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MickFromMaine

05/20/10 9:35 AM

#16277 RE: ounceoflogic #16274

I believe that he has said all of those things in the last update. Some choose not to believe him which is their right. I choose to believe, based on following and owning this stock for four years, that the man is honest, innovative, and as up front as any CEO I have worked with or seen for a public company.
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ack0605

05/20/10 9:40 AM

#16278 RE: ounceoflogic #16274

I completely agree Dean should release a PR stating as such and include more information about DVIS (for the first time reader) and information from the 2 radiologist review. A PR to update existing investors of the status and inform potential new investors of the potential of IMGG.
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IMGGorBust

05/20/10 10:17 AM

#16289 RE: ounceoflogic #16274

Your problem is in the second sentence. You refer to it is a "deadline," but every time this is discussed by Dean, by Mike, and by posters who have analyzed the FDA's website they have all said it is a guideline/goal not a deadline. After the first 90 cumulative days are consumed, it is literally "any day now" and there is no way to predict what will happen.

The FDA has set a goal for itself, that it claims to meet 90% of the time, that if you are in a second or later additional informatino action request, which we are, and if the 90 cumulative days of review team across all previous submissions has already been consumed, which it has, they aspire to respond with a final decision on Substantial Equivalence within 60 days. However, in Dean's experience, each of the previous 4 successful 510(k) applications he has filed, the final pass, after the 90 cumulative days was consumed on previous submissions, and upon receipt of the final submission, the FDA has responded each time at the end of 30 days of silence with a favorable decision. The 30 days was based on Dean's experience. The 60 days is based on the FDA's goal/guideline. But I will re-state it again for you, it is just a goal. A goal that they meet 90% of the time, but it is just a goal, NOT A DEADLINE. There is no recourse if they miss that goal. If they miss it this time, it wouldn't be the first, and it won't be the last. But it is at least something to hang our hats on.
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IMGGorBust

05/20/10 10:19 AM

#16290 RE: ounceoflogic #16274

Ounce, that's a great written statement:

"I understand the impatience and concern of our investors as this process progresses. Although I feel that I need to limit what I say in order to avoid further delaying the FDA process, I know of no outstanding issues or FDA requirements that have not been addressed/satisfied. The DVIS is functioning as proposed. Our finances are sound for the rest of 2010. The FDA review is proceeding but the timing of their decision is out of my hands. We are as anxious for word of approval as anyone, and we will make the announcement as soon as the decision is made."

I agree that something that clear and concise should be said by the company. But I really think he has said all of that. In fact, he seems to say that in every video on the Forum, which comes out every 3 weeks, on every conference call before that, and on every MoneyTV. My guess he'll say it again on the next video.