This is my interpretation Mirri. EBR has agreed to exclude non-responders from the application (not sure why this is the case, but that’s a different discussion). So if there was problems with this cohort, then that would be factored in.
My only concern at this stage is some underlying fault/problem with the device that we are not aware of. Unlikely.
Timing here is key. In my experience, once the FDA accepts an application (particularly one with both primary endpoints met) it’s a relatively straight line to approval. Bring on Q1 2024.
This is my interpretation Mirri. EBR has agreed to exclude...
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