I believe the FDA had trouble with the image file format, but I did not hear anyone say the FDA couldn't open the images. What I did hear was that the FDA team was having trouble seeing the differences in the photos that compare the predicate device images to the DVis images. As I understood it, the FDA team was asking for a clarification of the differences. SO. Dean in an effort to make the process go faster decided to resend the entire package with notations of the differences to the FDA. I do not believe the FDA requested an entirely new submission. Dean apparently did that on his own.
Dean's decision to resend an annotated package to FDA was his choice. So it would seem that it was not really a resubmission of everything, but a clarification of the images and the differences that concerned the team. I believe Dean was acting with an abundance of caution and making every effort to clarify whatever is holding up the approval. Pretty much a common sense approach after all this time, in my opinion.
Dean is not focused on price per share of IMGG, as many investors here are. He is focused on providing the FDA with whatever it needs to expedite this process. I see no conspiracy here. I see a new FDA team asking for and receiving clarifications that are critical to IMGG getting a final disposition from the FDA on the Dominion.
In all my years of investing, I have seen very few CEO's as open and transparent as Dean. He is not focused on investor impatience or frustration. He owns more shares than anyone else, so he understands that. Dean is not REQUIRED to give investors an update on each and every communication with the FDA or provide us with a play by play commentary of the process. Our expectations may be the problem and not Dean's actions. Yes, this process has taken a long time. But if you look at the time frame we have had with the new FDA review team, that is not such a long time. It's like remarriage after having a bad marriage. You don't count the time you were married to the first wife as part of the marriage to the second wife. WE STARTED OVER.
Nothing here stinks. It's just par for the course when dealing with any governmental agency. I understand our impatience. I understand our frustration. I understand our desire for frequent updates on the process. I perceive no dishonesty here. I believe we are closer to an approval than we were before and I think the biggest problem we have is our own frustration. I believe we are much closer to the end of the review process than we know.
Just my own opinion. Of course, you mileage may vary.
May All Your Investment Decisions Be Profitable Ones.
PARDON ME SIR, BUT I THINK YOUR GOLD HAS ARRIVED!
