Friday, August 05, 2022 12:51:04 PM
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"
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Now look at the NWBio PR from Oct 05, 2020
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.
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial-301145661.html
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Now take a look at the GB Clinical Trials website using the Wayback Machine
As of 8th Oct 2020 the new endpoints were already established
https://web.archive.org/web/20201008220341/https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB
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.
"this statistical analysis plan was made well before unblinding of the study and it was approved by the regulators"
---------------------------------------------------------------------------------------------
Now look at the NWBio PR from Oct 05, 2020
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.
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial-301145661.html
-----------------------------------------------------------------------
Now take a look at the GB Clinical Trials website using the Wayback Machine
As of 8th Oct 2020 the new endpoints were already established
https://web.archive.org/web/20201008220341/https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB
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.
DCVax could well be the biggest medical breakthrough - EVER
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