Certainly, not a part of the non-mutated patient population. So now you have a drug with a very, very clean adverse event profile, a very fixed and definitive course of treatment, with quite frankly, the capacity to have a meaningful course correction on the disease itself and the opportunity for complete remissions, which you do not see in this disease, with extended progression-free survival or treatment-free remission as well. So we kind of like the way this stacks up. I really can’t see, as you described, the wheels-come-off scenario here based on the drug, the mechanism, what we’ve observed and the consistency in terms of patient population.
Jonathan Aschoff: Yes. I think splitting the dose gives you a lot of punch for the pain. I think it was a very good decision. Lastly is kind of a yes or no. Would you anticipate a confirmatory trial being much different from this current trial?
James Caruso: Yes, we currently have ongoing discussions with the FDA, and those will continue. We believe we have some considerable optionality here. And so obviously, our discussions with the FDA are confidential, and we continue to explore those. We do believe, without specifically answering your question, that we have considerable optionality here just based on the nature of the disease, the very limited treatment options and what we believe is a very favorable product profile, as I described, both from an activity perspective as well as AE profile.
Operator: Your next question comes from the line of Jeff Jones of Oppenheimer.
Jeffrey Jones: Congratulations on the update. Following up on Jonathan’s question around the confirmatory study, the agency has been making noises on occasion about having confirmatory studies agreed to or in some cases, even begun prior to accepting the NDA application or alternatively approving the product. And so I guess, where — what are you hearing at this point? And then how do you think about recruiting for a trial like that in an orphan indication when the drug is available and on the market? And how does that impact your commercial strategy?
James Caruso: No, that makes sense, and hence, your upfront description of how the FDA currently behaves. That’s why, Jeff, we’re currently in dialogue and in discussions with them to ensure that we’re aligned in terms of how to move forward in the best fashion, not only for the approval of Iopofosine, but what additional information we can glean to potentially help WM patients and those patients suffering from WM. And so, Jeff, on the — impacting the commercial side of this, I’ll turn it over to you to see any, Shane, impact relative to the commercialization of the drug with this.
Shane Lea: Yes. No, I think, obviously, the key is, to your point, understanding how things play out with the ongoing discussions with the FDA and obviously, I don’t see any impact there from a commercial standpoint as we think about the opportunity.
James Caruso: Is that helpful, Jeff?
Jeffrey Jones: Yes, it was great. I appreciate it. And I guess on the financing, I believe the next tranche can come in on positive data? And can you remind us what — how positive data is defined in the financing?
James Caruso: The positive data was defined — and I’m not sure if this is in the public domain, but I would direct you to the pivotal trial. And the — in our corporate presentation, we have an overview and a slide on the pivotal trial. And there, we describe the statistical expectation that we agreed to with the FDA. And I think that would be directionally a good place to start in terms of what’s considered successful. I will tell you that our review of community-based performance at the literature relative to academic performance in these relapsed/refractory patient populations, it’s pretty clear that anything 30% or north would be a win for WM patients, both in the community and academic centers in these relapsed/refractory patient populations.
So I gave you 2 potential benchmarks there. One, FDA statistical alignment with our pivotal study and then just based on a variety of feedback from advisory boards, key thought leadership, both from the academic centers as well as in the community, and then community-based data that we’ve had access to and beginning to peel the onion back there relative to actual patient performance with WM as they’re treated in the community.
