Re your post " That document doesn't answer Blackkkkk's questions. "
I don't know why a poster would say that. Which questions are you talking about?
'That document', as you refer to it, certainly answers most of mine. Has @Blackkkkkkk read it in full? Have you read it in full? And have you also read the other documents referenced in it?
For example, this one which I find very helpful: https://www.fda.gov/media/85659/download
These SOPPs are intended by the FDA to work together. For example, have a look at this:
Let me know which of these provisions you find irrelevant.
GLTAH
Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-258
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