2023 The Final Countdown, page-52

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.