sorry, didn't mean a 500k block, just that 500k had traded. I thought it was a flash crash, so they really drug it out then, ouch!
so many prob had stop losses in that .30 range
Since we haven't heard from them yet, It was my thought that they are getting their ducks in a row before they make the announcement, possibly even getting their filings / reporting up to date.
Just want to confirm, we're talking about 50m shares on the float? 83m less katie & Claude appx combined 30m shares. I don't think it's small but not huge either.
Where is feoli? We didn't get the daily share price coverage. I almost lost it when it jumped .10 yesterday morning and hit .69, but it was small volume, roughly 10k shares or so but we still closed up another .01
I'll have no problem with these daily increases up until clearance, lead the way...lol
That's not what the FDA rep that I spoke to yesterday told me. Also based on the "fda is busy topic..." you will see the company issued a press release before the FDA officially announced the approval/clearance.
You won't find anything until the FDA actually provides clearance. That hasn't happened yet. Based on the change from 510K to De Novo review, the announcement should be appear under the De Novo approvals if and when it happens.
Again, you won't find anything until the clearance is issued and has been announced to the public by the FDA. The only thing you'll find right now will be an entry for the company/device registration.
No prob Feoli, one other thing re: the news itself...
Everyone thinks we are waiting to hear from the FDA. In my opinion this is incorrect. We are waiting to hear from the company.
The FDA will privately notify the company, the company will then report to the public. This is where a halt may be issued as the company will notify the market there is a news pending event.
From there, everyone will be biting their nails as the coin flip occurs, clearance or no clearance or I suppose there could be a third possibility, another delay. Anyway,
PR gets released, stock resumes trading
If clearance is given, then the FDA publishes within 30 days or so.
Head of FDA's device arm says agency aims to be first in the world to improve devices
May 1, 2015
The head of the FDA's device arm (CDRH) acknowledged that the division is failing to live up to its vision that "patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world" because advanced devices like transaortic valve replacements are regularly approved in Europe 5 years earlier than the U.S, but cited statistics showing that CRDH has been getting devices to market faster in an April 30 address.
If the same 5 year mark applies to Invo then we are right on schedule. Initially Invo thought they would be cleared in 2010, it's now 2015.
Let's go FDA, time to right this wrong....
This is true, that's why I was asking about the market numbers source to see what they base it on. The current IVF market is one thing, the market that will be avail when Invocell receives clearance will grow as more couples are able to afford the procedure.
It's in the November update.....
As many of you know, we filed a 510(k) Premarket Evaluation with FDA, this filing method is used for products that have a “like product” or predicate device already in the market. Our “like product” was the Petrie dish, currently used in IVF procedures. After several rounds of questions, the FDA changed their decision to allow us to file a 510(k) and disregarded our predicate device.
This resulted in INVO Bioscience submitting a DeNovo Petition to maintain its status as a class II device. Since that time we have continued to have several rounds of questions from the FDA and we have answered each set of questions as they have been received.
If this were trading on the Nasdaq I'd agree with you but since it is an OTC penny stock and Non Reporting there is alot of overhang based on that alone.
Also, it's a medical device, not a new pharma-drug with a billion dollar pipeline waiting in the wings..
I also base it on most issues I've seen upon approval go up from 20-40 percent
that's my two cents, take it for what it's worth
max my thought was $1-2 post FDA clearance...but I am much more conservative than many of the folks on here. Maybe they have insights that I don't have...
From there it really depends on how the company is performing, we need sales figures, the company has to get caught up on their reporting/filings, etc.
They could stand to hire a few employees once US sales begin to ramp up I would think.
Hell, I say go on Shark Tank and get the story out there :-)