2024 Here we go again., page-488

Based on this transcription I did from Si video presentation it appears Si ascribes some of FDA behaviour to anticipated widespread off label use after BLA - whether he anticipates same scale, dont know.

"But I think you know you need to appreciate the product even when its approved for children will be available for hospitals and users for much more, much wider use and I think the FDA want to be certain that when they release this product on the market its widespread use will come with potency assays and disclaimers that allow it be used safely."