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Hi there Janice... Let me just get this skin out of the way and I will inform you about FDA approval.
Firstly the FDA does not approve any device or drug. The FDA issues a market clearance. That means the FDA, after reviewing application and data, may permit the company to market its product according to a stated "indication for use" and market stipulation.
In Biel's case it was permitted to market (6-7 years ago) it's product under the extremely narrow indication of "reduction of edema following blepharoplasty" and with the stipulation that it only be used on the order of a medical professional.
That means that it is illegal for the company to market the product in the US, to anyone, for anything but that express use. Essentially they can market to healthcare professionals as a reducer of swelling after eyelid surgery ONLY.
Despite the messiah's contention that securing a pain relief indicaion for OTC distribution "is not an issue", it requires legitimate clinical documentation that the product is equivalent to the predicate device cited and poses no risk. It is an issue, and could be a barrier. It will take considerable time, may require specific clinical trials and at the end of the day may be rejected.
No massive dumping yet. Hopefully a good sign.
Uh oh
I missed the day for the PR release prognostication by 24 hours, hopefully the rest of that prediction is also wrong.
"Piramal Healthcare Launches BioElectronics Corporation's ActiPatch(TM) in India FREDERICK, MD, May 14, 2009 (MARKETWIRE via COMTEX).
... and we open with a sell...oh well, maybe its a coincidence.
Should not be any issues?
I guess you're right there should not be an issue with securing FDA OTC market clearance for a class 3 device that currently requires a medical order from a healthcare professional. Even though class 3s have the most stringent oversight, no device of this technology (PEMF) has ever secured it, and the data that they have is inadequate currently.
Yo must be right. I forgot they talked to the FDA.
What a joke.
So far I am totally and completely wrong...and happily incidentally.
Let's see how this plays out.
Uhm... let's see
"If you are so confident of your historical analysis" vs. "I may be wrong"?
Reading comprehension?
... and that will be the last we hear from Bella.
If historical patterns continue we should see a build continuation tomorrow, an announcement on Wednesday and a massive dump the rest of the week. PPS back to 1 tenth of a penny.
I may be wrong but I doubt it.
.01 by the end of the day?
Bella I thought you said you had stopped drinking during the afternoon.
Apparently I am able to pound the table with nothing but my my hanging chin skin.
It is up to you to keep pumping... er... I mean... pounding the table.
Hah! Well done.
I will be careful of the hanging chin skin.
Amazing. You bought shares based on the company's pumping no with no other due diligence, such as; financials, ratios, charts, product analysis etc(as he shakes his head in bewilderment).
You bought shares in a company based on reports that the company paid to have written (in tradeable shares) and an interview with their IR guy?
Fair enough.
If you read my posts, they heartily endorse and praise the product. My criticism has been of the buffoons and crooks that have relegated that product to a company whose PPS is a fraction of a penny.
Again maybe everyone should be asking themselves how such a highly effective product that has multiple applications across the entire medical arena has never achieved a million dollars in revenue in a single year, how the company that owns this product has lost millions of dollars every year, how the OS share has leaped exponentially over the last two years, and yet with those hundreds of millions of shares being dropped into the float, this company never seems to raise funds in a legitimate fashion.
These and many other questions should be contemplated by every investor in this sham.
Uh huh...sure.
So how are those financials coming?
Everyone here is free to determine the validity of what I have posted.
I would suspect that most, if not all, lend more credence to my posts than yours.
I sure would.
As i have repeatedly stated on this board, do a little research. Review the charts (peak volume periods) vs. the PR release dates and the OS share increase dates.
Al the information is readily available.
That seller is the group that was sold tens of millions of tradeable shares under market (and illegally). Now that most are sold the company will get its check.
36 mill and counting. Wow they must have taken in $50,000 from this dump. I wonder if the OS has passed 400 ml yet?
Whole lotta dumpin goin on!
Nearly 15 million in the first hour.
What a complete and utter joke.
I love how thelimeyone posted earlier in the week that there was no dilution and no toxic funding. That is all that there is here.
Nice?
This promise from the same folks who promised you the financials would be released LAST week.
...and the PPS drops on an announcement once again. I guess there is a finite number of times you can go to the well with a pump and dump.
They were not even able to get their typical small bump in advance of the PR.
... however they would still need to furnish new clinical data. The data they have currently would not qualify.
I guess I don't understand what you are trying to say.
They originally filed their 510k to secure their current indication. That clearance and indication came with the "medical order' stipulation. They could file a new 510k using either the old predicate device or possibly the newer disposable device which was awarded a general pain and edema indication but not OTC.
Regardless, any new filing would be to secure and expanded indication or a broadened stipulation.
I see. You are looking for OTC stipulation and an expanded indication for use.
Not going to happen with their data and with the chief investigator hawking the product off label over the net.
...and failed to even marginally impact the PPS.
I guess everyone has figured out their scam.
Buys today (even though there is no advancement in PPS) no doubt means that there is a pending PR about to released.
Curious how the buyers know in advance of an announcement.
This game has become so pathetic and abused that they can't even realize a fraction of a cent gain with the pump. Clearly too stupid to even conduct an effective pump & dump.
They do sell in the US and have been for doing so for 6 years.
That post reads, " Actually now that I think about it, maybe I should revise that to read; they have never NOT lied to us before."
The post wasn't clear but my intent was to express the thought that this management are liars and crooks.
I need a translation of that post?
Wish I could say the same, of course, maybe we will all be able to say the same soon.
Whole lot of dumpin goin on.
Management is either packing the boxes and pillaging the last dime or they needed to buy a new role of copy paper. 12ml shares.
If this is the prelude to the big announcements referenced the other day on this board, then their is not a lot of buying in advance of these PRs (standard procedure for this bunch). They may have drained the last drop of blood from the dead and decaying carcass.
I for one would not doubt, even for a second, anything communicated by this management team.
They have NEVER lied before... at least in the last 15 minutes.
Actually now that I think about it, maybe I should revise that to read; they have never NOT lied to us before.
There now I feel better.
Great. I can't wait.
So what do you think? After the close?
Because you were the one who posted that the financials would be filed this week. Clearly you have a direct link to management.
Soooo what do you think... after the close?
Messiah- what time will the financials be out tomorrow?
You guys are right to be excited about the product. It works and has wonderful potential.
Unfortunately the company is being run into the ground by its management. Incompetence and dishonesty is rampant and ingrained.
Revenues and earnings should be spiraling. PPS should easily be over a buck.
Anyone wonder why a product that works as well as it does and satisfies multiple needs within the medical arena is trading at less than a penny. How could that be? Did anyone ever wonder how the number of shares has grown exponentially in such a short period of time? Has anyone ever wondered why every PR results in a flood of sellers and a drop in PPS?
The product attributes that are glaring to everyone who has used it, are being eviscerated by those running this company. We as investors have been duped and exploited.
How does it feel to have your pocket picked?
John- is that in addition to the financials that he promised would be released this week?
Great stuff.
Maybe you should start reposting the old PRs as well.
Do you really believe that anyone reading this board even remotely believes, as per your accusation, "You obviously have no idea what you are talking about"?
I think every one here probably believes that I know exactly what I am talking about.
I plan to continue to share with everyone the full breath and depth of that knowledge.
Soooooo buckle up and get ready for the ride.