Karuna Therapeutics Inc at Goldman Sachs Global Healthcare Conference (Virtual) Transcript

Jun 08, 2021 / 05:20PM GMT
Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division - VP

Good afternoon, everyone. Thanks for joining us. I'm Salveen Richter, biotechnology analyst at Goldman Sachs, and we're pleased to have with us Karuna, and from Karuna, Steve Paul, CEO of the company.

Steve, thanks for joining us. To start here, with your KarXT program for schizophrenia, psychosis, the pivotal trials that are underway. As a reminder, how are these structured? And what is the data package that you believe will be required for approval?

Steven M. Paul - Karuna Therapeutics, Inc. - CEO, President & Chairman

Well, first off, Salveen, thanks for the invitation to participate in the fireside chat and tell folks about Karuna, I think, a very exciting story. Now to address your specific question, of course, at the end of our Phase II and our end of Phase II meeting with the FDA, we discussed extensively what a Phase III package would need to look like for a new drug application submission to the FDA. And that was the basis of. How we design what we're calling the

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