That, in the patient population we are treating, that has got our attention. And if such trends were to continue, then we would stop the expansion cohort whenever we feel we have enough data establishing efficacy, we would stop and have and end of Phase 2 meeting with FDA. As far as the previous question, let me just point out one thing about how many people went over the 550 milligrams per meter square anthracycline dose. Most of the patients, even before they started Annamycin, admit on another anthracycline in strong dosages. So, most of the patients have gone over the recommended limit. I don’t have the exact numbers either, but almost all the patients had prior anthracycline therapy, so almost all of them are over the 550 limit.
Jeff Jones: Okay, that’s sort of what I was anticipating, and appreciate the additional clarity on FDA strategy. And I assume, since those things are linked, the talks and discussions with the FDA on AML — or not talks, the cardiotox, specifically, you’ll also be able to leverage the data you’ve been generating from the STS trial as well as the AML trial when you sit down with the agency on that front?
Walter Klemp: 100%.
John Paul Waymack: That’s correct. Because when you write for an NDA, the integrated summary of efficacy, you’re only talking about efficacy in that indication. But when you’re talking the integrated summary of safety, you will talk and poll safety data from all clinical trials for all indications. And as I noted, we have yet to see a single patient develop an impairment of ejection fraction among all the patients treated in all the indications in all the clinical trials. So, we think the data are becoming compelling that Annamycin does not cause the cardiotoxicity typical of all other anthracyclines.
Walter Klemp: And I would just add to what Paul just described, I think we’re aware of the fact that there are a few other anthracyclines out there that are in clinical development that claim to have an improvement in the cardiotoxicity issue. But to our knowledge, we’re the only ones who are recording and reporting information as it relates to troponin levels, which are an indication for long-term cardiac impairment, the best indicator. So, to the best of our knowledge, we’re really the only ones that are thoroughly evaluating cardiotoxicity with every known measure, and then having it independently reviewed, in this case by the Cleveland Clinic. So, we’re really serious about demonstrating the safety record. And Jeff, I know we talked about this, that the liquid tumor division at the FDA took a different view initially years ago now, but took a different view about their confidence in the absence of cardiotoxicity.
Then a bit later when we were dealing with the solid tumor division, they were more sanguine, they were more convinced by our data, and of course at that time we had more data. And so, now by the time we go back to the liquid tumor division, we are going to, by comparison to the conversation we have with them several years ago, we got a mountain of data. So, we are really optimistic that we’re going to be able to make that point.
Jeff Jones: Great, really appreciate the additional clarity, guys. Thanks for taking the questions.
Walter Klemp: Yes, you bet.
Operator: Thank you. We have reached the end of our question-and-answer session. I would like to turn the floor back over for any further or closing comments.
Walter Klemp: We think we really necessarily covered it here as that the main message obviously is that there is critical data that’s going to be coming in, not just at the next quarterly call, but as it becomes available. So, obviously stay tuned. We can’t wait to get to the next data points to deliver to everybody. Thank you so much for your time, and have a great week.
Operator: Thank you. That does conclude today’s teleconference and webcast, and we disconnect your line at this time, and have a wonderful day. We thank you for your participation today.
