Antisoma of the UK has said that it faces an 18-month delay in filingfor US approval of its lead product, pemtumomab (formerly Theragyn) for ovarian cancer, after the US Food and Drug Administration asked it to extend the number of patients in a Phase III trial in order to improve its statistical power. The move comes after a lower-than-expected mortality rate in the initial stages of the study. The news drove the company's share price down nearly 18% to L1.55 ($2.19), as it emerged that the drug is unlikely to reach the market before 2004.
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