3SOF

I have wondered why DNDN has such a high short position. It seems to defy logic as the potential damage can be substantial when the 9902 data will be published (this summer!) Today skcotswonki posted the full background for the present PPS and it is really interesting reading so I hurry to quote it below:

QuoteDendreon reported final data on 9901 for time to disease progression that barely missed statistical significance, but a subset of the trial, those with Gleason scores of 7 and under were very significant. Dendreon redesigned a new trial, 9902B, to test for just this subset since the FDA doesn't approve drugs with retrospective analysis that wasn't established as part of the original protocol.

Dendreons arranged to have UBS underwrite a stock offering which was oversubscribed. Brean Murray's analyst Ashcroff put a buy on Dendreon in April with a $21 price target. The market, especially biotech stocks, slumped in the summer of 2004.

The plan was the company would seek FDA approval for Gleason scores of 7 and under and was negotiating in advanced talks with two potential partners. The partnership was never inked because Dendreon wanted too much of the U.S. market for itself. This was perceived as a negative by Wall Street.

UBS changed biotech analysts in the middle of 2004 and the new analyst, Maged Shendousomething, put a buy on Dendreon even though he had not previously followed it because the firm had a lot of Dendreon stock. This is a typical Wall Street practice.

Then, those of us who owned the stock were pumped on October 28, 2004, when the Company reported final survival data for 9901 showing 34% on Provenge were alive after 3 years vs only 11% on Placebo. The 4 1/2 month median survival was the longest extension of life in late stage AIPC patients ever seen in any published data for any form of Prostate Cancer treatment. The stock had slipped over the summer and rose back to $13. The company declared the price of a partnership had just gone way up.

Then a very unexpected and still mystifying thing happened while the Company was reporting on the data to analysts in a conference call (which some of us listened to). Dendreon released topline data and stated the full data would be released later at a scientific conference, fairly standard procedure in Biotech. The Brean Murray analyst Ashcroff, who had the highest price target on the Street, stood up and said Dendreon was hiding the data because they didn't design the trial correctly and, just like biotech company Genta, the trial arms were unbalanced and the sickest patients were crowded into the placebo arm. He basically called Gold a liar in front of everyone and placed a sell and $6 price target on the stock.

Maged of UBS, who didn't really know much about Dendreon and only had a buy because of the large following at the firm from the secondary offering, panicked and assumed Ashcrof knew something, so, he also downgraded the stock because of potentially poor data and placed a $6 price target on the stock.

I have never heard Ashcroff comment on Dendreon since. I think he is either incompetent, a self-promoting egomaniac, or was working for short interests all the time. You don't put a strong buy on a stock in April and accuse its CEO of lying in October after releasing breakthrough data.

In January, a press release was issued stating 9902A failed to meet significance for time to disease progression, even in patients with Gleason scores of 7 or less. However, the interim survival data was similar to the final 3 year and medium survival data seen in 9901. This is the trial we are waiting on this summer. The stock sank on the topline negative because of a poorly worded pres release that buried the good news in paragraph three, a journalistic no-no. No partner, no clear Gleason 7 and under pathway to the FDA, the stock was roasted. It didn't matter that TTDP is hard for Provenge because it takes a few weeks to work and this disease progresses within a few weeks. If Provenge was judged from time to infusion rather than randomization, Provenge achieved significance. But the trial design was established for time from randomization and not ime from when Provenge was administered, sometimes a two week gap or more. Fa

Dr Small reported great data on 9901 at the February ASCO Symposium that showed no imblance in the trial arms. In fact, the placebo participants were slightly healthier than the Provenge participants. Yet the damage had been done to Dendreons reputation primarily because Maged kept his negative stance. After ASCO he was clearly dumbfounded and stuned by the data and couldn't believe how good it was. But he said nothing in his reports and tried to save face. A few months later he upgraded Dendreon to neutral but kept the $6 price target since the stock was still under $6.

Failed expectations, poorly worded press releases, failed analysis by Wall Street, poor investor relations, and very powerful shorts are why Dendreon is stil $6.

But none of that matters longterm. Nor do positive comments matter. The only thing that will matter is Provenge and the 9902A data. Nothing anyone says or does will change the facts. And the truth is on the way.

In Ashcroff's last (as fare as I know) research report from January 2005 he says that any event related short squeeze would be transient and only serve as an opportune time for additional selling. (se below).

He most obviously know that this is not correct as an event related short squeeze would be set off by the FDA approval or likely approval of Provenge. So why is he lying? I think there is more to this story than what meet the eyes and I think I will profit from it 

today's early pop is probably related to the fact that DNDN was mentioned in CNBC in relation to MRK-GENR cancer vaccine partnership (as far as I know, GENR's vaccine is in a VERY early stage of its clinical trials)

Thanks Stockpicker,

That one had escaped my radar screen. Nice to see interest from "big guys". Dendreon is not looking for a partner at present but an approach from one of the large players could be interesting.

Geron's cancer vaccine is in PhaseI/II. We are hopefully close to file with FDA!

DNDN pushed higher yesterday on a generally weak market. I don't know if the stock is now ready to resume its bullish trend, but there's reason to believe the technical target of the breakout, at $8.10, will be reached over the coming weeks.

Holding DNDN.

Nothing new from the technical or fundamental side on DNDN. I'm holding at least until the technical target of the breakout at $8.10 is reached or, if I'm wrong and the stock closes below the blue asceding trendline.

DNDN continues to climb slowly, but momentum can pick up due to these news today:

Dendreon Completes Enrollment in Phase 3 PROTECT (P-11) Clinical Trial of Provenge in Early Stage Prostate Cancer

(stockpicker warned me this news is one month old, but an interesting read anyway, so I'll leave it. No change in the plan of holding DNDN)

David, this news is from June 21 (but I will take a pop anyday... 

Lol, I misunderstood the date, thanks stockpicker 

I'll edit the post ...

On FIRE !

Nice pick, David.

-Jeff-

really on FIRE:

Dendreon's Second Randomized Phase 3 D9902A Trial Shows Provenge Extends Survival in Patients With Advanced Prostate Cancer
Thursday July 21, 9:35 am ET 
-- Company to Host Conference Call Today at 11:00 a.m. ET --


SEATTLE, July 21 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that the analysis of the final three-year survival data of its second Phase 3 study (D9902A) of Provenge®, the Company's investigational active immunotherapy for the treatment of prostate cancer, showed a survival benefit in men with advanced prostate cancer who were treated with Provenge. Prostate cancer is the most commonly diagnosed non-skin cancer in the United States and the third most common cancer worldwide. The Company will host a conference call today at 11:00 a.m. ET.
In the D9902A study, the three-year final survival analysis in the intent-to-treat population of the double-blind, placebo-controlled study of Provenge in 98 men with asymptomatic, metastatic, androgen-independent (hormone-refractory) prostate cancer showed a 20 percent improvement in median survival for patients who were randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo. As expected, the results from this study did not meet the criteria for statistical significance based on a log rank test. A secondary analysis using a Cox multivariate regression analysis of overall survival, which adjusts for prognostic factors known to influence survival, met the criteria for statistical significance. The hazard ratio observed in this analysis was similar to that seen in the Company's first Phase 3 study (D9901).

As reported earlier this year, the final three-year follow up of the D9901 study of Provenge in 127 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.01; hazard ratio = 1.7). This hazard ratio implies that patients who received placebo have a 70 percent greater relative risk of dying than patients who received Provenge.

A supplemental analysis that examined pooled survival data from the two companion Phase 3 clinical studies (D9901 and D9902A) showed a statistically significant survival benefit in the overall intent-to-treat population of 225 patients. In this analysis, a 23 percent increase in median survival was seen in patients randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo. In the combined D9901 and D9902A analysis, a Cox multivariate regression analysis of overall survival also met the criteria for statistical significance.

Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.

As in previous studies, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.

"We believe the data from this second study support what we saw in the first Phase 3 trial -- that Provenge prolongs survival in men with advanced prostate cancer," said Mitchell H. Gold, M.D., Dendreon's president and chief executive officer. "We plan to share all of the data collected to date from our clinical studies of Provenge with the FDA to determine the most efficient pathway for bringing Provenge to market."

"The results of this trial support our understanding of the potential utility of Provenge in the treatment of patients with advanced prostate cancer," said Celestia Higano, M.D., director and associate professor of the GU oncology clinical research group at the University of Washington, Seattle and a principal investigator in the D9902A study. "The survival benefit observed in these studies combined with a favorable safety profile holds promise for the many prostate cancer patients who have few appealing treatment options available to them."

More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease.

Study Details

The study, known as D9902A, is a double-blind, placebo-controlled Phase 3 trial designed to evaluate Provenge in men with asymptomatic, metastatic, androgen-independent prostate cancer. D9902A was originally designed to be the companion study to Dendreon's completed first Phase 3 study D9901. The D9902A study was stopped in 2002 after 98 patients were enrolled when the analysis of D9901 showed that no statistically significant benefit in time to disease progression had been observed in the overall group, but that a benefit was seen in the subgroup of patients with Gleason scores of seven and less. In January 2005, the Company announced that the primary endpoint of time to disease progression in D9902A did not show a statistically significant delay in the overall group or in the Gleason score subgroups. Three-year follow up of patients for survival was the secondary endpoint of the D9902A study.

About Provenge

Provenge is designed to stimulate a patient's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP).

Provenge is being further evaluated in an ongoing Phase 3 study in asymptomatic, metastatic, androgen-independent prostate cancer (D9902B). It is also being evaluated in a Phase 3 trial, known as PROTECT or P-11, in men with early stage prostate cancer.


    Conference Call
    LIVE Access on July 21, 2005, 8:00 a.m. PT; 11:00 p.m. ET:
     -- Phone 800-240-8621 (domestic) or +1-312-205-0055 (international)
     -- Webcast connection through the Dendreon website at www.dendreon.com in
        the Investors/Webcast section.

    REPLAY Access:
     -- Phone replay, available for 3 days by calling 888-203-1112 (domestic)
        or +1-719-457-0820 (international); Passcode:  5910894
     -- Webcast replay is available for 90 days from the Dendreon website at
        www.dendreon.com in the Investors/Webcast section.

bought DNDN for an intraday move..crazy move this morning...maybe a move like MNTA..great results!  check it out 

I know g , I bought some a little after you did and already up .20

11 am is the CC about the news...could really move into that 

Hi all ... a first time poster ... this site is great.  I have been in and out of DNDN a couple of times and following for several months.  I had pieced together about the same story as in Michael's post from a few days ago.  I am not much of a technician, but the fundamental story sounded good, every insider was buying (there was a corporate resolution requiring ownership ... to me that is a board trying to send a signal to the market), and a vociferous group of shorts on message boards with 23% of the float sold short.  The book on the company is $3 and almost all of it is cash.  Unlike so many biotechs, DNDN seems to have kept marketing rights.  All told ... not a ton of risk, and a really staggering upside speculation.  Today's good news confirmed exactly what DNDN has been saying all along ... revamping the tests per FDA guidance produces one type of statistical significance but not another.  If this drug goes forward ... prostate cancer is common and a growing population of elderly folks ... the various estimates are all huge on market potential (pick one - all are big numbers).  I jumped in and doubled my position with the market news this morning.  I am appreciative of seeing the confirming technical analysis and astute observations on this board. 

tat would be nice. Its been a rough week for me. We all have them once and while. I could use a few xtra k'sss in the ole bank account to close the week.