Doc points to Dendreon's 'drug company incompetence'

Count Dr. Charles "Snuffy" Myers as one of the latest cancer specialists who faults a cruddy trial design by Dendreon as the primary reason for the FDA delay in approval of vaccine treatment Provenge.

His comments are available at PharmaLive.com. Here's an excerpt.

"Dendreon made major and obvious mistakes in developing Provenge. The FDA is not some sort of bad guy -- at least in this case and yet Dendreon's stock continues to rise," Myers' says. "The primary end point of a clinical trial seeking FDA approval should be either survival or improved quality of life, but Dendreon still chose to muddy the waters by changing endpoints midway through the clinical trial, forcing the FDA's hand with their poor design."

"This is actually the second time that we've had a useful drug fail in development. The other was Atrasentan (a.k.a. Xinlay)," Myers adds. "Again, it failed not because of the FDA but because of drug company incompetence. While the FDA is far from perfect, people need to understand who to blame in this case."

Myers, a prostate cancer survivor, writes for the newsletter ProstateForum.com.

Pupule Paul is long DNDN.

Transcript: Mike Huckman/CNBC on Provenge activist ad in Wash Post

Here's the full transcript off the Provenge/activist ad segment during "Closing Bell." And yes, I like typing up transcripts when Mike Huckman talks about Dendreon. He's been the most consistent and balanced member of the media when it comes to Provenge. By far.

Closing Bell, Monday, July 16, 2007

Melissa Francis: Investors in a volatile biotech stock are taking their case to Capitol Hill to reverse a controversial FDA decision and their fortune. Their effort doesn't seem to have made much of a difference in the shares of Dendreon today. Take a look at that. They closed the day unchanged. CNBC's pharmaceuticals reporter Mike Huckman joins us now with the latest episode in this soap opera. Mike?

Mike Huckman: That's right, Melissa, a soap opera it is. In this post-Vioxx era, it has become pretty commonplace over the last few years for consumer advocates to launch campaigns to get drugs taken OFF the market, but this is case where a different category of activists is pushing to get a drug put ON the market. (close-up of ad, "DYSFUNCTION AT THE FDA") A group of about 150 investors, patients and their advocates ponied up 24 grand to buy this no-frills, half-page ad in yesterday's Washington Post. It recaps the results of the clinical trials for Dendreon's controversial prostate cancer drug, Provenge, the favorable FDA advisory committee recommendation and subsequent negative decision by the FDA. And it's urging Congress to demand the agency to reconsider. Dendreon investor Arnie Mass spearheaded the fundraising campaign for the ad because he says, time isn't just money here; it's lives.

Arnie Mass: The mistake by waiting is about 30,000 deaths a year of patients who have prostate cancer. These patients can LIVE. We already have evidence of patients living (clears throat) beyond six years that ordinarily would die in 19 or 20 months, so to wait three years is another 90,000 patients that are gonna die.

Mike Huckman: Mr. Mass is referring to the fact that Dendreon says the FDA wants more data about whether Provenge, indeed, extends patients' lives. Preliminary results won't be available, though, until at the earliest, the middle of next year, and complete results are not expected for another two to three years. A Dendreon spokesperson said the company had nothing to do with this ad and that nobody at the company saw it until it ran in the Washington Post yesterday. Last week, Melissa, Dendreon did disclose that the SEC is now doing an informal inquiry into the Provenge clinical trials. Back to you.

Melissa Francis: Wow, what a story. OK, Mike Huckman, thanks so much.

Disclaimer: Pupule Paul is long DNDN.

From the minds and hearts of DNDN's retail investors

The Dendreon forum at Investor Village is a haven for true believers in the Co's pioneering late-stage prostate cancer immunotherapy treament, Provenge.

At least, they hope it will be a pioneering treatment. I won't go into the many levels and chapters of the war between all parties involved. Between lawsuits, the FDA, hedge funds, corrupt doctors, insider information and victimized shareholders, all the info could fill a fat book and then some.

For now, I'll lead you to a highly pertinent post by one of the forum's regulars. In his post, These are the Questions the SEC, the DOJ (FBI), and HHS OIG Should Be Asking..., warlord_2010 leaves no stone unturned.


It's unfortunate that most folks, including myself, have a soft spot in our hearts for the underdog. Since Dendreon went into this uphill battle against many murderous opponents hiding in the wings — the ones who orchestrated the defeat of Provenge — it's been a one-sided, bloody fight. If this were held in a boxing ring, the referee would have declared this a TKO long ago.

Read warlord_2010's list and consider what role the FDA currently plays in saving human life, or whether the FDA has become de-evolved into something it was never meant to be.

Disclaimer: Pupule Paul is long DNDN.

Just another dysfunctional day at Dendreon

This is the kid you love, the kid who has all the potential in the world.

Time and time again, though, he needs help. Someone has to bail him out, not literally. Not yet, anyway.

The good news for Dendreon today was that a late-session surge vaulted the PPS to $8.15, a 4.6% gain. Nice.

Then came the bad news. For those of us who caught the close but ignored after-hours trading, it was a body blow. News of the SEC's inquiry — informal, they say — regarding prostate cancer immunotherapy treatement Provenge scared off the weakest of hands. DNDN traded at $7.63 by the end of the day.

That's 16 cents lower than Monday's close.


It's the latest in the long, unpredictable history of Dendreon. Shareholders are, once again, feeling powerless to help. Only the most patient and optimistic are still in the stock.

Along with the SEC's inquiry, Dendreon announced that it received a letter from shareholders. The letter, addressed to the board of directors, requested immediate investigation and action against exeuctives who may have acted improperly after the FDA's advisory counsel approved Provenge in late March.

Whatever the case is with the SEC — there's no clear indication that it will be as "informal" as suggested — Dendreon may have more than a little scuffle ahead with angry shareholders who have filed lawsuits. If Dendreon execs have, indeed, gained financially by witholding vital information from shareholders, ugly won't begin to describe the train wreck.

Then again, those of us who are long Dendreon already expect the worst, and in fact, all of the worst-case possibilities are probably built into the stock already.

It's just that ... shareholders just want to breathe some air here, and Dendreon management shows no signs of providing an oxygen tank. Par for the course.

How bad is perception plus reality for shareholders? If Gold were fired tomorrow, the PPS would probably spike. Yet, even a dysfunctional family has better prospects if Daddy can just straighten out rather than be removed from the home.

Two days into the week, two days of major news. What more could happen tomorrow?

Disclaimer: Pupule Paul is still long DNDN.