Reuters logo
BRIEF-European Medicines Agency accepts design of neuroderm's nd0612 phase III indigo efficacy trial
June 6, 2017 / 1:41 PM / 3 months ago

BRIEF-European Medicines Agency accepts design of neuroderm's nd0612 phase III indigo efficacy trial

June 6 (Reuters) - Neuroderm Ltd

* European medicines agency accepts design of neuroderm’s nd0612 phase iii indigo efficacy trial

* Says received a scientific advice letter from scientific advice working party of european medicines agency

* Neuroderm - guidance in letter allows co to move forward towards submission of regulatory applications for nd0612 in europe by end of 2018

* Says letter accepts main design elements suggested by neuroderm for amended indigo phase iii efficacy trial

* Neuroderm ltd - ema suggested that co’s planned clinical and regulatory development program may be adequate to support a benefit-risk evaluation of nd0612 Source text for Eikon: Further company coverage:

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below