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Rare Events, Rare Disease: “Theoretical” Issues Central To FDA Soliris Review

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Executive Summary

The effect of Alexion's paroxysmal nocturnal hemoglobinuria therapy Soliris (eculizumab) on thrombosis, a major clinical problem associated with the rare blood disorder, was one of the most contested issues in the review of the Soliris BLA, FDA review documents suggest
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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