Dan GseekinAlfa

Dendreon Jumps on New Cancer Vaccine Report

Dr. Sclom doesn't seem to have COI with big pharmas and/or with other competing biotechs and/or with Venture Capital Funds that invest in biotechs, it is likely that he doesn't advise to hedge-funds and that he does not participate in FDA Panels on behalf of Pazdur after ommitting material information in his FDA-waiver request. Hence, his studies do not carry any scientific merit. Moreover, Schlom has to understand that tumor shrinkage is the gold standard for terminal diseases. Survival, pain and side effects are nothing but surrogate markers.

What a waste of time to conduct scientific studies or to participate in 2-day FDA-NIH-NCI immunotherapy symposiums a couple of weeks prior to AdComs ... the FDA and the pharmaceutical world are all about "HUMAN NATURE"


(or, in other word - CORRUPTION)

Dendreon: I Want the Truth

Excellent post, KK.

You might have forgotten to mention the new FDA regulations that prohibit the commissioner from approving drugs of sponsors listed on the REGSHO list. Moreover, FDA panel members with COI (Conflict Of Interest) should influence the FDA's final decision by posting their opinions on Cancerous magazines and are authorized to overrule any Panel decision if such decision is against their personal financial interest and/or against the financial interests of their sponsors (WS firm and/or Big Pharma) and/or the interests of offshore hedge-funds owned by their family members. A "COI Panel Member" is entitled to force the FDA to submit a CR letter to companies who sponsor novel drugs that would compete against a drug that the "COI Panel Member" is the lead investigator, especially if this drug is in a late stage clinical trial and that it demonstrates lower efficacy and higher safety concerns in comparison to the novel drug THAT HAS TO BE APPROVED IN A NON-CORRUPTED ENVIRONMENT.

A Revealing Move: Hastings Graduates from Netflix To Microsoft

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Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints

It is time to call the money-moving truck fleet as this is wealth re-distribution time --- from the HF crooks to the retail investors!!!

MAXim, oh poor Max, MAX PAIN is DNDN's shareholders GAIN!!!

|^^^^^^^^^^^^^|||___
| $ $ DNDN $ $ _||||__\,__
| "Screw the shorts" __|_] ]
(@)'(@);;''''(@)*(@)**...


|^^^^^^^^^^^^^^^^|
| DNDN LINES | . |"""\.., ____
|_..._...______===|= |__|...,....]]
"(@ )'(@ )""""*|(@ )(@)***(@)


|^^^^^^^^^^^^^^^|||___
| $$$$ DNDN $$$$ ||||__\,__
| PROVENGE ____|__] ] ]
(@)'(@);;''''(@)*(@)**...


It could even be a good opportunity to squeeeeze Edeleman's Perceptive Biotech Fund a little more (before it goes belly up) by shorting some IDEV... hmmm....

Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints

thousands of new retail investors, institutions (only 30% of the float is held by institutions) and a handfull of crooked hedge-funds (short interest - around 35,000,000) will all run after a float of 82 million shares most of which is held in VERY strong hands of retail investors that weathered the psychological war of the shorts and know the real value of DNDN.

Provenge's (sexy, if I may say) story is so amazing that it will reach the cover of many magazines in a matter of days.

HUGE DEMAND
VERY LITTLE SUPPLY


-->> PERFECT STORM

Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints

Max pain --- My GAIN!!!

:-)))))))))))

Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints

Maxim, did we read the SAME briefing documents? It took you 24 hours to post this MISLEADING "analysis" report so I am sure that you read the entire package very carefully. So let's examine your conclusion:

"appears to be an increase in the number of cerebrovascular accidents, with 5 people dying in the Provenge arm compared to 0 in placebo. "

-->> This is a LIE. Please check #2 in www.fda.gov/ohrms/dock... ... quote:
"Page 3, safety results, 1st paragraph, replace the phrase “compared to none in APC-Placebo treated subjects” with: “compared to 2.6% (2 out of 78) in APC-Placebo treated subjects.”

Hmmm... how come you missed this "LITTLE" correction? This minor correction makes this entire CVA thing a NON-ISSUE (and it is worthy a lengthy discussion, but perhaps you should first explain your readers why you've misrepresented the facts ONCE AGAIN - as all documents were posted at the same time.)


Now let's proceed to the meat of the report and let's jump right to the CONCLUSIONS of the biostats reviewer:

"Conclusions

· Based on the results of the statistical analyses of the efficacy data presented by the sponsor and the results of analysis performed by this reviewer, it appears that the two studies provide some evidence in support of using Provenge for the treatment of men with asymptomatic metastatic androgen independent prostate cancer.



· However, the key efficacy evidence (difference between the two arms in overall survival) is based on post-hoc analyses. Although it is impossible to precisely estimate the false positive rate due to the nature of the analyses, it is certain that the level of falsely claiming effectiveness for this product is substantially higher than the one in a conventional setting.



· It may be important to weigh the following points while considering the unfavorable strength of statistical evidence: 1) showing statistically significant difference in overall survival in Study 9901 and showing a trend toward improvement in overall survival in the second study; 2) showing a trend in favor of APC8015 arm in all comparisons for other important endpoints; 3) the safety profile of the product; 4) other existing effective treatments for the targeting patient population.



Let me post again the third and final conclusion as written by the FDA (stat) reviewer:

It may be important to weigh the following points while considering the unfavorable strength of statistical evidence: 1) showing statistically significant difference in overall survival in Study 9901 and showing a trend toward improvement in overall survival in the second study; 2) showing a trend in favor of APC8015 arm in all comparisons for other important endpoints; 3) the safety profile of the product; 4) other existing effective treatments for the targeting patient population.




Maxim, one more interesting point that is worth a lengthy discussion is about the recent ILLEGAL "printing/issuing" of phantom shares (aka "naked shorts") by the shorts. Your comment about this ILLEGAL activity will be very interesting ...

The Short Case on Dendreon Corporation

"One can compare AGIX and DNDN easily."

-->> This is like comparing an apple to a rock. DNDN completed its clinical trials which were then reviewed by the JCO. The only PUBLIC info wrt AGIX was pre-clinical and their phase 1-2 studies. Some criminals are calling medical centers that run the clinical trials and ask for inside info. One of these criminals is an analyst called Dr. Jonathan Aschoff that happens to be one of the 2-headed-monster that bashes DNDN day in and day out. Moreover, the abovementioned Joe Edelman is CONSIDERED to be one of DNDN's major shorts. Co-incidence? maybe ... but maybe not.

It will be interesting to hear ANY comment from the likes of "Bumblebee" whose contribution to this discussion has been nothing more than a disruptive "100% agree".


" In both cases long positions were based on flawed study data "

-->> Please explain DNDN's "flawed study data" in light of today's FDA briefing documents. What EXACTLY did you find "flawed"?


"I dont think a 120 person trial proves there is a survival benefit."

-->> Quote from the SUMMARY of today's STATISTIC briefing review: "1) showing statistically significant difference in overall survival in Study 9901 and showing a trend toward improvement in overall survival in the second study".

It seems that the FDA thinks differently...


"It is not just about a certain statistic"

-->> It IS about SURVIVAL ... that's all the FDA cares about. As quoted above, the survival in 9901 is STAT SIG, regardless of the sample size.



"I dont think anyone has ever tried to bribe a doc on a FDA panel. Sounds like a great way to land in jail. "

-->> I fully agree that this is a great way to land in jail. Moreover, printing phantom shares, also known as "NAKED SHORTS" is also CRIMINAL. The "only" problem is that the SEC has yet to force this rule and to punish the CRIMINALS that manipulate the market by selling phantom shares. Why do you think that DNDN is on the REG-SHO list, Maxim, do you think that there is a "bona-fide" to naked short DNDN in light of the recent positive news?


and lastly, dorotie97 was on the money with her lastest post. So many false "analysis" by the Maged-Jonathan duo - and yet not a SINGLE "I was wrong in my prior assumption that...."

In any event, I would also urge that Adam Fueurstein's $27 is way too conservative, since he used a $30,000/patient assumption. A quick correction to $45,000/patient will up his price target to around $40, and then one has to add int'l sales, label expansion (ADPC - 5x larger than AIPC) and pipeline --- all for sale today for $4.60, with a 50% downside to $2.50 .... I find DNDN as a bargain - shorts' implied approval chances are 15% (or less).

I made my bet - I am LONG

The Short Case on Dendreon Corporation

oooops

Disclosure: Author has a long position in DNDN

The Short Case on Dendreon Corporation

Some quick comments:

1. "Back in February I wrote how the "if it works, it will be huge" argument was not a very good one for owning Atherogenics (AGIX)"

--> How can one compare AGIX and DNDN??? Was AGIX rejected by the FDA after showing survival benefit? AGIX had a CLINICAL RISK (no phase-3 data was PUBLICLY out) -- so it was anybody's guess what would be the outcome. Right? WRONG! Joe Edelman has admitted in an interview that analysts call doctors that participate in clinical trials for "inside info":

seattletimes.nwsource....

quote: "...
"As soon as money gets involved, it attracts people, and people go to greater and greater lengths to get an edge on their competition," said Joe Edelman, portfolio manager of Perceptive Life Sciences Master Fund, a $600 million biotech hedge fund in New York.

The way to get an edge on Wall Street is with better information, Edelman said.

"If everybody has the same scoop, it's not a scoop," he said. "People will go to great lengths and throw a lot of money around to outdo the next person."


2. "... And while there was a survival benefit in the D9901 trial, it was only a secondary endpoint and therefore was never designed to conclude on whether or not Provenge extends survival. "

--> Maxim, the FDA has "reserves alpha" for SURVIVAL regardless if it is an end-point. Please check the FDA's decision re carvedilol". The meaning is that if a company shows the GOLD STANDARD - the company gets this extra alpha ON TOP of the primary endpoint(s)



3. "... So let's move on to the more important statistic, the one that was unaffected by patient crossover, time to tumor progression..."

--> HUH??? MORE important statistic ... in comparison to WHAT? Would one prefer to have a longer "time to tumor progression" or longer "SURVIVAL" with MINIMAL SIDE EFFECTS?


4. ".... And in a small 127 person trial in only takes imbalances of a few patients here and there to manufacture a benefit. "

--> Statistics 1.01, Max? Why do you think that BP are running huge trials? Isn't it in order to power the trial and demonstrate a useful benefit? "MANUFACTURING a benefit (ie, p=0.01 for survival, for example) in small trials is MUCH HARDER than with large trials, isn't it?


5. "For those of you following DNDN for years as I have, you will remember that initially they were going to run a 500 patient confirmatory Phase III under an SPA"

--> WRONG ... the initial SPA was for a 250-patients 9902B study. it was later expanded to 500. But who really cares about the fine details?



6. " ... And while we are on old management promises, remember how they were in final discussions with 2 or 3 potential partners for Provenge in 2004? What happened with that? I guess the experts in Large Pharma didn't believe the data either. "

--> This surely hurts UBS that missed some IB fees... The reason is simple ... By that time, DNDN realized that they have the golden egg ... that they are about to show a SURVIVAL BENEFIT. Why would they give this golden egg for a valuation that corresponds to a phase-3 company (and probably to lose control of the cassette technology).


7. "So what happens with DNDN stock? I think the FDA will do the prudent thing and recommend that they wait for the confirmatory 9902B trial results to come out"

--> I bet that some shorts spent hours speaking to doctors that will participate in the AC. I hope (and believe) that regardless of your (indirect?) offers to them, those top-notch MDs understand that there is NO REASON to wait 3 years to see the results of a powered study with 95%-chances-to-succeed... (this has been analyzed before - given that it measures SURVIVAL using Cox-regression -- p=0.0006 in the combined 9901+02A for Survival/Cox is a nice starting point) AND considering the mild side effects of Provenge AND considering that over 50% of the pts prefer NOT to take the only available drug today for AIPC.


My last point, Maxim, assuming you had no financial interest, what would YOU vote at the AC based on the data that we know TODAY?