Question-and-Answer Session
Operator
(Operator Instructions). And our first question is today is from Ian Somaiya from Thomas Wiesel Partners. Your line is open.
Kevin Gorman
Ian?
Operator
Ian Somaiya, your line is open.
Kevin Gorman
Okay then we can move on to the next on and then come back to Ian.
Operator
We will move to Bryan Adams from Oppenheimer. Your line is open.
Bryan Adams - Oppenheimer
Hi, its Bryan Adams thanks for taking my question. Looking ahead in the elagolix development program what's your sense based on your dialog with squad leaders and with regulatory agencies and to what ultimately the end points are going to be that the FDA will require in Phase III program?
Kevin Gorman
Chris I will give that to you.
Chris O'Brien
Thanks, Bryan. Clearly we are seeking in as an indication for elagolix, the management of pain associated with endometriosis. So the primary end point will be a pain end point. There have been and in the future may well be other indications either within endometriosis disease modification, fertility or other things that you could go after.
But we are going after pain as the clearest regulatory path to go down. This recent physician paper that I mentioned was consensus conference among academicians, clinicians, pharma, our regulatory authorities and they clearly outlined what they see as the path forward for drugs targeting pain reduction and endometriosis.
So their guidance is very much appreciated and obviously when we sit down at the end of Phase II meeting we will talk with the regulatory authorities in the US and in Europe and make sure that we have a consensus for the design and primary end points of the pivotal trials. But it will be a pain end point that we are going after.
Bryan Adams - Oppenheimer
Okay. In your sense that it might look something that might look closer to the numeric rating scale that's the primary end point in Lilac PETAL or something more along the lines of the modified B&B?
Chris O'Brien
That's a good question. If one looks to other therapeutic areas and other divisions at the FDA you will see that the numeric rating scale in fact has become the more as the gold standard whether you are talking about cancer pain or neuropathic pain or other kinds of pain end points.
The modified B&B at the moment isn’t a single discrete entity we have the old B&B scale which itself had been modified a number of times. Also once a month retrospective paper assessment of five different components.
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