Ann: BLA Filing Update for Renal Cancer Imaging Agent TLX250-CDx, page-69

I’ve been involved in regulatory processes- though not at this sort of high level, more at the level of plant and equipment- and really this sort of thing is par for the course.

It would be easy to finger point and lay blame, but details like this are easy to miss. Particularly if there are high level risks (spilling radioactive material!!!) that distract from the maybe lower level risks (E. coli on the container lids!! I’m just making that one up).

You can also have a situation where someone looks at the risk matrix and decides that they want to go from LOW to VERY VERY LOW and suddenly you’ve got to engineer in a bunch of redundancies to make the assessors happy.

So far on HC the response has been mostly pretty measured, but like I implied earlier (and I think others have said more explicitly) this is what the review is for.

Also, if I want to be cynical, it can happen that when you do an audit of something there’s pressure to find something wrong, so that it looks like you’ve done your job. The joys of safety culture.