Patient enrollment expected to commence at clinical centers in the U.S., Europe, Asia and later on in South America
The 212-patient confirmatory study is powered at approximately 97% to confirm a previously observed 0.34 hazard ratio, representing a 66% reduction in the risk of death
In the target population, Multikine followed by standard of care increased the 5-year survival rate to 73% versus 45% with standard of care alone
Pre-surgical tumor responses will be assessed and may serve as the basis for an early conditional or accelerated approval application with the FDA
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