The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Michelle Lim Gilson - Canaccord Genuity Limited, Research Division - Analyst
: I was just wondering, can you talk a little bit about the path forward for TransCon CNP? And what is the age range of patients that you plan to enroll
in your Phase II study? And then you talk a lot about correcting comorbidities. And can you talk a little bit about how young you think that patients
may be treated in order to correct for those comorbidities? And then I have a follow-up as well.
Question: Michelle Lim Gilson - Canaccord Genuity Limited, Research Division - Analyst
: Okay. And then when you think about dose in that Phase II, when you're choosing a Phase II dose range or dose, are you looking at trends that you
see in nature with CNP within the population or data from others in the space or what you're seeing in animals? And then are you thinking about
it, about looking at it based on concentration or titrating that dose?
Question: Jessica Macomber Fye - JP Morgan Chase & Co, Research Division - Analyst
: I wanted to follow-up on one of the earlier questions. I'm curious as you think about discussing Phase II with the FDA for TransCon CNP, what you
want to measure and what you might kind of ask the FDA for feedback on in terms of what you measure in that study, I guess, outside of just
growth?
Question: Jessica Macomber Fye - JP Morgan Chase & Co, Research Division - Analyst
: Okay. And I guess I'm just kind of asking because if you're-- if you think titration to maybe a given free CNP level may be how the product is used,
I'm curious what you might measure to establish an association that different levels have different effects on whatever those metrics are.
Question: Jessica Macomber Fye - JP Morgan Chase & Co, Research Division - Analyst
: Okay. And I'm trying to re-ask my question from last quarter. Can you just provide the latest status of where you stand on manufacturing for
TransCon GH and those validation batches?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
NOVEMBER 28, 2018 / 9:30PM, ASND.OQ - Q3 2018 Ascendis Pharma A/S Earnings Call
|