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prussian4profit

03/16/10 5:29 PM

#11993 RE: Approved #11992

I own shares in IMDS too and your skipping a few things. I do support your enthusiasm.

IMGG path is a little different. Dean's plan seems to be M/A so overseas deals does not apply here. It's a fair question, but Dean seems to be keeping his options open and committing to overseas distribution backs him into a corner for buy-out negotiations.

-p4p

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fidder05

03/16/10 5:55 PM

#11998 RE: Approved #11992

Good question, no it is a great question. Answer - IMGG has no current manufacturing line set-up is my expectation. It takes time, people and alot of cash to develop production facility ANYWHERE.
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IMGGorBust

03/16/10 7:38 PM

#12003 RE: Approved #11992

First of all, it's not true that you don't need agency approval to sell a radiation emitting medical device "over seas." The European Union and individual nations in Europe do have their own version of the FDA, and the same process we are following here would have to be followed there. Dean addressed this in the last call. The EU will accept FDA Approval to allow for sales in Europe, but the same is not true vice versa. In other words, if you have to go through the process of getting approval, get it from the agency whose approval really allows you to sell everywhere.

Second, selling the device overseas, before you tap into the huge market in the U.S., opens you up to the rampant theft of intellectual property in other parts of the World. If you start selling this thing in China, it will be copied and we'll find ourselves in IP litigation for the next couple of years.

Third, we are a week away from submitting our package to the FDA and a month away from FDA Approval. Why rock the boat with the FDA in the meantime? The FDA considers any piece of information about your device to be fair game in its review process, so the minute you start marketing overseas and seeing data coming in from consumers over seas, we put the whole review process on hold again, while the FDA requests and reviews all this new data.

Finally, the business plan here seems pretty obvious to me. We get approval, and before we start pouring mega money and resources into manufacturing and distributing, we sell to one of the big players. Dittling around with overseas sales means you start pouring that money and resources into manufacturing and distribution when you may not need to.

Moral of the story: (1) it's not as easy as just packing up a truck with a bunch of DViS's and "selling overseas"; (2) you run a big risk of having your intellectual property stolen; (3) you run a risk of delaying the FDA approval process; and (4) you spend money you don't have to.