Question-and-Answer Session
Operator
(Operator Instructions). Our first question will be from the line of Gary Nachman from Leerink Swann. You may proceed.
Gary Nachman - Leerink Swann
What's the status of the audit of Takeda, how long is this going to go on for and is there anything meaningful Amitiza so far? Do they have the same number of reps on Amitiza or has that changed at all?
Stan Miele
This is Stan. So I’ll answer that in two parts. The easy part is as it relates to the number of reps that has not changed, that’s the same as it was at our last earnings call. As it relates to the audit, the most recent update is we have hired independent consultants and we are currently having ongoing discussions with Takeda on the actual scope of the audit. So at this point in time, it is inappropriate for me to comment any further, but that’s where we are as it relates to the audit at this point in time.
Gary Nachman - Leerink Swann
Just for follow-up. Is there a termination clause in the agreement that would allow you I guess to get out of it and look for another partner if does need come to that?
Stan Miele
Yes. I think at this point in time, I think it's inappropriate for us to comment on that.
Operator
Your next question will be from the line of Scott Hirsch with Credit Suisse. You may proceed.
Scott Hirsch - Credit Suisse
With respect to the OBD study, are you prepared to like to know that the placebo response was caused by the methadone involvement or is it just co-relative at this point?
Stan Miele
I was checking the R&D. At this point, we’re still exploring the reason why the placebo event was so high in the 632 study. The results we have regarding methadone show that patient who are on lubiprostone had a lower response rate if they were on methadone. At this point, we don’t know if the methadone is related to the high placebo response rate.
Scott Hirsch - Credit Suisse
You’re still looking into trying to figure that out?
Stan Miele
Yes. We are still doing further analysis.
Scott Hirsch - Credit Suisse
So we could still see that you guys pursue the OBD indication going forward?
Stan Miele
That’s correct.
Scott Hirsch - Credit Suisse
Then, is there any detailed timeline on the EU filing decisions? I know you said by year-end, but is there any more granularity to that?
- To read the full transcript on Seeking Alpha, click here »
