response letter, page-36

http://www.spititoutblogspot.com/2013/02/bronchitol-power-to-patient.html

Not sure if this one has been posted before, however everyone should read this blog if they haven't already, it's regarding the FDA's negative vote for bronchitcol from a sufferers perspective.

It really sounds like the main issues were trial design, and not being able to break the data down into specific sub groups that demonstrated a clear statistical significance and safety. As the FDA accepted that it" very effective in some patients with significant improvements in terms of airway clearance, FEV1 and reduced exacerbations; and that it made a significant impact in terms of reducing the heavy burden of treatment associated with CF and materially enhancing quality of life". So even just by having more specific recruitment criteria that limited drop out rates, or by having specific FEV1 endpoint, we could of seen a different outcome from the FDA.

Hopefully with feedback now coming out of the EU/ AU clinics, MGMT should beable to construct a far more superior trial, that clearly demonstrates safety and efficiency across certain sub groups.