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Ribavirin Treatment IND

Executive Summary

Top FDA officials, including Commissioner Young, met with ICN's outside counsel on Dec. 1. ICN said the company has not yet filed a third Treatment IND request for the anti-viral agent. The previous two were rejected by FDA ("The Pink Sheet" Sept. 7, 1987, p. 11). ICN has developed a protocol for a U.S. trial, which is under review at FDA. A Canadian protocol has been approved, and the study is expected to begin in that country "imminently," according to ICN....
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PS014775

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