Showing posts with label immunotherapy. Show all posts
Showing posts with label immunotherapy. Show all posts

Monday, July 16, 2007

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.

Wednesday, July 11, 2007

Has Northwest Bio bottomed out?

Google Finance still has no financial data on it.

Yahoo Finance has some. No chart, though.

No matter if you are a bull or bear, credit is due to Northwest Biotherapeutics. This tiny company, which began the week with a $29 million market cap, is more than a blip on the radar now.

With limited approval in Switzerland to make its immunotherapy vaccine available to brain cancer patients, NWBO.OB is on the map. After taking a major bump down after running up 294% to $7.33, NWBO now sits at $4.20 with a pullback of 42% from the high.

Monday's humongous run was tempered by selloffs on Tuesday and today. Mind you, volume went from 3.9 million shares on Monday to 2.9 mil on Tuesday. Today? A mere 1.2 million shares traded — still a significant number considering the float is a measly 4.17 million. The current PPS is more than double what it was after Friday's close ($2.10).

The decrease in volume may indicate that the selloff is nearly done, and perhaps NWBO has reached a nice, new bottom. The question now that the daytraders are filtering out, is how much is the Swiss deal going to be worth?

There no numbers to work with, but Wolfeman at Investor Village has put together a reasonable list of facts that breaks down the information as well as any.


Still, all the investing and trading are based on the news and speculation. Of course, there's no other headline that grabs attention like "First Cancer Vaccine available."

For biotech investors with an eye on the future — and Northwest Bio's vaccine will be marketed in this quarter — this is definitely a situation worth monitoring. Enter at your own risk.

Disclaimer: Pupule Paul has no position in NWBO.OB.

Monday, July 9, 2007

Northwest Bio beats Dendreon to the punch

For those of you who are long Dendreon, today was either

a. disheartening, or

b. encouraging

I write this because a little-known Co called Northwest Biotherapeutics became the first to gain approval for a cancer vaccine today. Northwest Biotheraputics (NWBO.OB) announced early this morning that its Phase 1 (yes, that is not a typo) treatment for brain cancer has been approved for use in Q3 in Switzerland.

How is it that a Phase I treatment is already going to market in Europe, while Dendreon's Phase 3 Provenge sits idly with prostate-cancer patients waiting month after month, year after year?

Can it be that Northwest Biotheraputics simply has more finesse and maneuverability? Can it possibly be that Dendreon couldn't find a partner if it were the only boy at an all-girls school dance?

In other words, what the frick is going on here?


Northwest Biotherapeutics had a market cap of $29 million before today's session opened. (The Co is so small, Google Finance doesn't have a summary or quote price, though Yahoo has one.) After trading around $2 in recent days, the PPS spiked up at the open before bottoming around $2.50.

From that point on, NWBO.OB rocketed and finished at $7.33, a gain of 249%. Pink-sheet stocks don't trade in after hours, but there is almost absolute certainty that the stock will continue to climb.

European investors will get word of this news when the sun rises there. Media will also pick up the story. They'll learn that Northwest Bio not only has a treatment ready for market this quarter, but also has a treatment in the pipeline for other cancers. The tiny Co from Bothell, Wash. could trounce the bigger boys in Seattle. With all its eggs in one basket — prostate-cancer treatment Provenge — Dendreon could soon be left in the dust.

Full enrollment for Provenge Phase 3 trial 9902B may not be completed until next year, and the FDA clearly has its scopes set on shooting down Dendreon even if interim results are positive. Sure, the FDA is corrupt, but the game still plays on. The clock stops for no one.

Still, NWBO.OB is a risky stock to delve into. With a float of only 4.17 million shares, it's possible the continued rise in the PPS would make Dendreon's zany ride in March and April feel like slow motion. As quickly as the price goes up, however, it can come down. There's definitely risk in trading a stock like NWBO, but the good news is real.

For the Dendreons of the world, stockholders can only ponder and wonder, what the hell? What is it that Northwest Bio CEO Alton Boynton has that Dendreon's top brass does not? Before I leave you with a forecast of more doom and gloom, however, let's sit on the sunny side of the street. Maybe this will encourage CEO Mitchell Gold to pursue Europe with more vigor. If he has, as rumored, already turned down opportunities there in recent weeks, Northwest Bio's Great Leap Forward could prove to be a catalyst.

In other words, Dendreon's Board of Directors might pull their heads out of the sand and light a fire under Gold's okole. If a $29 million Co can do it, what's stopping Dendreon and its well-heeled (re: new slate of options) executives?

Gloom for longs? Yes. But the pressure is mounting. Good pressure.

Disclaimer: Pupule Paul is long DNDN and wishes he had been long NWBO.OB.