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Chemic,
Surely you know that what a stock trades for, especially a penny stock, has little to due with what a company and it's assets (including intellectual property) are worth. I am assuming that Dean's machine does what he says it does. If that's true then it might be worth while for a larger company to pick it up and push it through the PMA process. They would have to evaluate the device and make the determination as to it's market value, and the cost of R&D to come up with something comparable.
I would agree. I think that his best bet is to sell it to a company like GE or Toshiba, and see if he can get a few bucks a share for the IP, but that's only what I would do. I can't speak for Dean. Unfortunately there is a thin line between Christopher Columbus and Captain Ahab...
Yes. Though Dean doesn't come out and state it, what is described would correspond to a PMA. I work more in the technical side, so I wouldn't care to speculate on the eligibility for a 510k, however it's original intent was to allow competition. If the patent on a particular device expires, without the 510k, another company would have to go through the clinical trial process again to bring the same product to market. This would make competition nearly impossible because of the expense, this would allow a company to hold a monopoly on a drug/device which would make medical costs skyrocket.
The justification for a 510k is that since the original company already went through the PMA process, the FDA only needs to determine if the new company has a substantially equivalent product in terms of efficacy, safety and manufacturing quality, etc.
Just to enlighten you folks that don't know. I'd like to share with you a bit about the industry terms used in the press release. If you wish to question my authority on these items, feel free, but know that I work for a CRO (Clinical Research Organization).
A Protocol is an industry term for the set of rules that govern a clinical trial. It's essential a manual that outlines what tests will need to be done, and how they should be done, to determine if a drug or medical device is suitable for FDA submission. The data collected during this process is what the FDA evaluates to determine whether or not a drug or device is acceptable. In industry jargon, it is usually interchanged with the study itself, i.e. instead of "The clinical trial I am working on is ..." a CRA (Clinical Research Associate) might say "This protocol I'm working on is...". Of all the protocols currently being managed by my company, the shortest lasts for 1 year the longest 6 1/2 years.
Depending on the drug or device there are any number of protocols that must take place prior to FDA submission, each one of these protocols is a Phase. Usually there are 3, as has been outlined in the aforementioned press release. So if you are to assume a best case scenario for each protocol you would be looking at 3 years of clinical trials, in addition to the time required to write the protocol, find a CRO, get the protocol approved by an IRB/EC (Investigation Review Board / Ethics Committee) and compile and analyze the data after each phase, and submit for intermediate approval from the FDA after each phase. Only at that point could you submit for final approval.
There is also substantial costs associated with protocol, not only in the cost of management, but also, the cost of paying participants and doctors to participate in the study.
I don't mean to discredit Dean's efforts to get his device approved as an improvement to an existing device. As an improvement the requirements are significantly less stringent. However, investors should be aware of the timeline and cost associated with getting a new drug or device approved through the FDA.
I agree with going into other markets. The US Health Care industry is [Explitive Deleted] as it is. More is cared about making money than helping folks, and while Dean does want to make a profit, as he should, this device could mean lives saved in other parts of the world, and also profit.
To those who think Dean should step aside because of his failures up to this point. I disagree. Failure is part of the process. Noting ventured, nothing gained. Also this:
Woot successful bearing prototype!
More insane movement today. I suppose everyone got out when it was low, but I'm hoping for more positive movement this week.
Some pretty crazy movement on this today, I'm surprised there are no posts. I wonder what's triggering the movement.
I really hope that they get FDA approval and that the product is as hot as we hope, because based on their balance sheets the stock is extremely overvalued.
I'm also kind of disturbed to notice that their sales were down 45% from 2008
Stud, learn to math dude the EPS @ 100 units a year is 1.46 cents a share with the current shares outstanding. That said, the street sweeper didn't account for expanded production capacity in future years, nor training, nor maintenance. Additionally, a production partnership with a bigger company like GE could up the production numbers dramatically, even within the first year. And a buyout is always an option.
But let's be honest, this is a penny stock why the hell would you try to value it like a blue chip?
It seems that many are missing the obvious sign that it is the end of the year, and most people who day trade or even month trade stocks will sell off their low positions to balance any earnings on their taxes, only to buy in again after the first of the year.
The reason for the falling stock price is the selling pressure resulting from this. After all, this late in the year its a pretty safe bet that FDA approval is not happening in 2009. This is a government entity we are talking about, and after this week they are pretty much on vacation for the rest of 2009.
I do think that FDA approval will come early next year, and a lot of people who day/week/month trade stocks probably feel the same way, but if they sell now and buy in again at or bellow what they sold for, they can alleviate some of their tax burden from cap gains and maybe even come in at a better position in January.
So to any questioning why the stock price is steadily falling, it is this, and has nothing to do with FDA denial, or even fear.
I just checked this is the first conference call held after the market has closed.
It's interesting that the stock price is down in light of the CC.
Especially when you consider the conference call is happening after the market is closed. Which is when a company would have to make an announcement about something like, oh I don't know...
FDA Approval !!!!!111!!!111ONE!!!11!!
I'm just speculating.
I wonder how long FDA approval took for this.
http://rsnabuyersguide.com/productshowcase.php?ps_id=612&product=2View
lawl.
PS mods, this is sorta related it's being sold at RSNA as well. Just though I would lighten things up a bit.
I don't think it's fair to assume that the "rationing board" wouldn't fund the invention of this technology, especially because its cheaper and will save more lives. It does have value.
What I think most people fail to realize is that the amount of money floating around the health-care industry wouldn't change, it would just be allocated in such a manner that the life saving power per dollar is maximized.
That said, this is getting off topic, and I wouldn't be surprised if this is deleted, but I would be happy to continue this in pm.
I think it's a bit crass to call Dr. Emanuel's position raving. While his ideas may seem a bit Nietzschean, it does make sense. Where I 70 years old, I would much rather medical dollars be spent saving my grandchildren or daughter than my self. In a perfect world, everyone would have adequate medical care, but unfortunately more people want iPods than want to make this happen. Rather than discriminating based on wealth, it is more humane to allow those who have not lived a full life a chance.
The strength of the Dominion is that it is valuable in both a universal health care system, and a free market health care system, as both would strive to keep costs down.
It lowers health care costs in a broader scope than just it's purchase price. Making the machine portable and less expensive makes it more accessible to facilities other than hospitals, this will make diagnostics cheaper and more accessible, which in turn will lead to better preventative care. Treating a condition in the early stages is universally less expensive, and provides a better prognosis that treating it later.
That looks like a dying squirrel. Are you comparing IMGG to a dying squirrel?
I have a cash account, so I'm not sure if I can buy back in before my funds clear. I have Scottrade, and they make mention of requiring 25k in an account if I want to change my position in a stock more than 4 times in a week.
That said, I was originally curious as to any ideas that might explain the rise in the stock price, obviously reliably predicting the stock price is impossible, but in what ways can you look at trends in a stock price and say, "oh, that was because Dean was on xyx show." etc. Assume I have no real knowledge of what causes price fluctuations, and point me in the direction of some reading material.
Alright, so I will be the first to admit I only have a vague idea as to why stocks move in one direction or another.
Can anyone clue me in as to why the stock price seemed to rise steadily yesterday and today?
Weren't you saying yesterday that there were high fives all around IMGG offices, implying that good stock price raising news was imminent? Why would you sell before this great news is released?