Update: Bronchitol EU Marketing Application for Cystic Fibrosis
Release Date: 25/01/2011 12:00am
Pharmaxis made an oral presentation to last week's meeting of the European Committee for Medicinal Products for Human Use (CHMP). Subsequent to the meeting the CHMP has now provided the company with its outstanding issues and advised that the review timetable will conclude in Q2 2011.
“We are pleased with the ongoing discussions with the CHMP and believe we are in a good position to provide our response to their outstanding issues in a timely manner", said Dr Alan Robertson, Chief Executive Officer of Pharmaxis.
Bronchitol has been the subject of two international Phase 3 clinical trials and is the only new product in registration to treat cystic fibrosis.
Categories: News and Media