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kayak_wench

07/16/24 10:52 AM

#177082 RE: Rum_Tequila #177078

Someone implied I was worried about the 60ish comments, I'm not. I have never mentioned them. Vivos has addressed all questions and even repeated some tests that the FDA didn't ask them to (Korenko knows from past experience that more tests can pop up at any moment) and cleaned up all documentation and websites in anticipation of what could be commented on. Again going above and beyond what FDA asked/mentioned. Korenko has doing everything within his power to have this submission address all possible issues. I think the genotoxity was a complete curve ball thrown at them. They have a lot of experts (vets, radiation specialists, FDA consultants, etc) and it is obvious Korenko said consider everything the FDA could bring up at this point and lets address it before submission. Now we have to wait and see if team Vivos was succcessful with that brainstorming or the FDA has another surprise up their sleeve. If they do it will be an out of the blue like the genotoxity BS.