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Doesn't the IRS pull passports on people with large tax liens? IMO that's her retirment plan- retirement in a country with no extradition where all the money is hidden.
Maybe it's all about the Grables as far as the IRS, but not for the SEC. His name is on every SEC filing since inception.
My question about SRC was more in the aspect of if they sue IMDS/Grable or do they walk away from their losses. I guess that is a moot question- there is nothing for SRC to win as they would be subordinate to the IRS, and Grable divested both IMDS and herself of all attachable assets- IMO as a strategic move in advance of what she had to know were forthcoming IRS and SEC actions.
Any insight on the relationship between those two. Think she will get pulled in on this by the SEC. Schwartz signed off on every SEC filing and was the CFO. How is he not also liable. Wonder if he rolled on Grable?
I hope they find every dirty penny these crooks hid away and use it to repay the fleeced retail shareholders, and find a nice jail cell for the whole bunch.
IRS has attached a personal lien on Linda Grable - IMDS CEO- Jan 2, 2014, in the amount of $709,679.65, for pilfering of the company withholding funds from 2010 to 2011
1 To GRABLE,LINDA UNITED STATES INTERNAL REVENUE SERVICE 1/2/2014 Lien O 50448 23 112017445
IDSI was a regular guest on the news wires in 1998. It said clinical trials of its machine "will commence in hospitals in Miami, Chicago, Los Angeles, Boston and New York." It said the machine is in the "last stages" of development and is anticipated to be "ready for distribution" in the summer (1998). It projected sales of $66 million and pre-tax earnings of $32 million for the year ending June 30, 1999.
So far, none of these statements have come true. IDSI has obtained FDA approval to test its laser mammographer on up to 275 patients with breast abnormalities or positive mammograms at the Nassau County Medical Center in New York, but no where else. Grable said talks are underway with hospitals in other cities, making the company's original statement "still true." He wouldn't identify the other hospitals."
"Grable's most missionary endeavor, though, occurs in November, when he crates up his machine to show at the Radiological Society of North America convention and trade show in Chiago.
Because potential future customers are there in force, Grable has done the road trip to RSNA every year since 1995. The company buys a space on the trade show floor, displaying its laser mammography prototype and images taken from tested patients.
In 1997, Grable's preparation for that event turned into a scandal. Diane Strait, who joined IDSI as a technical writer and graphics designer in late 1996, said Grable declared breast images taken during clinical testing as unfit for use at RSNA. In a statement given to the FDA, Strait said Grable told her to modify the images with a computer graphics program called PhotoShop. On one image, she darkened two cysts. On another she brightened an area of cancer and moved it elsewhere on the breast.
"The altered images were posted at the IDSI booth at the RSNA meeting Strait said in her FDA affidavit. "None were identified with the statement "images enhanced".
When she learned that the company planned to send the images to the FDA, Strait said she objected, saying she didn't want to take part in a fraud. The following Monday, she said she was fired.
Grable wouldn't talk about Strait, her allegations or why she was fired.
"She made a statement filled with half-truths, and I'm not going to say what was true or untrue." He snapped. "I will not get down in the dirt with a disgruntled employee who was fired."
Strait, now a freelance technical writer, wasn't the only one at IDSI who was disgruntled. Investors had complaints too.
Strait, now a freelance technical writer, wasn't the only one disgruntled, investors had complaints too. In an interview, O'Leary raised objections over the ownership of the laser mammography technology. In disclosures, the company treats it as its own. But the patent was issued to Grable, who then licensed it to IDSI.
In return, Grable received 7 million shares of company stock and royalties of 6 percent to 10 percent of revenue from the machine. At present, the company has no revenue. It stock worth 51 cents a share Friday, makes Grables 7 million shares worth about 3.6 million. Altogether, the Grables own 32.5 million shares.
"Considering that IDSI has yet to sell a single machine, the Grables also draw lucrative salaries and stock options.
According to company documents filed with the SEC, Richard Grable received $286,000 in salary in 1998 and options to buy $500,000 shares of IDSI stock for 31 cents a share, worth 100,000 as of Friday. The year before, Grable earned $673,000 in cash and stock. Linda Grable received $119,000 in 1998 and the same option package as her husband.
Grable said he, his wife and executives [wife Linda, daughters Trishia and Deb] are, if anything, underpaid given the amount of work they do."
"Further, while IDSI is losing millions, the Grable family is spending millions on real estate and luxury cars - nearly $4 million on real estate since October 1996. Public records show they took mortgages on several of the properties.
The Grables paid $732,000 in 1996 for their house in Plantation Acres, then added a $1.3 million unit in the Tony Portofino Tower in Miami - $1 million of it borrowed - and a $185,000 oceanfront condo in Ft. Lauderdale's pricey Harbor Beach neighborhood off State Road A1A. In the past two years, Linda Grable has bought properties in Arizona and Ohio for sums totaling $483,000/
Two Grable relations on the IDSI payroll are living comfortably as well. Trishia Grable, and IDSI employee, bought a $400,000 house, also in Harbor Beach, in 1997 and drives a 1995 Jaguar. IDSI spokeswoman Deborah O'Brien - who says she is Linda Grable's niece, not her daughter, as Linda Grable told the FDA in 1990 - paid $565,000 for a house a block away from Trishia and drives a 1994 Mercedes S320.
Grable made the topic of his and his family's outside investments off-limits. The Grables lifestyles probably wouldn't bother IDSI's shareholders and employees as much if the company were meeting its product release timetables and sales projections.
Since its inception IDSI has lost $28 million. It has no venture capital backing, no credibility in the U.S. stock market and no deep-pocketed partners. In the past three years, most IDSI's cash infusions have come from offshore stock offerings that give hefty discounts to foreign buyers of stocks." Miami Herald Feb 22, 1999 --------------------------------------------------------------------------------
I messed up their plans by involving the retail community and exposing their plans. There is a short position > 1.2 billion shares now. They were planning on the notes due on 6/30 to convert to shares so they could cover, but with funding that ain't going to happen.
Now a large part of the SS is controlled by retail...and THAT right there is old fashioned investing. That is what made the dot com boom as special as it was. The last decade has been a series of crimes and manipulation, and by trend alone, it's time the honest investor came back and fueled the economy.
I've expanded the awareness on this company into the real world too. Family and friends and everyone else is buying shares, and there's nothing left the 3rd party hiring these hedge funds can do except plan on the cost of covering their shares, and then re-accumulating shares at a higher price, unless the shareholders hold strongly to what they own.
I plan on collecting dividends and becoming an integral part of the company when this is all said and done.
I think the SEC has a different opinion, since they filed charges against her and the CFO of IMDS.
Let me tell you a little secret. Mrs.Grable does not need this aggravation.IMO. She is probably trying to fulfill a goal. They are well aware of the things being said and done to her company and it drives her even harder to prove that she is right.IMO.Bravo for her.
KEY WORDS "private transaction". WHOM did she buy those shares from and for what purpose? MY guess is it is from Grable- restricted stock. Purpose- to pay Grable and daughter Deb's pay and keep the lights on.
I bet the SEC will be in contact with HIM! LOL He admitted several times he promoted the stock and stated his goal was to become an "integral part" of the company.
Yes. We all speculated that IMDS was going to try another R/S, and that was the reason they also blew out the a/s to 20 billion shares. Once the SEC started questioning IMDS about their financials and IMDS withdrew their S1's, we knew they were having problems getting the SEC to approve any more registrations. That's why IMDS had to resort to massive 144 shares and then getting Grable's neighbor to pony up money in exchange for a BOD position.
I surmise the toxic lenders have ceased loaning them money, and most likely all other sources as well. We'll never know as IMDS announced they will no longer be reporting their financials due to lack of funds.
read the SEC complaint. They allege both the CEO and CFO commited crimes including fraud,misrepresentation, and failure to disclose material facts over a multi year time frame.
IMDS has since stated they have no funds to file their required financial reports. I'm amazed the stock has not been suspended and/or moved to the gray sheets.
HAHAHAHA. Grable and Schwartz are not going to ever file another financial report again with IMDS. They are done. Plus, why would they give the SEC and other agencies additional information by which they can hang themselves with?
How long until the SEC makes them a gray sheet now? Time to shut this scam down now once and for all.
Can't see why anyone would want to step into this ratsnest. There are hundreds of clean shells out there. You have a two day old SEC complaint and the IRS overhang yet coming.
I'm eagerly awaiting Grable and IMDS response to the SEC complaint. That should be a riot.
Actually I have been trying to figure out something. At one time I had over 50 million of imds Then they Implemented their rs which they said would never happen! Which would have bought my orig 50 mill down to 100,000 Which is now theoretically worth $20 !,,,! What a scam,what a terrible scam. My thing was that I actually believed in the CTLM hook line and sinker. Be aware of what you are buying into here people. Even a 0.0002 to 0.0003 flip I would say will take a lot of luck, And even if I thought that was a good gamble I for one will never invest in a company like this ever again because they have just plain and simple lied and lied and sucked out every single cent they can. I hang around a little in hopes that I finally see this company go down and some people are finally made to p
When I get lied to then yes, I was told for months news of the financing would come a long time ago as early as July of last year and she ended up blaming the PR service, if you saw their facebook yesterday i was bitching at them cuz they decided to post more videos about breast cancer screening as if everyone involved doesn't already know what needs to be known about all that. After some back and forth of deleting/reposting they eventually removed my rights to post on their page. It wasn't the nicest of words but it sure as hell made a valid point.
Linda is not releasing a very important detail as to why financing has not been accepted, and its a detail she's not telling anybody for whatever reason. Its not just me who has spent the time to contact her repeatedly last year to be stuck in the same position we are now.
Yes the CTLM is great, their is an internationally enormous and lucrative market for it, but Linda, on whatever grounds is killing shareholders and billions of women around the world. The only assumption I can make in her defense of her actions is that if control of the company were given to whatever financer is or was involved, then she might have a fear of them destroying the CTLM altogether and still maintain patent control.
I've heard of a lot of companies like HOLX (Samsung too form what a lady told me an airplane once) getting involved in the laser imaging field, so if Linda can't make anything happen then eventually as they continue to drag this out they ultimately may be pushed out of the way, but that' yearsssss down the road.
Its a very politically and economically convoluted situation. The only gripe I have with Linda minus the lies is how she told me how her GOAL was to have the machine in the world, saving women's lives.
You think about it, there's a million and 1 ways that the CTLM machine can service the world, whether it be by giving control to a financing entity aka buyout, or financing to go through the process separately, or even donation for crying out loud. The way she is acting as a CEO goes entirely against her goal imo. If that be her goal, then the idea of losing all rights of the company and patent control shouldn't be an issue.
I did everything I could to generate awareness as well as help Linda, but she didn't pull through for any of us.
Its still very much now a long term investment, and yes if things pan out as they should for the positive, the stock should well be trading back in the upper dollars and back on the nasdaq, but each passing day increases risk.
Its been very frustrating for me dealing with this, not to mention I'm still limited to two posts per day on the board so its not like I could even influence the public anymore
HAHAHAHAHA... Don't most innocent people and companies normally respond with something to the effect of, " we strongly disagree with the the complaint and plan to vigorously defend the allegations. The company and management are confident that these allegations will be proven to have no merit."
INSTEAD... what IMDS and Grable respond with was...
IDSI and the individual defendants are in the process of analyzing the Complaint and their defenses
Typical Grable stall and BS. Defenses? Against the truth? That means what is the best deal can they cut I assume.
No need to wait. I've seen this story play out many times with these penny scams. IMDS simply took longer than most.
Can't see how this medical device scam will end up any different than DOBI, COI, or IMGG.
Add IMDS to the list now of failed scam medical devices run by Grable. Over thiry years of scamming people out of money to benefit her, AL, and her kiddies.
Here's hoping the SEC, IRS, NASD, and other agencies cast a very wide net.
Until Dead? lol ... the stock has been pegged at zero bid for months. The "company" is a sham. The CTLM is a POS that doesn't work as claimed. Three rejected FDA submissions. The patent for the CTLM is owned by Grable and that expires in two years.
Seems as if no DD was done on your part, or there is an unknown agenda here. The facts about this company do not support any of your speculation and hype.
Where are all the toxic lenders? Grable's now getting loans from her condo neighbors to pay her family, and of course giving away more free stock in exchange. Unbelievable. This woman will not stop scamming until they shut this down.
What, daughter Deb doesn't want to be CEO? Better to set up some rich, non-family member to take the fall. If Shotmeyer lends them another penny after the SEC complaint date, then she is either a fool or as shady as Grable and Co.
Why would anyone want their name permanently associated with a scam like this by choice? My guess is Shotmeyer did zero DD and/or was told a pack of lies by Grable, in order to keep the checks coming.
Read the correspondence between the SEC and Grable back in 2011. We told you that IMDS was lying and the SEC would get them- back then.
WHO WAS RIGHT?
March 25, 2011 Linda B. Grable Chief Executive Officer Imaging Diagnostic Systems, Inc. 5307 NW 35th Terrace Fort Lauderdale, Florida 33309 Re: Imaging Diagnostic Systems, Inc. Proxy Statement on Schedule 14A Filed March 8, 2011 File No. 000-26028
Dear Ms. Grable: We have limited our review of your filing to those issues we have addressed in our comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we may have additional comments. 1. With your response to this letter, please provide the acknowledgements requested at the end of this letter. To the extent applicable, please revise your disclosure to comply with our comment letter dated March 25, 2011 regarding your registration statement on Form S-1, file no. 333171327. Please tell us why this revised preliminary proxy statement was filed using EDGAR tag "PRE 14A" instead of "PRER14A."
2.
3.
Linda B. Grable Imaging Diagnostic Systems, Inc. March 25, 2011 Page 2 4. We note your response to prior comment 2. Please clarify what you mean by your disclosure that the "review process will resume." Do you mean that the FDA must complete its review within the balance of the 90 day period remaining at the time it requested additional information? Given that it appears that more than 90 days have lapsed since your 510(k) application, please clarify why you did not receive a response within the 90-day period that you cite. Please revise to clarify the basis for your statement that your expectation that the FDA will finish its review process in 2011 is reasonable given that you may be required to submit additional information to the FDA to support your application, the scope of which would be unknown.
Proposal 2, Increase in the Number of Authorized Shares..., page 26 5. We note your response to prior comment 6. Please revise to describe with more specificity the purpose for which you will use the proceeds to be received from the issuances of shares that have been reserved. It remains unclear how you determined the amount of additional funding you require given that you have now submitted to the FDA an application for marketing clearance. Please expand your disclosure in response to the second sentence of prior comment 7 regarding each related person's interest in the shares for which you are seeking authorization to identify each related person with an interest in the proposal, the number of newly authorized shares that each such related person could receive based on outstanding commitments, and the terms under which the related person could receive those shares. We reissue the last sentence of prior comment 7. For outstanding commitments pursuant to which you could be obligated to issue shares in excess of the number of shares currently authorized, including any notes that you may become obligated to repay by issuing shares, please provide all disclosure regarding such commitment as if shareholders were being asked to approve the commitment; see Note A to Schedule 14A. You should disclose the material terms of each commitment to issue shares and the purpose and effect of the commitment.
6.
7.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company's disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made.
Linda B. Grable Imaging Diagnostic Systems, Inc. March 25, 2011 Page 3
In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
You may contact Mary Beth Breslin at (202) 551-3625 or me at (202) 551-3617 with any questions. Sincerely,
Russell Mancuso Branch Chief cc (by facsimile): Robert B. Macauley, Esq. Carlton Fields, P.A.
March 25, 2011 Linda B. Grable Chief Executive Officer Imaging Diagnostic Systems, Inc. 5307 NW 35th Terrace Fort Lauderdale, Florida 33309 Re: Imaging Diagnostic Systems, Inc. Registration Statement on Form S-1 Amended March 15, 2011 File No. 333-171327
Dear Ms. Grable: We have limited our review of your registration statement to those issues we have addressed in our comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. Where you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Prospectus Summary, page 4 1. Please highlight prominently in your prospectus summary the statement in your auditor's report regarding the substantial doubt about your ability to continue as a going concern.
Risk Factors, page 6 2. Please disclose your pending proposal to increase the number of your authorized shares.
Linda B. Grable Imaging Diagnostic Systems, Inc. March 25, 2011 Page 2 Description of Business, page 28 Overview, page 28 3. With respect to your response to prior comment 3: Refer to the first paragraph of your response. Tell us more specifically when you determined that you could submit a 510(k) application instead of a PMA application. In this regard, please: o Tell us the nature of the "information provided by the consultants" which comprised part of the basis for your determination, and tell us when this information was provided to you. o Reconcile your disclosure that "The FDA added 510(k) `de novo' classification option in 2009" with the guidance you cited in response to the third bullet point of our prior comment that indicates this process was added in 1998. o Please clarify what you mean by "recent adjustments" on page 28, including the nature and date of the adjustments. o Tell us with specificity the "comparable medical devices" to which you refer in your response and when each of those devices received approval under the 510(k) process. o Clarify the nature of the "other factors" you considered in making your determination to submit a 510(k) application rather than a PMA application. From your revised disclosure that you determined you could submit a 510(k) application "while working with [y]our regulatory consultants," it remains unclear from reading your prospectus what occurred that made you determine that you could submit the 510(k) application. If the determination was based on the opinion of the consultant, please say so clearly and file the consent of the consultant as requested in prior comment 3. Otherwise, revise your disclosure to make clear how you made the determination and why your statement that the determination was made "while working with [y]our regulatory consultants" is relevant. It does not appear that you have explained why you believe you had no obligation to disclose your determination that you could submit a 510(k) application and the basis for your conclusion previously. Therefore, we reissue that portion of the first bullet point.
Linda B. Grable Imaging Diagnostic Systems, Inc. March 25, 2011 Page 3 4. Regarding your responses to prior comments 4, 5 and 8: Please clarify the reasons why you missed the disclosed goals. The "Key" that you provided in response to prior comment 4 and your related disclosure in this S1 is unclear because: o from note B in your response to prior comment 4, it is unclear why there were delays in obtaining Institutional Review Board approvals. Did you misunderstand the typical length of the approval process? Was there something about your potential product or study that caused the process to take longer than usual? If so, what was it? o it is unclear what the new "inclusion criteria" were. o you attribute delays to lack of cases for statistical analysis, but it unclear when you were aware that you would not have sufficient cases. In your table in response 4, you indicate that you were predicting that the PMA application would be submitted in December 2008 as late as November 13, 2008. Did you not know by then that you did not have sufficient cases? o it is unclear what you mean by "lack of cancer cases." Did the cancer rate decline during that time? o from note F to the table it is unclear when the improvements were made. From your revisions, it should be clear whether you disclosed that you would miss your target PMA application date when the improvements were made, and if not, why you continued to believe you would meet your target PMA application date at that time. o where your key refers to "H" and "I" regarding a 510(k) application, it is unclear why your disclosure continued to refer to a PMA application and does not refer to your potential submission of a 510(k) application. o from note G in your response to prior comment 4 it is unclear what amount of financing you believed you needed to meet the disclosed target PMA application date, how you provided investors sufficient information to understand the amount of financing required, the amount of financing you actually obtained, and when you determined that you would not have sufficient financing to meet the disclosed target PMA application date. Please revise your disclosure on page 38 regarding your prior projections to provide information regarding the magnitude of the missed projections. Include information regarding when you initially thought would file your PMA application and the number of subsequent missed PMA application filing targets.
Linda B. Grable Imaging Diagnostic Systems, Inc. March 25, 2011 Page 4
5.
With respect to your response to prior comment 6: In an appropriate section of your document, please describe sections 3(b) and 14 of the license agreement. Please tell us where the license provides that the royalty provisions do not apply before your receipt of FDA marketing clearance as you disclose on page 16. Given the disclosure contained in the first full risk factor on page 16, please add a separate risk factor highlighting the expiration in 2014 of the patent underlying the license agreement filed as exhibit 10.115, or tell us why you believe such disclosure is unnecessary. In an appropriate section of your document, please describe the scope, expiration date and jurisdiction that issued the patents mentioned in the second sentence of your risk factor beginning at the bottom of page 15. Please file Exhibit A to exhibit 10.115.
United States Government Regulation, page 32 6. With respect to your response to prior comment 7: Update your disclosure in this section, in your summary, and elsewhere in your document as appropriate to describe the status of the FDA's review of your 510(k) application. We note that more than 90 days have passed since the date of your submission. To the extent that the FDA has asked you for additional information, please revise to state the date you received the request and the status of your response. Balance your disclosure by revising here and elsewhere in the document where you present the FDA's timeframe for review to describe the typical duration of the entire review process, rather than the number of days of the FDA's review period. Also compare the total review period for: o a traditional 510(k) application, o a traditional 510(k) application followed by "de novo" review, and o a PMA application. If true, please revise to state clearly that in the event the FDA denies your initial 510(k) application and subsequently determines during the "de novo" review that
Linda B. Grable Imaging Diagnostic Systems, Inc. March 25, 2011 Page 5 your device cannot be classified as a Class I or Class II device, you will then need to submit a PMA application to obtain the necessary regulatory approval. Global Commercialization Update, page 41 7. With respect to your response to prior comment 9: Please reconcile your response that you have never shipped a CTLM system to any country without first obtaining the necessary regulatory approvals or registration with your disclosure on page 41 that indicates you have not yet submitted an application for regulatory approval in Indonesia. With a view toward clarified disclosure, please tell us whether any of the foreign jurisdictions listed on page 41 in which your product's regulatory status is other than "approved" require approval or registration in order to market your product there.
Management's Discussion and Analysis, second page 16 8. Please do not invoke here or elsewhere in your document a statutory safe harbor that is not applicable to you. When you include in your prospectus information that you also have included in a periodic report, please review your disclosure in the prospectus carefully to ensure it is applicable to the registration statement. For example, we note that here you refer to your prospectus as a 10-Q and you attempt to incorporate by reference when it appears that you are ineligible to do so. Please revise your document accordingly.
9.
Item 15. Recent Sales of Unregistered Securities, page II-3 10. Please update this section to disclose the information required by Item 701 of Regulation S-K. For example, we note your revised disclosure on page 51. Please note that Item 701 of Regulation S-K requires disclosure of the date of sale and the amount of securities sold.
Exhibit 5.1 11. We note your response to prior comment 11. It remains unclear why it is necessary and appropriate for the opinion required by Regulation S-K Item 601(b)(5) that counsel assume "compliance on the part of all parties to the Private Equity Agreement in all material respects with their
Linda B. Grable Imaging Diagnostic Systems, Inc. March 25, 2011 Page 6 representations, warranties, covenants and agreements contained therein." Please advise or file a revised opinion. With a view toward clarifying the exhibit, please tell us how counsel "relied" upon the documents mentioned in the third paragraph, including whether counsel relied upon those documents for conclusions of law or readily ascertainable facts.
12.
With respect to your response to prior comment 12: To the extent you file an opinion of counsel with a pre-effective amendment, please provide an opinion that is signed and dated. We note your statement that the opinion is provided "exclusively" in connection with the public offering contemplated by the registration statement. Please provide an opinion of counsel that does not seek to limit investors' reliance on the opinion.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company's disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Linda B. Grable Imaging Diagnostic Systems, Inc. March 25, 2011 Page 7 Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Mary Beth Breslin at (202) 551-3625 or me at (202) 551-3617 with any questions. Sincerely,
Russell Mancuso Branch Chief cc (via facsimile): Robert B. Macaulay, Esq. Carlton Fields, P.A.
February 17, 2011 Linda B. Grable Chief Executive Officer Imaging Diagnostic Systems, Inc. 5307 NW 35th Terrace Fort Lauderdale, Florida 33309 Re: Imaging Diagnostic Systems, Inc. Proxy Statement on Schedule 14A Filed February 7, 2011 File No. 000-26028
Dear Ms. Grable: We have limited our review of your filing to those issues we have addressed in our comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we may have additional comments. 1. To the extent applicable, please revise your disclosure on pages 2-3 and 26-27 to comply with our comment letters dated January 14, 2011 and February 10, 2011 regarding your registration statement on Form S-1, file no. 333-171327. We note your disclosure that you anticipate you will obtain 510(k) clearance in 2011. Please provide us the basis for that disclosure. Also, please balance your disclosure with equally prominent information regarding your previous statements to shareholders regarding when you would receive FDA clearance and the extent to which those statements were accurate.
2.
Linda B. Grable Imaging Diagnostic Systems, Inc. February 17, 2011 Page 2 How Many Votes Are Needed, page 10 3. Please tell us with specificity the authority on which you rely to conclude that proposal 2 can be approved by a majority of shares present rather than a majority of shares outstanding.
Security Ownership of Certain Beneficial Owners and Management, page 13 4. With a view toward clarified disclosure, please tell us why the beneficial ownership information in the table on page 13 is different from that in your amended Form S-1 filed on February 1, 2011. Reconcile your disclosure in note 6 regarding the total shares subject to options with the sum of the amounts of shares subject to options set forth in notes 3, 4 and 5.
5.
Proposal 2, Increase in the Number of Authorized Shares..., page 26 6. Please revise to indicate how you determined the size of the increase for which you are seeking authorization. Please disclose clearly the total number of shares that you may be required to issue pursuant to all options, warrants, convertible debt or other arrangements or understandings, whether written or oral, and briefly describe the material terms of each such commitment. Also disclose the extent of each related person's interest in those commitments. For outstanding commitments pursuant to which you could be obligated to issue shares in excess of the number of shares currently authorized, please provide all disclosure regarding such commitment as if shareholders were being asked to approve the commitment; see Note A to Schedule 14A. We note your reference in the third paragraph to shareholders' prior approval of increases in authorized shares, and your statement that you had hoped that the shares previously authorized would be sufficient to meet your funding needs. Please revise to indicate the date and size of your last increase in authorized shares. Also clarify your disclosure as to the reasons for the difference between your projection that the shares currently authorized would be sufficient to fund your operations and your actual need for additional funding through share issuances. For instance, clarify why international commercialization proceeded "slower than expected." Please tell us where you have filed your articles of incorporation that reflect the number of authorized shares that you disclose in the first paragraph of this section. Note that Regulation S-K Item 601(b)(3) requires that you file a complete copy of your charter as amended without requiring investors to piece together the document from multiple filings.
7.
8.
9.
Linda B. Grable Imaging Diagnostic Systems, Inc. February 17, 2011 Page 3 We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company's disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
You may contact Mary Beth Breslin at (202) 551-3625 or me at (202) 551-3617 with any questions. Sincerely,
Russell Mancuso Branch Chief cc (by facsimile): Robert B. Macauley, Esq. Carlton Fields, P.A.
Please file the consent of the consultant from whom you disclose that you learned that you "could alternatively submit a 510(k) application instead of a PMA application...." Also, with a view toward disclosure, please tell us specifically the date on which the consultant provided you this advice and why you believe you had no obligation to disclose this information previously. Reconcile your disclosure on pages 16 and 31 that you believe there exists a substantial equivalent to your product that allows you to meet the requirements of a 510(k) submission with: o your disclosure on page 26 that the FDA had previously determined that there was no predicate device and accordingly classified your product as a Class III medical device; and o your disclosure on page 31 that "Manufacturers of Class III devices must apply to the FDA for pre-marketing approval ("PMA") before marketing can begin." Clarify what you mean by the "recent regulatory changes with the FDA agency" that you believe allow you to meet the requirements for a 510(k) submission. Specifically: o describe the changes to which you refer and tell us when those changes occurred; o clarify whether those specific changes had the effect of permitting 510(k) applications for Class III medical devices; and o provide us citations to the specific regulations to which you refer in response to this comment. Advise us of the basis for your conclusion disclosed in the last paragraph on page 31 that your device "utilizes technology with low or moderate risk" such that a de novo 510(k) application would be appropriate in the event your "traditional" 510(k) application is rejected, as disclosed on page 32. In this regard, we note your disclosure on page 31 describing Class III medical devices as "devices for which the FDA has insufficient information to conclude that either general controls or special controls would be sufficient to assure safety and effectiveness...."
tell us why you have not previously submitted a de novo application; o tell us why you chose to submit a "traditional" 510(k) application instead of a de novo application; and o describe the procedural and substantive differences in the process between "traditional" and "de novo" 510(k) applications. Tell us whether you previously pursued 510(k) clearance, and the results of any such efforts.
Substantially revise your response to prior comment 3 to provide us with the location of the specific statements of guidance regarding when you would file your application with the FDA and the reason you were not able to achieve that goal, instead of referring us to a discussion of the regulatory status of your product contained in each of the filings listed in the table. For instance, the table indicates that filings keyed with the letter "H" contained statements disclosing that you were working with a FDA regulatory consultant to determine whether you were eligible to file a 510(k) application instead of a PMA application; however, no such disclosure appears to have been made anywhere in these filings and the disclosures you referenced discuss your intended PMA submission. With respect to the filings keyed with the letter "I" which is specific to a 510(k) application, there does not appear to have been any reference in those filings specifying that the submission "in the process of preparation, documentation and review" would be a 510(k) application instead of a PMA application. Similarly, we note your statement on page 4 of your Form S-1 filed on October 28, 2008 that you anticipated filing your PMA application in December 2008; however, your table only indicates that the disclosure contained references to information in keys "E" and "F" and does not contain any reference to the specific guidance disclosed in this filing about the timing of your submission. Please ensure that your revised table references what you specifically disclosed regarding when you would file the PMA application in each of the filings. If the revised table that you provide in response to the comment above indicates that you have revised your disclosed projections regarding the timing of your FDA application, please include in appropriate sections of your prospectus disclosure clearly explaining the nature, frequency, and duration of these revisions. Refer to the guidance in Regulation SK Item 10(b)(3)(ii). In circumstances where you disclosed that you would have sufficient financing but then determined that you did not have sufficient financing, ensure that your disclosure explains clearly why the financing proved to be inadequate; for example, currently page 9 of your document includes apparently contradictory disclosure that you previously thought you had sufficient financing to complete the FDA approval process but were delayed due to lack of financing. We note your disclosure regarding substantial equivalence. With a view toward clarified disclosure, please tell us where you disclose the scope and duration of the patents that you mention on page 15. Also, also tell us where you disclose the material terms
We note your disclosure that, on November 22, 2010, you submitted a premarket notification 510(k) application to the FDA regarding your computed tomography laser breast imaging system. Given your disclosure that this product was designated as a "Class III" medical device for which premarket approval, or PMA, is required prior to commercialization, please revise your disclosure to:
Linda B. Grable Imaging Diagnostic Systems, Inc. January 14, 2011 Page 2 explain why you submitted a 510(k) application rather than a PMA application; explain in greater detail the procedural and substantive differences in the FDA approval process between a 510(k) application and a PMA application; and clarify how your November, 2010 submission will enable you to "move forward in the process of seeking U.S. marketing clearance" and state explicitly whether you intend to submit a PMA application to the FDA.
It was always a scam. Those were merely two of dozens of fluffer PR issued to sell stock. Read the SEC complaint accusing the CEO and CFO of fraud and misrepresentaion of material fact.
How'd his work out now that the CEO and CFO are both being prosecuted by the SEC for fraud?
Devcool Thursday, June 14, 2012 12:41:06 PM Re: dejong post# 8443 Post # of 36526 I messed up their plans by involving the retail community and exposing their plans. There is a short position > 1.2 billion shares now. They were planning on the notes due on 6/30 to convert to shares so they could cover, but with funding that ain't going to happen.
Now a large part of the SS is controlled by retail...and THAT right there is old fashioned investing. That is what made the dot com boom as special as it was. The last decade has been a series of crimes and manipulation, and by trend alone, it's time the honest investor came back and fueled the economy.
I've expanded the awareness on this company into the real world too. Family and friends and everyone else is buying shares, and there's nothing left the 3rd party hiring these hedge funds can do except plan on the cost of covering their shares, and then re-accumulating shares at a higher price, unless the shareholders hold strongly to what they own.
I plan on collecting dividends and becoming an integral part of the company when this is all said and done.
I bet Dianne feels a huge sense of vindication now. FINALLY the SEC caught up to Grable and Schwartz. She tried to blow the whistle on these scammers almost 15 years ago, but it fell on deaf ears.
Same for Andrew Abraham, James McNair and several others who over the years exposed this scam for what it was- a public piggy bank Grable, Schwartz and the rest of management used to amass millions in personal wealth while at the same time lying through their teeth to the public.
I have said it for years. IMDS has and always was about selling shares, not machines.
The SEC confirmed that this week.
Prison is too good for these criminals. The IRS and SEC needs to have them forfeit every dirty penny they have and every asset, both domestic and foreign.
Why would Grable and IMDS start following the rules NOW when the SEC just accused them of multiple counts of fraud, misrepresentation, and other illegalities? They are already toast. In for a pound in for a penny as they say.
Long, have faith. The SEC isn't going to lay out all their cards on the table. We both know there is so much more than what was in that complaint, but I have a feeling the SEC only included what they know is a slam dunk. There is nothing stopping them from expanding the prosecution if in the course of discovery other crimes are uncovered, and other perps are shown to have been involved. One thing about the SEC, they are slow but cast a wide net.
Do you really think Southridge and the other toxic lenders are not going to get swept into this? The paid IR scum over the years? All of those phony sales PR's that were put out?
This is just getting started. The NASD, State of Florida, and other regulatory agencies haven't piled on yet. Then there is the 800 pound gorilla in the room- the IRS. Remember that pesky 1.4 million dollar fraud of pilfering the employee payroll taxes? Think the IRS wants the SEC to get that money instead of them?
I can't believe this stock is still trading.
Congrats for your efforts over the years. Same to Stockmaster and others.
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