Replies to post #147825 on Vivos Inc (RDGL)

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Agree. I hope I'm wrong too and things happen faster. But gotta be realistic that IDE submission looks many months away at best. Also I don't blame FDA for these lengthy pre-submission discussions. MK should have anticipated all these re-verification tests last year the moment he changed a component (resin polymerization process changed) or the Y90 dispersion process. He changed both last year. No way would FDA accept any prior tests results at that point. I put the lost year of not getting ball rolling last year with re-verification tests squarely on MK. Water over the dam now. GLTA