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What makes you think he is handling the case?
Much better....but how do you know that no one has seen the fully functioning device OR images created by the device? Even people who signed the NDAs? You know this for 100%? Can you give a link?
I agree with you on the other 3, by the way
That is not a fact my friend. Unless you have a time machine, that is still an opinion or a guess. I'm not saying I agree or disagree, just that you are incorrect.
It would be nice to see a device in the field.
Sure you are..."What if it's 'fundamental engineering'"? Come on now. Just be patient, please. This is all getting ridiculous with the supposing of this and that. I get that it creates discussion, but when you post stuff like that it, it generates concern about things that aren't real (yet). Is that what you're trying to do? Create a concern for BS?
No no....I was referring to the "fundamental engineering" that was posted by Sano. I think some are trying to stir the pot a little too much here. We're reaching for things to be worried about. Give it a rest until something is released by I3.
This is what I'm talking about...There's a lot of "I think" and "I bet" going on here. You are coming up with this stuff based on what YOU DON'T KNOW. How about some material based on what WE KNOW...unless you're privy to info we're not.
All these things could be real, but right now they are not, unless we somehow find out.
This ia absolutely manipulation, and it will not take something from the FDA to make it go up. It will take an update from the company on their next move.
When you say " This is going to do nothing until the FDA...", by nothing, what do you mean? If you are trying to say move in a positive direction, you are very, very wrong. There are going to be fluctuations, there's no doubt about it
Mcdermott...
Life Sciences - FDA
McDermott Will & Emery has significant experience representing companies before the U.S. Food & Drug Administration (FDA). We provide legal guidance in business planning, product development, product testing and clinical trials, submissions to the U.S. Food and Drug Administration (FDA), marketing, compliance and enforcement matters, and congressional activities. Our clients include medical product manufacturers, public and private institutions, IRBs, academic medical centers, clinical laboratories, clinical research organizations, and principal investigators in various matters pertaining to clinical research. Members of the group have served at the FDA, on Capitol Hill, in the Department of Health and Human Services, on presidential commissions, in trade associations and in private companies.
The FDA Practice encompasses strategic and regulatory planning for product approval, compliance counseling—including promotional compliance, enforcement defense, and government relations, including legislative lobbying. A substantial part of our practice involved developing scientific consensus to support regulatory and legislative actions. We have experience in drug, device, biologics, in vitro diagnostics, food and animal drug regulation and have a long history of successfully representing clients in FDA-regulated matters. We also have experience in the approval, compliance and regulation of biotechnology matters, as well as substantial experience in oncology, including work on early access to unapproved cancer therapies and engagement with some of the world's foremost neuro-oncologists.
Lawyers practicing in McDermott’s FDA Practice have substantial breadth and depth of experience across multiple FDA-regulated industries, including medical devices and pharmaceuticals, in handling the following types of matters:
Clinical research
IRB procedures and investigations
Preparing approvable marketing applications through the FDA review process
Obtaining state and federal approval to field test and market new products
Developing policies and procedures for testing, manufacturing, quality assurance, packaging and labeling
Obtaining and protecting favorable formulary status
Audit inquiries and investigations by the FDA
FDA or equivalent EU-based regulatory issues arising from plant inspections, “warning letters,” product modifications and changes to intended uses that may require supplemental marketing applications
Comprehensive assistance from product research and development through commercialization for FDA related products by working seamlessly with practitioners in other domestic and international Firm departments, such as pharmaceuticals, biologicals, medical devices and in vitro diagnostics with Medicare, Medicaid and private payors
A little tidbit from the McDermott website....
Life Sciences - Medical Device Patent Prosecution
Our patent prosecutors in the Medical Device Group have a wide range of prosecution experience with many types of medical devices. Examples include radiology systems (e.g., MRI, radiography, ultrasound, PET, CT), medical informatics and software, cardiology and vascular surgery (e.g., stents, electrophysiology systems for arrhythmia treatment, implantable cardioverter defibrillators), neurosurgery and neuroradiology (e.g., stereotactic surgical systems, intracranial aneurysm therapies), gastroenterology and bariatric surgery (e.g., enteric implants, gastric restriction devices for obesity), urology (e.g., cystoscopy, artificial bladders), ophthalmology (e.g., artificial vision, retinal implants, poststroke visual retraining, refractive surgical systems, macular degeneration therapy systems, contact lenses, glaucoma devices), other surgical specialties (e.g., lasers, suture systems, prosthetic limbs, orthopedic systems), psychiatry (e.g., therapeutic prediction software for affective disorders), and many others in all fields of medicine. Many of our patent prosecutors have advanced or professional degrees in electrical, biomedical or mechanical engineering, or medicine. Many are routinely involved with litigation and "build” into patent applications best practices gleaned from recent court decisions.
Our medical device team has experience not only with patent prosecution within the U.S. Patent and Trademark Office, but also with the U.S. Food and Drug Administration. We regularly provide clients with counseling on how to best achieve their goals within both federal agencies for their medical device technology. We provide corresponding services internationally through our European offices and our strategic alliance with MWE China Law Offices in Shanghai.
Can you prove they demanded it? This is interesting
Can you post the link to the information? Or is this the opinion of someone who bought and sold this stock irresponsibly? Show us the pudding that entails the truth....please
That's not what I'm saying at all. I'm saying it exists, that's it. I'm also saying that anything is possible. I also believe that something was wrong with the submission from Dean. Can't it be a combination of the 2? If anyone here believes that our Gov't is a clean, mean, efficiently running machine, then you are largely mistaken.
I believe there is A TON more to this than we can even fathom, from Dean and FDA.
I'm not saying I believe there is something going on, I really don't know and won't make any assumptions. All I'm saying is that the world of Gov't entities is extremely complex and that corruption exists. May not be in this situation, but if you're naive enough to think that it doesn't exist in the world we live in, then I have some candy and balloons in my van around the corner. It's the one with the tinted windows. All good intentions, I promise....I'm sure you'd believe that too. Don't be silly - IT EXISTS, it a matter of WHERE...that's all I'm trying to say. If this machine is as revolutionary and ground breaking as many have said, I think that there are grounds for the big guys to be concerned. This could have a signifact impact on the CT market. Who has a large stake in this?.....yes sir. It COULD exist.
....And for the record, I do not have candy and balloons around the corner in my van with tinted windows. If I did, I would have eaten it all by now, and sucked all the helium out of the balloons. This was only an analogy.
Sad to say, but I think your post is more accurate than not. I think we can all agree that the Gov't rabbit hole goes very, very deep. None of us have any idea what type of deals / shenanigans go one there. It could be 100% kosher, but I would venture to say is isn't. It is human nature to corrupt when given power, and the FDA and other Gov't regulated entities are run by man. Greed and Power - You hit the nail on the head. I hope to hell I am wrong about this, but my gut says otherwise.
This is from the McDermott website:
Life Sciences - Medical Device and technology
McDermott’s Medical Device & Technology Group is a global interdisciplinary team focused on counseling medical device and technology companies on the broad spectrum of legal needs they face. With leading practitioners from the Firm’s corporate, health, intellectual property, regulatory and trial practices, we provide our clients with comprehensive and integrated legal solutions. Our group includes 16 former senior prosecutors from U.S. Attorney’s Offices across the country and from the U.S. Department of Justice in Washington, D.C. Virtually all held senior supervisory positions. In addition, many of our lawyers came from the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA), or have served as in-house counsel for medical device and technology companies.
We advise medical device and technology companies on strategy in all stages of their development. From individuals and small privately held businesses to Fortune 500 companies, we serve your strategic growth objectives through acquisitions, investments, securities, joint ventures, licensing, venture financing and grant funding from public and private sources. We assist clients with issues surrounding royalty monetization; due diligence; advertising; off-label promotion; premarket approval/510(k) requirements; FDA inspections of manufacturing, research and other activities (including criminal investigations and FDA enforcement actions, such as warning letter replies and investigator disqualifications); and drafting and prosecuting patent applications. Our experience also covers contract review, clinical trial agreements, antitrust counseling, health care reimbursement, fraud and abuse counseling, federal tax matters, corporate maintenance and clinical research compliance.
Drawing on a team of more than 180 intellectual property lawyers, many with advanced scientific degrees, we work with clients to protect their intellectual property. We provide a comprehensive array of services, including patent, trademark and copyright prosecution; validity; non-infringement clearance analysis and opinions; portfolio evaluation; due diligence reviews; and licensing analysis and management. We routinely engage in “bet the company” litigation on behalf of medical device and technology companies. We have handled cases before the U.S. Court of Appeals for the Federal Circuit, U.S. district courts, state courts, the International Trade Commission, EU Member State courts, and arbitration proceedings in the United States and internationally.
Here's their link to this page:
www.mwe.com/index.cfm/fuseaction/sub_areas.detail/object_id/c179307a-7029-42f8-b374-e266acef7c62/practice_area_id/da30047f-a359-4e58-8764-b9bea8a7f6c2.cfm
Wha Wha Whaaaaaaaaat?!?!? Are you serious? This must be why he stopped posting here a while ago. This may indicate that Dean has, in fact, been exploring this avenue for the last month or so, or for the amount of time that Bust hasn't posted. That would make sense if that were the case.
The plot thickens....This is better than 'As The World Turns'...Dada da da daaaa, I'm lovin it
How do you know all of this? You must be a genius!!
How much EXACTLY (I want numbers) does IMMG have at this very moment. AND how much EXACTLY will this firm cost (I want numbers)? You would, of course, need to know this info in order to make a claim like that, so let's hear it.
I see there are 2 individuals here who are not very happy with this.
Exactly right, so they do care if it works. It will affect their win / lose ratio!!!
I'm assuming you mean a video demo at the RSNA, because we all know, because we've all been told a 1000 times, that no one, under any circumstance is allowed run an RED at the RSNA.
Dean just said yesterday that the consulting group will see it work.
FEEDING FRENZY!!!!
Don't think so buddy
T-10 minutes till the blood starts to flow. Any predictions at open? At 10, 1030, 11am?
Interesting observation!
I disagree. Charts mean nothing when it comes to what we're all waiting for - Approval. For all the people who have been day trading this, and doing so successfully, it means a great deal to. Madtig will be the first to say that he has been using his several charts to navigate his piggy bank. Although we take his word for his success, I believe they do work in the short, day to day game.
How do you know when or where they're going? Maybe that's why the monthly burn is so high hahaha.
If approved, I'd imagine a large line of credit would open up just based on that fact alone.
I'm sure they have plenty of manufacturing capability - Just not at their facility. Wouldn't you think Dean is either ready to sell the crap out of this once approved, or has been aligning someone else to manufacture this product OR is exploring resources and capabilities to open a new plant to get things going to themselves?
You are correct in saying they don't have the capability in the space they are in OR with the current staff they have.
Soon is a relative term. My point is that I don't think Dean was trying to be deceptive.
He said that approval was imminent; He never said when. Why would he comment on FDA approval timing? He, like us, doesn't know.
If it gets approved tomorrow, he's technically right by saying that it was imminent. Even if it gets NSE or AI, approval can still be imminent, just has to go through more steps to get there.
Bust - He's simply suggesting strategy. Please don't dive into that to much. You're asking a rhtorical question. A stop loss is set to sell, so if you want to split ..... hairs, yes that's what he's saying, but with the intent of implementing strategy.
Day 183 means nothing!! All's it means is that we've beat the record for longest time it's taken the FDA to come back with a decision - THAT IS ALL. This is not good and it's not bad.
What good and bad is if / when we determine SE or NSE. Until then this 150 days, 183 days is all BS and mindless banter. A decision will come.
I agree 100%
Nybuild1 - Read some previous posts before you make an assumption like this. As Bust and others explained hundreds of times, these are not arbitrary numbers the FDA pulls out of their asses. I'd like to know where you got that from.
Completely clueless. Where have you been for the past 3 years? Dean is holding because he knows the end game worth of this technology and product. You are grasping for any reason to be negative at this point. What will you say when this is approved?
Madtig - What are you thinking about this action? Are you still going in if we close at or above.30? Or are you going to hold in case of a dip after this Sept hooplah? Just curious. Thanks
Would you like to make a bet on this?
It proves that the radiologists wouldn't be able to say anything to anybody pertaining to the device they reviewed! Yes, it'd be nice if they jumped on this board to tell everyone "It's real, and it works great!!" But, legally, they cannot do that!!
Gotta love that Liberty Analytics for pumping the daylights outta this one. And they said they weren't getting paid for this. Comon now. They pumped this and TSHO to death. I tracked them since they recommended them about 6 months ago and look at where they are now. Horrible
Good man. Thanks
I was going to pose this same question. How is Dean "milking" this? His response is going to be, "yes, although he is not milking this to slowly sell his shares, he's doing it so his friends and family can make their money", which we all know is BS. Just be prepared for this type of response.