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At Stannsoporfin Advisory Committee, Talk Of Additional Studies Stirs Feasibility Doubts And High Emotions

Executive Summary

InfaCare’s jaundice drug needs more neurodevelopmental outcome studies, US FDA committee says, but one panelist doubts feasibility of long-term follow-up; talk of additional studies leads to an unusual tongue-lashing from one of InfaCare's experts, who says he was 'stunned' by the committee’s conclusion that efficacy had not been shown.

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