I read more about sprint meetings with the FDA ….

The goal in sprint meetings internally from an FDA perspective is to ultimately reach an “agreement” with a positive outcome with the company (i.e. Vivos).

What it sounds like, is if (hypothetically) the FDA knew they were stringing them along and were ultimately going to deny this submission, then they wouldn’t be scheduling “five” different sprint meetings.

So that at least is a positive sign (in the long-term here).

Just gotta wait an additional 6 weeks now, if not longer.

6+ weeks from now is close to late October …

So we’re looking at late October now for submission.
And late November for possible approval.

Yep, it means the FDA is taking this seriously.

In the long run that’s good.
In the short term, it causes panic among several OTC shareholders.

WTF ….

This is so annoying.

And people who are selling are morons.
This isn’t even that long of a delay.

$5.00 in less than a year

$0.05 by end of week ….

LOL

(sarcasm)

Looks like I’m a fortune teller

The PPS dropped from $0.15 to $0.08 on July 29 ….

And now it’s back up to near $0.14

I think we could see $0.15+ this week, and/or before the 45 days are up.

MM’s are holding it down.

Shidt, the share price went down after hours.

And soon it will become the 2nd most important device in the world right behind the iPhone.

Imagine how much the stock price will be worth at that point.

No CEO stock purchase yet this week?

We’re used to it at least once every week now, lol.

No CEO stock purchase yet this week?

We’re used to it at least once every week now, lol.

Amen ….

It’s a great thing they have 1/3 of the total O/S.

115 million total shares for Matt and Brian.

This is BY FAR the best quarter they’ve ever had.

Looks like Industries will be rolled in to Brands.

Yeah, they have plenty of cash for now

Probably middle of October ….

Which is 75 days after the announcement we got on July 29 about having to re-submit the IDE.

Yep, you can’t put a price tag on extending someone’s life.

Awesome ….

This is the most buying transactions he’s ever done in a short time span.

Yep, but add 30 days to that ….

For the FDA to review and approve IDE.
So we’re still looking at sometime in October.

It says this case is expired or invalid ….

Link doesn’t work.

so you never worked for Vivos?

in any way?

So are we looking at 45 days or 90 days now?

Someone on the other board said something about 90 days. Hopefully it’s still just the 45 days + 30 days to approve.

It’s already been 14 days since we got the news about 45 days.

He got fired by Dr. Korenko ….

It is blatantly obvious that his agenda is to slander his name in to the mud.

Yep

MM’s are walking it down at end of day ….

Just like they did yesterday.

Yep, that is now 150,000 shares Korenko has bought ….

in just the past 9 days, in now 3 separate stock purchases.

I’d say he’s confident.

Yep, Dr. Korenko has now bought 100,000 shares this week.

50,000 shares he purchased yesterday, plus the 50,000 shares he bought earlier in the week. Total of 100,000 shares for him just this week alone.

The fact he has bought shares this week in two separate installments shows that he has “double-downed” on his confidence that IDE approval will happen.

IDE approval can still happen in 75 days ….

Or technically 72 days, since it’s already been 3 days since the news of needing to re-do the submission in terms of going in a different route.

45 days to re-submit.
30 days afterwards for IDE to be approved.

But seriously ….

I think we will still see IDE approval before the end of 2024.

We’ll probably be on our 2nd consecutive 180 day delay for extended risk assessment from the FDA at that point

How do you know it’s insiders buying ….

Could also just be shareholders averaging down.

Vivos always uses up the whole timeline.

Always have in the past.

Currently at a $38 million market cap ….

Can still hit $380+ million in 75-90 days from now, if IDE is approved then.

10x return in the autumn season is very real here. On the bright side of things, this is a delay, not a denial.

Minimum of 75 days now until IDE approval ….

45 days to resubmit
Plus 30 days after that to be approved

= 75 days.

We’re looking at mid-October now (realistically at the earliest) before approval.

LOL ….

I mean, you can’t write this stuff ….

Oh ok. I thought it happened a few days before the deadline.

And I was thinking it was 30 days instead of 60 days, as that’s what this one is.

Thanks.

When the BDD was not accepted by the FDA in early 2021 ….

That was done before day #28.

We’re on day #28 now.

Yep, I see it now.

I’m thinking at least $10.00+ after full market approval (after human trials are complete).