Question-and-Answer Session
Operator
Thank you. Ladies and gentlemen, if you wish to ask a question please press "*" followed by "1" on your touch-tone telephone. If your question has been answered, or you wish to withdraw your question press "*" followed by "2". Questions will be taken in order received. Please press "*1" to begin.
Your first question comes from the line of Tao Levy with Deutsche Bank. Please proceed with your question.
Seth - Deutsche Bank
Yeah. Hi, guys. This is Seth calling for Tao. First, I just wanted to touch base on the Canadian filing. First, when did you decide to have a meeting with the Canadian Health Ministry and do you believe that the current data is going to be enough to get a product approval?
Sam Lynch - President and Chief Executive Officer
We initially decided to have that meeting, I would say, I don't know roughly a month or so ago, more or less, and it was after an initial conversation with them on this topic, we believe that we will be to our benefit to review that data with them. It's a very customary thing to do, to go in and have a pre-filing meeting with the regulatory agencies. And we just think that that will be very much to our benefit to have that meeting with them prior to making any submission.
So in regard to any speculation on the data, we have not received or have not finished analysis of the data. We do not yet have at this point any more data that has been publicly released. So, we can't speculate on whether or not that will -- that data will be sufficient until it's fully analyzed and we submit that to the Ministry of Health in Canada.
Seth - Deutsche Bank
Okay. So, Sam, assuming that we don't have any hiccups, you said shortly thereafter, we should expect the filing, does that mean by the end of the first quarter?
Sam Lynch - President and Chief Executive Officer
I would say if all goes smoothly, yes, it should be sometime next spring, early next spring. But I would say around the end of the first quarter.
Seth - Deutsche Bank
Okay. And then, to move over to the U.S. pivotal study, you said that enrollment is on-track. So, is it safe to assume, we're going to see top line data from this study by about this time next year?
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