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dr_lowenstein

08/05/22 12:31 PM

#501583 RE: Doc logic #501574

Primary Outcome Measures:
1. The primary objective of this study is to compare progression-free-survival (PFS) between patients treated with DCVax-Brain and concurrent control patients
Secondary Outcome Measures:
1. The secondary objective is to compare overall survival, measured as time-to-death, between DCVax-Brain treated vs. concurrent control patients.
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HyGro

08/05/22 4:25 PM

#501703 RE: Doc logic #501574

NWBO is obligated to post and keep the protocol public on clinicaltrials.gov. The provide the topline protocol and the trial endpoints. Methylated patient results are a sub-analysis the company has done and NOT an endpoint.

If the data doesn't meet FDA standards, subgroup analyses are not going to change their decision.

To correct you, SAP stands for Statistical Analysis Plan not standard assessment protocol. You are correct the SAP is not public as it is very detailed and useful for statisticians not clinicians, physicians, investors, patients, etc.