Stepping back, how would you characterize FDA's current view towards psychedelic therapies as more programs move into this late stage of development, particularly in light of that new guidance from last week?

Sure.

Great, and, you know, really try to tackle this question in two different directions.

It's kind of the bottom-up view at FDA and maybe the top-down view from the president on down into FDA.

From the bottom-up view, I think it's important to recognize that, you know, the recent executive orders and other actions coming out of the White House are entering, you know, an agency that I think has already shown a degree of excitement and enthusiasm for at least the potential, the potential of breakthrough medicines that might have significant impacts on mental health disorders.

A lot of these therapies that are coming through the pipeline now have breakthrough designations awarded by FDA as a signal of their enthusiasm, and those designations predate the Trump administration, go back several years.

I think if you listen to what, uh, FDA folks have said publicly, like Tiffany Farchione, who's the head of the psychiatric division that will review these therapies, they've spent their careers doing reviews of antidepressants where if you can find a 20% improvement on a rating scale i-in, like, two out of five trials, you're happy.

So a couple things that we noticed on the Cowen team, the guidance recommends a blinded controlled 12-week efficacy assessment and suggests that the blind- that blinded long-term follow-up of up to 12 months may be, quote-unquote, "most informative." How should sponsors interpret that? I mean, is that just a nice way for FDA to say, like, "We need 12 months blinded data to approve"? 'Cause that is something that the later stage applications are not designed to do, even though they might have alignment already.