Replies to post #55004 on Biotech Values

[walldiver]

I haven't yet seen any statistics on GVAX plus/minus Taxotere in randomized trials. Even with Provenge, the later Taxotere patients are merely a self-selected subgroup. So right now, it's only an interesting theory, albeit with much potential.

[iwfal]

it was not statistically significant for increased survival for either CD54 upregulation (post/preprocessing) (p=0.395)

This is the interesting thing to me (I missed it in the statistical review) - it bears, again, on the credibility of Dendreon management, since Provost's data showed something substantially different, albeit for combined 9901/2a.

[DrBengtP]

Thanks, Wall and Ranch. I had yet another look a the KM curve for the docetaxel treated population, and i wondered if - based on the observation that size of the steps down on the KM curve - it is so that more or less all of the docetaxel treatments were very close to the provenge treatment (close after Provenge treatment, as Dr. Petrylak mentioned that most docetaxel treatments took place after Provenge)?

A scarry thought came to my mind after reading Ranch's comment about the split of median survival improvement between docetaxel treated provenge patients and provenge-only treated patients. Could the FDA argue that the ITT population only had a survival benefit if also treated with docetaxel, and since such a treatment regime was not prespecified, sorry DNDN (and longs), any conclusions based on D9902B are just 'exploratory' (or whatever word is used)...?

And final question (for now): In the BLA appendix, it appears that the D9902B patients had a higher lower limit for CD54 cells than was the case for D9901 and D9902A - is this relevant as a predictor for the number of TNC?

Again, as usual, thanks for taking your time to answer my previous questions and TIA for the answers/comments I hope to get to the questions listed above.

B.