Rkmatters,
I am and have been extremely glad that this trial has a crossover option. While this is somewhat confounding, the reality is that FDA has the accepted monotherapy values for impact from previously approved therapies and those are the ones most likely to be used in conjunction with crossover. They will use these values to separate their potential added benefit from the total benefit observed. This is the way doctors and scientists operare. Dr. Linda Liau mentioned 2 chemotherapies and potential with checkpoint inhibitors that will show or most likely show synergy with DCVax-L and the chemo is relatively cheap and would be covered by insurance. This trial will measure synergies based on Stupp protocols during treatment and pretreatment and non Stupp, potentially optimized treatment, at crossover. This includes the potential use of check point inhibitors in combination without the full cost of a trial. I wonder if a company or 2 might be offering their checkpoint inhibitors to these patients for free. Win, win, win. This gives all patients a chance to benefit from the advances in research with regard to synergy and a look at what SOC may end up being later on. The flexibility at crossover is awesome. FDA has good reason to take their time with this and I understand AVII's concern with regard to stringent standards but this is where the flexibility that they have recently been granted will help if needed. Best wishes.
