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Low levels of vitamin B12 and vitamin D could be the reason

For its second application, the FDA set a PDUFA date of May 14, 2024, but this was pushed back by three months after Ascendis filed a major amendment to the application

However, the more recent DRIVE trial showed that patients with ferritin levels of 500 to 1,200 ng/mL will respond to intravenous administration of iron with an increase in their hemoglobin levels