Thursday, June 29, 2017 1:20:07 AM
And yes, I believe that even if the mOS goal for the trial is not met, an very large and long tail could get approval, my initial wish is to beat the ITT mOS. That beat is by far the easiest way to get viewed as very likely to get approved, imo. If we miss that, even if the survival curve is quite convincing of efficacy, we are already getting deep into the weeds. I think the headline numbers really matter - I want a PR that it doesn't take any expertise on these trials to figure out what it means.
If we expect upwards of 20 survivors from the SOC arm, what are the odds of getting 25 or more? And what will it mean for the p value if we have 25 SOC survivors?
BTW, could you pls dial down the insults a tad? Just because I disagree that your simplified model shows statistical certainty that doesn't make me an idiot by any means.
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