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«We worked closely with the world renowned lupus experts on our Clinical Advisory Board to develop this study design based on the BILAG index as a measure of hCDR1’s efficacy. The FDA’s recent guidance indicating that BILAG is an appropriate efficacy endpoint for our trial was a very significant and positive milestone. It enabled us to optimize our study design, and in our opinion, improves the likelihood of the study’s success based on the efficacy results of the prior Phase 2 trial when a 0.5 mg dose of hCDR1 was used with the BILAG index,» said Josh Levine, CEO of XTL.
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