On May 8, 2019, an FDA panel is slated to review the New Drug Application for Bronchitol, proposed for the treatment of cystic fibrosis in adults.Bronchitol, developed by Australian drug developer Pharmaxis Ltd. (PXSLY.OB), is licensed to the Italian company Chiesi Group.The FDA had turned down Bronchitol in March 2013 due to lack of sufficient data to support its approval. Addressing the concerns raised by the FDA, Pharmaxis’ licensee Chiesi Group resubmitted the New Drug Application for Bronchitol last December.If Bronchitol is approved by the FDA, Pharmaxis will receive a US$10 million milestone payment on the commercial launch of Bronchitol in the US and, mid to high teen percentage royalties on in-market net sales.Pharmaxis will be the exclusive supplier of Bronchitol for the US market. Bronchitol was approved in the European Union in April 2012.PXSLY.OB closed Thursday’s trading at $3.12, unchanged from the previous day’s close.