The partial halt was virtually a non-event, IMHO. I think the FDA expected that would be the case.
A concern for inflammation or “recurrence”, I believe, would not likely have been the primary real thought process, as THAT actually would likely be a safety issue and they’d have a duty to warn patients and the public, therefore. While a great case for that issue has been made on the boards, I believe the FDA did not see that as a “risk”, for that obvious reason... no warnings, no safety issue.
What the true cause was, I don’t yet have a final view, though I have frequently expressed the view that new placebo patients whose treatment would be delayed, would be at risk, and trials are not supposed to do that once a clear benefit and no downside has been demonstrated.
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