St Jude Medical Earnings Call Nuggets: the FDA Warning Letter and This Year’s Guidance Approach
The FDA Warning Letter
Kristen Stewart – Deutsche Bank: Just wanted to, I guess, ask just on the FDA warning letter. If you can maybe just give us just your thoughts on the progress that you’ve been making and any sort of timelines you might expect? Then secondly, just what gives you confidence in holding market share across ICDs and pacemakers going forward in 2003 as you stated in your guidance?
Daniel J. Starks – Chairman, President and CEO: With respect to the FDA warning letter, once we received FDA’s inspectional observations last October we reacted as though we already had received a warning letter. So, in October, we formed remediation teams; we implemented monthly progress reports to FDA; we gave highest priority to fully remediating all of the deficiencies noted in the Form 483 and now some of which were also noted in the warning letter, with the very highest degree of urgency. So, some of our remediation already has been completed. The remainder of it is going full steam ahead and is fully baked into our guidance. So, we expect to have all aspects of the warning letter remediated with priority and with urgency during 2013. Eric, is there anything else that you want to say about the warning letter?
Eric S. Fain, M.D. – President, Implantable Electronic Systems Division: No, I think you covered it.