NorthWest Biotherapeutics Inc (NWBO)

[tunnelvisionofplenty]

Thanks! Had this conflated with another non-small cell lung cancer drug (Sugemalimab) approved in the fall. This new medicine had an extremely long duration from 1st CHM meeting to approval – 378 days, which is the second longest in my dataset (just beating out mRESVIA (371), which was approved last week, and just behind Sugemalimab (398), the longest in the set). Perhaps the lengthy review period had to do with the amount of data supporting the application (supported by a clinical trial with 1074 participants)?

MHRA has now approved 3 non-IRP MAAs in the past 3 weeks. That's as many as they approved in the preceding ~3 months. The average time from first CHM to approval for those 3 medicines was much longer than the recent average – about 347 days. It's interesting that they should have approved these 3 applications in such rapid succession, after all of them had longer than average review timelines.