Two GREAT takeaways, page-7

@stockrock :
From yesterday's webcast around the 54:00 minute mark, this is what Dr. Itescu said "....I think ultimately, in a definitive Phase 3 which could be under an Accelerated Pathway post approval, we have to show an ACR20 benefit in the same way as every other biologic has achieved an ACR 20 benefit".

This is exactly what I have been saying for a while and I posted this almost two months ago (link below) - here is an excerpt:
"And though Cures stops short of explicitly removing a requirement for phase III trials, winning accelerated approval can make them unnecessary. “Accelerated approval is conditional approval,” Mills says. (Like conditional approval, it comes with the requirement to collect postapproval evidence of efficacy. The Cures bill also specifies that such evidence can come from sources outside a clinical trial, such as electronic health records or patient registries.)"

http://www.sciencemag.org/news/2016...-cell-advocates-expect-regulatory-shortcuts-0

Look:
The 21st Century Cures Act is a game changer. Phase 3 can be done AFTER a (accelerated) conditional approval, which is my way of saying that Phase 3 is not necessary for approval. And Dr. Itescu said as much yesterday. Hope that clears it up.