Those who laughed, you can do research yourself. So you don't cry and your mustache don't get burnt when NWBO can save years due to modern regulations that reflect the innovations in cell therapies today.
The new regulations paved the way accelerated approvals if the results at 90 days already showed amazing ORR and tumor melting and 10x t-cells infiltration into the tumors.
Nothing changed in the regs here. It has always been possible in many cases to gain approval based on ORR in a single arm trial. The reg change you are hyping is just paperwork details on variations being submitted are categorized.
You really should try to find source documents and not just rehash AI generated crap into human language,