That was actually meant for @Martin37 but didn't want to...

That was actually meant for @Martin37 but didn't want to continue cluttering the message board, so just left it.

"Sorry guys, I should not have said the FDA required an RCT in the CRL, and did in fact only recommend one. My bad."

I did not once say they said "required" in the CRL. You've just taken my comments out of context. I said "The FDA have made it clear that they require an RCT, whereas Mesoblast have consistently attempted to bypass this requirement."

Just look at the briefing document where it breaks it down. The FDA state "FDA frequently requires a randomized trial to support traditional approval". And now look at what everyone is saying, they're saying that MSB are bypassing the requirement for the RCT.

If you can find one of my posts where I have said " the FDA required an RCT in the CRL" then I will correct it, but I never did. That's not to say that I don't think a RCT may be a requirement for approval. It's clearly not a minimum requirement otherwise the resubmission would've been marked as incomplete, so let's see how this plays out. We'll find out in August either way.

My views, dyor