Thought provoking… Considering that there is absolutely nothing that extends survival for rGBM, DCVax is a miracle. Beyond doubling rGBM survival, it is safe and does not cause debilitating side effects. From a tax payer’s point of view, it is clear that the FDA and NIH are largely responsible for the development of DCVax … and from a common sense point of view, any rGBM patient would be outraged if told that this technology could not be approved for rGBM.
Who would not want DCVax at recurrence?
DCVax is a gem for rGBM, but rGBM is just the tip of the iceberg with this platform technology as cell science is certainly not limited to only one type of tumor.
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations" —Richard Pazdur, MD