Question-and-Answer Session
Operator
(Operator Instructions). And it does look like we're going to take our first question today from the line of Craig Gordon of Cowen & Co. Please go ahead, your line is open.
Craig Gordon - Cowen & Co
Hi. Good morning. A couple of questions. You had discussed the 12 month BMD data, at that time did you also collect data on bone biomarkers.
Chris O'Brien
Yes, Craig. We do collect serum N-telopeptide. As we reported earlier, there was to real change in N-telopeptide during the six months of active treatment, and there's no real change in the six months without treatment. So for whatever reason, the subtle changes that we see in DEXA are subtle enough that there is not major movement in the serum bio marker. So no evidence of a mark change in reabsorption.
Craig Gordon - Cowen & Co
And what are your thoughts on having to prove that in deed it does have disease modifying effect?
Chris O'Brien
So that's an interesting challenge. The reason we went after an indication of pain associated with endometriosis, is because that regulatory pathway is somewhat more clear and tractable than disease modification.
There is no uniform agreement as to how one demonstrates disease modification. So, although earlier approved drugs may have had some kind of language to that effect in the label, those were based on so called second look laparoscopic procedures where you go and count the number of lesions or describe the quality of lesions et cetera.
Since that was done many years ago, that has fallen in disfavor, and there is no agreement that that would be a way to getting disease modification and the label. So, what most people believe will be necessary is that we will have bio-markers that are more reflective of the actual pathophysiology of the disease. And it is only once these bio-markers have been validated that a true disease modification claim can be made.
But a lot of work is going on not just here at Neurocrine, but around the world on endometriosis to try o get a better handle on what that might be. I was in and out of the post marketing kind of thing.
Craig Gordon - Cowen & Co
Okay. That's what I was just going to ask you. So the whole disease modifying effect would be something that will be done in the future and theoretically you could get on the market and then you continue to work on that aspect of the drug?
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