Chris, any views on that, pre-subs?

Yeah, I mean, I'll just echo what's been said in the fact that you go in and you make the argument for what you want to do and then take the time to explain why, right? Take the time to explain why you believe that this is adequate.

If you believe that there are multiple aspects of your pending submission that are sort of asked and answered and straightforward, then just go ahead and leave those alone and make the pre-sub activities very targeted.

But if you believe you have, and I'll just stick to sort of study design here, if you believe you have the right endpoint, you believe you have the right control, you believe you have the right timeframe, and you compile those arguments in a thoughtful way, then you're very much advocating for that position.

I think one of the things that, and I'll just say that I've really struggled with sometimes looking back on these communications, is that as the sponsors do make these recommendations, they do lay out what it is that they want to do.

And what sort of come back is, well, you might want to consider, and this isn't the context of a pre-sub, but it might be in the context of an IDE approval, where you might get an additional consideration saying, you know, you can go ahead with your study, but we aren't sold on your primary endpoint, or we aren't sold on your sample size, or we aren't sold on whatever it is.

And that can end up just being really challenging, right? Because then you sort of find yourself, do I run this to ground or do I push ahead? So I'm sort of, I run hot and cold on pre-subs.

What does evidence in terms of a medical device look like, and, uh, where are companies getting tripped up in terms of providing the evidence for a 510[k] or for a PMA or for anything in between that FDA wants?