Pharmaxis Ltd (ASX:PXS) chief executive officer Gary Phillips updates Proactive Investors on the FDA approval timeframe for the company’s Bronchitol inhalation medicine used to treat adult cystic fibrosis patients. The company is confident it will meet information requirements for a Q1 2020 approval. Earlier this year, the FDA Pulmonary and Allergy Drug Advisory Committee (PADAC) released a positive vote that provides a clear path to meet this approval, subject to some further information being provided, which is now being undertaken and delivered.
The CEO also updated the market on the company’s deal with Boehringer for liver disease medicine, as well as its LOXL2 inhibitor program.
Pharmaxis has welcomed a positive decision by an FDA Advisory Committee on Bronchitol for adult CF patients in the USA.
In this video interview CEO Gary Phillips explains the US is the last major territory where Bronchitol has not yet been approved: