The Short Case on Dendreon Corporation

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). The same can be said for Dendreon Corporation (DNDN), which is currently having a rally thanks to an article by the usually sound Adam Feuerstein which suggested that you should wait for it because 'if it works it will be huge' (okay, more specifically, if Provenge is approved by the FDA, it will be huge). He even goes so far as to put a $27 price target on the then $3.80 stock. As the stock was already tough to borrow, it is no surprise that the end result has been a relatively strong rally. The same thing happened to Genta Inc (GNTA) right before its panel meeting in April 2004 - right before it crashed.

Why am I so sure DNDN will fail here? Because just like with AGIX, there is no clear evidence that the drug actually works:

First, Provenge has never hit a primary endpoint, a big no-no for the FDA as the primary endpoint is what the trial is designed to test. 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.

I've heard arguments that survival is the hardest endpoint out there so if they can show a survival benefit, how can the FDA not approve it? The answer is the simple reason that because of the design of the trial, Provenge might have had very little to do with that survival benefit. After disease progression, patients on placebo were given the option of going on Provenge or not. 68% of placebo patients then crossed over and received Provenge but not chemotherapy. If you were on Provenge and progressed, you had the option of receiving chemotherapy right away. This by itself could account for the entire survival benefit seen between the two arms as it is generally better to get chemotherapy sooner rather than later. The company has even disclosed data that showed that Provenge patients who subsequently received Taxotere had median survival of 34.5 months compared to 25.4 months for placebo patients (most of whom received Provenge before receiving chemo). Considering Provenge only showed a 4.5 month difference, this 9.1 month difference is pretty important.

Given these confounding factors it seems clear that the survival benefit is in question and will very clearly be questioned in the FDA briefing documents which will be released on March 27th. So let's move on to the more important statistic, the one that was unaffected by patient crossover, time to tumor progression. Here Provenge showed only a 1.7 week difference (11.7 versus 10.0), a difference that was not significant. And given the imbalance in the arms with factors like Gleason score (a higher Gleason represents more aggressive disease and DNDN itself has referred to it as "one of the most important prognostic factors") where Provenge had a major advantage which could easily explain the meager 1.7 week benefit. The Gleason score breakdown was:

39.0% of Provenge patients and 44.4% of placebo patients had Gleason scores of 8 or higher. These are the patients with the most aggressive disease and worst prognosis.

34.1% of Provenge patients and 40% of placebo patients had Gleason scores of 7, which is an intermediate type of score.

26.8% of Provenge patients and 15.6% of placebo patients had Gleason scores of 6 or less.

In other words, the Provenge arm had an 11.2% advantage in patients with the best prognosis. And in a small 127 person trial in only takes imbalances of a few patients here and there to manufacture a benefit.

The big question is, what is the company thinking, going in front of the FDA with this sloppy data? Well that was not initially the plan. 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 with the FDA (AGIX and Telik (TELK) also had SPA's by the way, so that just proves that SPA's don't count for anything in terms of the FDA signing off on a product). They did initiate the trial and were guiding for full enrollment in 2004. Then 2005, then ...

Well, they just decided that it might take years to fully enroll this trial (a very bad sign as doctors appear completely unexcited) so why not just file with what they have. That is not a very good reason in my mind to file with the FDA, because your Phase III isn't enrolling well (and is still not enrolled). It equates to a biotech hail mary pass. 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.

Besides not trusting management because of promises they have made in the past, I also think the CEO pays himself much too much to be an honest guy. Just like Michael Wick, the CEO of TELK, and Russ Medford, CEO of AGIX, CEO Mitch Gold pays himself a hefty salary of $673,000 (salary + bonus) with an additional $309,000 in restricted stock awards. In other words, DNDN's CEO pays himself over $1 million a year as he erodes shareholder value and can't even enroll a 500 patient Phase III within 5 years.

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 (DNDN is currently guiding for year end 2007 full enrollment, they really mean it this time) as that would more likely be able to definitively prove whether or not Provenge is a real drug or not. This would effectively mean a 2-3 year delay. The stock should then trade at no more than $2, given DNDN will have around $1 per share in cash (about $80m total as of March 31 by my calculations) and the bulls will likely give it some residual value unless the FDA is as unmerciful as they were with GNTA, in which case it would trade to $1.

And as they are burning through cash faster than a Weimar Republic pensioner (sorry. had a Dennis Miller moment for a second there), they are likely to have to raise cash again in the next six months. At $1 they would dilute shareholders 100% for 1 years worth of cash, at $2, around 50%. So this stock would likely be dead in the water for some time.

In conclusion, yes if it works it could be huge, but most likely it won't and if you are left holding this stock, you will end up with far less money than what you put into it.

Disclosure: Author has a short position in DNDN

DNDN 1-yr chart

Comments

[Wall Diver:]

Hmm....a number of factual inaccuracies in this article. Time to document them, with the comments from Maxim Jacobs in quotes.
----------------------...
"First, Provenge has never hit a primary endpoint, a big no-no for the FDA as the primary endpoint is what the trial is designed to test."

The principal trial that DNDN is basing on is the 9901 Phase 3 trial, where the primary endpoint was time to progression (TTP). Hitting the primary endpoint of TTP would mean that the p value equaled or bettered 0.05. The p value for 9901 was 0.052, so it's certainly debatable whether this endpoint was a hit or a miss. Jacobs not mentioning 9901's p value is either true ignorance or categorical dishonesty. While the second Phase 3 trial, 9902A, did not come close to achieving statistical significance in the TTP measurement, the fact remains that Mr. Jacobs saw fit to leave out 9901's actual p value in his article.
----------------------...
"I've heard arguments that survival is the hardest endpoint out there so if they can show a survival benefit, how can the FDA not approve it. For the simple reason that because of the design of the trial, Provenge might have had very little to do with that survival benefit. After disease progression, patients on placebo were given the option of going on Provenge or not. 68% of placebo patients then crossed over and received Provenge but not chemotherapy. If you were on Provenge and progressed, you had the option of receiving chemotherapy right away. This by itself could account for the entire survival benefit seen between the two arms as it is generally better to get chemotherapy sooner rather than later."

There was very little difference between the trial arms in terms of time to first Taxotere treatment. The difference was in the range of 0.5-1.5 weeks, as I recall...and it may have been the opposite of what Mr. Jacobs states..in other words, the placebo patients on average may have received Taxotere earlier than the Provenge arm patients did. DNDN mgmt has stated on more than one occasion that the placebo arm patients averaged more chemotherapy courses than the Provenge arm patients.
----------------------...
"The company has even disclosed data that showed that Provenge patients who subsequently received Taxotere had median survival of 34.5 months compared to 25.4 months for placebo patients (most of whom received Provenge before receiving chemo). Considering Provenge only showed a 4.5 month difference, this 9.1 month difference is pretty important."

This merely indicates that Provenge plus later Taxotere is probably synergistic. If one goes to the link below and scrolls down about halfway to Dr. Petrylak's presentation on Sipuleucel-T (Provenge), the really convincing slide is Slide 18, which compares the median survival of these subgroups:

-placebo arm patients who did not receive salvage Provenge but did receive Taxotere = 20.2 months
-placebo arm patients who, after cancer progressed, received salvage Provenge and Taxotere = 25.7 mo.
-Provenge arm patients who opted for later Taxotere = 34.5 months

Seems pretty convincing to me.
chemotherapyfoundation...
----------------------...
"Given these confounding factors it seems clear that the survival benefit is in question and will very clearly be questioned in the FDA briefing documents which will be released on March 27th. So let's move on to the more important statistic, the one that was unaffected by patient crossover, time to tumor progression. Here Provenge showed only a 1.7 week difference (11.7 versus 10.0), a difference that was not significant. And given the imbalance in the arms with factors like Gleason score (a higher Gleason represents more aggressive disease and DNDN itself has referred to it as "one of the most important prognostic factors") where Provenge had a major advantage which could easily explain the meager 1.7 week benefit. The Gleason score breakdown was:

-39.0% of Provenge patients and 44.4% of placebo patients had Gleason scores of 8 or higher. These are the patients with the most aggressive disease and worst prognosis.

-34.1% of Provenge patients and 40% of placebo patients had Gleason scores of 7, which is an intermediate type of score.

-26.8% of Provenge patients and 15.6% of placebo patients had Gleason scores of 6 or less.
In other words, the Provenge arm had an 11.2% advantage in patients with the best prognosis. And in a small 127 person trial in only takes imbalances of a few patients here and there to manufacture a benefit."

If the TTP of patients with Gleason scores (GS) of 6 and 7 or less were so important, one would think that these patients would have progressed slower than those with Gleason scores of 8 to 10. However, the median TTP for the GS

2007 Mar 26 08:35 AM

[Wall Diver:]

Forgot to disclose in my above post that I'm long Dendreon

2007 Mar 26 08:36 AM

[Maxim Jacobs:]

You bring up some good points Walldiver. Let me try to answer them or at least comment:

- First, it's not an inaccuracy if I don't mention the p-value. They missed plain and simple. The fact that it was close matters to bulls, not to the FDA. Also, even if they hit and it was 0.04 I would question it. Think about it, with a p-value of 0.04 there is still a significant chance that this data is a fake. Coupled with the fact that 9901 was never meant to be a registration trial and it was very small and I just don't see how anyone at the FDA can have confidence that Provenge is definitely a real drug. They will simply make them run another trial, as one is ongoing already. And I wouldnt expect patient groups to be up in arms about Provenge if it is delayed. And as you mention the 9902A trial, I've never seen the TTP data for that one, was it ever disclosed? I'm thinking it will be disclosed tomorrow in the briefing docs and the DNDN bulls may be in for a shock.

-The Taxotere statistical analysis is very questionable. First, it was not an analysis that was planned on being done before the trial and therefore is akin to data mining. Second, the problem with subsets is that the baselines may be even less balanced than in the trial as a whole. We are talking about only around 80 patients among the two trials after all, so there can be a lot of statistical hand waving going on.

-What I would have really liked to see is the TTP and survival for every Gleason Score integer in the trial. Theyre bundling of so many Gleasons together I think makes the data confusing.

2007 Mar 26 09:33 AM

[Wall Diver:]

My initial post was cut off. The final line that begins with, "If the TTP of patients with Gleason scores (GS) of 6 and 7 or less were so important, one would think that these patients would have progressed slower than those with Gleason scores of 8 to 10. However, the median TTP for the GS..."

should be completed with, "...GS

2007 Mar 26 09:40 AM

[Echo To All:]

Mark, the premise of your argument... "there is no clear evidence that the drug actually works" is questionable. as walldriver has shown. (and he is more qualified to debate the efficacy argument than I... far more qualified)

But the logical premise, in my layman eyes, is the fact that people are dying. And there is enough information out there that UNQUESTIONABLY proves the safety of this treatment, along with a very high likely of efficacy. But your statisical argument remains, and has allowed this stock to get punished (or manipulated... whatever word you like to use) on the downside for far too long.

the question any long or short should aske themselves is this... Why would the FDA delay a treatment if there is absolutely NO safety risk with a drug that has shown to increase survivability to a population that is medically underserved?

More information can come out during the committee meeting, that may prove one side correct over the other. But the inforamtion we have now does NOT merit DNDN to have been at 3.68 a few days ago.

2007 Mar 26 09:45 AM

[Wall Diver:]

"If the TTP of If the TTP of patients with Gleason scores (GS) of 6 and 7 or less were so important, one would think that these patients would have progressed slower than those with Gleason scores of 8 to 10. However, the median TTP for the GS 7 or less patients was 9.0 weeks, while the median TTP for the entire placebo arm was 10.0 weeks. This just goes to illustrate the fact that the FDA considers TTP a not so reliable surrogate endpoint, judging from the ODAC meeting a couple years ago on surrogate endpoints for advanced prostate cancer trials. Survival is the true gold standard.

2007 Mar 26 09:54 AM

[Wall Diver:]

Thank you for your civil reply.

- "First, it's not an inaccuracy if I don't mention the p-value. They missed plain and simple. The fact that it was close matters to bulls, not to the FDA. Also, even if they hit and it was 0.04 I would question it. Think about it, with a p-value of 0.04 there is still a significant chance that this data is a fake. Coupled with the fact that 9901 was never meant to be a registration trial and it was very small and I just don't see how anyone at the FDA can have confidence that Provenge is definitely a real drug. They will simply make them run another trial, as one is ongoing already. And I wouldnt expect patient groups to be up in arms about Provenge if it is delayed. And as you mention the 9902A trial, I've never seen the TTP data for that one, was it ever disclosed? I'm thinking it will be disclosed tomorrow in the briefing docs and the DNDN bulls may be in for a shock."

Not sure what your point is...even if the p value was 0.04, that's a 96% chance that the results were not random. Such a tiny miss of 0.002 in TTP is not going to be lightly discarded by FDA biostatisticians. I don't buy the argument that the 95% cutoff point is completely arbitrary, and 94.8% means nothing. In addition, there have been a fair amount of oncology approvals on trials of this size, plus some that weren't randomized and were approved on surrogate endpoints. As for 9902A TTP, the p value was in the 0.7 range, as I recall from the ECCO 2005 presentation. Most of the bulls know this already. Obviously not close, but the story ever since 2004 has been all about survival, especially after the FDA did away with time to progression as a valid endpoint for hormone-refractory prostate cancer patients.

-"The Taxotere statistical analysis is very questionable. First, it was not an analysis that was planned on being done before the trial and therefore is akin to data mining. Second, the problem with subsets is that the baselines may be even less balanced than in the trial as a whole. We are talking about only around 80 patients among the two trials after all, so there can be a lot of statistical hand waving going on."

The docetaxel analysis was released over 18 months after the bears first argued that 9901's survival benefit was due to more patients in the Provenge arm receiving Taxotere, in addition to receiving earlier Taxotere. This analysis successfully refutes that bear argument. The common statistically significant prognostic factors for each trial in overall survival were baseline PSA and number of bone metastases, with disease localization being a stat sig prog factor in 9901 and extremely close to stat sig in 9902A. Gleason score was not a stat sig prog factor in either trial. We haven't even discussed cause-specific survival for the entire intent-to-treat group in 9901. Basically, 13 patients in the provenge arm died of causes unrelated to their prostate cancer, while only 4 patients in the placebo arm did. This improved the p value from 0.01 to 0.002.

-"What I would have really liked to see is the TTP and survival for every Gleason Score integer in the trial. Theyre bundling of so many Gleasons together I think makes the data confusing."

They did that for the three-year survival data in 9901. Obviously, since there are so few HRPC patients with Gleason scores of less than 6, you can count that cohort as Gleason less than or equal to 6.

So, here is that data:
GS less than or equal to 6 Provenge arm: 41% or 9/22 survived for 3 yrs after randomization
GS less than or equal to 6 placebo arm: 28.6% or 2/7 survived
----------------------...
GS equal to 7 Provenge arm: 32.1% or 9/28
GS equal to 7 placebo arm: 11.1% or 2/18
----------------------...
GS equal to 8 Provenge arm: 40% or 4/10
GS equal to 8 placebo arm: 12.5% or 1/8
----------------------...
GS equal to 9 or 10 Provenge arm: 27.3% or 6/22
GS equal to 9 or 10 placebo arm: 0% or 0/12
----------------------...
All GS Provenge arm: 34% or 28/82
All GS placebo arm: 11% or 5/45)
P = 0.0046

I should add that the Cox regression analysis showed that there was an imbalance favoring the placebo arm in the trial...the Provenge patients were sicker on average.

2007 Mar 26 10:27 AM

[Dan Gseekin...:]

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?

2007 Mar 26 11:29 AM

[Dan Gseekin...:]

oooops

Disclosure: Author has a long position in DNDN

2007 Mar 26 11:39 AM

[Maxim Jacobs:]

Dan:

"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":"

One can compare AGIX and DNDN easily. In both cases long positions were based on flawed study data and the argument "if it works, it will be huge." And I don't understand the link between Joe's quote and the discussion we are having on DNDN. I dont know anyone who decided on their AGIX position because of "inside information" from docs. In such a large trial you can't trust a few docs anyway as they might have treated only placebo patients. AGIX, and DNDN, both had armies of people shorting them because of the publicly available information which showed pretty convincingly that neither drug is as effective as the companies want you to believe.

"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)"

I dont think a 120 person trial proves there is a survival benefit. Remember in the earlier TELK trials, the company was touting a survival benefit for Telcyta which evaported once in properly run trials which were actually targeting survival. Survival is only a gold standard when proven in a survival trial. At best this survival benefit is a signal at best and an anomaly at worst. I've seen that countless times in Biotech.

"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?"

The primary endpoint of a trial is always more important than a secondary from the FDA's point of view, especially when you have things like crossovers confounding the secondary data.

"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?"

It is not just about a certain statistic, but about convincing the FDA that the drug works. In a small trial there is a larger chance that you will have a false positive.

"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?"

I guess you got into a groove of trying to correct me but you correct a minor detail without answering the meat of the point which was, they were initially going to run a trial to back up the 9901 data, but couldnt enroll and then decided to go through with an FDA approval. Not exactly a great reason to apply for approval, because docs don't want to enroll patients in your trial. Also, the fact that they couldnt enroll a 250 patient trial makes it even worse than if they couldnt enroll a 500 patient trial.

"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."

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'd be wary of any of these creative statistical analyses as there are numerous ways to manipulate them. Especially post-hoc.

"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? "

I would still want to do a good job, whether or not I had a financial interest. If I believed in the FDA mandate to approve drugs that have the data proving efficacy, there is no way I would approve this drug. I would want to see the additional data first. If the FDA starts just approving every drug out there for cancer (which of course it will never do) it would probably be much harder for patients to find the right drug for them as they will be busy taking placebos.

2007 Mar 26 01:42 PM

[EP:]

Thank you Maxim. I agree with you 100%.

2007 Mar 27 04:10 PM

[dorotie97:]

"I would still want to do a good job, whether or not I had a financial interest. If I believed in the FDA mandate to approve drugs that have the data proving efficacy, there is no way I would approve this drug. "

Get real. whether or not. sure. you do have a financial interest in seeing Provenge fail and seeing cancer patients die and it was you and other shorts' efforts that contributed to shelving of other cancer drugs (e.g. for breast cancer) because the company could not raise as much money as it wanted through its offerings. Now shorts are selling shares that don't even exist. This is dirty business if you ask me.

But my issue with you is bigger than this. You are misrepresenting the company. I wonder why these shorts, and their crooked analysts keep misrepresenting things. You owe the company and the public a retraction of your original message and a correction of items which you misrepresented. I'll let you do it on your own and correct your false misrepresented and defamatory statements and I hope you do it voluntarily because all options are on the table for us and we will take action against crooked activities no matter how big you think you are.

2007 Mar 27 04:18 PM

[Dan Gseekin...:]

"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

2007 Mar 27 05:19 PM