Question-and-Answer Session
Operator
Thank you. We will now begin our question-and-answer session. (Operator instructions). And our first question will come from Brian Abrahams at Oppenheimer & Company.
Brian Abrahams - Oppenheimer & Company
Hi there, thanks very much for taking my question. I don’t know if there were some subtle differences in the BMD changes that you observed at six months with the 150 dose in Lilac Petal compared to what you saw in the Petal Study. And I am just wondering how meaningful in your mind are those differences if at all? And just given this variability, how reliable the (inaudible) regulators do you think their view of six months bone mineral density studies would be?
Chris O'Brien
Thanks Brian. It is interesting. We are talking about variability. There is a variability in a DEXA scan and then for an individual subject which is significant. In fact, for a given individual subject, if you want to reassess the impact of an intervention sometimes for these kind of subtle changes of 1% level or 0.5%, you don’t even get a meaningful read until you go out for say, one to two years, because of the noise that’s around that.
But in our case, we are talking about the variability of the mean for a group of subjects on the DEXA scan and in fact that’s why the FDA, we have looked at the lower bound of a confidence interval being minus 2.2% as the threshold that we’re interested in. So anything within that round, whether it’s minus 0.9% or minus 0.6%, those – that is just noise. It is the difference mostly likely between the population of one trial and the population for another.
If you look at the range of change in BMD for individual subjects in our studies as well as Lupron or DMPA or others, you see that the range is actually incredibly broad. You see changes as much as minus 10% to plus 5% depending on if the woman is 42 years old or 21 years old, contaminate medications, if she’s a smoker, how heavy she is, some genetics. But the good news I think for us and one of the surprises to me is that if a woman entered our trial with osteopenia and keep in mind, we didn’t allow anybody in with the osteoporosis. But if somebody came in a T score of minus 1.4, they feared no better or no worse than anybody else in the trial. So the effects of elagolix were consistent regardless of the baseline BMD status of limit. So this is just noise. The mean value is what’s important from a regulatory point of view going forward.
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