I suspect that management realized early on that the 483 issues are a problem that will cause a delay in approval. However, I also think that they were pleasantly surprised by the panel vote, as we all were, and thus concluded that they will get a minor approvable letter regarding the 483 issues only that could delay marketing till the end of 2007.
They then surmised that this will not make the stock crash as the coast will become clear but will simply make it settle for 2007 at around the low teens level, which is the place were Gold sold his shares. I am guessing that there thinking was that the stock will not pull back enough to cause the initiation of law suits and so they went ahead with their infamous sales instead of taking advantage of the upside to finance the company.
I believe they were surprised once again on May 9, as we all were, by the approvable letter that required further evidence of efficacy in addition to the 483 issues and they realized at that time that they could be in some legal trouble relating to the secrecy about the 483 letter and their selling of shares based on that inside information. I think this is why they went out of their way at the CC to emphasize that the 483 issues are minor and will not cause a delay in approval and that it is the extra efficacy requirement that is the reason for the time delay...
The fly in the ointment here is that the 483 letter may also be the cause why the FDA felt that they could dealy approval until they got further confirmation from 9902b. From the FDA viewpoint, since approval was going to get delayed to 2008 anyway because of the 483 issues, why not delay a bit longer and make sure the data is confirmed. I realize that the FDA decision was mostly political but I think the 483 issues gave them the excuse to cause the delay and ask for more data... If the lawyers could argue such a point in court and demonstrate a possible cause and effect between the delay for effcacy and the 483 letter, then I think the law suit could be quite successful and DNDN may be in trouble...
I am not joining the lawsuit for two main reasons. First I seldom join such law suits because my experience is that the claimants rarely get much from the suit and only the lawyers get the hefty rewards. Second, while I could claim some losses from the pull back after the May 9 announcement, net-net I made a killing on the upside of DNDN following the panel meeting and I am up over 1000% on DNDN for the year. So, from an investment point of view I do not think I have much of a claim given my gains...
AI
