News Focus
News Focus
icon url

SaulK

07/04/07 9:46 AM

#4429 RE: walldiver #4425

Wall--
I agree. Feuerstein is really not a careful reporter--he's more like a columnist--expressing his opinions and not always caring or analyzing carefully whether his opinions add up. Shoots from the hip. Reports his impressions. I was irritated by his statement that "The FDA examined Provenge's data and found it lacking". Talk about not being a reporter! That crystalizes the guy in a nutshell--ignore the politics at the FDA, ignore the mindless adherence to outdated endpoint purity, ignore the extra conflicts of interest revealed for Scher, ignore that the FDA truly pissed on its mandate to thoughtfully perform a cost/benefit analysis of Provenge with the idea in mind that terminal patients are desperate for treatment... I could go on, but you get the idea. He's typical of just about everyone at The Street.com--superficial lightweights flying by the seat of their pants. The only problem is those guys often move the market and are a factor in overall market perceptions. I don't usually do such a thing, but I sent him a reasoned email pointing out his sloppiness.
icon url

DewDiligence

07/04/07 10:47 PM

#4433 RE: walldiver #4425

>…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.