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: Jay Olson - Oppenheimer & Co. Inc. - Analyst
: Well, hey, congrats on the CTAD presentation and thank you for presenting this update today. A question for Dr. Arnold, along the lines of what
Cuong was describing, could you, Dr. Arnold, please describe what you would expect in terms of a six-month cognitive decline and also changes
in PET imaging, MRI and other important biomarkers in the placebo group so that we can try to imagine what might be happening in the active
NE3107-treated group?
Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst
: Great, that's super helpful. And maybe if I could ask a follow on. Because there is such a wealth of data here in terms of cognitive measures, imaging
and biomarkers, could you just talk about which part of this blinded data you find most intriguing?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst
: Okay, great. Thank you. And then maybe if I could, one last question. As we look ahead to the upcoming unblinded data, can you just describe
what you would envision as sort of a best-case scenario? And then assuming that we can achieve that best-case scenario, what would you recommend
is next steps for this study of NE3107?
Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst
: Great. That's super helpful. Thank you so much for sharing your insights, and we'll look forward to future updates. Thanks for taking all our questions.
Question: Robyn Karnauskas - Truist Securities - Analyst
: I guess I have few. One for Dr. Arnold, what delta on CDR Sum of the Box, at a six-month time point would you find clinically meaningful, if that's
what they choose to take forward in the statistical plan? And then how would you incorporate this drug as a process deferral on the market and
others? Did you add it on top of things or you did it as a first-line drug? And then I have a follow up for Cuong.
Question: Robyn Karnauskas - Truist Securities - Analyst
: Thank you. That's helpful. And Cuong, what options are on the table for changing the statistical analysis plan? Can you just go a little bit more into
depth as to how you're thinking about that?
Question: Robyn Karnauskas - Truist Securities - Analyst
: That's really helpful. And then just taking it one step forward in that scenario that I'm setting the low bar scenario, like how will the FDA view this
data and what then would be required to get on the market? Would you be able to incorporate this data in some way or would you think there is
a risk of having to run two Phase 3s?
Question: Robyn Karnauskas - Truist Securities - Analyst
: Would you have to run two or just one? You know, like --
Question: Robyn Karnauskas - Truist Securities - Analyst
: Okay. And then when you think back to the two Phase 3s because it seems like, you know, if Lilly, they had a positive Phase 2 and they are somewhat
positive Phase 2, it didn't fully hit and then a real positive Phase 3.
So how comfortable are you that the FDA is fine with that if you don't hit in the overall population, or is that, you know -- we think that the FDA is
just getting more comfortable with having a Phase 2 that's okay in some way and then a Phase 3 and then you can still get full approval? Just where
is your confidence level lie with the FDA? I think a lot of our confidence levels are very low at the FDA lately. So just wanted to get your confidence.
Question: Robyn Karnauskas - Truist Securities - Analyst
: Okay, great. Well, thank you very much for taking my questions.
| 
