On October 17, 2012, St. Jude hosted a conference call to discuss its financial results for the third quarter of 2012. During the call, the Company informed investors of potential advisory action by the U.S. Food and Drug Administration (the “FDA”) resulting from the FDA’s inspection of the Company’s facility in Sylmar, California. On this news, St. Jude’s stock fell $2.09 per share, or 4.87 percent, to close at $40.85 per share.
On October 24, 2012, St. Jude filed a Form 8-K with the U.S. Securities and Exchange Commission regarding the FDA’s inspection of the Sylmar facility and included a heavily redacted version of the FDA’s inspection report. In describing the inspection results, St. Jude claimed that “none of the observations identified a specific issue regarding the clinical or field performance of any particular device.” Following this news, St. Jude’s stock price fell $1.44 per share, or 3.63 percent, to close at $38.27 per share on October 25, 2012.
On November 20, 2012, the FDA released its own version of the Sylmar facility inspection report. The FDA’s report revealed numerous concerns relating primarily to the design, production, and quality control of the manufacturing process of Durata leads. On this news, St. Jude’s stock price fell $4.34 per share, or 12.15 percent, to close at $31.37 per share on November 21, 2012, on exceptionally heavy trading volume.
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