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: Uy Ear - Mizuho Securities - Analyst
: And congrats on the quarter, the recent data. So maybe the first question from us is, you indicate you'll be approaching the FDA to speak with
them in order to move forward. I guess what gives you confidence that the current data from the Phase II study would be sufficient for the FDA to
agree for NDV-01 to move into registrational studies. And I guess -- the second question maybe is you indicate that you're going to scale up supply.
Could you sort of elaborate what you mean by that?
Is this -- are they commercial products? Are they scaling up for clinical study only?
Question: Uy Ear - Mizuho Securities - Analyst
: Yes. So maybe just a follow-up on what you guys said in response to potential differentiation. So maybe Dr. Lotan, if you're still there, maybe one
of the feedbacks that we've gotten from investors is that this is kind of a crowded market. So maybe just help us understand how you see NDV-01
fit in the treatment paradigm when it comes to market, you have BCG, you have CG Oncology and other potential competitors who could be ahead.
Question: Uy Ear - Mizuho Securities - Analyst
: NDV-01.
Question: Matthew Barcus - Jefferies - Analyst
: This is Matt Barcus on for Andrew. I guess, regarding the latest data set for NDV-01presented at the AUA meeting earlier, when should we look
forward to sharing the complete response rate for the entire population? And how do you anticipate sharing the future updates from the program?
Like what more can we look forward to in those data sets throughout the year? And what are your expectations for success?
Question: Matthew Barcus - Jefferies - Analyst
: No, yes, yes, you caught it. And then I guess, like as you're thinking about talking with FDA on -- with these data and the design of the Phase III, I
guess, what would you want the Phase III to look like in terms of time points, endpoints and the types of patients you're thinking about enrolling?
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