Palatin Technologies Inc. (NYSE MKT:PTN) Q4 2020 Earnings Conference Call - Final Transcript
Sep 28, 2020 • 11:00 am ET
Thank you very much. [Operator Instructions] Our first question will come from John Newman, Canaccord.
Thanks for taking my question. I just wondered if you could talk a little bit more about the transitional service agreement that's in place for Vyleesi and just how that's going to allow you to continue to support commercialization of the products kind of in the Interim here and also just how that's happening really at very little cost to you? Thanks.
Stephen T. Wills
John, its Steve. Thanks for the question. The -- to be forthright, Palatin, when we were -- once we got to the position that we knew we were going to be taking the product back and shaking hands with AMAG, notwithstanding the payments and the releases. We knew we had to get any commercial and regulatory functions that that we didn't have in place entered into a transitional services agreement with AMAG, and we did that.
The one item, we've always been very strong. As you recall, we invented the product. We took the CMC right away. But things regarding, say, the pharmacovigilance, the quality, the government reporting, the market access oversight. Those are some of the specific functions that we engaged with AMAG.
So over the next several months, we're in the process of transitioning all those functional areas to Palatin, and that would include both internal or outside third party resources. So we're comfortable that we have sufficient time to do this in an orderly, informed fashion. And what was most important was to make sure that we had all the functional areas in place with agreements, so there was no patient access disruption and also to ensure all the regulatory compliance aspects were taken care of.
Okay. Great. And then I just wondered, in terms of the dry eye data that are coming up in the fourth quarter, I know that you're looking at fluorescein staining. Just curious as to what we should focus on there, if it's mainly just kind of a read on the primary endpoint, if we should also be considering signs and symptoms and things like that? Thanks.
Sure. Well, as I mentioned on the call, John, the signs and symptoms are the two requirements. Fluorescein staining is a measure of inflammatory lesions in the eye inferior just means is the bottom part of the eye, and part of that's just due to the way the study is being run. The bottom of the eye can be a little bit dryer many times.
So the way I think about it is this was a first attempt we took a little bit of risk by doing co-primary endpoints. But I think the risk is worth it because if we do hit them both, we believe this will count as one of the Phase III pivotal studies.
But there is a whole host of -- from an FDA perspective, they're fairly agnostic. There are a variety of signs that one can use and symptoms that one can use requirement