Ann: Trading Halt, page-722

I think you are still operating from the assumption that the FDA is very busy (that is an assumption I also share) and wouldn't do a trip to Singapore to do a PLA unless they were sure it wasn't going to be a waste of time rather than recognizing that once an applicant formally submits either a BLA or a resubmission the FDA has some obligations on it - busy or not - to try to perform to a reasonable time schedule to be fair to the applicants that as a class are largely providing the funding to do the inspections etc under PDUFA.

A complete response letter is not supposed to be punishment it is supposed to be a COMPLETE list of items that prevents the BLA from being granted - so its a finite what to fix list as opposed to being infinite - looked at in that way its supposed to help the applicant by giving them a list of things to fix.

I don't know how long the FDA inspectors would have spent at the Lonza site in Singapore - but I do know how long it takes to take a batch of cells through a 2D manufactuiring process and the inspectors would not be sitting around to watch that from start to finish.

Techinvestor - a frequenter of this forum and I believe now a holder has some knowledge/experinence in this area (has commented previously) that the Lonza Singapore site had not formerly (previously) been on some FDA list, if I recall correctly.