No, they announced the SAP and that they were going for external control arm basically when they commented on the updated policy and also when they updated us at various stages about the updated SAP as far back as November 2019, and at another relevant event in which the CEO LP explained quite carefully how they were proceeding on the updated SAP, and that it would not advance until after all 4 regulators had accepted. Subsequently the MHRA and EMA updated their clinical trials database, as the regulator maintains it there with the updated details including all the relevant factors we are discussing now, and clearly that approval came before unblinding.
Their SEC filings do not need to be updated in such trial details especially not given that it was widely discussed for more than a year before unblinding.
Had they been rejected they might have had an 8-K event, but even that I think is unlikely at that stage.
The fact is they updated the language related to those matters long after those changes had been made and this is a well known fact for anyone who has been a long-term investor and followed this closely at the time. None of the applications came after data lock, and given previous explicit assurances that they would not unlock until they had all 4 regulator approvals, and given the timing of the EMA and UK updated that confirmed that the regulators had approved the SAP and the explicit confirmation numerous times by various third-party doctors involved with the trial who are NOT employees and have no interest in lying about such a matter, it would be a ridiculous conspiracy of a huge magnitude that is extremely unlikely given the reputations of the institutions and scholars/researchers involved and the implications for the company if they ALL lied, which is what Hygro says every time he posts this nonsense, that there is som massive conspiracy involving UCLA, Kings College, the various regulators involved here and NWBO.
Preposterous!
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