Based on their public enrollment figures, IF there was no clinical benefit associated with the trial arm vs control arm, the "first look" would have occurred in August 2012. Im surprised no-one has picked up on this.
I am long the May $2.50 calls and I have to believe 32 events will occur by then...at 124 patients, that puts only 41 in the control arm so it might be close if very few are eventing in the treatment arm..
I have seen in this board another detailed calculations, which calculates the point of "IF there was no clinical benefit associated with the trial arm vs control arm" to be mid Nov. If I remember correctly, it was stated that Jan end will result in "excellent" data and Feb end will be "spectacular".
That would take speculation on how well ICT-107 works. If one wanted to plot the control arm and extrapolate to 32, that would be difficult as well since we don't have enrollment date for just that group.
There are outer limits, six mos. from full enrollment should produce enough incidents in the control arm. No?
The trigger is not just the control arm, BTW. By my detail calculations they should be at 32 events really soon if the results are similar to Phase I results (which is really good). If the results were closer to the Phase II signal target of 26mo survival we would have already seen the interim futility analysis. This assumes of course that OS for the control of this sub-population is about 15 mos. It is possible that this assumption is off and the current standard of care for this sub-population is better than 15mos. Also, because of the expanded enrollment the threshold to unblind may come sooner than expected perhaps around June.