Replies to post #5113 on Dendreon Corp fka DNDNQ

[exwannabe]

Re Fuzzy interim goals make no sense...

"Rancherho framed the question from "an ethical point of view." And from an ethical POV, it makes a lot of sense. Since when is thinking about patients 'wishy washy' logic? "

It's "wishy washy" because if some value above the SPA target is where the DSMB should stop the trial, then that is what the SPA should call out.

You can argue that the manner of alpha distribution is not in the best ethical interest of the patients, and I think many would agree with this. But this is up to the FDA and company to determine, not the DSMB (which is just acting as an indpendent party who can peek into the data w/o unblinding the trial to the company).

Simply put, the company and FDA have informed the DSMB that the trial should continue on at P=.011, if this is wrong ethically don't ask the DSMB to fix it.

[.01 is for example, I do not know it this is the real number]