Brief: Ascelia Pharma: Re-Evaluation Required After Intra-Reader Inconsistency in Scoring of Images from Phase 3 Study SPARKLE
08/08/2023 07:05
Aug 8 (Reuters) - Ascelia Pharma AB ACELP.ST :
* ON MONDAY REPORTED THE NEED FOR A RE-EVALUATION OF THE
COLLECTED
IMAGES IN THE PIVOTAL PHASE 3 STUDY SPARKLE WITH THE LIVER
IMAGING CANDIDATE DRUG ORVIGLANCE
* DURING THE EVALUATION OF HEADLINE DATA, THE COMPANY
IDENTIFIED A
HIGH LEVEL OF INCONSISTENCY IN THE IMAGE SCORING BY SOME
INDIVIDUAL READERS, I.E., INTRA-READER VARIABILITY
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Further company coverage: ACELP.ST
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