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Clinuvel Pharmaceuticals LimitedASX: CUV

FDA Schedules Pre-NDA Meeting for SCENESSE

Oct 12, 2016 at 11:00 PM EDT · Issued by Clinuvel Pharmaceuticals Limited

Filed with ASX · Oct 12, 2016 at 11:00 PM EDT · 3 pages · English

On 6ix: 6ix.com/news/fda-schedules-pre-nda-meeting-for-scenesse

Watch Clinuvel Pharmaceuticals' latest callClinuvel Pharmaceuticals (ASX:CUV) Q4 2026 Earnings Call · Replay · Aug 27↗

Clinuvel Pharmaceuticals Limited on 6ix

Story so far

  • FDA accept SCENESSE clinical data package for NDA submissionJul 18, 2016
  • FDA awards SCENESSE Fast Track designation for EPP treatmentJul 6, 2016
  • SCENESSE launched in EuropeJun 22, 2016

Earlier from Clinuvel Pharmaceuticals

  • 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
  • SCENESSE launched in EuropeJun 22, 2016
  • SCENESSE Treatment in EuropeMay 18, 2016

Later from Clinuvel Pharmaceuticals

  • SCENESSE - NICE England UpdateOct 17, 2016
  • CLINUVEL agrees with FDA on New Drug Application timelinesNov 8, 2016
  • CLINUVEL reaches agreement on German SCENESSE pricingApr 12, 2017
  • NICE England Update on SCENESSEMay 1, 2017
  • Amended Appendix 4C - quarterlyJul 31, 2017
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