Question-and-Answer Session
Operator
Our first question comes from Dave Windley with Jefferies & Co.
Dave Windley – Jefferies & Co.
I have a couple. I was wondering, Jim on the Phase III program for POSIDUR, is the two-year timeframe, is that basically the – is the rate limiting step there the pivotal trial and enrollment assumptions around that or will some of the supportive trials be clinical path limiters, just wondering what the two-year time span is dictated by.
Jim Brown
That is a good question and it is an estimate, as you might expect. We expect that the longest duration setting would be the pivotal study because that has the most patients compared to other studies with smaller groups of patients, but we're still right now just mapping out exactly which model we will use in those studies. So I think your assumption is correct, the pivotal study is a long duration.
Dave Windley – Jefferies & Co.
Okay.
Jim Brown
But we had built in time also at the end of that for you know typically more like six months for an NDA and all that. So we have allocated all of that into that.
Dave Windley – Jefferies & Co.
Okay, and you have done, while you have been waiting on the FDA to give you some clarity on this, you have been doing some, you should call them exploratory studies and Phase IIb studies. To what degree could they be used supportively or if not that, are those studies in then dictating the supportive studies that you will do?
Jim Brown
Actually both, I mean, some of those will be readily used and as I also said earlier, some of the Nycomed what they are doing (inaudible) be doing will also be used to answer some of these questions and also, you know we're doing that Phase IIb shoulder study down in Australia, that will help us in the construct of that, should we use that model, should we believe that we are in this point of time in the Phase II pivotal study. But the nice thing is that it is one, and not two, right, which is what we were thinking before.
Dave Windley – Jefferies & Co.
Okay, on the comments, Felix, that you just made, can you talk about the IP protection around the SABER depot and perhaps you know, even bring that into kind of the current litigious environment and how strong do you think that will be in an environment where you know non-composition amount or patents are challenged left and right and some hold and some don't, maybe more don't?
- To read the full transcript on Seeking Alpha, click here »
