Correct (not sure about the date, but March sounds
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Posted On: 09/06/2019 5:39:07 PM
Correct (not sure about the date, but March sounds right). I recall NP stating that FDA requested mono pediatric data for non-clinical portion of the BLA filing. Seemed a little odd to request mono data for combo BLA. But your article / theory helps clarify this a little. Hopefully my memory is not mixing info.
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