NWBO announce the unblinding of the data (data lock) on 10/5/20 with a press release. It was not until the 3/2021 SEC 10K filing that they announced they were changing the protocol, endpoint, comparator and SAP. So the clearly indicates that the trial changes were done AFTER the unblinding of the trial data.
They should be having discussions with regulators and they can provide them with a new protocol, etc. in advance, but it will not be until they make an actual application for approval that the regulators will give NWBO a decision on whether they will accept the application for review, and then their decision once they have reviewed it.
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