Wow, you are so far off base. The FDA inquired months ago whether the appropriate tests had been conducted regarding mechanics and vibration. Those tests had been done long before, were shown to the FDA and were cleared by the FDA. There never was an "issue," just a request for confirmation by the FDA that the proper tests had been performed. There was a software issue practically a year ago (actually not software but a piece of hardware that was replaced that was messing with the circuits), as any software research and development faces, but that issue was addressed long ago (2 submissions ago) to the satisfaction of the programers and the FDA. Why don't you bring up some other useless and inaccurate information from the distant past, too. I heard when Dean was a teenager he got a speeding ticket! Now we'll never get FDA Approval!
He has been completely forthcoming. In fact, the only reason you know about any of these so-called "issues" is because Dean publicized them during his numerous conference calls, public appearances, videos and posts. He has never been shy about sharing bad news, to the point of including such detail as the number of questions and follow-up requests asked by the FDA, the nature of the questions, and the status of responses, even when there were delays.
Dean is a former military man, a technologicial wizard and a highly ethical business man. He has been more transparent in his dealings with shareholders than any CEO I have seen in any of my previous investments. I believe it is his transparency, which should be applauded, that has actually opened him up to so much negativity by many here and on the Forum. The reason you don't see as much crying and whining on Boards for other companies is because shareholders don't get a glimpse at the ugliness that often arises in the day to day grind of running a business. We get that from Imaging3, which is why I am so confident in the Company's success, but it is also why we see so much whining here, too.
The fact is, the FDA raised 18 questions/inquiries last round. 17 of those were addressed and closed out by the FDA before the April 5 package was even sent in. The only remaining item was this CYA report requested so the FDA could hide behind it if there was ever an issue with the device. They have the report, and it was undoubtedly superlative or it would not have been sent in. If there were any additional issues or questions, the FDA would have contacted Dean in the first 14 days of this review cycle to raise them, as the agency always does for every 510K application. If there were any additional issues or questions that could cause delay, Dean would have informed everyone as he has done every time in the past if there were additional issues or questions that could cause delay. Seeing as that has not happened, and we are approaching the end of the 30-day review period, I am as confident as ever that we are golden this time. There's nothing left that could jump up and bite us at this point.
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