It's possible. I think with the pre-submission EFS will help their chances of IDE approval by a ton. IDE approval is obviously the most important thing right now, but I think FDA approval is very possible with the route they took with the FDA.
Also we have to remember that they can see results from the human trials within weeks to a month for their current indication, although the over all trials take longer to prepare and present for final approval. If IDE approval in Q2 I wouldn't be surprised to see final approval if things go well by the end of the year if not early 2023. Mayo Clinic has the connections and resources to find the best cases for them quickly.
Very exciting times ahead in my eyes. Still a couple years hold IMO, but man the potential is insane.
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