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IH Admin [Dan] Share Thursday, August 19, 2010 12:35:09 PM
Re: None Post # of 37292
Folks this board is to talk about IMGG.
Post about the moderator are off topic and will be deleted.
Posts that talk about other members will be deleted.
Comments about bashers or pumpers are about other members and those posts will be deleted.
Posts that talk about deletions are of topic and will be deleted.
Post about IMGG or don't post.
If you feel that you have had a message removed in error, please go to Settings/My Removed Posts to request a review.
However; please ensure that you have read when/why messages are removed on this site prior to requesting a review. Do not request a review if your post contained any content that justified its removal.
If you have any questions send me a PM.
NO public replies please.
This was a post by Investor 100 at another board.
ARIA:ARIAD to Present at the 13th Annual BIO CEO & Investor Conference
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA - News) today announced that it will present at the 13th Annual BIO CEO & Investor Conference being held at the Waldorf=Astoria Hotel in New York City, New York. Harvey J. Berger, M.D., chairman and chief executive officer at ARIAD, will provide an overview of the Company’s robust oncology pipeline and progress on its three lead compounds on Monday, February 14, 2011 at 11:00 a.m. (ET).
The ARIAD presentation will be webcast live and can be accessed by visiting the investor relations section of the Company's website at http://www.ariad.com/investor. A replay of the presentation will be available on the ARIAD website approximately twenty-four hours after the presentation and will be archived for three weeks.
About the BIO CEO & Investor Conference
The BIO CEO & Investor Conference is a must-attend event for institutional investors, industry analysts, and senior biotechnology executives focused on shaping the future investment landscape of the biotechnology industry. For more information on the conference, visit http://www.bio.org/bioceo.
About ARIAD
ARIAD's vision is to transform the lives of cancer patients with breakthrough medicines. The Company's mission is to discover, develop and commercialize small-molecule drugs to treat cancer in patients with the greatest and most urgent unmet medical need - aggressive cancers where current therapies are inadequate. ARIAD's lead product candidate, ridaforolimus, is an investigational mTOR inhibitor being developed by Merck that has successfully completed a Phase 3 clinical trial in patients with soft-tissue and bone sarcomas and is being studied in multiple cancer indications. ARIAD's second internally discovered product candidate, ponatinib, is an investigational pan-BCR-ABL inhibitor in a pivotal Phase 2 clinical trial in patients with chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia. For additional information, please visit www.ariad.com.
http://finance.yahoo.com/news/ARIAD-to-Present-at-the-13th-bw-4077571206.html?x=0&.v=1
Investor 100
I'll take Green Bay by 3 on Sunday.
Linda and Shelly what do you think?
IH Admin [Dan] Share Thursday, August 19, 2010 12:35:09 PM
Re: None Post # of 36798
Folks this board is to talk about IMGG.
Post about the moderator are off topic and will be deleted.
Posts that talk about other members will be deleted.
Comments about bashers or pumpers are about other members and those posts will be deleted.
Posts that talk about deletions are of topic and will be deleted.
Post about IMGG or don't post.
If you feel that you have had a message removed in error, please go to Settings/My Removed Posts to request a review.
However; please ensure that you have read when/why messages are removed on this site prior to requesting a review. Do not request a review if your post contained any content that justified its removal.
If you have any questions send me a PM.
NO public replies please.
Thank you BigOwl47 for your excellent DD on this.
Thank you Frank39
Your an asset to all at the board.
To start with the document you present has information almost a year old. The outstanding shares are incorrect also? Honestly, I see many inaccuracies because the document is so out of date. Can you provide something more recent?
Share Structure
Market Value1 $59,361,233 a/o Jan 27, 2011
Shares Outstanding 380,520,723 a/o Oct 25, 2010
Float N/A
Authorized Shares N/A
Par Value N/A
Shareholders
Shareholders of Record 790 a/o Apr 06, 2010 Beneficial Shareholders N/A
Corporate Actions
Ex. Date Record Date Pay Date
Thanks for the Money TV Interview post ND. I was amazed Imaging 3 has over 14,000 shareholders! The shareholders that post here are a very small portion of what’s really out there.
Discussion of the funding company is fine. When we veer off topic and begin to discuss company’s other than the funding itself is where it is off topic.
We are getting off topic here. Please keep post about Imaging 3.
The information is in the filings if you want to look up the name of the companys.
Institutional investors don't put that amount of funds in a company that does not have a working device, or one they feel won’t reach the SE mark with the FDA. Personally I think someone representing the intuitional investor has seen the Dominion in action prior to the check being signed. I guess I will never know for sure. I do know they did not just hand over a million dollars cash on a whim.
I don’t disagree with those numbers. The institutional investors have also stated there is an additional 3 mil in financial backing available if needed. With the institutional investors willing to place this amount of funds into Imaging 3 speaks volumes.
Below is the agreement from October 4, 2010 with the institutional investors. The AS shares held in reserve must total the amount of warrents in the agreement. This does not effect the other shares.
SECTION 1. REGISTRANT'S BUSINESS AND OPERATIONS
Item 1.01 Entry into a Material Definitive Agreement
Imaging3, Inc., a California corporation (the "Company"), entered into a Securities Purchase Agreement (the "Purchase Agreement") on
October 4, 2010, with two institutional investors for the sale of common stock and warrants for $1,000,000.22
The terms of the Purchase Agreement include the sale of 4,587,157 shares of common stock at $0.218 per share. The warrants include: (i)
Series A Warrants, which are immediately exercisable for a period of 5 years into 4,587,157 shares at $0.2725 per share; (ii) Series B Warrants,
which are immediately exercisable for a period of up to 18 months into 4,587,157 shares at $0.218 per share; and (iii) Series C Warrants, which
are immediately exercisable for a period of 5 years into 4,587,157 shares at $0.2725 per share but only to the extent that the Series B Warrants
are exercised and only in the same percentage that the Series B Warrants are exercised. All of such warrants contain customary adjustments for
corporate events such as reorganizations, splits, dividends, and the exercise prices of all such warrants are subject to full-ratchet anti-dilution
adjustments in the event of additional issuances of common stock below the exercise price then in effect.
The closing of the transaction is subject to the satisfaction of customary closing conditions and is expected to occur on or before October 14,
2010. The net proceeds from the transaction will be used solely for working capital purposes. In the Purchase Agreement, the Company agreed
not to use the proceeds to satisfy any debt, to redeem any of the Company's outstanding securities or with respect to any litigation involving the
Company.
At the closing of the transaction, the Company will enter into a registration rights agreement (the "Registration Rights Agreement") with the
institutional investors. Pursuant to the Registration Rights Agreement, the Company will be required to file a registration statement under the
Securities Act of 1933, as amended (the "Securities Act"), with the Securities and Exchange Commission (the "SEC") covering the resale of the
common stock to be sold and the common stock underlying the warrants to be sold (the "Registration Statement"). The Company will be
required to pay all expenses incurred in connection with the filing of the Registration Statement. The Company will also be obligated to use its
best efforts to file the Registration Statement within 30 days of the closing date of the transaction. In addition, the Company will be obligated
to use its best efforts to cause the SEC to declare the Registration Statement effective within 90 days of the closing date of the transaction (or
120 days in the event that the Registration Statement is subject to review by the SEC), and the Company will be required to pay certain
negotiated cash payments to the institutional investors in the event that the Registration Statement is not filed within 30 days of such closing
date or is not declared effective within 90 days of such closing date (or 120 days in the event that the Registration Statement is subject to
review by the SEC).
Thank you Mugs
On your question, I guess I will cross that bridge at that time.
Hello Mugs
"He told the SEC that he can resubmitt as many times as he wants to and I beleive that is his plan."
Can you explain this statement in more detail, in particular the part that he told the SEC?
Boxterfan
Your statement is incorrect. They did not say they would write the DIACOM. They intent was for both parties to use the exact same DIACOM. Here is what was stated in the last 8K report.
(ii) we did not provide our own Dicom image viewer that the FDA could use to better view our submitted images (we will supply our own Dicom image viewer),
IH Admin [Dan] Share Thursday, August 19, 2010 12:35:09 PM
Re: None Post # of 36245
Folks this board is to talk about IMGG.
Post about the moderator are off topic and will be deleted.
Posts that talk about other members will be deleted.
Comments about bashers or pumpers are about other members and those posts will be deleted.
Posts that talk about deletions are of topic and will be deleted.
Post about IMGG or don't post.
If you feel that you have had a message removed in error, please go to Settings/My Removed Posts to request a review.
However; please ensure that you have read when/why messages are removed on this site prior to requesting a review. Do not request a review if your post contained any content that justified its removal.
If you have any questions send me a PM.
NO public replies please.
IMGG News
BURBANK, CA, Jan 25, 2011 (MARKETWIRE via COMTEX) -- Imaging3(TM), Inc. (OTCBB:
IMGG), developer of a breakthrough medical imaging device that produces 3D
medical diagnostic images of virtually any part of the human body in real-time,
hosted their annual shareholder meeting on January 20, 2011 at its corporate
offices located at 3200 West Valhalla Drive, Burbank, California 91505.
A quorum of outstanding voting shares of the Company was present at the meeting
in person or by proxy. Shareholders were asked to consider and vote on five
proposals which amended the Company's Articles of Incorporation.
Proposal One increased the number of Authorized common stock to 750,000,000
shares and was approved by 86% of the voting shares.
Proposal Two voted to Authorize 1,000,000 shares of preferred stock and was
approved by 79% of the votes cast.
Proposal Three increased the size of the Company's Board of Directors from two
(2) to a range of five (5) to nine (9) with an exact number of directors to be
seven (7). The measure was approved by 96% of the voting shares.
Proposal Four provided for the election of three members of the Board of
Directors to hold office until the next annual meeting of Shareholders or until
their respective successors have been elected and qualified. The proposal was
approved by 93% of the votes cast.
Proposal Five ratified the appointment of the Company's independent registered
public accounting firm, M&K CPAS, PLLC, until the end of the fiscal year ending
December 31, 2010 and was approved by 85% of the voting shares.
Mr. Dean Janes, Chairman and CEO, presented a general overview of the Company's
business and after votes were cast and tabulated, answered Shareholder questions
until the meeting was adjourned.
About Imaging3 Imaging3, Inc., founded in 1993, is a leading provider of
advanced technology medical imaging devices. The Company has developed a
breakthrough medical imaging device that produces 3D medical diagnostic images
of virtually any part of the human body in real-time. Because these 3D images
are instantly constructed in real-time, they can be used for any current or new
medical procedures in which multiple frames of reference are required to perform
medical procedures on or in the human body. Visit the company's website at
http://www.imaging3.com for more information
Safe Harbor Statement Matters discussed in this press release contain
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. When used in this press release, the words
"anticipate," "believe," "estimate," "may," "intend," "expect" and similar
expressions identify such forward-looking statements. Actual results,
performance or achievements could differ materially from those contemplated,
expressed or implied by the forward-looking statements contained herein. These
forward-looking statements are based largely on the expectations of the Company
and are subject to a number of risks and uncertainties. These include, but are
not limited to, risks and uncertainties associated with: the impact of economic,
competitive and other factors affecting the Company and its operations, markets,
product, and distributor performance, technological obsolescence, competition
from other medical instrument(s) and imaging companies, lack of capital,
unexpected costs, failure or delay of FDA approval, absence of revenue, the
impact on the national and local economies resulting from an economic recession
or terrorist actions, and U.S. actions subsequently; unavailability of financing
for the Company or its customers, product malfunction and potential product
liability claims, and other factors detailed in reports filed by the Company.
Contact:
Imaging3, Inc.
Investor Relations
800-900-9729
SOURCE: Imaging3, Inc.
Copyright 2011 Marketwire, Inc., All rights reserved.
-0-
SUBJECT CODE: Medical and Healthcare:Facilities and Providers
Pharmaceuticals and Biotech:Equipment and Supplies
Medical and Healthcare:Medical Devices
Uh, Mug
I think you missed the entire point of my post? I was speaking on the topic of the FDA predicate date of 1976, not any company in particular?
My question to the FDA is: When are they coming out of the Stone Age, The 1976 date grandfather clause for predicate devices are over 3 decades old! I feel it’s time for the FDA to come to terms with modern technology. If I’m not mistaken in 1976 Bill Gates was developing the first personal PC in a Garage? Here is an excerpt from a very short search:
Apple Computer is formed with the introduction of the Apple I on April Fool's day 1976. Out of the garage and into the history books, Steve Jobs and Stephen Wozniak build the first single circuit board PC complete with video interface and 8K of RAM and a keyboard. The system incorporated some cost saving components including the MOS Technologies 6502 processor and dynamic RAM. Various potential investors were shown the prototype Apple I which was mounted on a piece of plywood with all components visible. A computer hobbyist group; the Homebrew Computer Club based in Palo Alto, California previewed one of the prototypes and its innovative features. A local computer dealer owner who agreed to sell the units required that they were assembled which was not the norm for customers buying computers at the time. Once displayed in his store, almost all the Apple I systems sold in the next ten months. 200 Apple I systems were built before the introduction of the Apple II. Jobs and Wozniak continued building systems out of their garage for two years before the move to the current Apple headquarters in Cupertino, California.
I’m sure our FDA is well behind the time line. This is why companies are moving to Europe and around the world seeking SE or similar approvals or countries that require no government approval.. Our FDA system is broken! It is not cost effective to go through the USA FDA approval. Just take a look at the path IMDS has taken.
ARIA beginning to fill the gap, up 4.4% /+ .28 @ 6.68 close today.
Imaging 3 8K on NSE letter
http://www.sec.gov/Archives/edgar/data/1205181/000106594911000007/i38kjan182011.txt
tree man
Here is a post from DonKeyhoti he actually attended the Share Holder Meeting.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=59014444
Obviously you must have attended to have such an opinionated statement: Can you elate what was said at the meeting to incite your statements?
Anyone choosing to believe the word of some penny stock CEO deserves what they get. I find a penny stock shareholder meeting laughable. Yes, he can refile over and over again and the FDA can reject over and over again!
Your statement gives the impression you attended? If not well ...................... I think most can come to there own conclusion of your post.
BT
That’s a great question Borntwice. Neither I nor any here can answer your question. I advised all that had questions where the Share Holder meeting was to be held and when? Did you miss my post to ALL MEMBERS?
Ok.. But what about images or a working demonstration of the device?
I suggest you search for the date of the next Share Holders meeting and ask your questions to the one person that can answer them; otherwise you will get twisted opinions from many at this board with less than 1 oz of truth.
Thats a great question Borntwice. I nor any here can answer your question. I advised all that had questions where the Share Holder meeting was to be held and when? Did you miss my post to ALL MEMBERS?
Ok.. but what about images or a working demonstration of the device?
Here is a second person that actually attended the Sh meetings opinion:
DonKeyhoti
The meeting lasted about an hour and a half. Dean's general comments were direct and he didn't duck any questions. He believes the company has adequate funding for the foreseeable future. He said there are funds available from a venture capitalist. He told us how much, however I think it's best to let the company tell you.
I was comfortable with the answer. Again the device was not operating as it's not practical to do it on the shop floor as it is a radiation emitting device and unknown civilians were present if you get my drift. He said there are 3 machines operating; one there and 2 off site. Someone said "In your garage?" and he laughed.
I could see he's clearly frustrated with the whole process. He said that he is confident that using MWE is the correct strategy and regrets the length of time it's taken in the past. He didn't make a bunch of excuses. He took responsibility period.
He was more guarded about making prognostications as to submital dates, approval or the like.
He was asked if the Dominion produces real time images in 3D. His answer was a firm one word answer: "Yes." (I know the firestorm this will create on this board so let er rip).
He was asked the usual questions of, will he manufacture it or sell the rights, how about the airport screening market, how about veterinarians and the like, etc. His answers were consistent with what he's said on the same subject ad nauseum in prior calls or on TV. He's focused upon the medical imaging market as it's the biggest. Possibly he might sell the rights or not. Or he will see what the situation is at the time of expected approval.
I've held this stock for about 3 years. In that time, I can see how he has evolved as a CEO. He's made mistakes and possibly cost his company and some shareholders money. Easy for me to say. Buy the way, I was a CEO and I've been there. Fortunately, unlike Dean, every decision I made was correct and I only made money for my investors and we all lived happily ever after. And all my shareholders loved me.
That said, I still believe he is worthy of my investment. He's learning in some respects the hard way which is not untypical of an inventor who must wear the hat of a CEO of a publicly traded company.
The technology is there in my mind. He says the patents are strong and have 25 years to run so it will be difficult for competition to replicate.
Can he get this thing over the line? That's a tricky question. He's doing the right things after foolishly thinking he could do it all on his own. Good CEO's take corrective action, they don't dwell upon the past and to use the Midwestern term; get er done. Let's just say the boy has potential...as does the stock.
Woodberry578
I just got home from the Imaging3 shareholders meeting. As promised, I wanted to let you all know my take on the meeting.
First off, I would agree there were closer to 100 people at the meeting vs. 50. As we all expected, all propositions easily passed. While Imaging3's CFO and an independent accounting firm tallied the votes, Dean gave all attendees a recap of where the company is at regarding the new FDA 510K resubmission process and opened up the floor for questions relating to anything Imaging3.
Here are some of the key points for me:
Dean is optimistic the new resubmittal will happen by either the end of February or March (I would not hold Dean to these specific dates. Remember: it is his best "guess-ta-mit"). The resubmission will be proceeded by a face-to-face meeting with the head of the FDA's Medical Devices unit and our FDA reviewer. On the Imaging3 side of the meeting, Dean will be there, Jim Cohen (lead attorney at MWE), and our Consulting Firm's Technical writer. The goal is to iron out key points needed to gain FDA approval once the new 510K is submitted. Again, the impression I got is: Dean is hopeful of a June answer from the FDA (again, an estimate on the timeline).
During the question and answer period, several other key questions and answers occured that I know the I-Hub Board members are interested in:
Is there enough cash to keep the company going through the new resubmittal process? Answer: several million dollars more are available (if needed) from the Investment firm who gave Imaging3 the recent million dollars. Money will not be a problem!
Will there be any new PPM's or dilution with the new approved shares in the mix? No new PPM's on the horizon. I'm assuming there would have to be some dilution should the Investment firm provide more cash! Also, the majority of the new approved shares will only be used in case of a potential "hostile takeover" occuring.
Are any OEM's still interested in the Dominion? ALL OEM'S are STILL interested in the Dominion and Imaging3! Also, Dean is prepared to manufacture (conservatively) 36 machines first year in Burbank. Cost to make each machine: $250,000. Sale price: $500,000 ($250,000 deposit to start each order). Possible 100 machines per year after that. Dean pointed out that the Burbank office / warehouse will be used for assembly only as all parts for the machine are subcontracted to outside vendors.
Are there any WORKING MACHINES in existence? Dean says there are TWO COMPLETE FULL WORKING MACHINES in existence! One was in the warehouse, and one is offsite (sounded like he has the other at his home so he can work on it after hours).
Anyway, those are the key points I can think of recapping at the moment. If anything else comes to me, I will post another message on the Board.
If anyone else who was at the meeting would confirm my recollection of events, please post so others will know I'm not "exaggerating! :)" Also, feel free to add to this. I think the more the shareholders know, the better for all of us!
Good luck to all!!!
Here is an update for those that could/or choose not to attend the Share Holder meeting from someone that actually attended and asked questions. Those that continue to post questions to Dean had their opportunity to ask Dean Janes questions in person and in public. They have opted to make their statements here, behind a keyboard, and not in person. Those post speak for them self, all were aware of the opportunity to confront the CEO of Imaging 3 with any question on their mind from what I have read he answered every question asked from anyone there.
Those that attended got answers. Those that did not attend, continue to post inaccurately here for their own reasons? I will let each reader figure this out on this own. I think its obvious who has questions and who attended from the post?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=59013767
Here is a second persons statements from the Share Holder meeting:
Woodberry578 Share3 Thursday, January 20, 2011 6:57:09 PM
Re: None Post # of 36004
I just got home from the Imaging3 shareholders meeting. As promised, I wanted to let you all know my take on the meeting.
First off, I would agree there were closer to 100 people at the meeting vs. 50. As we all expected, all propositions easily passed. While Imaging3's CFO and an independent accounting firm tallied the votes, Dean gave all attendees a recap of where the company is at regarding the new FDA 510K resubmission process and opened up the floor for questions relating to anything Imaging3.
Here are some of the key points for me:
Dean is optimistic the new resubmittal will happen by either the end of February or March (I would not hold Dean to these specific dates. Remember: it is his best "guess-ta-mit"). The resubmission will be proceeded by a face-to-face meeting with the head of the FDA's Medical Devices unit and our FDA reviewer. On the Imaging3 side of the meeting, Dean will be there, Jim Cohen (lead attorney at MWE), and our Consulting Firm's Technical writer. The goal is to iron out key points needed to gain FDA approval once the new 510K is submitted. Again, the impression I got is: Dean is hopeful of a June answer from the FDA (again, an estimate on the timeline).
During the question and answer period, several other key questions and answers occured that I know the I-Hub Board members are interested in:
Is there enough cash to keep the company going through the new resubmittal process? Answer: several million dollars more are available (if needed) from the Investment firm who gave Imaging3 the recent million dollars. Money will not be a problem!
Will there be any new PPM's or dilution with the new approved shares in the mix? No new PPM's on the horizon. I'm assuming there would have to be some dilution should the Investment firm provide more cash! Also, the majority of the new approved shares will only be used in case of a potential "hostile takeover" occuring.
Are any OEM's still interested in the Dominion? ALL OEM'S are STILL interested in the Dominion and Imaging3! Also, Dean is prepared to manufacture (conservatively) 36 machines first year in Burbank. Cost to make each machine: $250,000. Sale price: $500,000 ($250,000 deposit to start each order). Possible 100 machines per year after that. Dean pointed out that the Burbank office / warehouse will be used for assembly only as all parts for the machine are subcontracted to outside vendors.
Are there any WORKING MACHINES in existence? Dean says there are TWO COMPLETE FULL WORKING MACHINES in existence! One was in the warehouse, and one is offsite (sounded like he has the other at his home so he can work on it after hours).
Anyway, those are the key points I can think of recapping at the moment. If anything else comes to me, I will post another message on the Board.
If anyone else who was at the meeting would confirm my recollection of events, please post so others will know I'm not "exaggerating! :)" Also, feel free to add to this. I think the more the shareholders know, the better for all of us!
Good luck to all!!!
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=59068245
What poster are you referring to? Or is this a generalization post to the entire board?
At the beginning of this journey you were the Leader of this board. You Led all members to this point in time.
Shaka
Any investor should be aware of any company they invest in. If you read the unofficial NSE it does not state " it does not work" Is your post fact or opinion? I think the latter. Yes the FDA has questions,but I did not read anywhere in the unoficial NSE whare it stated it did not work?
Must have been an oversight on your part:
(c) Financial Disclosure: Finally, no financial disclosure information was provided for
the investigators, as requested in "Guidance for Industry: Financial Disclosure by
Clinical Investigators"
(http://www.fda.gov/Regulatorvlnfornation/Guidances/ucm 26832.htm). Please
provide this.
That was a fairly quick edit.
I’m in the same crowd. I held every single share. I know good things are on the way for ARIA. I look forward to see where we stand in a year. I think 7.32 will be a long was back in the rearview mirror.
ARIA moving higher:
Barclays increases target to 9
We are reiterating our 1-Overweight rating on shares of ARIA and increasing our price target to $9 following positive top-line data from the phase 3 SUCCEED study of ridaforolimus in advanced sarcoma. While the improvement in median PFS may appear modest at three weeks, overall risk reduction is significant at 28% and should be considered in the context of substantial unmet need. SUCCEED results should support broadening development by partner Merck and increase the likelihood of commercial success, in our view.
ARIA and partner Merck announced this morning positive phase 3 SUCCEED data for mTOR inhibitor ridaforolimus as maintenance therapy in patients with advanced sarcoma. Results of the 552-patient study suggested a 28% reduction in risk of progression (HR=0.72, p=0.0001) with median improvement of 3.1 weeks by independent review and 7.7 weeks by investigator site. Adverse events were in line with prior phase 2 experience with stomatitis, fatigue and thrombocytopenia.
We have previously estimated an incremental NPV for ridaforolimus in sarcoma of around $6/share with upside potential to $10.50/share, although with more modest three week benefit we see upside potential capped in the near term and have increased our price target to $9/share. Further upside potential could come from full data presentation, likely at ASCO in June, and from ponatinib pivotal data in CML, expected in 2012.
K Shaka
Unofficial copy of NSE in your mail box. If you require an official copy, you must file under the FOIA as everyone else has.
IMAGING3 INC
FORM 8-K
(Current report filing)
Filed 01/18/11 for the Period Ending 01/18/11
Address 3200 W. VALHALLA DRIVE
BURBANK, CA 91505
Telephone 8182600930
CIK 0001205181
Symbol IMGG
SIC Code 3844 - X-Ray Apparatus and Tubes and Related Irradiation Apparatus
Industry Medical Equipment & Supplies
Sector Healthcare
Fiscal Year 12/31
http://www.edgar-online.com
© Copyright 2011, EDGAR Online, Inc. All Rights Reserved.
Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.
UNITED STATES SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 18, 2011
IMAGING3, INC.
(Exact name of registrant as specified in its charter)
CALIFORNIA
(State or other jurisdiction of incorporation)
3200 W. VALHALLA DR., BURBANK, CALIFORNIA 91505
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (818) 260-0930
NOT APPLICABLE
(Former name, former address and former fiscal year, if changed since last
report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of
the following provisions.
[_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR240.14d-2(b))
[_] Soliciting material pursuant to Rule 14a-12 under Exchange Act (17
000-50099 95-4451059
------------------------ ------------------------------------
(Commission File Number) (I.R.S. Employer Identification No.)
CFR240.14a-12)
[_] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR240.14d-2(b))
[_] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR240.13e-4(c))
TABLE OF CONTENTS
SECTION 8. OTHER EVENTS.....................................................1
Item 8.01 Other Events................................1
SECTION 9. FINANCIAL STATEMENTS AND EXHIBITS ...............................2
SIGNATURES....................................................................2
SECTION 8. OTHER EVENTS
Item 8.01. Other Events.
On October 28, 2010, the Company received a letter from the United States Food and Drug Administration (the "FDA"), responding to the
Company's application to the FDA for clearance of its 3D medical imaging technology and device. In its application to the FDA under Section
510(k) of the applicable federal legislation, the Company states that its medical device is substantially equivalent to devices marketed in
interstate commerce prior to May 28, 1976 and therefore should be approved for commercial sale and use as a Class II device, without the
necessity for clinical trials. The FDA responded by rejecting the Company's position that its medical device is substantially equivalent to such
prior devices. The Company disagrees with the FDA's position and plans to re-file its application with additional information supporting the
Company's application for clearance.
Upon receipt of the deficiency letter from the FDA denying its application to market its Dominion DViS product in the United States, the
Company hired the law firm McDermott Will & Emery, a Washington D.C. law firm with expertise in FDA filings and their resolution. Since
the process has taken longer than management anticipated, management felt it prudent to engage outside consultants with sufficient experience
to assist the Company in the process. Upon review and discussion of its FDA application and response letters with the consultants, the
Company's management feels confident in their ability to assist the Company with the preparation and follow-up of the re-filing of its 510(k)
application. The consultants expressed the view that each deficiency cited by the FDA in its letter could be resolved and that FDA approval was
achievable, although not guaranteed.
In summary, the deficiencies cited by the FDA in its most recent letter to us include (i) the inadequacy of the comparative clinical images that
we submitted from other existing predicate devices in the market, some of which we obtained from websites rather than directly from the
devices because the websites gave us a broader selection of images (we will submit original images),
(ii) we did not provide our own Dicon image viewer that the FDA could use to better view our submitted images (we will supply our own
Dicom image viewer),
(iii) the format of our hazard and software analysis was not acceptable (we will reformat our submission), (iv) our discussion of vibration issues
was not adequate (we will supplement our discussion of this issue and believe our design mitigates it), (v) the explanation of our solution to
overheating was not adequate (we will expand our discussion of this issue and feel our design solves it), (vi) our description of predicate CT
scanners needs to be more detailed (we will add more detail in our re-filing), (vii) the explanation for the speed of the acquisition of
information by our device exceeding the published specifications of the off-the-shelf detector we use is not sufficiently justified (we believe
that we can explain and justify our claim), (viii) our technical user manual needs to be re-written in certain areas (we will do so), and (ix) we
need to supplement and strengthen our argument in favor of the fact that there are predicate devices already on the market, justifying approval
by the FDA of our device as a Class II device.
In light of the nature of the FDA 510(k) process and the Company's right to continually re-file its application after denial, the Company has an
opportunity to succeed with an approved application. The Company may also hire and has been in discussions with several technical writing
consultants to further assist and expedite the application process, improve the quality of the re-submission, and improve the chances of
receiving approval of the application. Management estimates the cost of these consultants to be between $50,000 to $100,000, depending upon
whether approval is achieved on the initial submission or if further information is requested by the FDA. Although this is a significant expense,
it is imperative that the Company eventually achieve approval for this device from the FDA to enable the Company to achieve its long term
business goals.
-1-
While we remain confident of eventually achieving FDA approval of the Company's medical device as a Class II device, there is no assurance
that such approval will be obtained or that the Company may not ultimately be required to file it under Class III where clinical trials would be
required.
In the absence of FDA approval for our medical device, the Company currently does not and cannot rely upon it as a future source of sales and
revenue. The Company is subject to the uncertainty of not knowing whether or when its proprietary medical device will be approved and can be
sold. Under those circumstances, management believes that the Company will continue its current trend of incurring operating losses, possibly
requiring it to raise additional capital or financing from outside sources. There is no assurance that the Company will be able to raise sufficient
capital or financing to maintain its business while it is incurring operating losses, and there is no assurance that the Company will become
profitable if its proprietary medical device is approved by the FDA.
SECTION 9. FINANCIAL STATEMENTS, PRO FORMA FINANCIALS & EXHIBITS
(a) Financial Statements of Business Acquired
Not Applicable.
(b) Pro Forma Financial Information
Not Applicable.
(c) Shell Company Transactions
Not Applicable.
(d) Exhibits
None.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
IMAGING3, INC.
(Registrant)
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Date: January 18, 2011
/s/ Dean Janes, Chief Executive Officer
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Dean Janes, Chief Executive Officer
Cpbball3
This is a false statement. We know the FOIA is how the NSE was released.
Dean Janes let an NSE letter be released to the public and did not file an 8K after he responded to it on facebook point by point. There is evidence to support this