Neuroderm logo

NDRM - Neuroderm News Story

$38.85 0.0  0.0%

Last Trade - 17/10/17

Sector
Healthcare
Size
Micro Cap
Market Cap £n/a
Enterprise Value £n/a
Revenue £n/a
Position in Universe th / 7335

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 
trial 
    * 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  
 
 ((Bangalore.newsroom@thomsonreuters.com;))
© Stockopedia 2021, Refinitiv, Share Data Services.
This site cannot substitute for professional investment advice or independent factual verification. To use it, you must accept our Terms of Use, Privacy and Disclaimer policies.