And so as we’re thinking about the patient population to study and this is why purposefully in the Phase IIb, we worked hard to make sure that we had some different patient profiles to be able to analyze. It’s really going to allow us to figure out and to determine what direction we want to go for the Phase II. We do think that actually we are going to need 2 Phase III trials for registration because this is such a novel indication and novel formulation of Sildenafil. So even though it is the 505(b)(2) pathway that I talked a lot about today, this would be a circumstance unlike XACIATO, unlike HRT1, where one Phase III is adequate. This is one where 2 Phase IIIs would be required. And that does also give us some opportunity to potentially have some differences in those studies, all of which would need to be discussed with the FDA.
And that kind of goes to the second, the first part of your question which I’m taking the second part. So first of all, as we’ve said before and John highlighted just today, right, we look at each of our products on an individual basis and further with 12 development stage candidates in our portfolio, we certainly have a lot of flexibility in terms of how we think about go-to-market strategy because we have such a broad portfolio in women’s health, all the same call point that there comes a time where it’s not a single product going to market, it’s multiple products on market at the same time, potentially, right, as you think about the portfolio as it advances. So we take into consideration a couple of different factors as we think about how and when to partner.
First of all, it comes down to how and who is going to be running the development program and how that can be done in a way that is most advantageous for the brand. I’m going to take Ovaprene is a great example. We and Bayer align together that for that program and the nature of that kind of very novel product, novel education, needing to be nimble, needing to be flexible and creative that it made a lot of sense for Daré to take the lead on that development program through the PIVOT study with Bayer behind us, supporting us, lifting us up, giving us advice, giving us insights but that we would lead that program. And whereas with XACIATO in bacterial vaginosis, that’s a very straightforward regulatory approval pathway and we knew what we needed to do to get a very differentiated label there.
And we knew also that we did meet, right, our commercial partners insight along the journey and that we could get it there. So as we think about the Sildenafil program, there are always pros and cons. And this is a long way of me saying, in the end, we always evaluate the opportunities and we evaluate what the program needs and we evaluate what Daré needs. And ultimately, we evaluate what is going to be best in building the value, the biggest value we can create and the fastest way to get to that value. And that’s exactly the analysis that’s going to come on the Sildenafil program. Clearly, there aren’t a lot of opportunities to have such a groundbreaking product. It’s truly creating a new category and that obviously generates interest. And so we will just have to be — as we do, we evaluate everything and we evaluate the possibilities and we’ll make the determination on what makes sense.
And the beauty for Daré is that we have that optionality. We have a portfolio that supports us being able to contemplate all different go-to-market strategies because we’re not relying on a single product.
Operator: Your next question comes from the line of Kumar Raja from Roth Capital.
Kumaraguru Raja: I had a question on PDMI. So in terms of doses that are being tested, how do they compare with systemically dosed versions? And is the expectation that a single dose would be sufficient for most of the patients that the pain is typically seen in the 24 hours?
