The TICE BCG shortage first hit in 2012 before prior to the Direct P1 when Sani had quality issues that forced a shutdown. That had no effect on the trial as there were still many millions of doses being made and one can always find a few.
So fast forward to 2024. NWBO wants to restart Direct again, this time in the UK. The approved BCG is from a different supplier in the UK.
NWBO needs to get the new API vendor approved, which is a very minor point. But they having the SMA spin this as some huge issue.