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NDRM - Neuroderm News Story

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BRIEF-Neuroderm to replace two Phase 3 clinical trials with small pharmacokinetic trials

Mon 5th December, 2016 11:30am
Dec 5 (Reuters) - Neuroderm Ltd  NDRM.O  
    * Neuroderm to replace two Phase 3 clinical trials with 
small pharmacokinetic trials following FDA meeting on ND0612 
regulatory development 
    * Neuroderm Ltd - to add patients to its long-term safety 
    * Neuroderm Ltd - company to pursue comparative 
bioavailability regulatory route instead of clinical efficacy 
development rout 
    * Neuroderm Ltd - company is also evaluating amending Indigo 
trial to a life cycle management trial 
    * Neuroderm - FDA also reaffirmed long-term safety data from 
co's ongoing beyond trial (trial 012) should be part of eventual 
NDA submission 
    * In addition, company will add approximately 50 patients to 
its ongoing long-term beyond safety trial (trial 012) 
    * Neuroderm - decided to discontinue preparations to 
initiate Phase 3 clinical efficacy trial of ND0612h, ongoing 
phase 3 trial (trial 007) for ND0612l 
    * Co's clinical, comparative bioavailability-based EU 
regulatory development strategy remains unchanged 
Source text for Eikon:  ID:nGNXNNIWJa  
Further company coverage:  NDRM.O  
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