Pharmaxis Receives Negative Trend Vote from CHMP on Bronchitol
Release Date: 25/05/2011 12:00am
Pharmaxis today announced that the Company had presented an oral explanation at the Committee for Medicinal Products for Human Use (CHMP) meeting last week as part of its European Union marketing application for Bronchitol® for the treatment of cystic fibrosis. Following the oral presentation, the members of the CHMP undertook a trend vote intended to show whether they were orientated to vote for, or against, the approval of Bronchitol.The outcome of this trend vote was negative.
While not a final decision, the trend vote indicates that the CHMP's current orientation is not to approve Bronchitol based on the existing application when it meets in June 2011. Pharmaxis considers it unlikely that this position will change before the formal vote is undertaken next month.
The Company is in the process of reviewing its alternatives with respect to the European Union marketing application which are outlined in the attached media release.
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