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MikeD

10/02/21 7:29 PM

#141178 RE: Reluctant Observer #141177

I’m hoping for an approval of an IDE supplemental based on the findings of the Feasibility study and justified by the Mayo Clinic clinical data taking RDGL to the next step Pivotal trial. Once RDGL gets to the Pivotal trial (only if the Feasibility study confirms the device is in its final form and then an additional IDE Supplemental is approved) the sp can run as long as there is not another offering by the company. Now if Vivos partners up with a company for funding of a Pivotal trial and/or gets some institutional buyers on board that is a game changer (and very well could happen with the Feasibility study IDE supplemental approval leading to a Pivotal trial). In any case, with all the data research Vivos has done already, this Feasibility study is taking the safe route- Vivos is just dotting their i’s and crossing their t’s. Time for the Pivotal trial and some real sp action. $RDGL