p3analyze...........re: Gemzar.............
"The only reasonable explanation that it did not make it to the label was because of either an overly conservative alpha was used for OS, or the final OS result barely missed whatever statistical alpha that was allocated to it."
I had saved this post for later. Good example, and the same with Gliadel too - in fact the Glidel case is very interesting.
In looking for a "reasonable explanation", I would say that the explanation is that OS was not the Primary Endpoint of the trial, and maybe not the Secondary either - just a guess as I have not looked up the label, etc.
As far as I know if an outcome is not the Primary Endpoint (or perhaps just an Endpoint), then the FDA doesn't consider the outcome proven, and therefore will not state it as such.
On the other hand, I presume that the OS result was tabulated in the trial results on the label, but no more than that.
That by the way is what I would expect would be Provenge's eventual label - the result will be listed there, but the FDA will not allow a statement saying that it demonstrated such a benefit.
"....on the biotech battle-field, you need some élan...."
