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Re: JamesGMS post# 258371

Sunday, 03/13/2016 1:15:21 AM

Sunday, March 13, 2016 1:15:21 AM

Post# of 346155
James, thank you for your learned response. Yes, I think if the Bavi arm proved to have a MOS of 14 months it should be approved. I think Bavi should be approved anyway whether or not it helps patients with advanced lung cancer, but that is only a feeling, and there are those out there that want more in the way of proof than our feelings, as you well know. The point is to get approval for ANY indication so it can be used off-label for others. However, even at that, the problem in real-life is that off-label use is considered E/I (experimental/investigationali) by insurance companies, and will not be paid for until proof of efficacy, or after vetting in large placebo/well-controlled/double-blinded studies. If it is the subject of a clinical trial for a given indication the insurance companies won't pay for it either.
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