Question-and-Answer Session
Operator
Thank you. (Operator Instructions). And we will take our first question from Adam Greene from JPMorgan.
Adam Greene - JPMorgan
Thanks. Good morning everyone.
Martin Driscoll
Good morning, Adam.
Adam Greene - JPMorgan
Marty can you talk about your decision to do an open label safety study for Dyloject. When do you think that it will start, how long should it last and by most importantly how much do you think about – the delay the filings for Dyloject? I think previously you had said second quarter '09 filings or is it six months I think its more late '09 rather than early '09? Then I may follow up.
Martin Driscoll
Sure. Adam – I am going to let Dan answer that if I may.
Adam Greene - JPMorgan
Sure.
Martin Driscoll
Thank you.
Daniel Carr
Yes. Thanks Adam for the question. Well let me reiterate what Marty said that we have seen no safety signal either from our clinical trials or our pharmacovigilance in the UK nor has the FDA informed us of any specific Dyloject safety concerns. But given the recent trend of the FDA to emphasize developmental processes that focused on safety, we are taking a belt and suspenders pro-active approach to anticipate regulatory directions by augmenting the patient numbers in our integrated summary of safety that confirms the recognized safety of diclofenac. Diclofenac as you know is the active pharmaceutical ingredient in the most recent to -- hence it's approved. So, we are speaking about a simple, efficient, observational, non-placebo controlled open label study that can leverage our having an approved drug on the UK market. So I would say that we are still on track to complete the NDA filing in late -- in 2009.
Adam Greene - JPMorgan
Thanks and follow-up on ketamine. Can you just remind us of the trial design for that and how many patients how long? And how confident are you with that product that the FDA will accept just one pivotal study? Then, also if you could update us on the status of the breakthrough pain trials for that product?
Martin Driscoll
Great, let Dan take that again Adam.
Daniel Carr
Well, first of all again as we have emphasized we have a fine relationship with the FDA and we enjoy open communications and I reiterate that it's our understanding we are doing what is necessary by having that trial complete to file a high quality NDA. While no drug company can produce – can predict every regulatory development we can certainly do our best to anticipate it. Based upon our previous discussions with FDA we are looking at a very simple trial in elective same-day orthopedic surgery, where we would compare PMI-150, our intranasal ketamine product with placebo over several doses for several hours in order to fulfill the check box for a multi-dose efficacy trial. We anticipate there will be about a 150 patients in that trial.
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