So I'm really hoping they have already requested a meeting, possibly in August.
They did say they have been talking to the FDA.
To listen to Geert they plan on submitting the BLA in 2022.
From a previous post of mine:
'After the meeting has been requested, the FDA will respond to a Type B meeting request within 21 days.' AND ‘ The FDA intends to schedule all Type B meetings to occur within 60 days of receiving the written meeting request.’
In order to make the end of the year, while addressing any of the FDA’s concerns, I think they need this meeting in mid-October.