Professor Dr Keyoumars Ashkan, the lead investigator in Europe states at the British Neuro-Oncology Society Annual Meeting on 23rd June 2022 (in his own words and also shown on the Statistical Analysis Plan slide)
"this statistical analysis plan was made well before unblinding of the study and it was approved by the regulators"
Northwest Biotherapeutics Announces Data Lock of Phase III Trial
With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.
So in conclusion, if they were blinded on 5th Oct 2020, how on earth could they have been unblinded before the SAP was approved and posted on the 8th or even earlier.
Why would you possibly think the primary endpt is not OS after all the info that has been shared from multiple sources and has been publicly disclosed. The primary was changed to OS compliantly prior to unblinding. There is no question about this other than yours. You are aware I presume that PFS is only used as a surrogate for OS and FDA greatly prefers OS as the trial metric right? FDA only allows PFS to be used due to the length of time to develop OS data. And the FDA is aware PFS is not the best proven surrogate either. Due to all of this FDA is gratified to see a company compliantly change from PFS to OS.
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