Looks like some serious SPLAAANIN going to happen soon w/FDA.
Remember Dr.Fadiran worked for the FDA for 24years, and is advising Dr.Missling on FDA affairs. While I have not been happy with the apparent additional enrollments(versus published clinicaltrials.gov numbers), and longer schedules, it may be that this is due to Dr.Fadiran's advice... maybe to help solidify the phase 3 data acceptance for approvals.