The BDD had a definitive deadline within which the FDA would respond with yes/or no some <x> days after the submission was accepted The IDE submission for an Earlier Feasibility Study (EFS) first in humans seems has no set schedule within which the FDA has to respond. So investors don't have any idea when the outcome of the submission will be known. I think that will make it harder for many to decide to invest.
Interesting the prize for an EFS is much bigger than for BDD. BDD just gave us hand holding through the IDE submission process. The EFS submissions seems to me to be another mechanism to get some additional hand holding (via the submission process) with the prize being a limited IDE awarded for a single small study.
From their PR they either decided not to have a EFS pre-submission meeting, or already had it. From FDA documentation it was an option. Could be that since there are Covid travel restrictions the pre-submission meeting would have been online anyway so maybe it all blended into 'communication' which RDGL did mention they were having.
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