Question-and-Answer Session
Operator
Thank you. (Operator Instructions) Your first question comes from Tao Levy from Deutsche Bank, please proceed.
Tao Levy -- Deutsche Bank
Just a couple of quick questions, obviously we just saw you guys last Thursday at the analyst meeting, but maybe Sam, could you tell us what did you learn so far in the U.S., you know, like you mentioned enrolment was running a tad slower than expected. Anything with the handling of the product, packing and mixing, you know anything?
Dr. Samuel Lynch
I’m not sure if it is in the pivotal trail but one of the things that we learned in the pilot U.S. study as well as to some extent in the Canadian registration trail early on and that surgeons – and obviously the surgeons picked up on this again right away should not or we call over stuffed the joint, in other words, as you heard more and necessarily better. In these fusion cases, the objective is to get as much bone on bone opposition and if you pack too much of the PCP component of our product in that joint space and essentially distend and extend the distance between the two bony ends, it just takes more time as I think its maybe common sense if it takes more time for that site to completely view, so we have certainly been over that very extensively as you saw with the investigators in the pivotal trail and I think you saw a video of that procedure last week in the investor and analyst meeting how that material is being packed in and how they are getting basically primary bone on bone opposition following packing of that in. So that’s clearly one of the things that we learn other than and after surgeons report very good handling of the material of the any issues there. There has been no migration of the particles or anything like that, so I think we are very happy with that. Certainly, we know that surgeons really like the GEM OS2 injectable putty formulation and we are excited about that and of course we continue as we talked about to develop that as well.
Packing will be a double blister pack, packing for convenient use in an operating room setting and we are well on our way to having that well undergo, so I don’t see any issues there, and I think in enrolment as you alluded to in the first part of your question tail, you know, as we talked about with many of you, we don’t see – I mean obviously we would like to the faster of course, but what we don’t want the investigators to do is to push so hard to enroll patients that for example one of the issues is being just a logistical one, just having patients that may come from two or three hours away and many of these centers again our major thought leader centers and recruit patients from long distances, and so we have been careful about advising the investigators to only enroll those patients that are geographically located near enough to the clinical site that they are not terribly inconvenience by coming back for the multiple follow up visits that are required as part of FDA study. I can say that slightly differently what we don’t want is to push so hard on our clinical investigators as they started enrolling patients that live two or three hours away and that patients fuse in three or four months and see no need to come back for their 6 and 9 month followup and that would not be good and of course 6 month as you know is our primary end point for example, so we really must make sure that we collect that data. So, we’re walking a fine line between continuing to push patient enrolment and not pushing so hard that we risked the data quality.
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