Paediatric Study2 Sep 2024 08:20
Any thoughts on the paediatric study and the results that were due back by late Aug which have not arrived yet?
What impact could a negative result on these have on the SP?
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Shield is enrolling patients in a paediatric study, which if successful, could lead to an expansion of the indication and uses for Accrufer®/Feraccru® in both US and EU markets. The study, a requirement of both FDA and EMA, is enrolling patients with iron deficiency ranging from 12 months to 17 years of age. This is another population where iron deficiency is prevalent and similar challenges to OTC irons exist. As part of this study, Shield is using a new liquid formulation, which, if approved may offer an alternative approach for those who can't swallow our current capsule formulation.