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: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: Hi, Todd, thanks for taking the question. I was wondering if you can comment on turnover at the FDA in the ophthalmology division this year
and specifically in the reproxalap review team, any changes between the personnel who were there at the time of NDA acceptance versus
at the December 12 meeting? Thanks.
Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: Got it. And then is it -- looking through some FDA industry guidance and it seems that it is standard to submit all CSRs regardless of therapeutic
impact with an NDA. So is this -- has their guidance changed? Or what was the rationale behind [maybe in some of the CSR]
Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: Got it. And then -- is there -- have you seen a label, a draft label prior to the one that was shared in the beginning of December?
Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst
: Okay. Got it. Thanks, Todd.
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Question: Yale Jen - Laidlaw & Company Uk Ltd - Analyst
: Good morning, Todd and thanks for taking the question (inaudible) details. In terms of the label discussion you mentioned in the press
release stated in February of next year, if that happens, you will -- and my question is, would you guys report that after the discussion with
the FDA or you will have communicated street once the PDUFA day has done?
Question: Yale Jen - Laidlaw & Company Uk Ltd - Analyst
: Okay. Great. Maybe just one follow-up. For the last communication you have with the FDA or requesting kind of lay toward the PDUFA date,
was there something you anticipate or something that is a surprise.
Question: Yale Jen - Laidlaw & Company Uk Ltd - Analyst
: Okay, great. Thanks a lot and thanks for providing all the details.
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