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Post# of 177588
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Saturday, 12/09/2023 10:24:47 PM

Saturday, December 09, 2023 10:24:47 PM

Post# of 177588
This screams that they're almost there. I would be shocked if we don't see submission by the end of Q1 2024. I think they'll be ready to submit by the end of January at the latest, but will need to request a FDA meeting and we all know that takes time.

I'm thinking the next quarterly update will say all the testing is done and written up or wrapping up and they requested a meeting.

Mayo Clinic Protocol and Institutional Review Board (IRB)
After receiving FDA approval to conduct clinical trials we need formal approval from the Mayo Clinic IRB. In anticipation of this step and to help expedite the proccess we have submitted the Clinical Trial Protocol to their “gatekeeper” for comments. We have also been conducting certification training for Dr. Paz Fumagalli. Next quarter we are planning to complete the final training certification step using high activity RadioGel™ in a full-dress rehearsal operating theater.
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