Quote:It is true that approvals are for treating diseases, but not that long ago the FDA took the position that accelerated approval could be granted if appropriate surrogate endpoints were reached. Raising PD-L1 would not be such an endpoint, but shrinking tumors could, I think. I wonder if reducing CAMLs and CTCs (circulating cancer cells) might be such a surrogate endpoint? Especially since the poster clearly showed that reduction after Leron was given.
The approval is based on evidence of effect but the approval is not for the effect itself.
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