Pharmaxis Ltd Expects Review of Bronchitol NDA to be Completed by mid-2020
Release Date: 07/05/2020 10:20am
Pharmaxis Ltd (ASX:PXS) (OTCMKTS:PXSLY) (FRA:UUD) CEO Gary Phillips speaks to Proactive's Andrew Scott after it was announced its US licensee Chiesi Farmaceutici SpA filed a resubmission to the FDA for Bronchitol® .
The move addresses issues raised by the US Food and Drug Administration (FDA) in a complete response letter received in June 2019 and follows completion by Chiesi Group of a supplemental human factor study in the first quarter of 2020.
If Bronchitol is approved by the FDA, Pharmaxis will receive a US$10 million (A$15.5 million) milestone payment on the supply of Bronchitol for the US commercial launch and mid to high teen percentage royalties on in-market net sales.
Watch the interview here.
Categories: Video Content