InvestorsHub Logo
Replies to #56974 on Biotech Values
icon url

exwannabe

01/03/08 1:29 PM

#56975 RE: daved #56974

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 :-)