I missed your last question, I believe AA is given by the FDA, but it can be requested.
That is based on the original BLA CRL, where MSB requested a type A meeting to request AA.
Now, although MSB has not said it, I do think AA will be discussed 100% in this meeting.
But after the meeting, I *think MSB will need to submit a BLA still. ( I could be wrong, but I imagine, a BLA style application would be needed to cover CMC etc. )
I'm not too sure about the AA process here though, JB or a few other people probably understand it a little better.
2023 The Final Countdown, page-52
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