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HoneyBager

09/30/21 10:39 AM

#141100 RE: HoneyBager #141099

Also interesting information on page 26.

“In the IDE submission, the study should be clearly identified as an EFS. Since the EFS is a small study (limited number of patients and sites), it does not require registration on www.ClinicalTrials.gov.”

classics99

09/30/21 11:23 AM

#141113 RE: HoneyBager #141099

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.

Malibew66

09/30/21 3:35 PM

#141124 RE: HoneyBager #141099

honey badger, Amazing document. I also feel that page 14-potential patient benefits plays well into short term prospects