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flipper44

12/28/13 6:47 PM

#3079 RE: gpb #3077

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.


ou71764

12/28/13 7:07 PM

#3080 RE: gpb #3077

gpb/flipper,

Thanks for your posts. Besides how many events each arm has had, it's also a question of when they occurred. I would be surprised if there haven't been treatment arm events yet. But maybe the treatment arm events are relatively recent, from patents who have been in the trial for a longer time period. And maybe the control arm events occurred quicker after enrollment.

gpb, I appreciate that you took the time to see what the numbers might show. I've done calculations before and it's time consuming and you aren't likely to get much thanks for the time spent. But I'm wondering if you have enough information to even do that. The company has been hesitant to release any enrollment data. And even if they had, we don't know the timing of the occurrence of the events.

Maybe I'm concerned that the low end of your calculated range of 5 to 13 months of DCVax-L superiority would leave us short of the primary endpoint. We need 6 months. Phase I had 18 months. You're saying that the best we can hope for will be nowhere near that.