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Vaccine Development (Staphylococcal Infection)

Positive Interim Results in Nabi-StaphVAX Trial

Published in Medical Letter on the CDC and FDA, September 6th, 1999

Nabi, Boca Raton, Florida, announced that, based on an analysis of interim data from its pivotal clinical trial of Nabi-StaphVAX, it believes that statistical significance may be achievable at study end given the trend towards protection seen to date.

The double-blinded, placebo-controlled trial, involving 1,800 end-stage renal disease patients on hemodialysis, has been fully accrued and will continue to completion. The company anticipates that final results will be available by next summer (2000). If these results demonstrate statistical significance, Nabi will pursue U.S. Food and Drug Administration (FDA) licensure.

"We are elated that the...

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