... "once we determine where were going on AA" or some such. (not an exact quote). That means it could be starting up in weeks. No waiting. This is from his opening talk.
he said along with our plans for production in the event of an early approval
Mid-scale is up and running and large scale is ready to go - just waiting for the signal. We're ready if the FDA is ready.
Another key point - stability testing should not be a factor to delay approval, as they will have good stability data on small & mid batches and the drug is not expected to sit on the shelf for any extended period of time after launch.