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lumpy9200

11/24/07 7:53 PM

#5088 RE: walldiver #5087

Wall,

So, it's tougher for the Provenge survival curve to gain separation from the control curve, as there usually is a bigger difference in the two curves from the 30-month point and on.

Wouldn't it be wiser then for DNDN to set the interim look based on two factors being achieved: 180 deaths AND all patients being enrolled for a set minimum time period? I realize this would push the date out for the interim look significantly, but it would also give the look better odds of being stat sig.

With that said, is it even allowable to have an interim look be based on two data points?

Best regards,
Geoff
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Bio_Tech_Boss

11/25/07 8:43 AM

#5096 RE: walldiver #5087

Wall, I agree that the effect of late enrollees and the inability of these patients to show benefit due to the short time of their participation, reduces the chance of a successful outcome at the interem look.

OTOH, would the longer survival of early enrollees, for example early patients surviving for over three years, have an offsetting effect?


BTB