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Original Source: FD (FAIR DISCLOSURE) WIRE
. Mary Kay Ladone, Baxter Healthcare Corporation, VP IR . Bob Parkinson, Baxter Healthcare Corporation, Chairman, CEO . Rick Wise, Bear Stearns, Analyst . Michael Weinstein, J.P. Morgan, Analyst . Larry Keusch, Goldman Sachs, Analyst . Susan Lichtenstein, Baxter Healthcare Corporation, General Counsel . Glenn Reicin, Morgan Stanley, Analyst . Rob Davis, Baxter Healthcare Corporation, CFO . Ben Andrew, William Blair, Analyst . Steve Hamill, Piper Jaffray, Analyst
The Co. announced earlier on 06/29/06 that it has reached agreement on a consent decree between BAX and the FDA regarding its COLLEAGUE and SYNDEO infusion pumps.
S1. FDA Agreement (B.P.) 1. Highlights: 1. The Co. announced earlier on 06/29/06 that it has reached agreement on a consent decree between BAX and the FDA regarding its COLLEAGUE and SYNDEO infusion pumps. 2. The Co. now has a roadmap that defines the necessary
milestones that it must achieve before it is able manufacture
and distribute COLLEAGUE and SYNDEO for the US market. 1. This agreement resolves the FDA's court action that started with the seizure of pumps in the Co.'s northern Illinois facility in Oct. 2005. 3. Many hospitals waited to order new devices. 1. By virtue of the aforementioned announcement, the Co. believes it is now on a path towards resolving these issues so that BAX can serve patients and medical professionals by delivering the quality, the reliability, and innovation that they expect and deserve. 2. Overview Of The Agreement: 1. The official document was filed on Form 8-K on 06/29/06. 2. Pumps currently in use will remain in the field.
1. Once the decree is entered BAX has 20 days to get the FDA
plan describing the corrective …