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: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: On the 501 review, have you started labeling discussions and what are your expectations or goals for the label and how do the different options
there impact your commercial expectations for the drug?
Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst
: I have a couple. Now that you're closer to your action date, are there any commercial variables that you feel might need more focus what you --
versus what you had announced in your commercial day in light of some of the changes that you've had at the top? And secondly, on the dementia
data, could you give us some specifics on what exactly you've aligned with the FDA so far on starting a potential Phase III there?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Just to build on your comments on the sales build-out, could you just quantify how many you have hired versus how many you ultimately expect
to hire? And then where are you in the process of replacing Bill Kane? And then just as we think about the launch of 501, are you expecting to
provide revenue guidance post-approval?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: And on the potential sales guidance post-approval?
Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst
: Firstly, I had a question on the FDA PDUFA date. Would the Agency currently sort of adjusting all the backlog of applications, how confident are
you of sort of receiving the decision by January 5? Or is there a possibility of them coming with a decision earlier? Or how early are we likely to
know if they were to extend that time line?
Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst
: Okay. That's helpful. And then I just had a quick question on the basket trial with MD Anderson. What sort of additional efficacy data do you expect
to see from that study?
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