12 month phase 3 trial finds bronchitol safe, page-5

VVS, my understanding is that you're wrong. The latest quartlery newsletter says that they intend to file a marketing app for Bronchitol with the TGA once the 12mo safety study reports, which it did today (the passage is copied below). Perhaps you're thinking of the USA's FDA (rather than Australia's TGA), which does require another phase 3 trial before PXS can apply for approval. That process is more in line with the 18mo+ you mentioned.


This is from the quarterly report to shareholders from July:

Long-term safety study in Bronchitol due to report. A 12 month Phase 3 clinical trial evaluating the safety of Bronchitol in over 100 subjects with bronchiectasis completed in June.

This study was an open label extension to a three month efficacy trial which has already reported, showing that Bronchitol improved quality of life and mucus clearance. The objective of the open label extension is to determine the adverse event profile of Bronchitol following prolonged use. Following statistical analysis, the results from
this second phase of the trial will be reported in the next quarter. After receiving the study report, Pharmaxis intends filing its first marketing application
in Australia for Bronchitol.