Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Gary Nachman – Leerink Swann.
Gary Nachman – Leerink Swann
Marty, on the Dyloject filing, what are you including in the NDA in terms of a (rense) program? Could you elaborate a little bit on that? And then have you guys actually had a pre-NDA meeting with the FDA so just to give you more clarity in terms of what you need to file. Its sounds like you're filing everything, but that would be just comforting. Then do you guys think you'll get a priority review just like the Acetavance and Caldolor did.
Martin J. Driscoll
On your three questions, first number one, a (rense) program that's not required for Dyloject. A (rense) program has not been asked for by the agency. There's been no indication and we would not anticipate. Remember, this is an NSAID and all the recent NSAIDs approved by this division over the last two to three years, including of course that diclofenac NDAs which have been approved – I think three have been approved in the last two and a half years, no (rense) is required. So that's not to be required for Dyloject.
Secondly yes, we've had a pre-NDA with the agency sometime ago. We've had a number of meetings with the agency and we feel certain that we're filing in this impressive application all that the agency asked of us. And then your third question in terms of a priority review, we'll have to see. It's hard to predict that. As you know as you mentioned, Caldolor received that because they sought an indication and received an indication in adult fever.
So we think we feel we have a compelling application and we'll file in the next – very shortly, and a priority review we'll have to see and work with the agency on whether we get that.
Gary Nachman – Leerink Swann
In terms of partnership discussions that's been ongoing for a while. It sounds like once again you're pretty close. I mean is there any chance that you would wait to file if you think a partnership is imminent or that's going to happen regardless and then we'll probably see a partnership deal after that.
Martin J. Driscoll
That's dynamic. It certainly and our partner, because the discussions are with high quality groups with good experience, they're adding a lot of value to our NDA submission.
- To read the full transcript on Seeking Alpha, click here »
