SoWell Wellness System
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Description
Intercepts NDA application was based on an interim analysis from their 18-month Phase 3 REGENERATE (ClinicalTrials.gov NCT02548351) clinical trial of Obeticholic acid with nearly 2500 NASH patients with fibrosis enrolled (Figure 1)
The weekly administration, inconsistent titration schedules, and the risk of breastfeeding cessation during this extended period posed significant challenges in collecting milk samples at steady state
The next big surprise came as some female patients began to report the drugs were improving their fertility odds
Furthermore, plasma amino acid levels are not routinely measured or reported
