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freethemice

08/26/12 5:45 PM

#88624 RE: exwannabe #88621

I think whether the ORR is significant or not is not relevant here. Survival is the
only thing that does matter. Even the survival might not be significant, but if the
survival data is very strong then continuing on to phase 3 is still very possible.
See my post # 88488 for how Avastin was not statistically significant for ORR or
survival in its phase 2 first-line NSCLC trial with C+P, but a phase 3 trial was
carried out and the survival data was statistically significant and Avastin was
approved for first-line NSCLC with C+P. We will see what happens.
Additionally, if the second-line NSCLC trial has very strong survival data filing
for advanced approval is not out of the question.