>I think we generally agree, accept with respect to TNFs. I look at the class and see PML, cancers and deaths. Extreme toxicity.<
You could well be right. But I put the TNF-a drugs in a different FoB tier from EPO because of the differing expectations that people have about their safety.
Most people assume EPO is relatively safe when used within the confines of the FDA label, but everyone knows the TNF-a drugs are toxic. Thus, perhaps paradoxically, the FDA may be more willing to accept small variations in FoB’s for the TNF-a drugs because these drugs are assumed to be toxic to begin with.
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