Thursday, September 30, 2021 11:23:47 AM
I think we are def in phase 3
I'm new here to this board and this is my first post ever. I've literally read every post here for like the last 6 months if not longer. I've been in RDGL since 2020 and have a 50% weighting in my portfolio with it. If I had more money to spend, I would buy more shares for sure.
That said, we are absolutely in phase 3 of the EFS process. This is based on the last article posted and the latest PR statement.
PR Language - Clue 1: "Vivos Inc....has submitted the IDE...as part of a pre-submission meeting process." ---- Only phases 2 & 3 mention directly reference a "pre-submission". Phase 4 is the final IDE submission
PR Language - Clue 2: This review typically takes several iterations and we will continue with biocompatibility testing in parallel.
In the EFS article linked before, under phase 3 referencing additional pre-submissions: "A pre-submission can be provided to get crossfunctional feedback on items like sterilization validations, biocompatibility testing, animal study protocols, and/or clinical study protocols. This is a very interactive time and should be done before testing is started to maximize the interactions and feedback.
This leads me to believe they are in Phase 3 and we have 2-3 months left before IDE acceptance.
Thanks to whoever found the article because I was also wondering where we were, but a little cross-reference and all of the sudden the PR sounds a lot more specific than it did 10 days ago.
I'm new here to this board and this is my first post ever. I've literally read every post here for like the last 6 months if not longer. I've been in RDGL since 2020 and have a 50% weighting in my portfolio with it. If I had more money to spend, I would buy more shares for sure.
That said, we are absolutely in phase 3 of the EFS process. This is based on the last article posted and the latest PR statement.
PR Language - Clue 1: "Vivos Inc....has submitted the IDE...as part of a pre-submission meeting process." ---- Only phases 2 & 3 mention directly reference a "pre-submission". Phase 4 is the final IDE submission
PR Language - Clue 2: This review typically takes several iterations and we will continue with biocompatibility testing in parallel.
In the EFS article linked before, under phase 3 referencing additional pre-submissions: "A pre-submission can be provided to get crossfunctional feedback on items like sterilization validations, biocompatibility testing, animal study protocols, and/or clinical study protocols. This is a very interactive time and should be done before testing is started to maximize the interactions and feedback.
This leads me to believe they are in Phase 3 and we have 2-3 months left before IDE acceptance.
Thanks to whoever found the article because I was also wondering where we were, but a little cross-reference and all of the sudden the PR sounds a lot more specific than it did 10 days ago.
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