Best case is they have done all the required Flaskworks qualification work and include it in their BLA submission, whether rolling or normal and this then just depends on BLA approval timing.
Next best case is they have done all the required work but choose to hold for post approval submission, which could then take between 6-12 mos for approval post initial product approval.
Worst case is they still have qualification work to do which takes more time than the BLA approval cycle time which then extends past the 6-12 mos by the amount of time needed to complete the work, say an add'l 6-12 mos, then that could then take say 12-24 mos post initial product approval.
If they have begun a rolling submission there is a greater chance they would wait until post initial product approval, but anything is still possible with what we know to date.
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