Agree with LED.
At least with CBERs SOPs, that letter is only "if necessary."
We already know PDUFA, inspection scheduled, and ADCOM already conducted. So why would they need to send one?
That said, if they did send one, and there were deficiencies MSB could remediate prior to PDUFA, I think they probably wouldn't advise share holders as the message could be misunderstood both ways.A day 74 letter with deficiencies doesn't mean approval or non approval.
Given they did announce bla lodgement, acceptance, and inspection, I think they will inform on the mid cycle progress, - even if it is only that.
They might have already done the final review aswell... anything is possible, but based on logic and the usual FDA timing, and the usual FDA processes my gut feel is Lonza last / this week, Mid cycle end May or first week June.
That will be welcome news if it materialises.
2023 The Final Countdown, page-419
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