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: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: I have 2. The first one is, can you help me think about, on an ITT basis, with the patients who started the extension, how many of those would have
met the primary endpoint planned for Phase III? Exclusive from Slide 15, you had 53 patients of vitamin D and calcium on -- on vitamin D and on
calcium doses up to 500 milligrams. And then later in the slides, you say 86% of subjects meeting the Phase III criteria. If we just look at the -- maybe
a simple (inaudible), what's the numerator and the denominator in that 86%? And if it's not ITT, can you just tell us how many patients which the
number of patients who would have hit the Phase III endpoint here?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. And then the second question relates to the -- against the endpoint you're using in Phase III that doesn't have urinary calcium as one of the
components of the primary endpoint. It seems pretty clear that you're well positioned on the primary endpoint that is written. But given the
feedback from physicians that urinary calcium is important to them, I'm curious if you think that your urinary calcium data can get on the label if
it's in the secondary endpoint?
Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst
: Congratulations. So I guess to start out, could you help us understand how many patients had normal urinary calcium at baseline and how many
were coming into normal range? And also, you mentioned previously, Jan, that a lot of these patients could have become responders had they
been titrated perhaps a little bit more. And have you seen additional titration of dose in -- following the 6-month period and having patients maybe
coming into the biochemical endpoint or the deposit endpoint that you're evaluating?
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Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst
: Okay. And just to follow-up, in the Phase III design, could you maybe more specifically talk a little bit about how some of these learnings made its
way into perhaps that 10-week titration algorithm? How some of the -- maybe some of these challenges have helped you to, I guess, be more
specific about these things? And then also on the design was -- I noticed that in the endpoint, you had -- you're using 600 milligrams of calcium.
Could you maybe describe why that changed a little bit? And also, on the powering in the 4-week analysis, previously, there were some placebo
responders. What would you expect or what would you expect for that placebo arm as far as those response rates to this endpoint as well?
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