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CEL-SCI bias analysis concluded that the demographic and baseline characteristics of the Multikine treatment group and the control group were comparable in the phase 3 study. There were no mixed baseline parameters in the Multikine treatment group and control group. There were no biases in the study, and no biases favorable to the study product Multikine were found. As a result, the study data are reliable, explainable, statistically significant, and have been shown to support the clinical effects of neo-adjuvant (pre-operative) Multikine immunotherapy in extending the lifespan of these patients in phase 3 studies.
This is critical information because CEL-SCI will conduct a confirmatory registration study on 212 patients on Multikine in accordance with FDA approval. The target population of the confirmatory study showed that patients treated with Multikine had a 5-year survival rate of 73% for advanced primary head and neck cancer, compared with 45% in the control group.
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“富贵险中求,也在险种丢,求时十之一,丢时十之九”控制风险是最重要的因素!
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