Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Bill Plovanic - Canaccord Adams
Bill Plovanic - Canaccord Adams
On the OsseoScrew you said that you submitted to the FDA and received questions back. Can you give us a little color on the types of questions you're receiving on that?
Dirk Kuyper
It wasn't anything that we hadn't really anticipated. The primary one related to bony integration because the screw is slightly different then a traditional screw, they wanted to know that bone would actually grow around the screw which we showed them histology slides from an animal study that we had done. The second one had to do with retrievability post surgery and we showed them both immediately at the time of surgery it could be un-deployed and removed and also after six weeks that it could be un-deployed and removed and that study is continuing and we will give them additional results after they're in.
Bill Plovanic - Canaccord Adams
Do they need those additional results for the approval?
Dirk Kuyper
They haven't asked for them at this time.
Bill Plovanic - Canaccord Adams
Do you think that this will get approved before year end or early January?
Dirk Kuyper
We're hopeful. We think that we addressed their questions in a very substantive way. We're hopeful, they have 30 days basically to get back to us from the 22nd so we should hear right before Thanksgiving. Always the Holidays make that a little more difficult as things definitely slow down at the FDA but I think worst case certainly early first quarter.
Bill Plovanic - Canaccord Adams
On GLIF could you give us some color on the changes that you made and is this the final tweak and you're ready to go, start manufacturing instrumentation sets?
Dirk Kuyper
We've actually already started manufacturing the instrumentation set. What we found in the initial surgery was with, a lot of time lumbar surgery is done on people who are obese and one of the first patients that we got was extremely obese and we saw that the portal was a little bit too short for that type of scenario and wouldn't stay in place so we actually lengthened it a little bit and then also added a couple of pins to it to lock it down into the vertebral body. That's been done, we confirmed it in a lab a couple of weeks ago and so we believe we've got the final solution now. We'll do some more cases in the beta and then the idea is to launch basically right after the beginning of the year.
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