(June-September-2014) accelerated opening of sites was the input that has set everything else on an accelerated pathway. The accelerated opening of sites allowed the acceleration of patients entering the trial. (That full enrollment remains on track for December.
That accelerated enrollment produces accelerated eventing. Accelerated eventing means first and second look-ins will follow full enrollment quickly because the enrollment comparator will be at a full stop, but the eventing will still be accelerating.
My take is that the First Look-in (33% eventing) will contain 66% Docetaxel control arm events, to 33% Bavituximab events. That is based on the 2:1 Bavi Doce ratio that we saw in the phase2 trial. Bavi patients live much longer than patients treated with Docetaxel.
So the acceleration was put into the trial very early on. It began moving slowly like an old steam locomotive. Although still blinded today, if we could look into the trial activities we might see something more like a bullet train.
So, in general, what has seemed like molasses for a couple of years, could mature very suddenly.
The First-Look-in, 33% eventing of the 582 enrollment would be about 192 events.
If 127 events (66%) are from the Doce arm, and 65 events (33%) are from the Bavi arm, what might the IDMC recommend?
What is the benefit for patients receiving Bavituximab compared to those receiving Docetaxel? What are Docetaxel patients missing by not receiving Bavi?
I think SUNRISE is moving much faster than many realize.
IMO
sunstar
AI
Market Data 
Markets 
