Tuesday, September 09, 2025 4:56:47 PM
No, they actually agreed well before, when both the UK and Europe changed their versions of clinical trial, which surprised NWBO, but represented what the regulators agreed to and let the trial proceed.
The SAP was dated Sep 23., 2020. The final trial protocol was dated Sep 23 2020 (though it would need to be signed by LL prior to submitting)
Who knows what NWBO sent to UK/GA to get them to change the trial registry a few months earlier than that.
As far as NWBO being surprised, that was back in 2015 when the hold leaked. Why NWBO failed to disclose the FDA hold is another issue.
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