Operator

Greetings, and welcome to the BioXcel Therapeutics webcast. [Operator Instructions] It is now my pleasure to introduce Vimal Mehta, Chief Executive Officer and Founder of BioXcel Therapeutics. Thank you. You may begin.

Vimal Mehta
Founder, CEO, President, & Director

Thank you, operator. Good afternoon, everyone, and thank you for joining us today. We appreciate your time and interest as we share an update on the commercial strategy and launch plan for IGALMI, ahead of its potential approval for the treatment of acute agitation episodes associated with bipolar disorders and schizophrenia in the home setting. As you all know, these episodes represent a frequent and challenging reality for patients and caregivers, often occurring outside of clinical settings where there are currently no FDA-approved therapies.

We are entering a key period for BioXcel Therapeutics as we prepare for the upcoming November 14 PDUFA target action day for IGALMI. At this time, our focus remains on executing our launch readiness, activities to ensure we are well positioned to bring this treatment to patients and caregivers as efficiently as possible if approved.

Finally, I would like to thank our Interim Chief Commercial Officer, Mark Pavao, who has been instrumental in developing the launch plan and commercial strategy for IGALMI and our moderator, Michael King, for leading today's event.

With that, I will turn it over to Michael King.

Michael King
Rodman & Renshaw Research

Thanks, Vimal, and good afternoon, everybody. It's nice to join you today. I'm delighted to have been asked to moderate the Q&A session