News Focus
News Focus
icon url

walldiver

06/08/07 7:58 PM

#4146 RE: Gametheory101 #4143

It's all water under the bridge now...but for Dr. No to succeed, he needs some willing tools. There also may have been more than meets the eye on the company's side of things. Not having any discussions with the FDA after the positive advisory panel vote strikes me as odd (no labeling discussions, no post-approval 9902B discussions?), and perhaps it means that CBER never was going to approve Provenge on this go-round. What other issues were going on behind the scenes that we'll never know about?
icon url

nerdseeksblonde

06/08/07 8:43 PM

#4147 RE: Gametheory101 #4143

<sarcasm>wow,
I would have thought Gold would be soliciting criticism,
second guessing himself, thinking he could be doing
more to find out how provenge cured Mr. Garcia,
planning a more dedicated effort to understand
provenge so that there wouldn't be any issues as they
translate it to neuvenge etc.

I'm surprised...
</sarcasm>
I hate to beat this to death but this is an important
point- the data is arguable and the only thing that would
help it win the acceptance of responsible critics is
supporting science. This was true before, and is true
today and is still not understood or appreciated by many at DNDN. It isn't
just a political affront to try to advertize an testiminialize and politicize provenge, it is
a disservice to patients who would benefit more from
accurate science than trying to spin questionable and confusing data.

I'm not advocating "Science for science's sake" or
"managment is the only one responsible" characature positions. Rather, if you look at the simple business issues related to "what would a potential customer think" in terms of "honest" considerations ( what does the product do as opposed to how many free trips can you give to the Medicare admin folks), supporting science was a feasible way to demonstrate and qualify the product value.