Question-and-Answer Session
Operator
(Operator Instructions). Your first question comes from the line of David Amsellem with Piper Jaffray.
David Amsellem - Piper Jaffray
Hi, thanks. Just a quick question on denufosol. Can you talk about what if any new data you may be presenting at the North American CF conference this September?
Christy Shaffer
Yes. We are hoping to present some additional data. Jenny, would you like to describe that?
Jenny Kobin
Yes. We haven't specifically said what it is, but we do have an abstract accepted and as the time grows closer, we would talk about that.
David Amsellem - Piper Jaffray
Okay and then on the ex-US partnership discussions for denufosol. Can you discuss what if anything has changed surrounding your discussions, and give us a sense of whether you are in advanced discussions with any parties?
Tom Staab
Good morning, David. Yes, we have been in conversations with various parties since the fall of last year, and we continue those conversations. However, we are not going to go into specifics in regards to partners and timing, and any other type of specifics that would be surrounding the partnership.
David Amsellem - Piper Jaffray
Then on Prolacria, can you remind us if you will be in a position to file on the ongoing study positives, and when you plan on doing so? Also, what other considerations does the FDA need to explore in any future NDA review?
Christy Shaffer
That's a great question, David. So, as I mentioned, the enrollment is going very well, and we expect to have enrollment completed in the fall of this year. It is a six-week trial. So, once the patients have completed the six-weeks, we will be gathering the data and analyzing the data, and announcing top line results; and importantly, putting together an NDA of the data if positive.
We believe that we will continue to maintain priority review. We don't have any reason to believe otherwise which would mean a six-month review process. As you probably have noticed, the majority of new ophthalmic products for which NDA's are being submitted are going to advisory panels. In fact, there was a recent advisory panel on a product called Rejena by Lantibio which is licensed by Alcon. So, we would expect potentially to have a panel as part of this.
We do have this protocol under a special protocol assessment. So we've agreed on the primary endpoint, and various aspects of it. However, as we've mentioned before, we believe that the FDA is going to look at the entire body of evidence for Prolacria, not just this particular study.
- To read the full transcript on Seeking Alpha, click here »
