What I can say is that is one of our very important milestones for this year, right? Are the IND-related activities for DARE-HRT1 and the Phase III clinical study initiation plans and work that needs to happen. So please stay tuned for more on that one. We definitely look forward to giving more updates because we — we’re very, very excited about this program.
Joanne Lee: Got it. I appreciate all the additional color. And for the company’s earlier stage program which there are several assets that you guys are planning to advance. Specifically regarding DARA-PM1 which, as you’ve mentioned, is being developed using the same validated platform technology you to develop Sildenafil Cream. I wanted to ask if you could talk a bit about the importance of bringing a safe drug to this population of women with primary dysmenorrhea. And given the 505(b)(2) drug pathway as diclofenac is well NSAID. What could we interpret a positive Phase I study to mean? And although it’s not powered for efficacy, would PK be almost sufficient to imply efficacy because we already know the drug sort of worked which heavily derisks the program already?
Sabrina Johnson: Yes. Thank you for the question. And for clarity, it’s the same gel that’s in XACIATO. Yes, so we are definitely got one, like the 505(b)(2) pathway, obviously, we’ve talked about so much today. We love that pathway, right, because you’re getting to on drugs that have already demonstrated safety and have already demonstrated efficacy. So in the case of PDM1, we absolutely can look at — we know the levels of diclofenac systemically for effectiveness. We don’t know the local levels of diclofenac for effectiveness but we know the systemic levels. And we know the systemic levels for sure, for safety. What we have — and so first, I’m going to talk about the regulatory part and then I’m going to tell you to talk about the other part of your question which is like the unmet need and the why.
But from a regulatory perspective, what I will say, what we have — the beauty of working in one therapeutic category and being so broaden as we are is we have a lot of interactions with the FDA all the time with a lot of the same people at the FDA and you start to see trends. That’s part of also the value of the way we work and the efficiency, right and the way we work. So the trend we have seen is that — and Sildenafil is a great example where we’ve had very mature discussions with the FDA that because in the case of Sildenafil, it’s a brand-new indication and it’s a brand-new route of delivery they want 2 trials, right, 2 Phase III trials. So — and we saw with HRT1 that because we know about hormone therapy and even though it’s novel for us to have both hormones together, vaginally, their support for a single Phase III trial.
PDM1, hard to know today where it’s going to land because to your point, diclofenac is already well known, very well established, labeled for this indication already. We’re just delivering it in a different form. So we are hopeful, obviously, that we will be able to get to leverage the Phase I data robustly to the benefit of a more efficient, streamlined registration program but a little early to project on that one. What I will say about the unmet need, though, is that I alluded to, a lot of the women that are very bothered by this, a reproductive age women, that’s younger women, it doesn’t get better. It’s not like they grow out of it in a year. This is a problem that can be very persistent for them, very disruptive for them. And there is — there are a lot of data, right, around the potential risk of long-term use of oral NSAIDs in terms of other just risk factors and complications apart from just the disturbance in the side effect profile that they can have from a GI perspective.
