Question-and-Answer Session
Operator
(Operator instructions) Our first question comes from Tao Levy with Deutsche Bank. Please proceed sir.
Imron Zafar – Deutsche Bank
Good afternoon. This is actually Imron in for Tao. Thanks for taking my questions. My first question is on the Canadian filing. Can you, Sam, please just give us a little bit of light on what the nature of the questions were from Health Canada?
Samuel Lynch
Yes, Imron, basically the normal types of questions that you would expect ranging all the way from the clinical trial itself to manufacturing type issues, safety assessments, pre-clinical studies, and so forth. So we think fairly standard type of questions.
Imron Zafar – Deutsche Bank
Okay. And then as far as GEM OS2, the regulatory strategy there with the foot and ankle indication, can you just talk about what you expect there as far as the pivotal trial?
Samuel Lynch
The pivotal trial for GEM OS2, is that the question, Imron?
Imron Zafar – Deutsche Bank
Correct. Yes, please.
Samuel Lynch
Yes. We obviously are very encouraged and very enthusiastic with the results from Dr. Daniels' trial in the foot and ankle indication. As he said, it's hard to get better than all your patients being successful, having successful clinical outcome. So we clearly feel very, very good about that, but understand that it is a 10-patient trial and that we need to get – generate further data to further support the product in that indication. But we also want to make sure that we see the data from Dr. Larsson in the Swedish closed distal radius fracture study. And as I mentioned, that should be out around the end of September. And we want to make sure that we have an opportunity to review those data as well and to digest them. We then will get together with our orthopedic advisory board and review the data with them and select a final indication for moving forward into a pivotal or registration type trial.
Imron Zafar – Deutsche Bank
Okay, and then a couple of questions for Dr. Daniels. Dr. Daniels, in the 10 patients you treated with GEM OS2, can you just give us a little bit of sense of the patient composition? Were these de novo patients, or were they previously treated with a different type of surgery or – how many were smokers? How many were diabetics? And how many were both? Thanks.
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