My previous reply was to Ymav. FYI. Missed Andrew's post.
Completely agree Andrew. Though I expect it possible in CVac's case, the FDA would approve based on PFS alone (fast track), as there is little risk to the patient.
Avastin's approval for breast cancer was revoked primarily because the risks outweighed the benefit.
This is where I went off-track with my incredulity in my above post - EMA vs FDA.
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