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Vivos Inc (QB) (RDGL)
Vivos Inc (QB) (RDGL) News

Vivos Inc (QB) (RDGL)

0.15095

0.001

(0.67%)

Closed July 27 3:00PM

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Form QUALIF - Notice of Qualification [Regulation A]

Form 1-A/A - Offering Statement [Regulation A]: [Amend]

Form 4 - Statement of changes in beneficial ownership of securities

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form 8-K - Current report

Form QUALIF - Notice of Qualification [Regulation A]

Form 1-A POS -

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form 1-A POS -

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

Form 1-A POS -

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Statement of Changes in Beneficial Ownership (4)

FORM 4 ☐ Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b...

Annual Report (10-k)

0001449349 false FY

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lovethatgreen

lovethatgreen 4 hours ago

30 days from June 28 is this Sunday July 28 unless folks are counting June 28th as a day
I don't think that's how it works

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nathanial

nathanial 8 hours ago

At least there were no known questions from the FDA that we are aware of. Smooth 30 days.

Rum_Tequila

Rum_Tequila 10 hours ago

I live in Vegas, where it’s 7pm and 104 degrees, sipping raspberry liqueur (in a brandy glass, over ice) and toasting now to all the patient longs here, we’re invested in something very special

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CatfishHunter

CatfishHunter 10 hours ago

I’ve no idea if FDA works weekends. Given that likelihood, they may not get the actual notice until Monday. Regardless we will all find out results soon enough. GLTA!

nathanial

nathanial 10 hours ago

Well guess the waiting is over. Should have a decision by next week. Best of luck to all.

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rogers711

rogers711 11 hours ago

Will they announce same day you think?

mc73

mc73 12 hours ago

Awesome to hear - thank you for sharing!

lovethatgreen

lovethatgreen 13 hours ago

1hunglo

1hunglo 14 hours ago

BBANBOB

BBANBOB 14 hours ago

Catfish and since I doubt any federal agency works on SAT today would imho been the last day they could have refuted the application....
SO I SAY WE ARE IN LIKE FLINT

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Tiger Money

Tiger Money 14 hours ago

Thank you! I hope we get the mother of all PRs or Tweets this weekend/monday!

CatfishHunter

CatfishHunter 14 hours ago

Correct. Company just confirmed with me clock started on June 28th and day 30 is tomorrow.

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classics99

classics99 15 hours ago

My over is a full approval announcement

My under is just a monthly update.

I need more shares either way

HoneyBager

HoneyBager 16 hours ago

Go vote then if you feel negative or go vote if you feel positive about the upcoming decision

$RDGL Will @RadioGel @VivosIncUSA Have FDA Approval For Human Testing???— TalkingOTC (@jsanto2387) July 26, 2024

HoneyBager

HoneyBager 16 hours ago

You have been here all of three days or so, thank you for your once again info but I’m rarely on iHub now because it’s a platform of mostly ignorance. Thought today would be different but admit I was 100% wrong on that

chemist72

chemist72 16 hours ago

Not to be "picky" but RDGL close was $0.15095 - LOL.

chemist72

chemist72 16 hours ago

Once again, SEC requires certain material events to be reported within 4 business days with an 8-K filing.

However, a Section 8 event ("other events") has no such deadline.

Here is the pertinent part from an SEC webpage*: Companies have four business days to file a Form 8-K for the events specified in the items in Sections 1-6 and 9 above. * https://www.sec.gov/answers/form8k.htm

Tiger Money

Tiger Money 16 hours ago

Dude….it was a post on this board by someone recapping their calm with IR….. pretty convenient we closed at $.15…..even the mms are telling us it is today….

mikepgator

mikepgator 16 hours ago

I don’t see it on their X feed.

CatfishHunter

CatfishHunter 16 hours ago

Again and for the last time. Submission was on the 28th June. Vivos is in WA. FDA HQ is in Maryland. Unless Vivos submitted after hours ECT, reception by FDA is on the 28th. And that depends on disclaimer by FDA about reception of electronically submitted docs after normal business hours.

HoneyBager

HoneyBager 16 hours ago

Also remember the company may have a 4 day period before they must announce. At least that information is just what I’ve been hearing not exactly sure where that info get validated

Tiger Money

Tiger Money 16 hours ago

mikepgator

mikepgator 16 hours ago

I never saw the Vivos response about looking at the website this weekend, if anybody has a link to that it might clarify things.

Tiger Money

Tiger Money 16 hours ago

Well written, thank you

chemist72

chemist72 16 hours ago

Just nonsensical arguments about knowing the exact date and time approval will be known.

Only 2 entities know exactly. They are the company and the FDA. So who cares? Only those trying to time a trade exactly before approval is announced?

No one will know until the company announces it. End of story.

So good luck everyone and enjoy the weekend. I will, knowing that sooner or later I will know the answer for myself.

SPOILER: My guess is probably before the open on MONDAY.

Sheesh.

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Tiger Money

Tiger Money 16 hours ago

Agreed and I’m not saying you are 100% incorrect. If the poster wasn’t lying, the company wouldn’t have said to check its website this weekend. Who knows 100% sure unless you were told by IR the date received was 6/28. This was not a formality but close to it. The FDA wants the trials to start. I know, shocker, right as the fda has been the biggest blocker to medical innovation the last 40 years….

chereb19

chereb19 16 hours ago

The submission on the 28th was an amendment to an existing submission.

The clock started on the 28th

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mikepgator

mikepgator 16 hours ago

We will find out soon enough if an announcement is made Monday morning.

kayak_wench

kayak_wench 16 hours ago

The slide clearly stated the submitted on Jun 28 and it clearly stated that the FDA has received and accepted the submission. The slide does not clearly tell us the date it ‘received’ it. You can infer a date of Jun 28 but it is not stated as that. It isn’t a big deal if it isn’t that date from the information I found it should be that date or a day or two after.

Tiger Money

Tiger Money 16 hours ago

The below is an “update”. When you read it is says they are currently reviewing. They couldn’t be “currently reviewing “ if submitted on the 9th…..

Also, a poster called and the company said to look to its website for an update this weekend.

Putting all together, the 29th looks to be the day…….

https://radiogel.com/ide-submission

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Tiger Money

Tiger Money 16 hours ago

All of that crap was done on the first submission.

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mikepgator

mikepgator 16 hours ago

You’re saying the 30 day window started on 6/28 but I’m saying it started sometime between 6/28 and 7/9, that is all I’m saying, and I am 100% not wrong. And I’m pretty sure you are not right.

If you look at the FDA website, it looks like there could even be something that needs to be physically mailed. (may or may not apply here, didn’t really look too much into this)

For most devices, you must mail the Company Cover Letter and valid eCopy to CDRH’s or CBER’s Document Control Center (DCC). The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-application#addfor

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wrinklesobw

wrinklesobw 16 hours ago

To many stupid people on this board

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HoneyBager

HoneyBager 16 hours ago

For Being under a BDD, EFS IDE path, and Mayo backing, I seriously doubt it took 7 business days between submitting on June 28 and the July 9 update to get accepted by the FDA. If you’ve done your search on BDD, EFS IDE, etc. you would understand this

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HoneyBager

HoneyBager 16 hours ago

I just posted my proof, however you have yet to post your proof that it wasn’t accepted on the 28th.

Done now with your ignorance as you have not earned anymore comments from me

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HoneyBager

HoneyBager 17 hours ago

Perhaps you thinking on July 9 was when FDA accepted the submission is wrong, perhaps July 9 was when the company told the public to get off its back about it because everyone was asking. The slide clearly states the 30 days started and submission was June 28. Otherwise the slide would be wrong and they should have said ide submitted and once fda accepted the submission then 30 days would start.

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mikepgator

mikepgator 17 hours ago

Just like I thought, you have no proof of when the FDA received the application, you just keep repeating the day the application was submitted.

ElonsMusk

ElonsMusk 17 hours ago

This is actually correct. On July 9th they released this

https://vivosinc.com/ide-submission

HoneyBager

HoneyBager 17 hours ago

https://radiogel.com/ide-submission

HoneyBager

HoneyBager 17 hours ago

Go find the proof yourself it’s out there. I can do the work for you, I’m not ignorant, not wasting time on this anymore. June 28th was the date the clock started per Dr. K

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mikepgator

mikepgator 17 hours ago

Show me proof. Application was submitted 6/28 and on 7/9 the company acknowledge the FDA received it, so the 30 day window started somewhere between those dates but we don’t know exactly. The submit date and receipt date are not the same. There is processing time.

kayak_wench

kayak_wench 17 hours ago

Go back and look. The company said multiple times they submitted the application on the 28th. They never clearly told us that was or wasn’t the FDA accepted the submission.

HoneyBager

HoneyBager 17 hours ago

You are wrong, the company has said it multiple times that the date was June 28th.

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edzett

edzett 17 hours ago

1st week of August is also qtrly earnings report.

mikepgator

mikepgator 17 hours ago

Hundred percent not wrong, the 30 days is somewhere in that timeframe. end of story.

CatfishHunter

CatfishHunter 17 hours ago

What time frame’s you looking for? Other than company already stated they hope to have market approval by this time next year, 12 month or so, there’s no way for them or any company to give exact time lines for clinical trials. They’d be stupid to do so.

HoneyBager

HoneyBager 17 hours ago

Tiger Money

Tiger Money 17 hours ago

Yep, that is why they said to check their website this weekend

mikepgator

mikepgator 17 hours ago

30 days is somewhere between Sunday and August 8, only the company and the FDA know the exact date.

Tiger Money

Tiger Money 17 hours ago

The company knows when the official receipt is. That is why one poster said the company said to check their website this weekend when he talked to them…. Let’s not make this rocket science guys, especially since that is what the company told us to do, check it this weekend. Hhhhmmmm

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