I vaguely recall they extended the number to 390 from the original 350 to make the trial more statistically robust.
Back in 2010 ACL wrote,
"After consultation with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), both regulatory agencies indicated that the successful completion of the planned single pivotal Phase III trial will be sufficient for registration in both regions." - 12/7/2010
That suggests that PFS is OK as an endpoint.
- Forums
- ASX - By Stock
- TSN
- trading today
trading today, page-49
-
-
- There are more pages in this discussion • 1 more message in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add TSN (ASX) to my watchlist
|
|||||
Last
1.0¢ |
Change
0.000(0.00%) |
Mkt cap ! $1.409M |
Open | High | Low | Value | Volume |
0.0¢ | 0.0¢ | 0.0¢ | $0 | 0 |
Featured News
TSN (ASX) Chart |
Day chart unavailable
The Watchlist
1CG
ONE CLICK GROUP LIMITED
Mark Waller, MD
Mark Waller
MD
Previous Video
Next Video
SPONSORED BY The Market Online