Question-and-Answer Session
Operator
(Operator Instructions). We will take our first question from Gary Nachman with Leerink Swann.
Gary Nachman - Leerink Swann
Hi, good morning. Marty, first what exactly are you looking for the Dyloject observational study? How long are patients actually being tracked, and do you think that could be a gating factor for potentially signing a partner in the US?
Marty Driscoll
All right. Thank you, Gary. It's good to see you, good to hear from you this morning. First of as we told you, we are looking for 850 evaluable subjects. We are taking patients all patients to be evaluable on the trial must be measured beyond 48 hours.
If they have been dosed only for 20 or less than 48 hours, we don't consider them a part of the evaluable population, so it is a robust large study, it has being done simply so that we can have a robust integrated summary ISS and our NDA. This NDA will have more than 1,600 subjects on the dossier, where more than 1,100 will be in the ISS.
So, it's simply to observe safety. It is not an efficacy trial. You know as we pointed out Gary it’s an open-label observation trial and we are taking them out beyond 48 hours and we are ensuring rather large population to actually out to five days as well. And in terms of your last question, is it a gaiting factor for the partnership, no.
Well, in fact I will tell you the fact that we moved so quickly has helped because it’s evidenced to the companies we are speaking to that we are going to file an NDA later this year. And the beauty is it’s an open label trial, so we can see the data as we move along. And I think it actually assists us because the observations in the trial have been very consistent with the available data from the UK. So, I think it is more confirmatory to the fact that we are getting it done ahead of schedule actually benefits our partnership discussions.
Gary Nachman - Leerink Swann
Okay, but if your 95% enrolled then you are pretty close to be in complete with the entire study?
Marty Driscoll
Yes, but as you know in the trial you got to do a data clean-up and you got to do all of your statistical work. So, the key is I would imagine by the end of the month we have done an enrollment and then you push your follow-up period in line. But we are right on schedule and it was the gaiting factor for the filing in the NDA, so we are in good shape. And I think there were some skeptics out there that didn’t believe we did complete this as quickly as we had put forth and now they see that we can.
- To read the full transcript on Seeking Alpha, click here »
