Submitting for a new application probably means that as they were looking for clinical collaborators they were advised by experts at the Mayo Clinic and/or others on their SAB that inaccessible (non-resectable) cancerous lymph nodes was a better initial clinical indication with potentially higher POS. I have worked on many drug development projects and these changes can happen with little to no detriment or delays in the program if properly justified.
Given that Radiogel is a single day therapy, the biocompatibility testing should be well on its way and could be completed soon. Once the IDE has been submitted, the FDA has 30 days to respond. Radiogel/Isopet has been very well tolerated in animals and appears to have a high benefit/risk ratio. There is no obvious reason why the FDA would not allow for clinical testing. The ultimate device classification (II/III) is another issue and could hold up approval but it should not keep Vivos from running clinical trials and generating data.
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