(Total Views: 366)
Posted On: 09/30/2019 7:07:56 PM
Post# of 148899
What surprised me about applying for BTD was that NP negotiated 6 months stability data down to “only” 3 months.
It felt a kind of trying to outsmart the FDA if BTD was requested for immediately after FDA’s approval of the 3 months.
But maybe that’s just me thinking that.
It’s more elegant to request for approval to file the stability data a little later while the FDA is still reviewing the BLA.
Maybe that’s more pragmatic for the FDA too?
It felt a kind of trying to outsmart the FDA if BTD was requested for immediately after FDA’s approval of the 3 months.
But maybe that’s just me thinking that.
It’s more elegant to request for approval to file the stability data a little later while the FDA is still reviewing the BLA.
Maybe that’s more pragmatic for the FDA too?
(1)
(0)Scroll down for more posts ▼
