Brief: Oncozenge Gets Response From Regulatory Authorities In Europe, USA

Oncozenge AB

09/05/2023 07:20

May 9 (Reuters) - Oncozenge AB  ONCOZ.ST :
    * RECEIVES RESPONSE FROM REGULATORY AUTHORITIES IN EUROPE
AND USA
    * FDA REQUIRES ADDITIONAL SIX-WEEK TOXICOLOGY STUDY TO BE
CONDUCTED IN ALTERNATIVE ANIMAL SPECIES BEFORE PHASE III STUDIES
CAN BE STARTED
    * FDA ALSO REQUIRES 2 SEPARATE SIX-MONTH PERIODS TOXICITY
STUDIES
BEFORE MARKET APPROVAL IN USA
    * FDA'S RESPONSE DOES NOT AFFECT ONCOZENGE'S PLANNED PK
STUDY
    * FDA'S RESPONSE HAS IMPLICATIONS FOR CO'S AMBITION TO BE
ABLE TO
PRESENT PHASE III PHARMACEUTICAL PROJECT FOR COMMERCIAL PARTNERS

Source text for Eikon:  ID:nWkrDbdBq 
Further company coverage:  ONCOZ.ST 

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