Because with BTD designation, stability data requi
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Posted On: 09/30/2019 5:46:22 PM
Because with BTD designation, stability data requirements would be waived, saving us a month or so. If it was such an absurd thing, then Nader wouldn't have stressed it couple of weeks ago... ("immediately apply"
This is a breakthrough, so it should get the formal designation of a breakthrough, especially if we get the stability data advantage.
We already are eligible for priority review via fast-track designation.
I think FDA denied ORPHAN DRUG designation.
This is a breakthrough, so it should get the formal designation of a breakthrough, especially if we get the stability data advantage. We already are eligible for priority review via fast-track designation.
I think FDA denied ORPHAN DRUG designation.
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