William Tanner – Lazard Capital Markets
Brian, I know you had a couple 483 letters, at least, certainly this year. I wonder if you could give us a rundown on any outstanding issues that there may be at any of your plants or others relevant to King? Just a second question on the Purdue settlement, was there an attempt to encompass the oxycodone NT with that or is that something likely you have to revis in the future?
Brian Markison
Bill, thank you for the question on the Purdue settlement, but we really can’t and will not add much too it than what we’ve already said, but I appreciate the question. With the 483s, I’ll let Joe speak to that.
Joe Squicciarino
As you point out, we had two of our plants underwent inspection earlier this year, one in Rochester, Michigan, where we manufacture Bicillin, and the other is in Middleton, Wisconsin, where Thrombin-JMI is manufactured. So the outcome of the Rochester, Michigan 483s, we had relatively low number of observations. All of the corrective actions pertaining to those observations have been completed. We submitted the final report to the Detroit office of the FDA about a month ago. So nothing earth shattering there and we feel good about that audit and the outcome.
In Middleton Wisconsin, we had slightly higher number of observations; many of them or some of them I should say pertaining to process validation and a couple of other issues. We have addressed about half of the observations in Middleton. So they’re complete and the remaining observations that are yet to be addressed pertain to future production run, so we won’t be able to address those until those future production runs take place, but in both cases we’re in a good shape.
William Tanner – Lazard Capital Markets
Then just nothing else subsequent to those?
Joe Squicciarino
When you say, no, nothing…
William Tanner – Lazard Capital Markets
In terms of the other 43 letters?
Joe Squicciarino
No, no, we have not received any.
Brian Markison
Keep in mind, the Rochester facility is a single purpose plant for Bicillin only, and as Joe mentioned the Middleton facility is a single purpose plant for THROMBIN-JMI. Again, we believe that the Company’s management or the process is going to accept those steps well.
