Brief: PolTREG Says Gets Positive Opinion Of EMA Paediatric Committee For Clinical Tests In Children

Poltreg SA

08/06/2022 08:46

June 8 (Reuters) - PolTREG SA  PTGP.WA :
    * MANAGEMENT SAID ON TUESDAY IT HAS RECEIVED POSITIVE
OPINION FROM
PEDIATRIC COMMITTEE OF EUROPEAN MEDICAL AGENCY (EMA)ACCEPTING
PLAN OF CLINICAL TESTS AS PART OF TREATMENT OF TYPE 1 DIABETES
IN CHILDREN  
    * SAID THE DECISION MEANS THE ACCEPTANCE OF PIP PAEDIATRIC
RESEARCH PREPARED BY THE COMPANY, WHICH IS NECESSARY FOR PLANNED
CLINICAL TESTS IN CHILDREN TO OBTAIN A MARKETING AUTHORIZATION
    * ACCORDING TO THE APPROVED PIP, THE REGISTRATION PHASE OF
CLINICAL TRIALS IN THE PEDIATRIC POPULATION AS PART OF THE
TREATMENT OF TYPE 1 DIABETES IN CHILDREN SHOULD END IN 2028 -
2030, WITH THE FIRST INTERIM RESULTS (INTERIM ANALYSIS) MAY BE
KNOWN AS EARLY AS 2024

        
 Source text for Eikon:  urn:newsml:reuters.com:*:nEMcbjsG9a
 Further company coverage:  PTGP.WA  

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