Replies to post #4311 on Dendreon Corp fka DNDNQ

[iwfal]

Is the FDA licensing process subjective enough for a hostile FDA to fail us on the interim look, even if we pass statistically?

To some degree. For instance if the alpha assigned to the interim is 0.01 and Dendreon announces a p value of 0.0095 then there is reason for concern that the FDA will 'find' an error somewhere. (They might approve anyway - but it is far from certain)

OTOH if they get a p value of 0.001 on the interim vs an alpha of 0.01 then it is unlikely that Provenge would be rejected.

FWIW.