What happened?
DI says they need Flaskwork’s practice runs in parallel with manual specials runs (apparently) in Sawston.
Sawston was supposed to start first specials run before Sept 22 2021, but this didn’t happen until February 17, 2022.
That set Flaskwork’s PQ back by five months at best, that is if they needed the parallel runs to be at Sawston.
For manual, it took at least from March 16 to February 17 to go from practice runs to first specials patient at Sawston.
There were MHRA delays, so that could have caused about three to five months damage to get to first patient.
At best Flaskwork’s is seven months out, not because they had not done the other _q stages ahead of pq, but because they were left waiting until February 17 to start practice runs which they earlier thought would start in late summer 2021.
Part of Flaskwork’s delay is definitely due to earlier MHRA delays on manual. Hopefully Advent Sawston is a higher priority for MHRA this time around.
Imho.