Originally they were planning on submitting to the fda in the spring which takes about 6 months to hear from them, but with this submission that they did for device break through the fda has 60days to respond. Which will probably be shorter because radiogel is working with 3 cancer doctors from the Mayo Clinic now. If this submission gets approved it changes all deadlines and approvals which means I have no idea other than that the human testing will be a lot shorter. It will only need to be months of testing not years. So a lot is riding on this device break through submission. Remember if it is denied it’s not over it just means that the human testing when approved will take longer.
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