All reasonable points, and if the bone met/pain effect was marginal, I would completely agree with you. But I am postulating that the effect on bone mets turns out to be real and lasting, in which case I could see the FDA being more flexible here, allowing an accelerated approval process followed up with an OS confirmatory study.
The other wild card here is potential approval for thyroid cancer, followed by off-label use in prostate.
Peter
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