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Re: borntwice post# 20887

Thursday, 07/22/2010 1:16:09 PM

Thursday, July 22, 2010 1:16:09 PM

Post# of 59551
That is what every investor believed. Last October Dean assured us that when the F.D.A . asks for the intended use statement they are at approval. He said that "the nature of the questions being asked made him believe that approval was imminent"....."I have seen this step reached before in previous 510K applications and then approval was granted". He assured us that "it was only the wording" that the F.D.A. was waiting for. So of course we waited right through Nov 13th when the stock hit $1.95. And so so so so slow was the submission for the wording. Dean told us that "he was taking his time because he wanted to get the wording perfect"..."dot all the i's and cross all the t's." he said. "I have been communicating directly with the F.D.A. to get the wording just right". Then we heard that the F.D.A. wasn't happy with the wording, and that a resubmit was necessary. Then it got very quiet...Dean went on a well deserved extended christmas vacation while we watched the PPS going down the drain. Finally reappearing Dean announces that there has been a change in reviewer. It was at this time that I realized that I had to get out....and in a big hurry. It made absolutely no sense to me that the F.D.A. would change the reviewer at the label stage of an application that was already a few years running.