Rob did say that under normal operations LDX would have expected the process to be complete around now, also that the trials hit all of the targets required by the FDA, and that they have been running further trials with outstanding results that should enhance marketing and rollout. Rob said that they were very optimistic about approval and I think indicated that they wouldn't be surprised to be notified soon.
They are certainly including FDA approval and rollout in the US in the early FY22 activities in their forward looking slide.
Ann: FY21 Annual Report, page-4
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