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: Maneka Mirchandaney - Evercore ISI Institutional Equities, Research Division - Analyst
: Congrats on this data. Just want a very quick one on Slide 14. I think the insulin levels were post-fasting, but could you talk about how the levels
kind of change during the day, like throughout the study before the sulfonylurea challenge, if you have that data? And how important it is to
replicate the normal fluctuations, also prevent any potential cases of overshooting in hyperglycemia?
Question: Maneka Mirchandaney - Evercore ISI Institutional Equities, Research Division - Analyst
: Yes. That makes sense. And just given that you described about kind of the range of patients and their weight, would you consider a weight-based
dosing in the next study? Or do you think you can start with the fixed dose?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: I'm curious, when -- could the next trial be a single arm study? And if not, would the active control -- the glucose support? And what would the
endpoint involve? Would it be able -- being able to back off of glucose support in the experimental arm? Or should we think about the endpoint
being kind of like glucose levels?
And then second, sort of related to future clinical development. On the safety side, what do you anticipate the FDA would want to see in terms of
either patient numbers or duration on treatment in addition to efficacy to support approval? It seems like this is a kind of situation where you may
be able to generate an efficacy result fairly quickly, so I'm not sure how much traditional kind of safety follow-up you might need.
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Great. And then on the side effect profile, can you tell us what the rate of nausea and vomiting was with the 120-milligram dose, and how it
compared with the lower doses? I.e., is this a dose-dependent side effect?
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