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: Jason Butler - JMP Group LLC - Analyst
: No, that's great, Remy. I'd like to talk about what you just said. Maybe we just start off with the Phase III results from the double-blind portion. You
said you saw a significant result early in the study. Can you maybe talk about the magnitude of the benefit that you are seeing and how meaningful
the improvements that you are seeing are?
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JUNE 16, 2021 / 2:00PM, NERV.OQ - Minerva Neurosciences Inc at JMP Securities Life Sciences Virtual
Conference
And you mentioned the functional improvements as well. How impactful are the functional improvements that you are seeing in these patients?
And I guess maybe just as a little bit of context, how important are those functional improvements to this patient population?
Question: Jason Butler - JMP Group LLC - Analyst
: Great. And then if we then move on to the open label data, can you again just reiterate the importance of that data to you, how it gives you
confidence that the effect that you are seeing with the drug is, a, robust and real and, b, durable?
Question: Jason Butler - JMP Group LLC - Analyst
: Great. So if we could then switch to some of the details of the FDA interactions. You said you had the meeting with FDA last year. There was some
items out of that that you wanted to resolve and gain additional information and go back to FDA with. You mentioned the bioequivalent study;
maybe we will start there.
Can you just highlight first a key question? What did they want to confirm bioequivalence from and to? And what is the study -- just give us some
overview of the study that you are running and, again, I think you said you have results from later this year?
Question: Jason Butler - JMP Group LLC - Analyst
: Okay that's great. And the other thing you mentioned was the endpoint discussion. I guess from my recollection you had a good amount of
discussion with FDA as you designed the Phase III trial about what the right analysis of the PANSS would be. Can you maybe just talk about the
work you're doing now to reinforce that the Marder endpoint is the right one in your view and from what the FDA has asked you to go in and look
at?
Question: Jason Butler - JMP Group LLC - Analyst
: Perfect, great. And then, just I guess in the last couple minutes wrapping it up into the FDA has asked you for this additional information. You are
working towards that. When do you think that meeting with FDA could occur, and what are your goals out of the meeting? What could the next
steps from the next FDA meeting be?
Question: Jason Butler - JMP Group LLC - Analyst
: Great. Well, Remy, really appreciate you being with us this morning. Obviously lots of exciting information to look forward to, new (inaudible) to
look forward to in the weeks and months. So we'll be watching anticipatedly. And again, appreciate your time this morning.
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