Replies to post #4469 on Dendreon Corp fka DNDNQ

[Wolfeman]

Ranchero,
The first question at the AC was in regard to consistency of the manufactured product. Could this question have been in response to issues that the FDA inspection team reported? I agree that these CMC issues are a major management blunder by the BOD. But is it possible that they are minor and Gold said they'll be resolved by the end of the year simply because there is no rush. Also the FDA is obviously busy and a reinspection of a plant that is not fully operating is pretty far down on the list of priorities. It's my understanding that Provenge is being manufactured at the NJ plant. Do you know anything about this? Seems like an expensive building to operate for a few dozen doses of Provenge a month.

Can I just verify something? You are just participating in the lawsuit or did you start it?

BTW, I'm done with Investor Village for good and will be reading and posting here. Those idiots started today by writing mean spirited letters to Rob Stein, the guy who put the Provenge story on page 1 of the Washington Post. They can't even tell a friend from an enemy anymore. I wonder if all their efforts are actually hurting Provenge's chances rather then helping. After all the FDA would never want to seem to be caving to pressure from investors. Ha!

Thanks,
Wolfeman

[nerdseeksblonde]

you may want to mention this
to SEC webmaster and help establish my claim that
there is significant, unmet financial need for fulltext document search and structured documents along with custom search criteria implemented at home by nerd's using the SEC's API ( which they claim is a low priority).

Seriosuly, if you start a lettter writing campaign to decision makers, be sure to indicate that the small investor who happens to have any computer skills can mine SEC data and stock charts to look for statistical anomalies ( grant dates coinciding with price minima, sales coinciding with maxima, etc). Be sure to mention that correlation between various sources- patents, medical literature, etc- is essential to getting context and this requires providing an API for the use, not a fancy web interface that forces you to use a computer for manual operations.

[croumagnon]

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...