Question-and-Answer Session
Operator
(Operator instructions) The first question comes from the line of Michael Tong - Wells Fargo Securities LLC.
Michael Tong - Wells Fargo Securities LLC
Can you give us some insight into what you think the timeline for AFRESA and Dreamboat will be? How far they might be separated from each other in terms of approval.
Dr. Peter Richardson
Clearly our goal is to accelerate Dreamboat as quickly as we can. We had a discussion with the agency as to what our strategy should be here. We want the approval at mid term, with the date of January 16th, I think you all know, and then be in a position to submit as rapidly as possible a file supporting the approval of Dreamboat which will largely be a technical file. We have well-characterized the device. As I said in this conference call I think we have a good feeling for what we need to do in terms of bioequivalents. We are waiting for the formal feedback from the agency at the moment in terms of the specifics of that design. Also given their recent concerns of what exactly we will do in terms of physicians handling data and some other information which would be normal for a device in that area.
It is hard to give an exact time when we will be able to submit that file but as soon after approval of the NDA would be our goal with this which we would hope would be a matter of months.
Alfred Mann
The FDA asked us not to amend our NDA filing but rather to submit the Dreamboat as a supplemental. I shouldn’t say they asked us. They suggested it.
Operator
The next question comes from the line of Simos Simeonidis – Rodman & Renshaw.
Simos Simeonidis – Rodman & Renshaw
Could you tell us when the last time you spoke with the agency was and was it during that communication or earlier ones you got any indication that the PDUFA might be pushed back? Whether it be for a panel, and I know Hakan said they told you that you don’t need a panel, or for backlog of work? Do you still expect them to reply by January 15th?
Hakan Edstrom
We speak with the agency every week or more. As I said the expected questions we have are in facilitating their arrangements for the inspection and audit of our sites where we conduct the clinical studies, all of which have been progressing according to plan. We see absolutely no indication in terms of the agency anticipating anything that would lead us to believe that there would be a diversion from that date. We have seen a great deal of energy and diligent review as I would expect from the agency on this and we have had a variety of questions to clarify and to deal with the things that one would expect to find in an NDA review, but nothing that has come to date which has been anything that would mean an indication around that.
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