DURECT Corporation Q2 2008 Earnings Call Transcript

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2008-09-13 22:03:13.0

Tags: Durect Corp.

Question-and-Answer Session

Operator

(Operator instructions) Okay. Our first question is from Geoffrey O'Brien from Punk Ziegel. Go ahead, Geoffrey.

Geoffrey O'Brien Punk Ziegel

Good morning, guys. Just wanted to give a quick question here on POSIDUR; you mentioned earlier that you have made some progress with the FDA regarding Phase III discussions. Just wondering if you could give a little more color on that? At this point have you decided which pain models that you are going to use in Phase III, or is that still in discussion?

Matt Hogan

I'll take a stab at that. I think we've – we know what we want to do, but there's no point in getting anything started until you've kind of got agreement with the FDA that you're doing what they want you to do so that at the end of the process, you put together a package that's in good shape to get approval. So I think that we have a good sense for what we want to do with the program. It's a matter of just making sure that the FDA is in alignment with that for all of the details that are involved.

Geoffrey O'Brien Punk Ziegel

Right. That makes sense. So do you think that you're in a position to comment at this point as to whether or not you think Phase III would start by the end of 2008, or do you think there's a possibility that that might start early 2009?

Matt Hogan

We really can't say, and it's not entirely in our control, because we're dealing with the FDA. If we could completely control the timing, we could probably put down something; but, until we're done with the FDA, we really can't be precise.

Geoffrey O'Brien Punk Ziegel

Okay. And then just a question on ELADUR. You know, you guys had talked about starting Phase II or running additional Phase II-B studies during 2008. I was just wondering if you can give an update on the timing of that, and when you might have data from the 2B study.

Jim Brown

Well, with respect to ELADUR, you know, we've been spending a lot of time really trying to plot out what our clinical and regulatory strategy might be and to some extent, that has been influenced by some of these discussions with potential partners. So that we're in alignment with what a potential partner might want to do. And at the same time, what we've been doing is all of the steps to line up supplies to do additional Phase II studies as well as Phase III. So I think at the moment, if you can just hold off a little longer, I don't think we really want to lay out yet what the next steps will be. We do envision doing additional Phase II work, but being a little more precise on the timing, I think we'd rather hold off on that for just this moment.

 

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