(Total Views: 406)
Posted On: 09/30/2019 5:46:22 PM
Post# of 145248
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.
![](/m/images/icons/icon_wink.gif)
We already are eligible for priority review via fast-track designation.
I think FDA denied ORPHAN DRUG designation.
![](/m/images/thumb-up.png)
![](/m/images/thumb-down.png)