I believe that iressa used PFS (either RECIST or WHO), which falls into one of my two 'yep, the fda does have a history of approving such SPAs' categories. (Even today there are ocassional SPAs for PFS - see Delcath for instance).
My question is about non-standard surrogates that are not clinically relevant by themselves.
PS Even if iressa used a non-standard surrogate I am not sure it has much relevence at this point since that was in the McClellan era.
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