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Pharmaxis’ Bronchitol Will Face Efficacy Questions At FDA Panel Review

This article was originally published in The Pink Sheet Daily

Executive Summary

Several statistical issues, including differential rates of missing data between treatment arms in the pivotal studies, make it difficult to assess mannitol’s benefit in cystic fibrosis patients, FDA says in briefing documents for the Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 meeting.

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