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: Ed Levy - Jefferies Group LLC - Analyst
: I'm just wondering the two other Phase 3 trials are still ongoing and when do you expect to provide data? You intend to include this as part of the
NDA package or originally communicated with FDA to see if they're needed for submission. And as a follow up, any potential option exercise or
payments from (inaudible) data. Have you had any recent conversations? Thank You.
Question: Ed Levy - Jefferies Group LLC - Analyst
: Very helpful. Thank you.
Question: Marc Goodman - Leerink Partners - Analyst
: Our last question is, were there any other secondary endpoints at all assessed in this trial or no? Thank you. That's it for us.
Question: Yale Jen - Laidlaw & Company Ltd. - Analyst
: Good morning. Thanks for taking the questions and congrats on the outcome. Two questions here. The first one is from the thought of -- figure
you showed that the event in the pre, -- pre administrating the drug you already see separation, and obviously, the second does give a much
greater consistent separation. So my question is that was first pause. Does that have any clinical meaning of value even business and not the
primary endpoint? And I have a follow-up.
Question: Yale Jen - Laidlaw & Company Ltd. - Analyst
: Okay, Great. That's very helpful. And then maybe just one more question here, which is that in terms of the the absolute value at the end of the
100 minutes, are you guys going to review that or even present in a medical conference somewhere later -- sometimes later anything?
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Question: Yale Jen - Laidlaw & Company Ltd. - Analyst
: Okay, Great! That's very helpful. And again, congrats on the last puzzle you needed to clarify.
Question: Catherine Novak - JonesTrading International Ltd - Analyst
: Hi, morning. Congrats on the data. I just wanted to ask, I guess a question thinking about how FDA might be looking at this. How does the endpoint
here of ocular discomfort compare to the Phase 2/b endpoint we use ocular discomfort for symptom questionnaire is considered are substantially
the same.
And then, does the FDA care about the endpoints being read out at multiple times. You had 12 weeks in the prior study and here is the acute
chamber study? And i have a follow up.
Question: Catherine Novak - JonesTrading International Ltd - Analyst
: Okay. And I guess my follow-up question was related to the acute symptom relief. Can you remind us from a comparative standpoint what, if any,
acute symptom data data has shown in a potentially in a short term chamber study? Or is it really just efficacy over a period of weeks.
Question: Catherine Novak - JonesTrading International Ltd - Analyst
: Got it. Well, congrats again on the data and looking forward to hearing more updates in the second half of the year?
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