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Congrats, I hope you got a good return for your time & effort. I decided to stick it out. We'll see if it was the right move or not.
This is such an interesting change of pace, don't you think? For all that time it was just you, Risk and Alert posting on here. I was checking in from time to time though, just a' lurkin'.
I'm definitely long as well on this one.
Have you been on CSO's website lately? They don't have any distributors listed anywhere in the Americas:
https://www.csoitalia.it/en/pagina/2-contact-us-at-cso-ophthalmic
Although they're everywhere in Europe, North Africa, and the Middle East.
I myself haven't heard anything specific about June 2, but I'd sure like to know what's going on there. I've made a couple of inquires to my old contacts, but everyone's being pretty cagey so far. I need to find out more, I'll be in touch.
You probably remember that Paradigm had exclusive rights to distribute CSO's products. I was talking with CSO's US representative in late 2012, and he told me they had a couple of ongoing FDA submissions.
It looks as though they couldn't get them through that round. So CSO, at that time, decided to put its efforts to expand into North America on hold.
My point is, the time is ripe for that to change. As the Boomer generation ages, more of its spending will be put into healthcare. And damn if they aren't going to want the best eyecare devices available on any continent.
There's more to the story that that. It's taken some time, effort and funds to keep the legal entity and the name around during this interval.
But believe what you like, it's no skin off my @zz.
Tell you what I know about Paradigm. Some of the people around the company are tied in with 1-800-CONTACTS, they’re all together there in Salt Lake City. It’s a whole larger group who’ve been trying to liberalize US eye care laws for years.
Europe has always had better ophthalmic devices than the US. CSO in Italy has had corneal topographers that detect glaucoma earlier and more accurately, for a couple decades now.
And if there was ever a time when you’d see some real opening up of US eye care laws, this would be it. Baby Boomers are hitting that age when they’re starting to suffer from eye diseases like glaucoma, cataracts, etc. Boomers are a very powerful demographic group, politically and economically. If anyone can change the status quo here, it’s them.
Buy-to-sell ratio has improved the past three days-- it could be at its low inflection point here. I guess we'll know before too much longer.
Looks like it's stabilizing at this price level. Anyone know what's in the works here?
I’ve had a few conversations with different people associated with Paradigm. They’ve always been very informative. It’s one of those companies that’s been trying to liberalize the eye-care laws in the US, and force us to finally catch up with Europe.
I noticed that Utah just legalized medical marijuana in March of last year. That can only be good news for glaucoma patients in that state, and for Paradigm.
I’ve never spoken with Randall Mackey, but I hear he’s an engaging person to talk with. If anyone has his contact info, could you pass it on? I’d like to give him a call if possible.
Nice to see all the action here lately. I'm another one of those people who's been holding this company's stock for ages. Does anyone know what's cooking?
From Paradigm's latest quarterly report, explaining where things stood at the end of their last 510(k) application for approval of the Paramax:
"In June 28, 2011, the FDA issued a Non Significance Equivalence (NSE) letter stating that CSO failed to adequately respond to requests to provide descriptive and validation information regarding the ability of the Paramax to deliver light stimuli, measure electrophysiological signals, and provide reference value information to the user. The letter contained a detailed list of remaining issues that FDA deemed still open. The FDA then added in the letter that should CSO resubmit a new 510(k) application, all those issues need to be properly addressed. CSO is currently in the process of submitting a new 510(k) application for the Paramax that will address the issues in the NSE letter."
Hi Gain, I just sent you a private message as requested. I'll be glad to share anything I find out with the board.
Hi Gain, could you give us the contact info for CSO's agent in the USA? I'd like to give him a call myself if possible.
TRQ holding up well despite the down day in the overall market.
RIO looks OK as well.
Hi Gain:
I tried to send an email through their webpage, but it didn't work. Then I tried it directly from my home email, and that time it went through.
By the way, I misspelled the email address in my last message. It's actually cso@csophthalmic.com (I missed the extra "h" last time.)
The email that I sent is below. I'll let you know if I hear back.
--------------------------------------------
Dear Sir or Madam:
I am an investor in Paradigm Medical Industries, which is CSO's distributor in the United States. I am writing to find out if CSO has resubmitted its 510(k) application for the Retimax/Paramax to the FDA in the United States.
I know that CSO did submit a 510(k) in 2010, but that you received a "Not Substantially Equivalent" ruling in July of 2011, because the FDA required more data.
So I would like to ask, has CSO sent a new 510(k) application since that time? Also, could you tell me the date that it was sent on, and whether CSO has received any requests for "Additional Information" from the FDA?
If CSO has not yet sent a new 510(k) application, could you tell me when you project that a new application will be sent?
Thank you in advance for any information that you can provide.
Hey good idea!
Here is CSO's English-language page:
http://www.csophthalmic.com/english/english.html
The email address shown is: cso@csopthalmic.com
Actually since this is the English-version page of their website, we could probably just send the request for info in English. You just click on the email address and it takes you to their general email box. Do you want to take the first crack at it?
Gain,
I also called Paradigm and left a message about a month ago, but haven't heard back. I'm disappointed, because when I called Paradigm in June of 2011, I heard back from Mr. Davis the next day.
I tried calling the FDA as well, but they told me that any information of that nature was confidential. It sounded like their canned response.
Do you (or anyone else) know anyone who speaks Italian conversationally? If so, you could ask that person to call CSO directly to find out whether they have resubmitted.
Are you talking about the photo that shows the "Available: Cushman & Wakefield Commerce" sign?
The photo says, "Image Date: August 2007". PDMI didn't move to that location until 2009, right?
BTW in the video, Dr. Ivanchulev begins his discussion of how the US lags behind Europe in the field of opthalmology at the time 0:59:30
(In case you don't feel like watching the whole four hours)
http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=8806
For anyone who hasn't seen this already (and has four hours to kill), check out this video of the FDA policy hearing that took place during July of last year:
http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=8806
At one point during the hearing, one of the experts specifically mentions opthalmology as an area where the USA lags behind Europe.
As I understand it, the Retimax/Paramax technology can detect glaucoma before it does any permanent damage to the eye; the existing technology in the USA cannot do this.
The Retimax/Paramax got its CE Mark (European equivalent of FDA approval) years ago. However, there doesn't seem to be much will within the FDA to bring this technology to US patients.
Any speculation as to why this is?
Thanks for your reply, smf. Can you point me to a document showing how much IMGG made from the December 2011 PP?
Is anyone out there considering taking part in the latest PP? As the guy on the conference call said, "it would behoove us investors to reinvest" if we want to see a resubmission.
The stock is dirt cheap right now, there's no denying it. Market cap is currently $6.12 Mil. Isn't the patent alone worth some multiple of that?
Gainmaker, could you tell us how you came up with these figures re buys vs. sells? Does this mean that:
15,549,990 shares were bought by private investors from the market makers
7,194,106 shares were sold by private investors to the market makers
28,999,900 shares changed from one private investor to another private investor, or from one market maker to another market maker
Correct?
Hey Lobcrab,
Wanted to know your thoughts on couple of points:
Is it possible that the consultants are advising DJ to stretch the process out over all these months? They would have a clear motive to do so. I suppose that if the "slow and steady" approach ultimately pays off, it will have been worth it.
We've heard in the past that some of the consultants are former FDA staffers; it seems there's a "revolving door" phenomenon going on on here that we find so often in government. To me this suggests that having the right contacts might be as important (or more important) for approval than the application itself. Do you agree?
Thank you for your detailed answer, Bogdan.
I have one further question if you don't mind: what do you mean when you refer to a buy-to-sell ratio for Imaging3?
As I understand it, on any given trading day, the number of shares bought of any security is usually equal to the number of shares sold. Of course the number of shares held by the market makers will vary from day to day, but there will still be two sides to each transaction.
Connecting the assertions you made in your recent posts, I conclude that your position is as follows:
1. Imaging3 is in possession of the written minutes of the October meeting;
2. However, the next 510(k) application will nonetheless receive an NSE determination;
3. Imaging3 will then claim that the setback was caused by the lack of written documentation of the agreed-upon protocols.
Is this correct?
Why can't he tape MoneyTV on Thursday, and submit an 8K on Friday?
After all, Money TV is a public forum. Anyone with a TV or computer can view it with minimal effort.
OK fair enough Kimble. If the FDA told Dean that IMGG had to go the PMA route, then that could constitute a material event for this stock.
In that case, a company is allowed 72 hours to submit an 8K for any material event, so if the meeting took place on Tuesday, then Dean could still satisfy the requirement by filing tomorrow (Friday).
Here's a list of "material events" as defined by the SEC:
http://www.sec.gov/answers/form8k.htm
If anyone sees "Preliminary meeting with FDA to establish 510K application protocols" anywhere on the list, please let the board know.
I guess you're right cl, I don't see any entry on the "exempted" list for the actual X-ray tubes, which generate the radiation. But I am heartened by the statement they make on that same page:
"FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues." Jeffrey Shuren seems to have meant it when he said he was committed to making the review process more efficient.
Hey dayneyus, have you seen this page on the fda website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
The page shows a list of devices "that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act)." Radiology Devices are included on the list.
The bottom of the page says that it was last updated on October 3, 2011, so this must be the latest thinking at the FDA. It certainly seems to indicate that there will be no PMA required for the DVIS.
I guess they still might want Dean & Co. to do the De Novo 510K though, do you have any thoughts on that?
Your quote from Steven Nissan strongly suggests that the DVIS is a Class II device, not a Class III device.
The DVIS would not be "used to sustain life or preserve health" (Nissan's description of a Class III device). The DVIS is a diagnostic tool.
Artificial hearts. Knee replacements. These are the kinds of Class III devices that are "used to sustain life or preserve health", not radiological systems.
C'mon SMF, you know that the DVIS is a Class II device, not Class III. If you look at the FDA's definitions of various radiological devices, the entire list is populated by either Class I or Class II devices:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=892
----------------------------------------
Flouroscopy systems are specified as Class II:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.1660
Sec. 892.1660 Non-image-intensified fluoroscopic x-ray system.
(a)Identification. A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b)Classification. Class II.
----------------------------------------
CT (computed tomography) systems are also Class II:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.1200
Sec. 892.1200 Emission computed tomography system.
(a)Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
(b)Classification. Class II.
Dubb10: Any insights on why the Paramax/Retimax got an NSE decision? I would have thought it would have a pretty good chance of getting FDA approval, since it's been available in Europe for years.
I remember you menntioned that you weren't holding your breath for approval. Was that because of some fault of the product or the 510k submission? Or did it have more to do with the general state of things at the FDA? Thanks in advance for your opinion.
Possible Reasons Why DViS Demonstration Was Limited To A Stationary Object (from Bearish to Bullish)
1. The DViS does not work as advertised. The images shown were a post-processed simulation, designed to mimic adjustments in the Z-axis.
2. The demonstration of real-time 3D on a stationary object was genuine. Dean chose not to demonstrate real-time 3D on a moving object, because the reconstruction software cannot yet render an effective (impressive?) image of an object in motion. In this case, how much does it matter from a surgical perspective? In surgery the object being scanned would mostly be stationary (e.g. a patient under anaesthesia).
3. Dean chose not to show real-time 3D on a moving object, due to FDA considerations. Dr. Polk claims that the audit last year was sparked by the office walk-through video. (Pretext or genuine? If genuine, it tells us little about how close the software is to showing real-time 3D on a moving object.)
4. While many IHUB posters consider it a given that Dean is a minor Madoff hawking a counterfeit product, Dean does not view himself this way. He has been working under the premise that reasonable people would accept, at face value, the demonstration of real-time 3D on a stationary object. If so, and if the reconstruction software is ready, maybe we will see a demonstration with a moving object soon.
Kingfisher raises a point which will become very relevant in the months to come. We know that under the FOIC we can obtain FDA documents related to a completed 510K application. But can we obtain documents related to an ongoing application?
After IMGG submits its next 510K, will we be able to obtain copies of any AI requests that the FDA sends back? Or will we have to wait until that 510K application has concluded?
Mr. Sano, as the poster on this board who has demonstrably obtained FDA information via the FOIA, could you shed any light on this? TIA
I think that FDA approval for the Retimax/Paramax would constitute a "material event" for this company. If so, they would be required to file a Form 8-K with the SEC within four business days after receiving the news. Once the 8-K was filed, then anyone would be able to see it on EDGAR.
IMO this is the reason why PDMI now has the potential to be more than a "printing press":
http://www.paradigm-medical.com/press_04162009.html
04/16/2009
"Paradigm Medical Industries, Inc.(OTCBB: PDMI.OB - News) announced today that the Company signed a distribution agreement with Italian company, Costruzione Strumenti Oftalmici (CSO), whereas Paradigm will represent exclusively one of CSO's products in the US market, Retimax, the next generation for Standard Ocular Electrophysiology. The Retimax performs innovative tests for the early screening and follow-up of important pathologies like Glaucoma, ARM (age related Maculopaty), vascular retinal degeneration and other optic nerve diseases."
The Retimax appears to be better than any equivalent opthalmic device currently available in the US market. As I understand it, no current devices can "Identify retinal dysfunction before it becomes irreversible damage" (from the Paramax/Retimax description on PDMI's website).
The question is, will the FDA give CSO's 510(k) application a "Substantially Equivalent" ruling in this next round? It may be some months before we hear anything.
fidder05,
I've been all over the FDA website and cannot find the "applications record" entry for IMGG which states that a decision will be reached in October. If you could point us to the page that shows this information, I would be greatly obliged.
I have just submitted the question below on PDMI's new website. I will let you all know when I get a response.
--------------------------------------------------------
While reading the IHUB message board recently, I saw that CSO had notified PDMI of a delay in the Paramax’s 510(k) approval process.
I am wondering if the FDA has made a request for “Additional Information”. If so, CSO will have to submit the requested information before the FDA restarts the approval clock.
Could you let me know whether this is correct? Also, when did / when will CSO submit the new information?
Thank you, and congratulations on PDMI’s new website.