How many years have you been repeating this type of nonsense? Five years?
Read carefully the following part from ASM transcript, go through all the new guidance from FDA about rare disease, and ask yourself the question:
Should Dr. Vinay Prasad and Dr. Makary be amazed by the intensity of anti-tumor immune response triggered by DCVax-L in treating the hardest cancer?
Another example has been multiple regulators, including US FDA, including just very recently, coming out with new and modernized policies to embrace and start increasing the use of real-world data and real-world evidence. We’ve treated, for example, hundreds of compassionate use patients, and that real-world data is increasingly valuable as the policies move in the direction of embracing and supporting use of that data in regulatory decision making processes.