1. Do you believe
Alimta has a more favorable toxicity
profile than docetaxel?
2. If the answer is yes, does the more
favorable Alimta toxicity
profile with supporting efficacy data on tumor response and
PFS outweigh the uncertainty regarding loss of docetaxel
survival effect by using Alimta?
3. Given
the potential confounding effects of cross-over,
and problems in estimating the control effect, is there a
convincing effect on survival to warrant regular
approval?