From my vantage point which is that of a non-scien
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From my vantage point which is that of a non-science trained individual your comment here raises some questions for me. I instinctively think a count of a patient's circulating tumor cells would be a definitive analysis of that patient's prognosis and condition. Yet, it appears, from your comment that the FDA does not share that belief. Is the notion of a high ctc count a new or proven or unproven scientific notion?
I'm sure the FDA doesn't look at CTCs as definitive proof of direct effect even with metastasis. They'll want to know if tumors shrank or were eliminated and a comparison of metastatic lesions to best standard of care. It would just prove one of the mechanisms of action for leronlimab.

