RRRichmond,
I doubt very much they're meeting with the FDA over L. The only possible thing they might consider to discuss is a potential change the crossover arm to restart the treatment clock, given the 51 data info.
DCVax-L main cohort of the trial is in no need of change. The Ph III trial modifications essentially ensures that more long tail events will be taken into the median --assuming the low WBC is a concern for some of the early eventers.
However, those placebo patients whose events were captured very early due to low WBC concern, would crossover to the vaccine and those patients would become eligible to receive much more of their vaccine treatments. This in theory could extend the time to death for those crossover patients, as the earlier the event, the closer the treatment schedule left to administer the vaccine remains. As remember it's blinded so if the low WBC patients had their first 3 treatments as placebo, then their 4,5, 6,7,8 etc. would follow the vaccine schedule, and their treatments would be essentially mimic a vaccine patient. But if a placebo patient events at let's say treatment 9 of cycle, then their would receive only treatment 10, 11, 12, according to what's left on the clock. So as you can see, depending on when the placebo patient events, their survival potential due the vaccine is altered. Since this data doesn't affect the PFS or OS, no reason why they can't commission the FDA to consider restarting the treatment clock for ALL patients that event.
News 
Market Data 
Discover 
