InvestorsHub Logo
icon url

IMGGorBust

07/27/10 1:38 PM

#21174 RE: ounceoflogic #21173

There were two issues that came up at the same time. One issue was the reviewer discovering a couple of image files that wouldn't open on his computer (note that he did have a hard copy of everything he also had electronically). The other issue was a series of questions all asking the same thing... why has Imaging3 included certain unusual sets of data and information in the evergreen, evolving application. The answer to each of those questions, coming in piecemeal as the reviewer made his way through the application front to back, was the same... the nutter FDA reviewer, who had been fired, asked for all of this unusual data and information. So Dean addressed both issues. He sent back the couple of image files that the reviewer couldn't open, and he sent the full application annotated to identify each set of information that was included only because of the prior reviewer's off the wall questions. The idea was to speed the process along so the reviewer would not have to sit there and scratch his head asking why certain information, that would not typically be included, was included.

The application is an evolving document. You don't remove information, you only add to it. All of that useless information was in there and was confusing the current reviewer. Dean made a wise judgment, in my opinion, to point out exactly what was in there because of prior questions, and what those questions were.