InvestorsHub Logo
Followers 11
Posts 116
Boards Moderated 0
Alias Born 02/15/2010

Re: IgnoranceIsBliss post# 471

Thursday, 10/13/2011 10:35:54 PM

Thursday, October 13, 2011 10:35:54 PM

Post# of 16750
I'm not sure!

Part of me says that because PFS allows accelerated approval, they almost certainly would not "stop" the trial now because they need the overall survival data to cement approval.

Let's say they succeed - it wouldn't really stop, but everyone would still be followed for OS. I guess they could censor all OS at the next patient who recurs locally -- from that point on all would be eligible for TDox + RFA. I suspect with another years' maturation the numbers we have now would still show the trend needed for OS.

The other alternative would be keeping the arms intact - not horrible, because the placebo DOES get RFA which does work.

Keep in mind, 5-8 months filing for the NDA and 6 months review means that approval still wouldn't occur until late 2012.