here's that word again - imminent, page-21

Addressing your "comfort" points, TDA:
1. I preempted this point. I gave an explanation why this might not be meaningful. Giving an opinion as to why do you not think that is a valid point may be more useful than just repeating what you've said in the past?
2. Agree, and I also take SOME comfort in that, BUT ....there are public signs of systemic problems elsewhere. "Systemic" means they may well be pervasive within the organisation.
3. Cannot understand why a plant being either near or not near a problem plant should be particular meaningful, unless you think regional management prevents systematic problems at a local level. Need to address the likelihood of broader systemic issues.
4. I take only very nervous comfort in this figure, and sometimes wonder if I'm in danger (because of the large amount of ACL I hold) of mentally filtering out some of what that number doesn't tell us. The raw mean-time-to-approval is useful but the devil is in the detail. I've looked at the FDA data Tweks kindly provided a link to previously and used common fields to merge as much as I could into a single data-set. I wanted to get a feel for the average time to approval for each of the different cohorts of generic types (injectables versus oral; first generic versus later etc). Unfortunately, not so easy. I suspect, however, that first generics would have a quicker approval time than that for the raw mean you quote. It would also be interesting to see the data for the average time taken, for a first generic, from the last FDA question after the last inspection to the approval announcement. Do you believe ACL has now sat passively on someone's desk at the FDA for almost 6 months?

To repeat a phrase: but that's just me .....