DURECT Corporation Q3 2008 Earnings Call Transcript

  • download
  • Print
  • Recommend
  • 0

2008-11-20 04:05:32.0

Tags: Call Transcript, Earnings, Jefferies & Co., Federal Government, Government, Seeking Alpha, Call Transcript, Earnings, Jefferies & Co., Federal Government, Government, Seeking Alpha, Durect Corp.

Question-and-Answer Session

Operator

(Operator instructions). Our first question comes from Dave Windley. Dave, please go ahead.

Dave Windley - Jefferies & Co.

Hi, good afternoon, gentlemen. How are you?

Jim Brown

Good, Dave, very good.

David Windley - Jefferies & Co.

Great. Thank you. I want to start on POSIDUR. Your initiation of these additional Phase II studies in the shoulder, are these -- first of all, are they also to be arthroscopy type models or more invasive than that?

Jim Brown

We haven't -- we aren't giving any detail with regard to the model, but I don't know, Peter, if you want to --?

Peter Langecker

Yes, this is Peter Langecker. Typically, this is done arthroscopically (inaudible) evolves.

Jim Brown

So the majority of these surgeries are done that way, but we aren't giving a lot of detail as far as the specifics of the trial.

David Windley - Jefferies & Co.

Okay. And you might beg off on the next one, too, but you talk in your filings about having already done some exploratory Phase II studies in shoulder. And I'm wondering how these will differ from the already completed Phase II trials.

Jim Brown

It's a great question, and also the timing of the whole thing could be another question that one might need to ask. But we've been going on these ongoing conversations with the FDA, and as the conversations have matured over time, we've gotten to the point that we felt like this was a good opportunity to do some additional work that will just be defining as we said, I think the best term we used, the study conduct, and the way we will be approaching the study. The difference between this and the Phase IIa is that there will be a few more patience. Those Phase IIa studies were 15 patients, 12 patients, that kind of thing. This will be 60, but still be significantly smaller than what we expect from a Phase III where you'd look for statistical significance, those would be many, many full more.

David Windley - Jefferies & Co.

And using only the five ml dosage strength?

Jim Brown

Right.

David Windley - Jefferies & Co.

Right. Okay. My last question, I will jump out. On ELADUR, you mentioned that the $93 million I believe in remaining development milestone value spreads over multiple clinical indications. Can you quantify how much of the $93 million is tied to the primary PHN indication?

 

BNET TalkbackShare your ideas and expertise on this topic

Please add your comment:

  1. You are currently: a Guest |
  2.  

Basic HTML tags that work in comments are: bold (<b></b>), italic (<i></i>), underline (<u></u>), and hyperlink (<a href></a)

advertisement
advertisement
  • Click Here
  • Click Here
  • Click Here
advertisement
Click Here