iwfai,
"Witten changed the question to be exactly in alignment with black and white FDA language. What would you suggest she have done instead? Cite ODAC precidents? Seriously and per your own interpretation of FDA precidents, it is clear that given the official FDA language, if anyone is out of step it is ODAC."
I would have had her do exactly what Dew suggested: She should have framed the question in terms of "approval" vs. "approvable." That would have helped eliminate the ambiguity that now exists.
The second letter states: "There is no deviation between Advisory Committees as long as they conform to clearly articulated regulatory requirements." This statement is patently untrue, because the premise of "clearly articulated regulatory requirements" does not exist. The term "substantial" does not provide "clearly articulated regulatory requirements." This is the crux of the matter from a linguistic point of view. What provides the "clearly articulated regulatory requirements" are the precedents set by previous regulatory approval processes. When Scher says that there are now two sets of criteria for cancer drug approvals (assuming Provenge is approved), his logic is unassailable. (You simply cannot resolve this contradiction/conflict by appeals to the exact language--as Goodman tried to do--in the regulations, because it is the (vague) language that is causing the problem in the first place.
Bladerunner
AI
