Dendreon Corp fka DNDNQ

[DewDiligence]

>…Adam stated incorrectly that this is why the FDA issued the CR letter, when in fact the FDA likely centered on the missed primary endpoint of TTP as the reason it couldn't approve Provenge. I'm not sure why Adam would make such a wildly incorrect statement.<

Feuerstein shoots from the hip a lot and makes a lot of mistakes but, in this instance, he is closer to the truth than you are, IMO.

It was indeed the survival data that came up short in the Provenge BLA. The FDA ruled that one trial with a p-value of 0.01 plus one trial with a p-value of 0.33 is not a data set worthy of approval for marketing.

Everything else is a sideshow.