Should also remind everyone again about this statement from the FDA-
"The FDA’s Pulmonary-Allergy Drugs Advisory Committee unanimously voted against recommending Pharmaxis’ cystic fibrosis (CF) drug Bronchitol for approval. While committee members were concerned the Bronchitol (dry powder mannitol) was not proven safe and effective in children, MOST said they would have voted in favor of approval if the indication was only for adults."
Once again reiterates my point re trial design. Bronchitol itself can be a brilliant treatment option for many CF suffers, however the poorly constructed Trials we've run have eluded us from any FDA stamp... Again it's the same story with many Aussie biotech's( ACL, TIS, QRX,SPL etc). I don't understand why boards don't pull in some big swinging dick from the US, with regulatory experience to run these Company's, and actually get the job done.
However in saying that; from what we've heard about the bronchiectasis PH3, re it's criteria/ trial design- it sounds like we might finally be on the right track...
PXS Price at posting:
30.0¢ Sentiment: None Disclosure: Held
