Calliditas Interim Report Q3, 2019

Positive Regulatory Outcome – Enhanced study design

“This third quarter of 2019 saw us move steadily towards full recruitment of the NefIgArd study, despite a somewhat slower pace during the summer months. We can now see the finish line and we hope that the next couple of months develop as planned so that we can achieve our ambitious goal. Due to our interactions with the FDA during the year, we have been able to achieve acceptance by the FDA of a revised design of the confirmatory part of our study, using a more sensitive endpoint, which reduces the number of patients and shortens the confirmatory part of the trial substantially. We also received positive advice from EMA related to our revised study design as well as a confirmed path forward towards conditional approval in Europe.”

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