MNTA
#Well, that is something that is Sandoz's decision and we are not commenting on it, but what I will comment on is this this is a very different situation than the other patents.
We look at this one and think there could be some very definitive ruling in the Court, so Sandoz is an experienced generics company.
They will evaluate that at the time, but we are pretty confident about this set of patents that we can get some un-ambiguous rulings here.
Sure.
Thanks.
Sure.
Thanks.
I will take those in order.
First, our confidence on the approval ---+ I can not talk about specific regulatory(inaudible), but our confidence on the approval is pretty straightforward.
What took the time last time was the approval of the API, all right, showing that we actually had material.
There is not even a review this time.
We are actually referencing our drug master file for the 20-mig product.
It is exactly the same API, but this is basically a review of a reformulation so it is a much simpler review.
It is a standard formulation, which is something that the FDA looks at in many, many products; so we do not anticipate anywhere near the challenges we had in the earlier program, and as the only one with an approved API we figure that give us a pretty good edge in terms of 40-mig.
So we remain very confident on that approval.
In terms of the draft guidance, there was really nothing unanticipated there.
I think what we saw is the FDA is giving guidance in terms of the kind of things that need to be looked at.
but they are continuing to respect the confidentiality (inaudible) of details of the approaches that we took to answer those questions.
And that to us was our expectation, and that is we did see in the guidance.
In terms of the read-through on Synthon, I think that the message that Synthon got was that if they want to use J pathway they have to show their analytic payments as well as clinical trials.
So they have chosen to the J pathway I think they are still going to be held to the same analytic standard as we have as they are trying to get approval for the J so.
Sure.
Thank you.
Thanks everybody.
Thanks for accommodating our earlier time slot, and I look forward to updating you next quarter.
So thanks again for joining us.
