5/4/2026

speaker
Unidentified Analyst
Analyst

that design was chosen? And I guess if it's positive, would you expect to have to do a parallel study after that?

speaker
Herriot Taber
President and Chief Executive Officer

Thanks for the question. So we do anticipate that we would need two positive trials. That's the standard for any approval for any indication at the FDA. And in terms of the reason for the randomized withdrawal design, One of the challenges with neuropsychiatric indications and depression in particular is the high placebo response. So, you know, how do you deal with that? So, in the prior studies, in the prior study which we conducted with psori-amphetols in this indication, what we saw in the active arm was clearly a very pronounced antidepressant effect. What we wanted to make sure is that we're able to tease out and really demonstrate that this is a drug effect and while minimizing the impact of the placebo response. So that's the rationale behind the selection of that study design.

speaker
Unidentified Analyst
Analyst

Okay. Thank you very much. And can I also ask, just like, Long term, how are you thinking about profitability? And does the increased conviction and ability and what that could do from a sales perspective, does profitability start to become a goal for the company? Or is the focus kind of more on sort of revenue growth?

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