Let me help you to understand biotech a bit better: The safety of DCVAX has already been proven in phase 2 with by the way outstanding results. The efficiency of the trial is being proven in a phase 3 study if you believe it. To proof efficiency, one must agree on endpoints with the authorities as they have done in the UK and EU via Germany.
I have spoken with the EMA and they have CONFIRMED me that the endpoints are approved. The EMA confirmed to me that if endpoints are met in general the biotech is granted approval. But since you know so much better please go ahead and call the EMA yourself: +31887816000
Your point 2. enough has been said and posted about that here now. But what you are saying is also nonsense