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Re: gpb post# 3077

Saturday, 12/28/2013 6:47:35 PM

Saturday, December 28, 2013 6:47:35 PM

Post# of 700556
Did you calculate it based upon 1 person presenting the potential of 2 events?

At a rate of 19.5 total enrollment per quarter. If the 33 were trial arm, statistical analysis would demand increasing rate of control enrollment in 2011 until 3/1 ratio is back in balance.

That's more than 7 control arm enrollees per quarter. Take just 7 of those quarters = 2nd quarter 2011 to last quarter 2012. 7 x 7 = 49. 49 x .9 = 44.1 tumor progressions by end of this quarter if 90% reach Tumor progression within control arm in 12 months (It was 8.1 months back in phase 1. (Very conservative.)

Then , unfortunately, you must include event deaths, even if they include someone who already rated with a tumor progression event. The crossover arm mercifully almost certainly reduces death events. So say 10 from the control arm since the study began. Total events from control arm until now -- approximately 54. That leaves 12 events to take up the balance from the much larger trial arm.


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