CEO Itescu needs to go, page-403

What we don't know is why they want the trial. Is it to satisfy the "at least one well-controlled study" requirement or is it to provide comfort (as SI put it) to the FDA that the product will continue to provide a benefit.

But what about post approval reporting?
The main reason the FDA has historically been obsessed with controls is patient safety. Look at the papers on reform of the FDA in lagging behind technology.
Benefit to patient is secondary but material, so if it benefits an appreciable number of patients and is safe, what's the issue?
The data will pile up as the numbers do.

But no. The FDA is fixated on this and it's out of proportion to the patient need and lack of risk to patient safety.

It's confounding that people wrap themselves up in what the FDA wants, rather than asking the why in terms of policy.

What's needed is FDA reform. Remember 9-1 of the expert medical panel recommended approval , yet everyone is acting as if that's just water under the bridge!

It's just medieval.
It's like the witch methodology episode of the Holy Grail.