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SIDEROS Trial Interim Analysis Update From Santhera


As you know from our previous updates, the SIDEROS clinical trial is fully enrolled and Santhera has been working with the Food and Drug Administration (FDA) and regulatory authorities in Europe to assess the potential to conduct an interim analysis of the study. We are happy to report that Santhera will proceed with conducting an interim analysis of the SIDEROS clinical trial. This letter aims to provide general education to the U.S. Duchenne community about how and why companies conduct interim analyses in clinical trials and the potential outcomes of those analyses.

What Is an Interim Analysis?

An interim analysis in a trial is an analysis of a subset of the data that is conducted before data collection has been completed.

 

SIDEROS Trial Interim Analysis Update From Santhera

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