NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

Took a quick look at Gale as you suggested.
During an interim checkpoint the IDMC recommended the PRESENT study be stopped for futility. IDMC suggested the NeuVax arm did not perform as expected in relation to the control arm.

Not sure of the relevance of this to DCVAX-L Phase-3. There has been no safety issues or futility concerns from the IDMC and we are well past the interim checkpoints. Again if DCVAX was no better than the placebo we would have hit the 248 events ending the trial long ago. Everyone is living longer. The concern has been that the FDA mandated crossover. Placebo patients that have tumor reoccurrence will be offered that option to switch over to DCVAX. This complicates the trial making it difficult to show statistical significance relative to a > 4 month PFS? IMHO the phase-3 has been going on long enough that it will be clear overall survival is significantly better than the SOC which with tumor removal, chemo (temodar) and radiation. Tumor reoccurence is 6-12 months and pretty much no one lives longer that 24 months with SOC. If > 30% of the GBM patients (Mesenchymal subgroup) are effectively cured by DCVAX as many of us believe there is no way the FDA won't approve it else there will be riots in the streets. That is why Linda just lets this keep going.