AI
Thursday, January 03, 2008 1:29:06 PM
GNVC, a few questions.
1) How did they get away with changing the trial primamry after having unblinded about 1/6 of the patients? Would the FDA re-run the data w/o these events?
2) If I can count tics, the early unblinding after the 51'st patient was treated had 15 events. [Correction, it is 12 events] Not all that significant (OS HR was p=.15).
3) Where does the 42% OS gain come from? It's not on the poster for this data:
http://www.genvec.com/download/ASCO%202007%20Poster%20Handout%20FINAL%20OUT.pdf
They do show a nice median OS benifit, but most of that benifit is driven by a single patient.
Anyway, best of luck here. Just don't bet the farm on the N=92 interim data
1) How did they get away with changing the trial primamry after having unblinded about 1/6 of the patients? Would the FDA re-run the data w/o these events?
2) If I can count tics, the early unblinding after the 51'st patient was treated had 15 events. [Correction, it is 12 events] Not all that significant (OS HR was p=.15).
3) Where does the 42% OS gain come from? It's not on the poster for this data:
http://www.genvec.com/download/ASCO%202007%20Poster%20Handout%20FINAL%20OUT.pdf
They do show a nice median OS benifit, but most of that benifit is driven by a single patient.
Anyway, best of luck here. Just don't bet the farm on the N=92 interim data
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