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Vasogen Trial Stymied by FDA Reversal

FDA has reversed itself over patient-recruitment and statistical-analysis issues for Vasogen Inc.'s Celacade System, a combination product that treats heart inflammation. Responsibility for lead review has been switched from CDRH to CBER (though the product will remain regulated as a medical device). CDRH had asked the company to use a Bayesian study design, but it now says the approach is not justified because of concerns about how patients in the product's two main studies were recruited.

The company says it will respond to the agency soon. Vasogen was named one of MD&DI's 50 Companies to Watch in 2006. What this means is that the watch will last longer than expected before it's known whether the firm will have success. UPDATE: On April 14, 2008, Vasogen said it would cease funding studies for Celacade and shift focus to a different field. It also said it would cut 85% of its work force.

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