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Stryker Misses the Goal with OP-1

Executive Summary

Analysts watching the progress of Stryker's OP-1, the first orthobiologic device to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended the product for European approval on January 3. But three weeks later, FDA sent Stryker a not-approvable letter. As it turned out, however, the OP-1 news, coincident with the company's announcement of strong financial results for 2000, barely put a dent in its stock price.

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