there.
JJ Bienaimé: I will also I add, the U.S. is around 25%, correct, remember. But what we did when — we did some analysis on AAV5 seroprevalence around the world, Germany was higher, was more like 35% plus. So, there are differences around the world in terms of AAV5 seroprevalence. And on top of that also some patients might not be eligible for all the reasons that AAV5 antibodies are like, for instance, they could have active liver disease or kind of stuff. So, Hank?
Hank Fuchs: And as far as eligibility, yes, these issues could conceivably subject to other eligibility criteria. But yes, they would be eligible for a trial in the AAV5 study that we have up and running.
