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Jun 03, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Bronchitol mannitol regulatory update

Based on an end-of-review meeting with FDA, Pharmaxis said the agency is requiring an additional 6-month pivotal trial of Bronchitol mannitol in order to gain approval. The trial will enroll about 300 cystic fibrosis (CF) patients >=18 years of age. The primary endpoint will be forced expiratory volume in 1 second (FEV1). Pharmaxis said a post hoc analysis of the subgroups of...

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