Excellent info - thanks
The way I read the 2013 announcement you refer to the FDA didn't need the data prior to giving the go ahead for the clinical trials. That's all.
But final approval would need it.
The EMA would have known this and probably wanted to have equal rigour in its own assessment.
TIS should have got this message long ago but we're blind.
TIS - EMA position may be reasonable, page-2
-
- There are more pages in this discussion • 5 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)