Now, having said that, we think the more likely approval trial design will be an all-comers trial, and it’s very likely to be first-line patients. So, we realize that the data we’re talking about today is not precisely the target that we’re setting for a likely approval trial, but everything gets easier for us, we think, as we design this approval trial structure.
Jeff Jones: Okay. That’s helpful. Thank you. On the AML side, you’re in sort of your timelines. You’re talking about an end of Phase 2, the first half of 24, and a potential pivotal start second half of the year. And as you were talking about, that is depending on single arm or otherwise in a randomized study, 100 to 300 patients, what did the costs look like for pivotal study, both, frankly, in AML and SDS at lung meds, or SDS as you were just implying?
Walter Klemp: John, that’s clearly in your ballpark. You want to handle that one?
Paul Waymack: Oh, sure. So, you’re talking about a Phase 2, 3 study, pivotal study? You’re talking roughly $18 million, drug included.
Jeff Jones: In which indication?
Paul Waymack: AML.
Walter Klemp: And, Jeff, we might not have been that articulate about it, but it looks like there’s enough in Paul’s segment, he mentioned this, there’s enough enthusiasm on the SDS side among institutions that are specializing in this. It looks very likely that we’re going to have external funding for a pivotal trial on SDS.
Jeff Jones: Okay. What would the total funding be required for the SDS pivotal study?
Walter Klemp: Well, I would say, from a, well, it really depends how much we get from the externally funded trial. I get.
Jeff Jones: And you’re talking about? Exclusive of external funding. So, all in, and then external funding would obviously reduce your investment requirement.
Paul Waymack: Yes. Phase 2B, not a pivotal, would probably, just to get it off the ground, would be fairly cheap. We’d estimate less than $5 million. That does not include the pivotal population.
Walter Klemp: Well, I think practically speaking, it’s, frankly, it’s not a lot different than the pivotal AML trial in terms of cost.
Jeff Jones: Okay. That’s helpful. Thanks, guys.
Walter Klemp: Thanks, Jeff.
Operator: Thank you. We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Mr. Klemp for closing remarks.
Walter Klemp: Thanks, Gerald. Look, we’re clearly excited about this data, having it for the first time. Something real to talk about. I think we’re finally at that point where we’re able to stop talking about what might happen in the future and start talking about what is happening right now. Look, our loyal supporters have been patient for a very long time. So, we couldn’t be happier to be finally delivering this kind of data. And for those of you who are new to the story, frankly, your timing couldn’t be better. You should expect more positive updates in the next few quarters because this data is building. And so, we’re going to establish a pivotal pathway for Annamycin, and we’ll communicate that as quickly as we can to the marketplace. This is what we’ve all been waiting for. So, thank you a lot and have a great week.
Operator: Thank you. This does conclude today’s teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.
