Dendreon Corp fka DNDNQ

[p3analyze]

<lender, would probably want at least some clarification..guaranteeing that there are no material undisclosed CMC issues that imperil approvability >

I have a question about this - I wonder if the lenders had access to the CR letter so as to know exactly what CMCs are. If not then I agree there probably would be some clarificaitons work. Will investment bankers typically not have better disclosure than do retail investors?


<i don't see why it necessarily would (or should) have held up a financing before 5/9 - after all, the 483 was not considered serious enough to prevent Gold & other insiders from selling...
>

The 483 non-disclosure probably was not serious enough to prevent insider sales, but would have generated huge liability to the company had a secondary been done prior to May 9, because the secondary subscribers would have have bought without knowledge of the 483, however benign it was, and their risk reward equation would only have had FDA vetoing AC as the sole risk factor.

If the theory of institution investors are more privileged than retails is true, then I think the following is plausible.

Prior to when Gold sold stock options (April 5th), DNDN completed all necessary remedies to all 483 findings and requested reinspection and received confirmaiton that reinspection would take place prior to PDUFA date of May 15 - my guess is after April 30th (someone noticed tightened security at the NJ plant that day). It proceeded with dialogue with institutions, who agreed to broker the deal if the pending PAI reinspection were successful.

This openned up a window of trading opportunity (per Monique) for Gold and executive. They fully anticipated that they would pass the PAI reinspection, and they know that PAI inspection would not be finalized until sometime between May 5th and May 9th. So they pulled trigger yet believing it wouldn't jeopardize the secondary - I recall someone said if he sold stocks within 30 days of secondary, then he was lible for suit of insider trading if the secondary price is lower than what he sold for.

Unfortunately, the second PAI did not go well, the secondary cancelled. And here we were, Gold had to deal with the consequence of ignoring the likelihood of a failed PAI reinspection.

Edits: if the PAI reinspection took place prior to May 9th, then another 483 would almost certainly have been issued. Gold et al would almost certainly be anticipating a CR letter, regardless whether FDA veto the panel or not.