Question-and-Answer Session
Operator
(Operator Instructions) We'll take our first question from Tom Russo with Baird.
Tom Russo - Baird
Congrats for starting COPD. I was hoping first to start with exacerbations and ask if there is any signs or data that you can share on the correlation between FEV1 coverage in reducing exacerbations, basically what would generate yours and Glaxo's confidence in bridging from what you've shown in Phase 2 to the primary endpoint in Phase 3 ,where we haven't seen anything yet?
Rick Winningham
Tom, I think this has been a standard pathway for looking at medicines to treat COPD. I think given the airway expansion that we've showed in the Phase 2b studies, in particular the 600 patients that clearly were quite confident in the Phase 3 program and the Phase 3 design and the ability of the combination of 444 and FF as well as well as a 444, a monotherapy to demonstrate the benefit in the study, so it's a standard. We are following a relatively standard path to approval here, and I think the Phase 2 data supports the design of the studies, as well as the probability for being successful.
Tom Russo - Baird
Then last quarter, three months ago Glaxo made some comments about asthma and kind of what was left to resolve with FDA, and it didn't sound like much. Can you give any color now that three months have gone by and it sounds like it's kind of at a similar status, is there anything you can share on that front, the asthma front?
Rick Winningham
Other than what we both companies said in the press release, there's not much more that I can share. I think the tone in the press release was meant to convey a sense of optimism and the fact that we look forward to talking about the asthma program in the upcoming months.
Tom Russo - Baird
Are there any new obstacles, or is it just kind of working through what was already there last time we heard?
Rick Winningham
I would say that the discussions with the FDA are ongoing, and we look forward to updating the public in the upcoming months.
Mike Aguiar
One quick comment I'd like to add Tom. While we continue to remain quite optimistic about the ultimate outcome in asthma, the most important indication for us really was, whatever the first indication was principally due to the royalty structure that we enjoy, which is that we get the majority of our royalties in the first $3 billion worth of sales. So, we were extremely pleased to have COPD started. That has the potential to take us largely, if not all the way through that first tier. So that has been probably the single-most important event that we've had occur here lately, and we're extremely happy about that. With that being said, we continue to remain confident that we're going to get to the right place with asthma.
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