Question-and-Answer Session
Operator
(Operator Instructions). Your first question comes from the line of Alan Carr with Needham. Please proceed.
Alan Carr
Hi good afternoon, everyone.
Jack Lief
Hi, Al.
Alan Carr
A couple of questions, one -- minor one I just wanted to get out of the way. First about your financial guidance, could you clarify again the guidance for the contract manufacturing for this year?
Jack Lief
We gave total revenue of 8 to 12 million and that includes about 7.5 million in contracts manufacturing revenue.
Alan Carr
Okay, thanks. And, I guess what I wanted you to comment in a little bit more detail with about is the impact of this ever changing strategy of including the BLOOM-DM trial in your NDA submission. So, can you talk a bit about how that’s going to impact timing for submission of the NDA and then when do you think you will be able to submit this SNDA?
Jack Lief
Yeah. So the NDA will be submitted on schedule next year, the BLOOM-DM trial is ongoing and it’s just been rolling as many of these trials enroll relatively slowly and so we expect to be able to file results from this trial when it’s completed possibly even after we file the NDA next year. Bill, do you have anything else to add in that regard.
William Shanahan
We had a window after filing to put in some supplemental data. So, we will just keep you updated, we are not certain yet of what the final time will be to recruit this trial.
Jack Lief
Yeah, keep in mind that it’s the study is nice to have for labeling, but not essential for approval.
Alan Carr
Okay. So as the change you may not need to do SNDA after course enough. Do you think then enrollment with the DM trial is that something that’s going to be -- is that kind of go into the fourth quarter of this year even or do you have a sense at this point?
Jack Lief
I don’t know. And so we would like to make predictions on things that we know. And so, we are telling you the way things stand right now and as the trial gets further enrolled we will be able to address specific timing in either case, it’s not going to affect the NDA or the commercial opportunity that we have with lorcaserin.
- To read the full transcript on Seeking Alpha, click here »
