Brief: Oncopeptides Provides An Update From The Meeting With FDA's Advisory Committee ODAC

Oncopeptides AB

23/09/2022 07:28

Sept 23 (Reuters) - Oncopeptides AB  ONCO.ST :
    * ONCOPEPTIDES PROVIDES AN UPDATE FROM THE MEETING WITH FDAS
ADVISORY COMMITTEE ODAC
    * A MAJORITY OF PANEL CONSIDERED THAT OCEAN DID NOT CONFIRM
A
FAVORABLE BENEFIT-RISK PROFILE IN CURRENT INDICATED PATIENT
POPULATION
    * ODAC, US FOOD AND DRUG ADMINISTRATION (FDA), HAS FINALIZED
DISCUSSION ON BENEFIT-RISK PROFILE OF PEPAXTO®
    * ONCOPEPTIDES - FDA WILL NOT ISSUE FINAL DETERMINATION ON
ISSUES
UNTIL INPUT FROM ADVISORY COMMITTEE PROCESS HAS BEEN CONSIDERED
AND REVIEWS FINALIZED

Source text for Eikon:  ID:nPn3tlHLqa 
Further company coverage:  ONCO.ST 
 ((Reuters.Briefs@thomsonreuters.com;))