Pharmas Market with Mike Huckman

Dendreon's Provenge: Soap Opera Drama Over SEC Probe?

While I'm sitting in a plane on the tarmac at Newark Liberty Airport for going on four hours now I write about the latest twist and turn in the Dendreon saga.

Late Tuesday, in an SEC filing, the company disclosed that it got a letter dated July 9th informing Dendreon that the agency has launched an informal inquiry "related to the Company’s clinical trials for Provenge ®, the Company’s Biologics License Application for Provenge filed with the U.S. Food and Drug Administration (“FDA”), and the FDA’s review of Provenge and related correspondence to and from the Company, from January 1, 2007 through the present."

The same filing also makes mention of a July 2nd letter it received in connection with an investor lawsuit alleging "damage to the Company from alleged wrongful disclosure and insider trading and demanding that the Board investigate and take legal action against certain Dendreon officers and directors. The wrongful disclosure allegations stem from Dendreon’s disclosures surrounding correspondence with the FDA during the first half of 2007 pertaining to the Company’s Biologics License Application filed with the FDA for Provenge. This potential claim is not against the Company. The Company’s Board of Directors will be evaluating a response to the letter."

Dendreon says it won't talk any more about the SEC probe until it's finished but investors are talking plenty. The stock, which rallied to close over $8 on Tuesday, fell when the news hit after hours.


The Dendreon story has now officially turned into a soap opera. Patient activists and advocates have made it clear they prefer to be spared the drama and to be given access to the drug.

Questions?  Comments?

Related Tags