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Clinuvel Pharmaceuticals LimitedASX: CUV

CLINUVEL agrees with FDA on New Drug Application timelines

Nov 8, 2016 at 10:46 PM EST · Issued by Clinuvel Pharmaceuticals Limited

Filed with ASX · Nov 8, 2016 at 10:46 PM EST

On 6ix: 6ix.com/news/clinuvel-agrees-with-fda-on-new-drug-application-timelines

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Earlier from Clinuvel Pharmaceuticals

  • SCENESSE - NICE England UpdateOct 17, 2016
  • FDA Schedules Pre-NDA Meeting for SCENESSEOct 12, 2016
  • Clinuvel completes combination therapy pre-clinical studyAug 3, 2016
  • FDA accept SCENESSE clinical data package for NDA submissionJul 18, 2016
  • FDA awards SCENESSE Fast Track designation for EPP treatmentJul 5, 2016

Later from Clinuvel Pharmaceuticals

  • CLINUVEL reaches agreement on German SCENESSE pricingApr 12, 2017
  • NICE England Update on SCENESSEMay 1, 2017
  • Amended Appendix 4C - quarterlyJul 31, 2017
  • Preliminary Final ReportAug 30, 2017
  • CLINUVEL provides update on SCENESSE FDA filingSep 18, 2017
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