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Novo: FDA-rejection could be caused by a lack of data

A heavy reduction in the number of patients in the final stages of the study forming the basis of FDA’s decision to reject Tresiba could be the reason why the drug appears to have a worse cardiovascular safety profile than its rival.

Foto: Novo Nordisk / PR

When the number of patients drop statistical uncertainty goes up and that might be the reason that Novo Nordisk failed to gain approval for its new insulin, Tresiba, in the US, according to several sources.

Data from the meta-analysis FDA based its rejection on shows that the patient population decreases dramatically as the study advances.

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