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Unimed Cryptaz

Executive Summary

Company will not pursue cryptosporidial diarrhea indication for nitazoxanide and will not perform the necessary additional studies recommended by FDA's Antiviral Drugs Advisory Committee May 6, firm says ("The Pink Sheet" May 11, p. 6). Unimed maintained that the decreasing rate of CD in AIDS patients due to new antiretroviral therapies and the fact that many patients are obtaining nitazoxanide from Mexico makes it difficult to enroll people in trials. No new patients will be enrolled in the "compassionate use" protocol but patients currently enrolled will continue to receive the drug free of charge

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PS032209

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