Jan Mikkelsen: I think when we look on the biology and the product design of TransCon PTH, we are providing a stable physiological level of PTH 24 hours, seven days a week. We are not providing any hyperphysiological concentration of PTH that can provide to the anabolic effect that in animal model have been associated with the osteosarcoma specific to rat model. And from that perspective is that and also why we got a waiver to make a carcinogenic trial or animal trial, we will not expect and we have not seen any indication in our labels discussion that we will be coming in the same, you can see, group of short acting PTH that basically got the same class labeling, because we are providing a complete different product profile than the short acting PTHs. So to our best knowledge today and in our discussions, we don’t expect any REMS program or we don’t expect any blackbox warning.
So that was your first question. And you’re quite right. How we designed TransCon PTH was really to prove a product profile that was reflecting hormone replacement instead of an adjunct. That’s why to be successful in the clinical trial you need to stop 100% from active vitamin D and you also need only to take calcium supplements that really are just reflecting a normal multivitamin from . So we are really addressing a complete different product profile.
Operator: And our next question is coming from Li Watsek of Cantor.
Li Watsek: I guess for TransCon PTH, just wondering if you can share some of the latest feedback that your sales team maybe received from payors and physicians? And then maybe talk about your latest thoughts on how you might approach pricing and market access?
Jan Mikkelsen: When I think about the patients, when I think about this physicians, the measures have not been different for the latest. Everyone recognize that hypopara is a serious disease and everyone understand the benefit of replacing a missing with a physiological level 24 hours, seven days a week. How it both address short term symptoms, like quality of life, urinary calcium but also long term risk. And what we’re seeing is that the awareness of that is being building up much, much more about the awareness of the disease. And I believe this is where we come in with our indication, first telling about the awareness of the disease, which are really a big part of what is happening today with all our established infrastructure here in the US.
And after an approval, we can go out and explain how we can benefit this kind of disease, both short term and long term. So I really, really, really feel that we are right. What we did with SKYTROFA is the guidance we do with always our product. We develop best in class products, addressing real unmet medical need. And we take a premier responsible pricing situation where we believe if you really develop a product that really address a real unmet medical need with a real product, that is enough for both the patient, the physician, the society and the payor, for us to share that cake, because then everyone is winner, no one is loser. And this is where we want to be with each of our products. We need to have them so highly differentiated, addressing a real unmet medical need and everyone believes it’s a win for everyone, and we can see that with TransCon PTH.
Operator: Our next question is coming from Paul Choi of Goldman.
