Tuesday, July 07, 2009 11:31:55 AM
Knowing that safety was the major hurdle to approval for any indication with the drug and realizing that the safety hurdle for endo might not be as high for endo, can you speculate on why the company chose UF?
My guess is mostly naivete. An amazing number of companies are naive about the underlying attitudes/culture of the pertinent portions of the medical community and/or FDA. For a prime example of that look at Zymogenetics which assumed that surgeons would really want recothrom - completely ignoring the fact that medical practitioners believe what they need to believe (if at all possible) in order to justify the procedures they do. (Note that I do not mean to imply MDs are any different than the bulk of humanity - but this is a board about medical treatments).
The need to avoid cognitative dissonance will trump weak data (e.g. bovine thrombin bleeds that happen only rarely and 7 or 8 days after surgery, or emotional reactions (women wanting to keep their uterus) unless unequivocally medically necessary to remove it)
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