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CatfishHunter

07/27/24 4:28 PM

#177720 RE: edzett #177719

Given the submission has been an “interactive review” process and they’ve already had back and forth dialogue, it won’t be a “no response” automatic approval imo. With over a 1000 pages of docs and data to review, I’m not surprised FDA is taking their time on such an important approval process. They should. Vivos will get notification Monday. I’m expecting news PR Tuesday.