Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-178

Ok - I'm upping the ante with this post
$3,000,000 per treatment
unmet need
800 patients per year

Bottom paragraph page 7
The review team recommends accelerated approval of this BLA with three Clinical PostMarketing Requirements (PMRs). Two Clinical PMRs are to provideconfirmatory evidence to demonstrate the long-term efficacy of SKYSONA (guess that's why we waited for the 4-year results)

But page 11 is where the fun really starts- guess who does the cell manufacturing- L O N Z A

A fascinating insight into a BLA approval

https://www.fda.gov/media/162098/download