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: Jon Wolleben - Citizens JMP - Analyst
: Hey, congrats on the progress and thanks for taking the questions. I got a few initially on kind of enrollment expectations and then a follow-up.
But I was hoping you could tell us a little bit about differences in inclusion-exclusion criteria between COMFORT Toddlers and EPITOPE and remind
us what the screen failure look like there, if there's any learnings and what gives you confidence that you can hit timing given the inclusion of a
food challenge in these young kids.
Question: Jon Wolleben - Citizens JMP - Analyst
: And looking down the road, I don't think you guys have talked about this much, but what would a confirmatory trial look like? Because about a
year from now, you'll have to have that up and up and running. So can you talk a little bit about that design?
Question: Jon Wolleben - Citizens JMP - Analyst
: Okay, all right, I'll jump back in the queue. Thanks for taking the questions.
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JUNE 25, 2025 / 9:00PM, DBV.PA - Dbv Technologies SA Corporate Call
Question: Sam Slutsky - LifeSci Capital - Analyst
: Hey, good afternoon. Appreciate the --
Question: Sam Slutsky - LifeSci Capital - Analyst
: Hey, just -- I'm curious how you guys are thinking about success in COMFORT Toddlers in terms of what you want to see there for that -- I guess
both from FDA perspective as well as just your own interpretation of the data? And then how important are the six-month initial data versus some
of the open-label extension data for the FDA?
Question: Sam Slutsky - LifeSci Capital - Analyst
: Got it. Okay. And then just jumping to the tests real quick, just assuming obviously a positive outcome later this year, just walk through how you're
thinking about pre-commercialization prep and then expectations on distribution, whether that'd be specialty pharmacy or some other path.
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JUNE 25, 2025 / 9:00PM, DBV.PA - Dbv Technologies SA Corporate Call
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