Sorry thought I answered this - my reply seems not to have gone...

Sorry thought I answered this - my reply seems not to have gone through.

The FDA is key performance indicated against the number of BLAs and BLA resubmissions it manages to do in a a period of a year or so - it has to report on those. This means it has to project manage so as to give itself the best chance to achieve a 6 month response time once it has accepted a resubmission for review.

Booking and sending inspectors to Singapore would be something necessary to do unless it was already clear the BLA resubmission was going to fail. Presupposing failure - before taking a good look at all the details of the submission would be wrong - so booking and doing an inspection is just necessary to try to ensure the FDA can give a response in 6 months as its supposed to do.

Reviewing all the info in BLA resubmission critically and fairly is a big project - it has to be handled with critical path analysis for the FDA to meet its time commitments - that why in my opinion.