9year low..., page-33

Sorry missed your link at the bottom there primaus, was viewing on my phone.

Not the most promising at face value, however that 2007 study was over 12 weeks, while the milestone Phase 3 was over 52 weeks. It also has different primary end points, different trial design, and also more specific recruitment criteria.

The primary end points (quality of life and mucus clearance) changed from the 07 study because they weren't significant enough on their own. It was your typical poorly designed Aussie biotech trial, that the FDA would of laughed at. The primary end point of the reporting milestone Phase 3 is to show "a significant difference in the rates of graded pulmonary exacerbations, in patients with bronchiectasis treated with Bronchitol compared to control"- which was advised on by the FDA/EMA...

"The study did not achieve statistical significance vs. control in the St George Quality of Life Questionnaire (p value 0.304) which was also a primary end-point. "

Hang on a minute, I thought the Bronchiectasis trial in 07 did meet all it's primary end points?? I just thought the problem was that the endpoints weren't adequate?

http://www.pharmaxis.com.au/assets/pdf/2007/2007_08_29_B301_results.pdf