Replies to post #1448 on Dendreon Corp fka DNDNQ

[io_io]

rancherho:

I would add only one morsel:

<<<"Earlier this year, Gold projected that 9902b enrollment would be completed by the projected FDA approval in 1H07">>>


That's a good landmark. Reading the ALTH AC minutes recently, it was a situation where there was a new Phase III enrolling in exactly the indication sought. What was stated was not that the new Phase III might later under-mine their decision; instead the sole concern was that any approval would kill the Phase III enrollment (it was an AA case). Therefore to have 9902b fully or on the point of full enrollment will not hurt in that sense.

Obviously though we can't shut out the fact that waiting for 9902b is an alternative "cop-out" for them, but that's technically a lesser issue (perhaps I should say technically speaking not an issue they should be allowed to even consider ....LoL).

And yes Good Luck to all DNDN longs - may Fortune Favor the Brave.

[iwfal]

the Cox regression adjusted hazard ratio is 1.8, ie 80% prolongation of median OS, or close to 50% reduction in risk of death, powering the study at 90% would only require 1definitely will require only 122 events (scary thought - I have to go back to my event curve to find where they are at - I wouldn't be surprised that can be reached at in early 2007).

I suspect that P3 is NOT accounting for Cox Regression of 9902b in his powering analysis. He is just answering the question "Assuming the HR found by Cox Regression in combined 9901/9902a is the true HR (the same found in plain Log Rank for an infinitely large trial), then what is the powering of 9902b when the analysis method of 9902b is plain Log Rank". Make a huge difference? Probably not. But some since no credit is given for 9902b Cox Regression.

[Gametheory101]

...Earlier this year, Gold projected that 9902b enrollment would be completed by the projected FDA approval in 1H07, and that based on unblinding upon reaching its projected number of events, it would be unblinded in 1H08....

Thanks for confirming my faltering memory.

So again a question, knowing 9902B is back-end loaded, how can they have data in 1H 2008 assuming over 80% crossovers?