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Re: None

Monday, 08/14/2017 5:36:47 AM

Monday, August 14, 2017 5:36:47 AM

Post# of 20689
Probability of approval this Q?

What probability do you guys see for the approval of Glatopa 40mg this quarter?

Gregg Gilbert
I want to ask the Glatopa question a different way, Craig. Is there any new info that you're privy to that makes you more or less confident in this happening this year versus your language last quarter?

Craig Wheeler
Yes. That is quite a different - it's a little bit different angle at it. So look, we're getting updates and information on a very regular basis in terms of exactly what's going on there. I can't disclose what those are. But I am - I continue, as I said last quarter, to believe that we have the opportunity to get this in this quarter. Obviously, if - I'm caveating the heck out of that because it requires a remediation; it requires an agency to work with multiple companies to get this all done. Our belief is, from what we see that, that could happen to allow us to get into the market in the fourth quarter of this year. But there are delays that could happen. There are things that could go wrong, which could push us into next year. So we're continuing to be - I think I would put us in the mode of cautiously optimistic that we could actually get those resolved based on what we have seen from the very good work that both Pfizer and Sandoz are doing.