Dendreon Corp fka DNDNQ

[io_io]

iwfal - thnkx for answer .........


<<<"The results were pretty consistent - in 1000 trials of the same size a Cox Regression has a median improvement in p value of greater than 2x. Sometimes it was less than 2. But it never approached a 0x improvement.">>>

You probably covered these types too, but let me ask just in case - in DNDN's trials one unique thing is that there are almost no censored patients - also I wonder if your generated trials were there both "regular/classical" and "random/odd" shaped curves - but you thought of all that already ?



<<<"I suspect that they do push and generally the FDA pushes back.">>>

Just to remark that a doubling of the p value is like the difference between a 1-sided and 2-sided test - which of course the ICH guidance docs generally require, and the FDA generally gets.

Next time I see a Cox as a primary endpoint, I will be wondering what the justification is. But it does bode well for 9902b.