Vivos Inc (QB) (RDGL) News

Awesome to hear - thank you for sharing!

Thanks !

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

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

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

My over is a full approval announcement

My under is just a monthly update.

I need more shares either way

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

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

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

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

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….

I don’t see it on their X feed.

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.

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

It was a post

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

Well written, thank you

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.

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….

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

The clock started on the 28th

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

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.

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

All of that crap was done on the first submission.

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

To many stupid people on this board

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

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

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.

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.

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

https://vivosinc.com/ide-submission

https://radiogel.com/ide-submission

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

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.

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.

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

1st week of August is also qtrly earnings report.

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

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.

Wrong

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

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

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

Why are you so sure? It seems like it's the 9th not the 28th based on this paragraph: Electronic Submissions: For electronic submissions, the receipt date is typically when the FDA's system acknowledges and logs the submission, which can still be different from the exact time the submission was sent.

This article makes it sound like it's all on ad-hoc basis but "faster"(sometimes)

Yeah very close like a few seconds

The receipt date is not necessarily the date received. But it sounds like if it was electronically sent the submission date and received date should be close.

Submission vs. Receipt Dates:
Submission Date: This is the date when the sponsor (usually the device manufacturer or developer) sends the IDE application to the FDA. This can be through various methods like electronic submission or physical mail.

Receipt Date: This is the date when the FDA officially receives and logs the submission into their system.

The date the FDA marks as the receipt date can indeed differ from the submission date. Factors influencing this difference include:

Shipping and Handling: If the submission is sent by mail, the time taken for delivery will affect the receipt date.

Administrative Processing: Once received, there may be a delay in logging and processing the submission within the FDA's systems.

Electronic Submissions: For electronic submissions, the receipt date is typically when the FDA's system acknowledges and logs the submission, which can still be different from the exact time the submission was sent.

Importance of Dates:
The official receipt date is crucial for regulatory timelines. The FDA typically has 30 days from the receipt date to review an IDE submission and respond to the sponsor. Therefore, understanding these dates helps in planning and anticipating the regulatory review process.

You must be done buying if you're done buying.

Now it's "Way to go RDGL!" instead of "This is very bad."

LOL

The article does not have any timeframes and it has no BDD scenario