Nonsense. First, FDA doesn't request anything in these pre-submission discussions. Yes, they make suggestions that a company would be foolish to resist, but they don't formally request anything. Record is clear. MK was aware of this suggestion before second meeting in May 2022 (he came to that meeting with outline of containment verification test plan via direct PET scan imaging of Radiogel.), and the 8 "new" reviewers he blames for this were at first meeting in Nov. 2021, 15 months ago. Moreover we know per first meeting update, FDA suggest "additional specific testing". And here we are in 2023, still waiting for this testing to start.
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