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: Umer Raffat - Evercore ISI - Analyst
: Thank you for taking my questions. I have four, if I may? I'll ask the fourth one in the end, perhaps? First, were both the Phase 3 trials stat sig? Second,
were both doses also stat sig? I just wanted to make sure that was the case. And if you could give us early color on how the placebo-adjusted delta
defers between the first trial versus the second trial for each dose?
And then also what about the weighted FEV, because I think the results in the (inaudible) are there for the trough FEV? What about the weighted
FEV?
And my fourth one, and perhaps you can answer towards the end, on a totally different program, JAK inhibitor, curious how you think about putting
a Pan -- I'm sorry, putting a TOFA prodrug in the clinic as opposed to the Pan-JAK that's in the clinic? Why do you think you felt the need to do that?
Question: Geoffrey Porges - Leerink Partners - Analyst
: A number of questions, first, Brett, was the benefit consistent in the volume or in the percentage improvement at the trough FEV1 all the way from
moderate to very severe? And then related to that, do you expect labeling to ultimately include both monotherapy and add-on and from trough
to very severe, which is obviously very consistent with the trial?
And then I have a couple of detailed questions, if you could just address those first?
Question: Geoffrey Porges - Leerink Partners - Analyst
: Great, thanks very much. If I could just follow up? Could you remind us, Rick, about the patent life of revefenacin. And then so, Brett, the data
question, there was a slightly higher rate of headaches in the patients on the active. Could you talk a little bit about the severity, duration and
whether there were any discontinuations associated with those headaches?
Question: Geoffrey Porges - Leerink Partners - Analyst
: Okay, great. And then the patent one?
Question: Douglas Tsao - Barclays - Analyst
: Just trying to understand what you think about the landscape of other LAMAs that are on the market with handheld, in particular Spiriva. Just
curious in terms of how you think about the sort of target patient that would be appropriate for a nebulized therapy?
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