Replies to post #177363 on Vivos Inc (RDGL)

[Rum_Tequila]

gonna see buying pressure mount on Thursday and really ramp on Friday with a close in the 20s easy

[familyof5]

"There is no day after if they don't get approval"

It's trading the way it is because there is no more momentum play left. All the catalyst events have happened. If you invest today, it's all or nothing. There is no day after if they don't get approval. The company has been really quiet and approval is not a guarantee. In 1 week it will either be worth something or nothing. Tic toc. Fingers crossed.
DermMD

Dare I ask but from what plausible line of reasoning do you draw this dooms day ALL or NOTHING conclusion. There are 3 possible outcome scenarios relative with this filing according to information disseminated by RDGL themselves through the TradersQue article .https://tradersque.com/vivos-inc-announces-ide-submission-for-radiogel/ All of which have their own varying degree of consequences (AWESOME, GOOD, or NOT SO GOOD). But none of which indicate the end of the road if there is a temporarily disapproval. A disapproval of the application requiring further data or changes would certainly be a setback for RDGL's aspirations for human clinical trials no doubt about it. But would the FDA's request for further data or changes mean the human trials option would no longer be considered? Odds of the worse case scenario are about 33% based on the number of potential outcomes we have been presented with. That would mean there is a 66% chance of the outcome being a more favorable outcome. Sixty six percent is not the kind of odds you bet the house on. But any BET, and I stress BET because that's what this trade is, that is better than 50%, is worth chancing IMHO just so as long as IT IS PLACED WITH MONEY YOU CAN AFFORD TO LOSE (No AND'S, IF'S, BUT'S or MAYBE'S).

The company IMHO is obviously selling shares ahead of this decision as indicated through a recent filing and the presence of Market Maker OTCN. That is also the most likely reason we have seen Market Maker ASCM, known for SHORTING, here for weeks atop of the ASK and jumping the BID when need be. So in conclusion no matter whatever the FDA decision (AWESOME, GOOD, or NOT SO GOOD), we will see traders and investors alike selling, buying, holding. Each with their own personal interest driving whatever decision they choose to make. So the "There is no day after if they don't get approval" statement IMHO seems a little extreme, considering what RDGL has indicated as to what the implications of a disapproval would mean and require going forward. Either way this should go without saying. Anyone putting money into RDGL now will have to accept it will be with gambling money. Not money they can ill afford to lose.....or be in need of in the near future if a disapproval should be the outcome.....




Understanding the IDE Submission Process and FDA Review Timeline

This IDE filing addressed 63 FDA comments from previous correspondences, including reports on two complex studies: RadioGel® genotoxicity and the retention of RadioGel® at the injection site in VX2 tumors in rabbits.

The Investigational Device Exemption (IDE) submission is a crucial step in gaining FDA approval to conduct human clinical trials for new medical devices. When a company submits an IDE application, it includes detailed reports, studies, and data demonstrating the device’s safety and efficacy. Once the application is submitted, https://radiogel.com/ide-submission the FDA has a 30-day review period to evaluate the information provided. During this time, the FDA can respond with one of three possible outcomes

Approval: Full authorization to proceed with the clinical trials.
Approval with Conditions: Authorization to proceed with specific conditions or modifications required.
Disapproval: Denial of the application, requiring further data or changes.