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Pharmaxis expects an FDA decision on Bronchitol mid-year after positive committee recommendation

Pharmaxis Ltd (ASX:PXS) chief executive officer Gary Phillips updates Proactive Investors on the positive recommendation received from a US Food and Drug Administration advisory committee for the use of its inhaled powder Bronchitol in adult patients with cystic fibrosis. 
 
Phillips says the US is the last major territory where Bronchitol has not yet been approved and the company expects an FDA decision mid-year.
 
Clinical trials have shown Bronchitol improves lung function in CF patients.
 
It is delivered by a portable inhaler, allowing patients to fit in taking medication with their daily lives.

 

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ASX:PXS
Market: ASX
Market Cap: $41.5 m
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Pharmaxis Ltd expects review of Bronchitol NDA to be completed by mid-2020

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)...

on 6/5/20

2 min read