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08/05/22 12:18 PM

#501574 RE: HyGro #500558

HyGro,

The clinicaltrials.gov site is easily accessible and gives a very short version of methods and goals. The standard assessment protocol (SAP) for the DCVax-L Phase 3 trial is neither easily accessible or anything close to a short description of the protocol. You are confusing the purpose of each and besides, even the earlier leaked interim version of protocols had methylated being accounted for separately.
By the way, there is only one final version of the SAP that was ever presented to FDA and other regulators before data lock and unblinding. Nothing else was ever written in stone or unable to be modified while blinded. There have been many unsubstantiated claims made on message boards and elsewhere to the contrary. Best wishes.