Replies to post #2421 on Dendreon Corp fka DNDNQ

[stuck_holder]

Thank you Wall for sharing your expertise and experience.

to a layperson like myself, it is a bit unnerving to see how these reviews are conducted and ultimately decided...compared to the apparent level of rigor that the trial results and stats analysis are subjected to before it gets to the public testimony stage.

thank God for Dr. Mule asking that the FDA clarify the efficacy question and ultimately for the CTGT & not ODAC holding the AC meeting.

just a guess, but it seems to me if this panel had been convened by pazdur & ODAC, it might have been a different outcome.

In any case, congratulations & many thanks.

[corpstrat]

Walldiver

It was a pretty scary thing to watch wasn't it? I can well imagine your frustration with some of the limper DNDN work today. I thought Nicole Provost did an impressive job - but of course her Cd 54 stuff only tended to confuse the issue for many and to leave her to defend the drug seemed absurd.

Also I thought the DNDN statistician made a brave attempt to pull the panel back to good sense after Hussain had machine-gunned the DNDN case.

BTW, was Hussain in order to say that Provenhge's 4.5 mo median OS is not comparable with Tax's 2.5 mos, because Tax pts were much sicker? Where was the Halabi or other basis for that comment? And why did no one call her on it if she was off base? I suspect that her rudeness to the CBER guys was ultimately helpful to DNDN. There must have been a couple of voters whose desire to support immunotx was strengthened by Hussain's undisguised contempt.

Best to you Walldiver for the tremendous insight you've had on this process from the get-go. Someone posted at IV that you'd predicted the panel votes to a person. I could not find that to verify but it does not surprise me. You said it was going to be close and how right you were! A sweet day.

[io_io]

<<<<"it was OK to vote thumbs up to let Provenge on the market AND stipulate that DNDN continue with the ongoing trial 9902B.">>>>


But did this AND actually formally happen ?!?

TiA

and thnkx for hosting on IV