Phillip Koo:

After every one of these big meetings, we see all this wonderful data. Sometimes patients might go to their doctor and say, hey, why am I not getting this? Why am I getting that? And there's a good reason why. So, let's sort of go through them and sort of explain or maybe predict when patients might be able to see this in the clinic.

So, starting with CAN-2409, it was a Phase 3 study. When will patients be able to access something like this in the clinic?

Zachary Klaassen:

Yeah, it's a great question, Phil. I think, you know, when we look at this data, we get excited about it. We have these great discussions, and we see what's coming. The FDA takes this data, and they have to review it. And so, this is kind of an unpredictable timeline, and it depends on a lot of factors that are maybe beyond the scope of this conversation, but it's the quality of the data. It's how quickly the company files for the approval. They're very specific in how they want their approval data submitted. So, this can go back and forth a little bit.

The one thing I'll say, something brand new like CAN-2409, it may take a year or two, just because this is the first indication, first label of CAN-2409 in prostate cancer. And so, what I mean by that is if you take, if we look at the ARANOTE approval, which was darolutamide plus ADT, the FDA already approved darolutamide plus ADT plus docetaxel. That's about three or four years ago now. And so, this was moving an additional label to something we already know something about. And so, I think that approval process likely is a little bit quicker than something that's brand new. So, we saw that ARANOTE was presented November 2024 by January, so that's what, excuse me, June, that's about eight months, we get approval for the doublet.

Hopefully we get an approval that quickly for something like CAN-2409. Phase three, great trial, you know, the FDA looks at the quality of the trial, head-to-head, randomized, placebo-controlled, very well-designed trial that will help with hopefully approval. My guess is it may take a little bit longer just because this is the very first indication for something like that. So, I can't predict what the FDA is going to do, but probably I'm guessing a year or two down the road.

Phillip Koo:

All right, good. You know, it's encouraging, obviously, because the data is great, and hopefully that leads to a smooth path to approval. You know since we have a little bit of time, can you talk about this concept of Phase 4 type trials and sort of what that means?

Zachary Klaassen: 

Yeah, it's interesting. So, we start at phase one, which is making sure it's safe in humans and getting doses right. We move on to phase two, which gives us a little more of a signal. Phase 2 is kind of a broad topic. Often, it's a hundred or so patients. Sometimes it's randomized. If that's feasible, then we get onto a phase three, which we've talked about with CAN-2409. We've talked with ARANOTE, we've talk about with AMPLITUDE. And we've talk with EMBARK. And so that's really the big one that kind of gets approval.

Phase 4 is sort of this post-approval space of what happens when it's approved, what happens in the real world. Sometimes there's a little more leniency in who's eligible for Phase 4. It's a little more on the real-world side, how it's being dispersed in the early days after approval. So, it's not as, I don't want to say it's not as important as Phase 3. Phase 3 is often what leads to the label from the FDA. But it's great to see how these work in a fashion once we get approval, how they're distributed across the country.