NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

That is a different issue. That’s not what is being said. Their SAP clearly has already been accepted, which is why I said the agency is assuring them it is policy, already. And in fact the FDA has suggested they will have some test cases I believe, initially. I think the FDA may be waiting to publish the final version of the ECA policy intentionally. But a journal wants to know that it is following policy, for certain, and whether they got comfort from the private publication that Pazdur participated in or not is probably more the issue for a private journal. This is why I think the focus may be on the UK, for publication, with a footnote re FDA. I could be wrong.

On the other hand I once speculated that there might be debate as to qualifying language or a footnote about a pending FDA final policy document, etc., and if a journal would agree to that circumstance.

I honestly don’t doubt the policy is being acted upon and is currently real FDA policy. I just think that the agency is being a bit overly cautious. Otherwise I cannot see any reason for the delay in a final version of that policy. Also, they may be waiting for real world applications of the policy to finalize it.