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Re: iwfal post# 1160

Monday, 10/16/2006 5:06:07 PM

Monday, October 16, 2006 5:06:07 PM

Post# of 12660
Thanks Iwfal.

The presentation by Dr. Kylstra is dated with respect to the enrollment numbers, finally I see this (but I think the lack of an easy-to-find date of the presentation is kind of an excuse...). Another mistake of mine: A bit more careful inspection of the P11 trial design in the above presentation made me see that the PSA level to be met by the Lupron shots was not "undetectable" as I mistakingly wrote but 1 ng/ml. I don't know where I got the impression that "undetectable" was the threshold.

Sorry for the confusion.

I have spent some time looking for references that could give some indication as to how long time to expect for the placebo part to event. Do you have a good suggestions for my reading (I have free access to most scientific journals)? TIA

BTW, the history of Provenge includes several events that could possible trigger a (temporary?) increase or decrease in the enrollment rate, particularly the D9901 results, and there was also a temporary halt of enrollment. Is it possible to include such pieces of information in a meaningful way in terms of enrollment as function of time? - x^2 or x^4 etc. seems to be extremely arbitrary to me.

Just wanted to direct your thoughts in this direction. I realize that including any such enrollment assumptions in the model is at best only going to give a questionable results, but to me, x^4 and the like is even more abstract?


Best regards,
Bengt

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