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Monday, May 13, 2024 2:54:20 PM
Depends if ide doesn’t get submitted until end of June then possibly a full 30 days for FDA to look at and decide if it passes.
My opinion this will only take 10-15 days at most. If FDA approves IDE
I’m guessing around 30-60days after IDE approval they will start human trials. So at the earliest August/September for human trials to begin. Granted I have no clue what the Mayo will have to do before they can start trials. Training has already been completed to use Radiogel which is required by the FDA I believe.
As for human market figure 12-18 months after human trials start.
My opinion of course. Could happen sooner or later
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