BioXcel Therapeutics Inc Q2 2021 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : I have just one. We've seen the FDA become more unpredictable with pending NDAs just ahead of action dates. In that context, could you remind us as to how confident you may be about satisfying pre-approval requirements for your sublingual film such as site inspections so that you can receive approval in a timely fashion? And when do you expect labeling discussions to begin if they haven't already?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : Related to the same pre-approval type discussions. Have labeling discussions started? Or when do you expect them to start?

Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst : This one is just based on the comments earlier. I was wondering like when 501 is initially introduced in the hospital setting, but eventually, when it's expanded for other treatments, that's where it could be administered at home, could you sort of describe the market size and opportunity for that?

Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst : That was helpful. And just one more. Of the -- like how do you sort of plan to allocate your resources between 501 and potentially developing that in the other indications and then the early-stage 701 candidate?