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 Corp., Research Division - Analyst
: I guess the first one, can you maybe discuss the cadence for TransCon GH of getting onto the formularies? How did that happen over the course
of the year?
And then my second question. For TransCon PTH, from a safety perspective, is there a difference between replacing PTH at physiological levels in
hypopara patients, I guess, at the dosage you're evaluating versus adding pulses of PTH to stimulate an anabolic effect? And then, I guess, at the
doses that you're evaluating for TransCon PTH, would you expect there to eventually be a black box warning or limitation on duration of therapy,
like there is for Forteo, given these different effects on the bone?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: This one might be for Dana. Can you tell us whether the necessary pre-approval inspections have taken place yet for TransCon Growth Hormone?
And your expectations for those being completed prior to the PDUFA given any COVID travel issues? I know you said multiple times on the call
that you guys expect approval in 2Q. So it sounds like maybe things are on track there, but that's the first question.
And then second, kind of building on the last question, thinking ahead to the 12-month open-label extension data for the PTH Phase II trial coming
up in 2Q. Can you talk about what you would expect to see on BMD at the 12-month time point and what that means for the product? I guess,
more specifically, at what point do you expect to have clinical data that will demonstrate that the normalization that you're seeing in BMD early
on does not overshoot and lead to below normal BMD?
Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst
: Just a couple here. Could you please remind us the sort of time line in terms of the pediatric Phase III trial that would commence in Japan? So I
know you have applied for the CTN, so when -- is it sort of likely to -- so you're going to get the green signal to go ahead?
And then in terms of the HP Phase III trial, would there be any change to the trial design itself in terms of inclusion or exclusion criteria of patients
based on your 6 month data?
Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst
: Okay. And then as far as the Phase III HP trial, would there be any changes in the trial design based on the 6 month data?
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