Jan Mikkelsen: Yes, we are planning to give you this data. And we think is extremely, extremely important to give you this data where we see the continuous effect of Ascendis Pharma’s TransCon CNP, because I’m still in this extremely struggling manner. And this is what we really had got a lot out of analyzing all the data for our ACcomplisH trial to find out why they’re staying 100% on this treatment, and we starting to get a much, much better understanding of that. And this is why we now are discussing the regulatory agencies how we can have other secondary endpoint that’s really are reflecting how we are addressing really the comorbidities and not just linear growth. Linear growth is not really the biggest issue for this patient group, they seek the comorbidity and other effects of disease.
And this is why we believe TransCon CNP is a unique product because it have continuous exposure of the CNP molecule and therefore changing things that is not only related to linear growth.
Operator: Our next question will be coming from Ahmad of Bank of America .
Tazeen Ahmad: As it relates to HPT, can you just give us an update, if you haven’t already, on how many patients you’ve enrolled in the Early Access Program so far? And do you have a sense of how many patients will be enrolled in that program by the time of the PDUFA and then following with the launch?
Jan Mikkelsen: I think that is an extreme — first of all, we are extremely pleased with how the program is progressing and our regulatory interaction, and also that we got approval to start an EAP program with give the opportunity to get patients under the treatment before we get the expected approval. We are executing on that, really starting the entire system. And we will explain when we come to the approval process, what is the number of patients we will have in this trial, and also how we continue with patients.
Tazeen Ahmad: Maybe just a follow-up then. Would you expect that to be an early source of patients to convert to commercial?
Jan Mikkelsen: I just think we are addressing a key element in the EAP program. We are addressing the patient group that already were experienced with a PTH treatment regime, a short acting PTH treatment. It could be the , it could be , it could be or someone else, but that was exactly what we’re addressing. The vast population where we basically recruited patient to our Phase 2 program and our Phase 3 program, they’re coming from what we call patient that never really had been exposed to PTH treatment. So I don’t see — that is really, really a differentiation between these two patient groups. I think both patient groups have the same high unmet medical need, they have the same benefit of the PTH treatment. So I don’t see any kind of difference between these two groups related to be firestarter in our programs.
Operator: Our next question will be coming from to Tazeen Ahmad of Bank of America.
Tim Lee: I think she just asked the question, so I’d go to the next one.
Operator: The next question is coming from David Lebowitz of Citi.
David Lebowitz: As the PDUFA date is approaching, could you give us any insight into what the label might ultimately look like? I know that NATPARA was considered an adjunct, you seek to be going more as a hormone replacement, and NATPARA has the presence of a blackbox for osteosarcoma, but you didn’t really have an osteosarcoma experience. So could that blackbox be removed? Just be curious to hear your thoughts.
