Cell Therapy News/Articles, page-16590

me: "I personally don't think that currently they can have enough data to satisfy the FDA's need to have at least one adequate and well controlled trial."

WesM: what do you mean "need"?

The FDA has a legal requirement - they operate under statue to have at least one "adequate and well controlled trial" in order to grant a biologics licence. There is no legal requirement for a randomised control trial (an RCT) but there is a legal requirement for at least one adequate and well controlled trial. However having said that - it is in my opinion always going to be the FDA themselves that get to legally determine the meaning of adequate and well controlled trial because it is extremely unlikely a United States Court would step in on behalf of an applicant that was rejected to overrule the FDA. So, in practice, the FDA, someone like Steve Bauer will ask themselves and their department officers - do we have here in our opinion at least one adequate and well controlled trial so as to meet the minimum requirements of the statute - and if the answer is no - the in my opinion the FDA will not grant a BLA.

If you into the presentation material put together by Steven Bauer of the FDA in the wayback link at the start of this thread you should be able to find him discussing that. You'll get the reference to the either the regulation or the US Code from there. I won't walk you back to that from here because I don't get to that knowledge myself by that route I rely on hardcopies and downloads I made when the Event Materials had not yet been archived along with the other stuff like transcripts. Look for the FDA slides.

I've absolutely nothing against you, but I don't have an obligation to teach you at the expense of my time either.

I'm leaving the rest of your post. For now. I'll see what you do with what I've given you if anything.