Ascendis Pharma A/S (NASDAQ:ASND) Q4 2019 Earnings Conference Call - Final Transcript
Apr 01, 2020 • 04:30 pm ET
Thank you. [Operator Instructions] Our first question comes from the line of Jessica Fye with JPMorgan. Your line is now open.
Great. Good afternoon, guys. Thanks for taking my questions. I have two. First is on growth hormone, second is on PTH. First on growth hormone. Have you heard back from Pitco on your pick and if not, when do you expect to hear feedback from them. Second is for the PaTH Forward topline results, will you tell us the proportion of patients who met each of the individual components of the composite primary endpoint. I think in prepared remarks, you mentioned that you're most excited to see the proportion of patients able to withdraw from standard of care. Is that a result that you will provide in addition to the primary endpoint. Thank you.
Jan Moller Mikkelsen
Thanks, Jess. Thanks for the question. I will start initial and then, Dana, she will take over. So let me start with a little bit about the PIP, one of my love story cornerstone because I am from Europe and it has been really interesting for me to talk with a lot of U.S. investors about PIP and what is very meaningful a PIP and what is the entire procedure for PIP. So I have to think this is really great it's coming up again and I have to say I was really extremely positively surprised, because if I look on the traditional way that how the PIP committee have dealt with the long-acting growth hormone that just giving a waiver meaning is that basically have said that we don't believe that is really providing a benefit to current therapy or it could be potentially looking on a safety perspective or other things like that. So all other long-acting growth hormone to my knowledge that either have been done with protein infusion or other things like that, some some of them was permanent pegylated or anything, got just what we call it PIP waiver. And this is basically not a great thing to have when you're basically have a pediatric program. So from our perspective, PIP waiver is very fast to get. It takes only -- this is the first interaction, you get it and what we actually observed, which was very, very positive for us was that we actually have now a constructive dialog with them how really to interact and how to make a program that also fullfill the need for the pediatrc or the people part on it. I do not know if you have anything to add on around that, Dana.
Sure, yeah, this is Dana. As Jan mentioned, we did receive initial feedback from Pitco and basically they requested more information and what they had requested was fairly consistent with what we are planning to do with the program. So until -- and we have submitted the responses to the Pitco questions at the end of of March and so we are waiting to hear their assessment of that. Again the