Biotech Values

[iwfal]

EXEL -

I'm assuming the primary endpoint would be some composite of pain reduction and multiple types of bone scan - technetium, PET (maybe both FDG and fluoride ion) and CT or even gadolinium-enhanced MRI.

First, let me be clear that I was not busting your chops when asking whether there were ANY examples of an SPA for cancer endpoint that wasn't either well-established (e.g. RECIST PFS) or of unambiguously clear clinical significance. I don't remember any, couldn't find any in a web search and doubt that Pazdur's org would ever approve such - but asking this board is the final step in being sure. (e.g. I think the silence when I asked about any examples of a drug approved based on not-pre-defined interim was hugely helpful)

Ok, so that out of the way - I personally think an endpoint of a composite of different scans would be justification for approval when combined with pain. (in contrast I do not think bone scan plus pain is adequate for all the reasons I've given.) HOWEVER I'd be surprised if the FDA approved such a novel endpoint in cancer.