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FDA Provides Guidance on Bronchitol Approval Steps

Oct 27, 2019 at 10:41 PM EDT · Issued by Syntara Limited

Filed with ASX · Oct 27, 2019 at 10:41 PM EDT

On 6ix: 6ix.com/news/fda-provides-guidance-on-bronchitol-approval-steps

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Story so far

  • Pathway to US Bronchitol Approval Clarified in FDA ResponseJun 20, 2019
  • US Advisory Committee Positive Recommendation on BronchitolMay 9, 2019
  • Pharmaxis announces resubmission of bronchitol nda in usaDec 20, 2018

Earlier from Syntara

  • Pharmaxis Receives $6.2m R&D Tax IncentiveOct 16, 2019
  • Quarterly Shareholder Update - June 2019Jul 25, 2019
  • Pathway to US Bronchitol Approval Clarified in FDA ResponseJun 19, 2019
  • US Advisory Committee Positive Recommendation on BronchitolMay 8, 2019
  • Quarterly Shareholder Update - March 2019Apr 29, 2019

Later from Syntara

  • Quarterly Shareholder Update - September 2019Oct 30, 2019
  • Pharmaxis Business Plan UpdateDec 17, 2019
  • Quarterly Shareholder Update - December 2019Jan 30, 2020
  • PXS Cancer Drug Ready to Commence Phase 2 Studies Q4 2020Apr 27, 2020
  • Pharmaxis Quarterly Shareholder Update - March 2020Apr 29, 2020
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