Dendreon Corp fka DNDNQ

[mouton29]

Isn't the question whether the FDA would be willing to aprove a "free" look to allow the company to raise funds? Presumably, the FDA is not clueless and they understand that if permit an alpha allocation that is highly unlikely to be acheived -- presumably lower than the current "very highly powered" allocation -- they will be under pressure to approve. Why not face the issue now and allow a free look, with the idea being that if it meets some reasonble threshhold, say, .03, the FDA approves conditonally with the explicit understanding the drug is pulled if the final p-value is less than .05? Since, at the time of the interim look, the trial would not only be fully enrolled, but presumably all placebo patients would have progressed and crossed over or not, I don't see that the look or conditional approval would affect the remainder of the trial and its statistical validity.