Thursday, August 16, 2018 2:40:13 PM
As we are dividing the total population of 928 into SOC and SOC+ Multikine, then each arm would have 463-464 patients.
If we review the data provided by analysis from the seeking alpha article and another poster here (I'm afraid I've forgetting who), and we look at the OS over 1 and 5 year survival rates, then we come to about 172 events expected by May 2018 in the SOC arm, for a 10% increased survival therefore we would need 172*0.9 = 155 events in the SOC + Multikine arm. Thus we are talking about a 17 patient difference based on that analysis up to May 2018. Even at this 10% improvement, it would have assumed that 327 people would have died by May 2018, which is far above the 298 needed. The fact that the 298 have still not been reached is what the seeking alpha author indicated leads to the logical conclusion that things are better than not for SOC+Multikine. This however does need to be finally determined by concluding the trial.
If we extrapolate this out further, then we would be hoping for an even greater difference in patients between the two groups. However 17 patient difference may not seem like a lot to go off to be sure they the IDMC may think it important to let the trial run its course and reach the final conclusion with full statistical power in place.
I do also recall the other poster pointing out some flaws in the analysis of the seeking alpha article, but even if there are discrepancies in the exact number of expected events. With existing 5 year overall survival statistics, it would very much make sense that 344 events should have occurred by May 2018 if patients were all on SOC only. Again the fact that that has not yet happened should mean more of a positive than negative for Multikine.
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