Corey B. Davis - Jefferies & Company, Inc., Research Division
I have 2. First, now that Purdue has filed the Citizen's Petition on what they think a generic should do to prove tamper equivalents on OxyContin. Couple of questions: number 1, do you think what they proposed is reasonable? Or number 2, have you done any of these types of studies already for your ANDA that's on file? And number 3, when, if ever, do you think the FDA actually provides official guidance on this?
Carole S. Ben-Maimon
So, this is Carole. So I think, I don't really want to comment on what we have or we have not done. Clearly, tamper resistance has been an issue. It's been not only in the news, but it's been an issue at the government level, at the federal level. And these tactics have been tried for many, many years. I think what's really important is, there is nothing in the labeling for any of the tamper-resistant products at that time that allow them to claim tamper resistance. In addition, non-tamper-resistant products at the brand level still remain on the market, and there are even non-tamper-resistant generics still on the market for the lower strengths of the Opana ER. So although I know that it's an issue, and clearly, we can't predict what the agency is going to do. I think the jury is still out and we won't know until the agency actually takes action. When do I expect them to take action? That's up to the agency. They have said they're targeting the end of this year, which would make some sense, given the patent expiries and the potential launches that are about to occur. But again, I don't think they're going to make any -- take any action until they're actually comfortable with what that decision is. And we can't forget also that there is now a new head of OGD starting, and that may impact their timing as well, because I'm sure he's going to want to weigh in on it.
Corey B. Davis - Jefferies & Company, Inc., Research Division
Okay, great. And second question, do you still expect to be able to launch your generic Opana ER in January of 2013? And at what point can you start actually getting DEA quoted to be able to start manufacturing inventory to be prepared for that launch in January? Is it something you can start on now-ish through purchase orders or is it closer to the end of the year when you would actually start building inventory for that?
Carole S. Ben-Maimon
So as you know, we have approval. So as long as that approval is not withdrawn because the FDA decides that the product was removed from the market, the brand product was removed from the market for safety reasons, we will continue to have approval. We obviously don't want to provide a lot of competitive information to anybody who we'll be competing against, and so I don't want to really comment specifically on what our plans are. We're obviously aggressively evaluating the market, and if we think there is an opportunity to launch the product and sell appropriately into the market, we will. With regard to quota, we can -- you can get a quota in anticipation of a launch. I don't want to give you details about what we are or aren't doing, but clearly, we're aggressively evaluating the market, and if we deem it appropriate, we will launch in January.
