Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Cory Kasimov - J.P. Morgan.
Cory Kasimov - J.P. Morgan
I won't ask anything on partnership right now, but I'm wondering from a clinical standpoint, some of the outstanding studies, the commercially focused studies like I think it's 117 and some of the other ones that are out there, when might we expect to get a read on any of those?
Alfred E. Mann
Well, Peter's not here today so I hate to answer for him, but the 117 program is moving forward, primarily with the Dreamboat inhaler, and can't restart until September, so you're not going to see data from this until well into next year, probably after mid-year.
Cory Kasimov - J.P. Morgan
And then as far as that Dreamboat inhaler is concerned, can you talk a little bit about what you believe at this point in time you need to do from a regulatory standpoint? And when you talk about potentially using this as the inhaler at launch, would that imply a protracted timeline to get that ready to go?
Alfred E. Mann
We haven't really said that. We're simply saying that it depends to a large extent on what the FDA requires for us to do. When we changed to the Model D Medtone from the Model C, which was just a moderate change in the design in order to make it more rugged and more manufacturable, the FDA simply - actually at the pre-NDA meeting at the very last minute a member of the FDA team from the Device Bureau said I think we'd be more comfortable if you did a bioequivalency study, so that's what we did and that's what delayed us a few weeks, which was why we didn't finish by the end of the year. But we did complete that study and it showed bioequivalence and that was fine.
We are hoping that that's all that the FDA will require this time because we're not really changing the powder and the Dreamboat is simply much more effective in emptying the cartridge and doing it more consistently, so we're hopeful that the FDA will accept the introduction of Dreamboat, which would have a lot of advantages for the patients as well. But we can't make the decision until we get a response from the agency.
Cory Kasimov - J.P. Morgan
Okay, but it's safe to assume that at least in terms of the Phase I data that you have in hand now that [PK] profile with Dreamboat is in line with what you've seen with Medtone based on your internal [inaudible].
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