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The whole CDRH division of the FDA was replaced at the beginning of the year, and since they have been replaced (the last two quarters), decisions have been reached 100% of the time within 150 days.
In the last two quarters, the FDA has reached a decision on 100% of submissions within 150 days... Pretty good stat to go by...
Madtig, I know its early in the trading day, but any analysis from this first hour?
For a buyout, it doesn't matter how many units Imaging3 can produce by itself. Plus, stock price is not only based on what the company can do currently, but also the potential of the company. Hence the current PPS.
Gotta close above .5 ;)
What can we expect after this dip? Another big bounce up at the end of the day like yesterday?
I don't see an article? That looks like it is just a statement of the company profile...
The amazing thing about this run is that Imaging3 has not been reported on by any MAJOR news outlets... If it does appear in a story by a major news outlet, I can see a new stream of investors pouring in.
A pinch is when the range bands converge to "pinch" the price to where a pps move is inevitable in either direction, and it is usually a big move in one direction
i believe Dean said the reviews said the images were of at least equal quality, and possibly better. he did not say the were definitively better, but all the FDA needs to know is that they are of equal quality.
It comes from the FDAs website and guidelines for decisions on devices.
They aim to reach a decision--be it the need for more information, SE, NSE, or any formal request--on all products submitted with 150 days of submission. In the past two quarters, they have reached a decision on 100% of products within 150 days.
Now, the DViS submission will have been in the FDA's hands for 150 days on/around September 8th without any formal requests or decisions.
After e-mailing him again, he responded to my inquiry with reducing A/S with this.
Yes. We are seeking advices from our legal counsel to determine the best way to address this concern.
Thanks
This is the e-mail I just received from them. It does not seem like they have any plans to reduce the stock.
Dear Mr.Thompson,
Thanks for your message.
Due to various corporate action laws of the State of Nevada, we needed to increase our authorized capital to a very large number in order to complete the restructuring we needed for our going public transaction in an efficient manner that cost the company the least amount of money. We have no intention of issuing all 12 Billion shares.
Also at present, we don't have any plan for issurance of the stock in quantity.
Best regards,
Mickey Jiang
Heli Electronics Corp. (OTCBB: HELI)
Office Tel: +86 020 36356928
Email: mickeyjiang@haier-ia.com
Web: www.helielectronics.com
Message It states in your Form 8K that you have 12 billion shares of common stock authorized. What exactly do you plan on doing with this stock? Are there any plans for issuance of this stock in the near future? Thank you.
Im surprised no one else has noticed this, but I looked at their 8K from June and they have 12 billion shares authorized. Anyone's thoughts? I'm considering investing, but to tell you the truth, that scares me a lot.
Any insider sells have to be reported to the SEC. Nothing has been reported.
We held 0.27, what does that mean for the resistance at 0.27?
when you buy a stock regularly, the most you can lose is 100%. when you short, you can lose more than 100%, say 1000%. if you short at .2 and the price goes to 2.00, you would be losing 1000%. If you buy at .2 and it goes to 0, you lose 100%
from pendragons old posts...
This is what Mike replied with to me when I asked him the question.
"What Dean sent the FDA was on his own initiative not at the request of the FDA for a formal resubmission like we had to do for the new review team in April. My understanding – and if my understanding is off-base in any way I’ll let you know – is that Dean annotated the document so that the reviewer could connect the dots faster. The prior review team had asked for some non-standard things (for lack of a better phrase) and these requests from Team #1 complicated things for Team #2. It was just easier for Dean to expand the table of contents with more specific information and then tag those sections in the document. This would be best accomplished by simply giving them another copy of the full document with annotations and other explanatory text to help this reviewer understand the structure of the document which has become very large."
Here is the timeline
April 2, 2008
FDA approval for investigational distribution.
“This approval to distribute the Dominion Vi Scanner is for investigational purposes only allowing the company to glean clinical imagery and functionality during the FDA 510(k) approval process"
Many awards following this announcement.
July 6, 2009
Conference call updating investors on FDA progress.
"Mr. Janes reviewed the Company’s progress to date on a number of substantive initiatives, including; intellectual property, new product developments and the company’s progress with the FDA. Mr. Janes’ presentation was followed by a lengthy question and answer session."
August - December 2009
Many conference calls held as the FDA process took a turn for the worse and started to get tricky.
January 12, 2010
Conference call regarding the FDA asking for new information.
"The purpose of the call is to update Shareholders and other interested parties of the current developments with the company’s 510k FDA submission. Currently the FDA has requested further information and Mr. Janes would like to discuss the company’s plans to address these questions."
During this call, we learned that the FDA people reviewing the DViS 510k were replaced by new people. Hence, a new packet submittal and an obvious reason for a delay.
April 5, 2010
Dean submits new information to the FDA. The FDA clock restarts.
August 12, 2010
Most recent conference call in which Dean stated that the FDA has not formally requested anything new, so the clock has been ticking since April 5. Therefore, 150 days is up around September 8.
First post on the board--I've been following off and on for a while.
The good news that came out of yesterday is that the clock was not reset. While Dean did not specifically say, "the FDA clock was not reset," it was implied throughout the whole conference when Dean was very clear that they did not get any new formal requests from the FDA. Spin it how you want, but in this case, that means since April 5, progress has not been impeded. That is GOOD news. This has not happened since April 2, 2008. After this press release, http://imaging3.com/press_april2_08.html, the DViS has gotten resistance in some form or another from the FDA--until now.