3SOF

Quote from: la-onda on September 30, 2006, 03:59:06 AM
not much price action after the 3 presentations hold on conferences....

Oliver,

Players might be tired of "Waiting for Godot."  At least, that's how I felt. 

Quote
more patience from my side will hopefully rewarded

I hope so, too, Oliver.

Technically, the break of the channel (red) was a pain in the neck, but maybe the Falling Wedge (blue) will break out to the upside.

Good luck!

fyi:
Mitchell Gold - Dendreon President and CEO
Insert forward looking statements and risk factor disclaimer

Let me tell you a little bit about the company. The company is headquartered in Seattle, Washington. It was founded in 1992 from 2 scientists out of Stanford University. We recently built out a commercial manufacturing facility in Hanover, New Jersey. And that's 158,000 square foot manufacturing plant that will serve as the commercial site for the launch of our lead product candidate Provenge. We currently have 220 employees that are mostly focused today on the commercialization today of our lead product candidate Provenge.

So what does Dendreon represent from an investment opportunity today?

I think it represents a very compelling investment opportunity.
We have the potential to be the first cancer immunotherapy to the market. We show a very strong survival benefit in phase 3 clinical studies. There is a significant amount of physician interest in bringing better tolerated and less toxic forms of therapies to patients with late stage prostate cancer.

We currently own 100% of the worldwide rights to our lead product candidate Provenge and we're studying Provenge not only in late stage prostate cancer but also in early stage prostate cancer as well. We believe our androgen delivery cassette technology has been validated with the survival data that we've seen in our lead study with Provenge and that we can apply that to other antigen in vivo types and toward other cancer indications.

So what does active immunotherapy represent from a cancer treatment perspective?

Well these are much, much different than chemotherapy type products. They are designed to be highly specific, potentially affecting only cancer cells. They are very well tolerated when compared to traditional chemotherapies, and they can be used both prior to and in combination with other agents. So for Provenge, we see Provenge being used as front line therapy in patients with metastatic androgen independent prostate cancer, but it can also be used in combination with other products either in early stages of disease or chemotherapy can be added along with the regiment later on for patients with late stage prostate cancer.

The patient completes a full course of therapy with Provenge over a 1 month period. After they are done with that treatment protocol they can go on and live their normal lives so they're not having to go in every three weeks and get an infusion of a chemotherapy based regiment. They get their treatment regiment in 1 month and they go on and they live the life that they want to live. That is an important feature for patients. And of course the potential for the immune response to be durable is very important for these patients so we see that really bear itself out in the survival data from our primary phase 3 study 9901.

So why are we so excited about Provenge?

This is a slideshow highlighting the data from our first phase 3 study 9901. That study was a large double blind randomized placebo controlled study. It showed a 31% delay in time to disease progression which was a primary endpoint of that study, but more importantly it showed a 41% overall reduction in the risk of death, a median survival benefit of 4 1/2 months, and that survival benefit was statistically persuasive, with a p value of .01, and clinically meaningful. It's much more significant than what we are seeing with the current standard of care in Taxotere. Most importantly Provenge was very well tolerated so that therapeutic index of this product was very different than what you see with traditional chemotherapeutic agents.

This is a new class of therapies and we believe that one of the key features, one of the key reasons that we've had the success that we've had is because the proprietary technology that resides in our antigen delivery cassette. The antigen delivery cassette is something that is unique to Dendreon and there's two key principles behind it. First that we select a well validated and well characterized target, in the case of Provenge that target is represented here by the orange structure is prostatic acid phosphatase and we fuse that to a dendritic cell binding protein gmcfs and that fusion protein allows us to get much more efficient antigen uptake by the antigen presenting cells then if we just used the naked antigen by itself. 100% of our patients generated immune response against the cassette itself. That's one feature.

The second is that we manufacture this as a recombinant protein so we don't source our antigen from a patient's own tumor tissue and we don't source our antigens from algenetic cell lines. We make this through standard manufacturing biologic techniques and as a result it's highly scalable, we've scaled it up to 2000 litres, which is our commercial launch scale. But much more importantly from a regulatory perspective, it's extremely well characterized. So we know exactly what this protein looks like on ?paresis.

Now how does this work with the immune system?

I am going to show you a video here that highlights how this program works.

see slide show
http://www.dendreon.com/img/DendreonImmunotherapyAnimation-ref.mov

We're all very familiar with the advent of monoclonal antibodies and what they meant to the treatment of different types of cancers. Monoclonal antibodies are a passive form of immunotherapy. You give them and you have to repeatedly administer those products. This new class of products known as active cellular immunotherapies is very different. Once you administer these products, the body creates a memory t cell response and they have the ability to stick around and be much more durable. Very similar to the immunizations that we've received against pathogens such as measles, mumps and rubella. So we're leading the way for this this first in class type of product, to bring this type of product to patients with late stage prostate cancer.

So what's the need for a product like Provenge?

If you looked at the spectrum of patients with prostate cancer today what's amazing to me is that while there are a million patients that have a diagnosis of prostate cancer, about a half a million of those men are currently actively being treated for the disease. It's usually they've been initially diagnosed, or they've been treated and they've recurred. The primary forms of treatment include surgery, and radiation therapy and sometimes cryotherapy. About 40% of those men will fail primary therapy, and they go on what's known as androgen deprivation therapy LHRH ?therapy. That's not a pleasant experience for most men. All men will eventually become resistant to androgen deprivation therapy, they become what is know as androgen independent or hormone refractory. And for those men there are few appealing treatment options available to them today. The label that we are currently persuing for Provenge, will position it for frontline therapy for men with asymptomatic metastatic androgen independent prostate cancer. Taxotere is currently approved for the treatment of asymptomatic men and symptomatic men and in the asymptomatic setting only about 5% of patients are currently electing to go on Taxotere. Once they are symptomatic it is closer to 20% of the patients are currently electing to go on Taxotere. So there is a hugh gap here and a need for new treatment options that are better tolerated for patients with asymptomatic androgen independent prostate cancer, and that's what we're persuing in our BLA filing with the FDA this year.

If you look at the market size for this patient setting there is about 132,000 men with hormone refractory prostate cancer, of which about 96,000 are metastatic. It's a fairly large patient segment for us to be persuing on our primary label. Now this is the data for the Taxotere label. Again Taxotere is the only form of currently approved therapy available for these patients. The median survival benefit is 2.4 months, this is from the Tax 324 study that was published in the New England Journal of Medicine. That survival benefit typically is associated with significant ?morbidities or significant toxicities, the biggest one is being the male changes and the peripheral neuropathy, but certainly also the neutrapenic changes are debilitating for these patients. So it shouldn't really be a surprise, and this was a study that was conducted by the largest prostate cancer advocacy group, when they polled patients to see how they were satisfied with the current treatment regiments, only about half of those patients said that they were currently considering chemotherapy as an option. When you actually look at the usage patterns it's consistent with that you're seeing about a 14% overall penetration for Taxotere in patients with hormone refractory prostate cancer. So there is clearly a need for new treatment options.

In summary androgen independent Prostate Cancer is a deadly disease. On the average these patients die in about 19 months. There's been a modest survival advantage but an important one seen with docytaxl regiments that provides about a 2.4 month benefit in median survival. The majority of patients are currently electing not to go on Taxatere based regiments mostly due to the side effects profile and the impact on quality of life which is highlighted by the S?2 study and there is clearly a need for better tolerated, new treatment options. We think we have the opportunity to provide that with our lead product candidate Provenge.

The data from our principle study, the 9901 study, was published in the July issue of the Journal of Clinical Oncology . This was the first ever randomized double blind placebo controlled trial for cancer immunotherapy. It enrolled 127 men with metastatic androgen independent prostate cancer at 19 centers across the US. The primary endpoint of this study was median time to abjective? disease progression and the study protocol required that we follow all patients for 3 years after randomization for the survival endpoint which is obviously the gold standard endpoint, not only in oncology but particulary in hormone refractory prostate cancer.

These are the curves that were published in the JCO article and here you see Provenge in orange, and placebo in green, and the curves separate very nicely from the beginning. There is a 4 1/2 month median survival benefit that achieved a statistically persuasive result, p value .01 and the hazard ratio of 1.7 suggests that there is a 41% overall reduction in the risk to death for men that got drug compared to placebo. Personally I like hazard ratios more than medians. Hazard ratios give you a better overall estimate of what the drug effect is as opposed to a point estimate such as medians.

What is really compelling is the durability of this type of product. So at the end of the study 34% of patients on drug were alive compared to 11% of patients in the control arm. So a three fold improvement in 3 year survival. Now this benefit is seen with very minimal toxicities. The most common side effect that are associated with Provenge are what you would expect from a cancer immunotherapy. There are fevers and chills, They are usually of low grade and of short duration. They last for about 1 or 2 days and then they go away. So in contrast to chemotherapy this is an extremely well tolerated agent.

So the 9901 study which is highlighted in blue is a primary study that we are using to support the biologics license application for Provenge. And again in that study we showed a 21% of 4.5 month improvement in median survival and a three fold improvement in 36 month survival. We tested the robustness of this survival benefit. This hazard ratio of 1.7, a p value of .01 with a multivariate cox regression model to make sure that this survival benefit wasn't due to imbalances in other factors, other major demographic factors, and once we plugged that into the cox regression we can see that the p value stays strong, see that value of .002 and the hazard ratio went up slightly. This data set 9901, is supported by data from a second phase 3 study, 9902A, as well as data from an integrated analysis of these two studies.

So from a regulatory perspective this is a product that has been residing within the CBER branch of the FDA and in particular the Office of Celluar Tissue and Gene Therapies, In September of 2005 we held a formal pre BLA meeting with the FDA and they agreed in that meeting that the survival benefit observed in the 9901 study, supported by data from 9902A and the absence of any significant toxicity, that that data set would serve as a primary basis of our biologics license application. And it is important to note that this strategy is consistent with the current regulations for single study approval. The data is clinically meaningful, it's statistically persuasive, and it is supported by other data from other studies.

So if you look at the time line for the Provenge program going forward, we held our pre BLA meeting with the FDA about a year ago, in September of last year, and we announced our decision at the point to submit the biologics license application at that time. The data was published in JCO this summer. We've completed the conformance runs now for the recombinant protein with our contract manufacturer Diosynth. That was a very important event for the organiztion. We've also completed the buildout of our New Jersey manufacturning facility which will be the facitlity that will host the pre approval inspection with the FDA. That facility is still in the process of being validated. Once that's done we plan to complete the CMC section which is the final section of the BLA to the FDA which will start the PADUFA clock. We will also request priority review at that time. We anticipate that we will go in front of an advisory committee early in 2007, probably some time in the first quarter, with the potential approval by the middle of next year.

So this is really a near term opportunity for the company, near term opportunity for the patients and a near term opportunity for investors. Its been a long road to hoe, We've been working on this for over 10 years. But we are pretty excited about the packages that we're putting together and what it means for patients with late stage prostate cancer.

We have another study called the Impact study or 9902B. It's similar in design to the 9901 and the 9902A studies but it potentially allows us to expand the label into minimally symptomatic disease. So if you look at what we have ongoing with Provenge to date, the green area are the studies that we're using as a primary basis of the BLA. We do have an interest into moving into earlier stage prostate cancer. We've completed two phase 2 studies, both 9905 and P-16 which showed an improvement in PSA doubling time in those two studies. One was a model therapy study, the other was Provenge in combination with Avastin. We expect to get the results from P-11 study sometime before the end of this year, which is a phase 3 study in early stage prostate cancer. The primary endpoint there is a biochemical endpoint. Classically those endpoints have not been used, have not been acceptible for label expansion, but we do think that this will help educate the physician community on the potential utility of Provenge in early stage prostate cancer. The primary purpose of that study really is to use the patients of that study to supplement the overall safety database which the FDA has agreed that that safety database is adequate in size. And then the 9902B study, the Impact study that is currently enrolling, is actually enrolling very well right now. We expect to complete enrollment in that study next year. A little bit on that study, It's a large study, it's 500 ,men, similar in design to 9901 and 9902A, 2 to 1 randomization. It's enrolling at 70 sites. The primary endpoint of this study is survival. It's designed really off of the integrated analysis of 9901 and 9902A, so it's appropriately powered. It's being conducted under a special protocal assessment that we've agreed on with the FDA and the primary statistical tool to analyze survival will be the cox regression analysis and again patients from that study will be used to supplement our current application for the BLA.

The manufacturing process itself, from a commercial setting, a physician will write a prescription for Provenge, the patient will get a standard blood collection, a procedure known as a leukoparesis. That will be sent off to our commercial manufacturing facility in Hanover, New Jersey where it is combined with the antigen delivery cassette of the recombinant protein and over about a 30 to 40 hour period they are cultured together and that is sent back to the physician's office for infusion which occurs over 30 to 60 minutes. It's a standard IV infusion , just like any infusion based medicine.

About half the physicians in our clinical trials are urologists and half the physicians are oncologists. They are very comfortable administering infusion based products. This process is repeated 3 times over a 1 month period, then the patients are done.

We have as I mentioned earlier, completed construction on our state of the art, first in class, manufacturing facility in Hanover New Jersey. It is a 158,000 square foot facility, and we will be able to expand that facility as necessary.to really meet the commercial manufacturing needs that we anticipate for Provenge. Also we have completed the conformance lots of the recombinant protein of the antigen delivery cassette with our contract manufacturer Diosynth. That will all be included in the CMC section of our BLA.

From a marketing perspective I don't think that this is much different than other oncology programs. There's really 2 physician segments that we are going after. It's both Urologists and medical Oncologists. They are easily targeted through a sales force of about 98 reps and if you include the support personnel along with the sales reps it's about 125 total people in general which is easily managed by an organization like Dendreon. So we plan to commercialize this product ourselves in the US through this easily managed sales force and are seeking a commercialization partner outside the US. There is a hugh market for this patient segment with metastatic hormone refractory prostate cancer. We think the data that we have in hand and the favorable benefit to risk profile supports Provenge as front line therapy in patients with metastatic androgen independent prostate cancer. We will have some data later on in the fourth quarter that suggest that patients can go on chemotherapy and what that looks like with Provenge. It's an easily targeted customer base and we expect that pricing will very much be similar to other biologics that are currently available for patients with late stage cancer.

We are building a pipeline beyond Provenge, both in early stage prostate cancer with Provenge itself but also into other antigen targets. We really want to leverage the antigen delivery cassette technology so we have a program that targets her2neu, called Neuvenge, and we will be studying that in ovarian, colorectal, we are particularly interested in bladder cancer indication, cea for colon, lung and breast cancer, ca9 primarily for renal cell cancer and the trp-p8 program.

We currently have a very unencumbered, a very clean balance sheet. We ended the second quarter with 106 million in cash and no debt.

So this has been a very productive year for Dendreon. We've submitted the clinical and non clinical sections of the BLA to the FDA in August, we've published our results of our principle phase 3 study 9901 in the Journal of Clinical Oncology and that was extremely well received in the physician community, we've completed construction of our manufacturing facility in New Jersey, and as I said we've also completed our conformance lots with our contract manufacturer Diosynth. We published the results of the NCI study looking at Provenge in combination with Avastin in men with earlier stage Prostate cancer.

Looking forward I think it will continue to be an eventful fourth quarter for the organiztion. We'll be completing submission of the Provenge BLA to the FDA prior to the end of this year. We are on track to do that. That's going very well. We'll report top line results from the P-11 phase 3 clinical trial of Provenge in early stage androgen dependent prostate cancer and we'll have numerous scientific presentations in the fourth quarter that really highlight the robustness of the survival benefits that we've seen with Provenge.

So as I said earlier I think that Dendreon provides a unique investment opportunity today. We have the potential to be the first active immunotherapy to market for patients with late stage prostate cancer. We're showing a strong survival benefit with a favorable safety profile. The physicians are clearly interested in a better tolerated treatment option for their patients. We own 100% of the worldwide rights to this program and we can move it both into earlier and later stages of disease. And once we get Provenge across the goal line, we will be able to invest much more substantially in our other assets and expand the pipeline as a whole. I thank you for our time today. I believe our breakout is in the booth room downstairs.
http://www1.investorvillage.com/smbd.asp?mb=971&pt=msg&mid=520814

Nice transcript La-Onda

Keep an eye on this one, it really sounds like DNDN could be big in 2007.  Just thought I would throw up some charts.  Potential breakout of melf's falling wedge is imminent.  However, the real breakout play will occur when DNDN breaks $5 again.  It is pretty clear from the medium and long term charts that this will be significant.  I also like the support of the new ascending trendline, which comes in around 4.33 right now, giving a bit over a 4% risk to the trade.

DNDN really has a huge amount of potential, and it vexes me as to why it has been such a difficult stock to trade.  I am waiting for it to show me that it is a winner.

Quote from: ScottishTrader on October 10, 2006, 05:42:18 PM
Potential breakout of melf's falling wedge is imminent.

Scotsman,

On October 5, the top of the wedge came in at 4.559.  The close was 4.56, smack on it.

Yesterday, the top of the wedge came in at 4.506.  The close was 4.52, so that's a technical breakout on a closing basis.  If the recent highs of 4.57 and 4.61 get taken out, it "should" run.

The 34/55 RSIs have been struggling, but they've shaped up in the past couple of days.

The 55/89 RSIs have looked fine since mid-August.

The MACD has looked ratty for awhile, but it's at least showing signs that it wants to move higher.

I'll show you those 3 charts next.

Quote
iit vexes me as to why it has been such a difficult stock to trade.  I am waiting for it to show me that it is a winner.

No kidding! 

I stopped it out at 4.39 when it looked like it was going to rollover to the downside.  Nope!    

I'm quite certain that if I pay up for it and buy this technical breakout, the danged thing will tank on me, so maybe if I leave it alone, you guys can get rich on it!    

Sorry, I put up the wrong chart in the last post.  It's been corrected.

We can see that the 34/55RSIs have had problems recently.  The 34 fell below its shadow (55) twice, and it failed at the 55 EMA twice.

On the more recent failure, though, the 34/55s came into Bullish Synchronicity, and then bounced higher.  The high in the stock was 4.57, so that's the "buy pivot."  A print of 4.58, which we haven't gotten, is a buy signal.

Sometimes, a Fibonacci pairing, like this 34/55, will become "asynchronous," so to speak (out of sync), in order for the next pairing in the sequence (55/89) to come into synchronicity.

We'll look at the 55/89 RSIs next.

The 55/89 RSIs have been fine since late June, with only a minor "Oops!" which immediately was corrected.

In the recent time-frame, while the 34/55RSIs were acting quite sloppy, the 55/89RSIs were coming into Bullish Synchronicity, and they bounced right when DNDN made a low at the bottom of the Bullish Falling Wedge.

That's very nice, technically.

Naturally, we need price to capitalize on that, and breakout.

There's a bullish divergence in the MACD histogram, which is encouraging, but we don't want to see it roll over and die here, from below the signal line. 

On watch DNDN

Quote from: Terliso on October 13, 2006, 01:04:04 AM
On watch DNDN

Alister,

I'm watching alright, and what I saw was a slide all the way back to 1.35, on a day when the general market was rallying like gangbusters.

What the heck is this stock doing?     

At least it managed a close at UNCH, and a close back above the Bullish Falling Wedge, but I'm being generous calling it a BULLISH Falling Wedge, when it hasn't proved that at all. 

Quote from: Melf Elf on October 11, 2006, 04:49:21 AM
A print of 4.58, which we haven't gotten, is a buy signal.

We still don't have the print of 4.58. 

Quote from: Melf Elf on October 11, 2006, 04:30:37 AM
If the recent highs of 4.57 and 4.61 get taken out, it "should" run.

A print of 4.58 is a technical buy signal basis the 34/55RSIs, but it wouldn't be as convincing as a print of 4.62, above the September 28 high.  The top of the Kumo (Cloud) is 4.6175, adding  significance to the print of 4.62.  That would give us a "higher high," and also would put the stock above the Kumo (Cloud) resitance.

Quote
The 34/55 RSIs have been struggling, but they've shaped up in the past couple of days.

That's still okay, despite more sloppiness in the stock.  The 34 still is above its shadow, the 55.

Quote
The MACD has looked ratty for awhile, but it's at least showing signs that it wants to move higher.

MACD now is kissing the signal line, from just a hair below it.  It needs to go through it, and up through zero.  "Feet, don't fail me now!"   

Quote
iit vexes me as to why it has been such a difficult stock to trade.  I am waiting for it to show me that it is a winner.

It continues to vex, Scotsman! 



SHOW US 4.62!! 

Quote from: Melf Elf on October 13, 2006, 02:49:10 AM

A print of 4.58 is a technical buy signal basis the 34/55RSIs, but it wouldn't be as convincing as a print of 4.62, above the September 28 high.  The top of the Kumo (Cloud) is 4.6175, adding  significance to the print of 4.62.  That would give us a "higher high," and also would put the stock above the Kumo (Cloud) resitance.

Thar she blows!

4.58 got printed at 1:20 PM...4.62 followed at 1:33PM.






RALLY, YOU DAWG! 

Quote

Quote from: Melf Elf on October 13, 2006, 02:44:29 PM
Thar she blows!

4.58 got printed at 1:20 PM...4.62 followed at 1:33PM.

DNDN doesn't score any points for volume, only 150,000 shares today, but it's taken out Friday's 4.67 high, and is inching higher. 

I'd like to see more buying interest.

nice chart, you are in again MelfElf? 

Quote from: la-onda on October 16, 2006, 05:40:43 PM
nice chart,

Oliver,

Yes, it is! 

Quote
you are in again MelfElf? 

Yes, I got back in at 4.58 on the technical buy signal basis the 34/55RSIs, which also was a mini W-Bottom breakout off the 4.30 and 4.35 lows.

We've now got THREE Bullish patterns, nested within a FOURTH Bullish pattern, the large Symmetrical Triangle (pattern in black).  The technical breakout of them for yesterday was 4.805. 

The close was 4.82!! 

The volume was only 692,000 shares, a little better than average, which is disappointing when a stock has a technical breakout like that (multiple nested Bullish patterns), but it's a technical breakout nonetheless. 

Technically, the RSI Fibonacci pairings look great.  MACD went up through its signal line, then up through zero on Friday...

This is the type of chart that could expode to the upside, even without any news, like GIGM did on September 7, strictly on a technically based rally. 

This morning would be a great time for the company to put out one of those "fluff" bits of news, or for some analyst to say something nice about the stock.  The momo boys would jump all over yesterday's technical  breakout

By the way, even using the less conservative Left Leg (4.30) of the mini W-Bottom breakout, thatpattern target of 4.84 already  MADE yesterday afternoon, which is good to see.  The high was 4.86:

Math:

4.57 - 4.30 = 0.27 + 4.57 pivot = 4.84 IN PLAY






QUADRUPLE BREAKOUT...RALLY, YOU DAWG 

Quote from: Melf Elf on October 16, 2006, 11:24:40 AM
I'd like to see more buying interest.

This has to be a joke..a QUADRUPLE breakout, and NO buying interest!??     

The Scotsman is right.  This is the most vexing stock I've ever encountered. 

The 50DMA still is slightly below the 200DMA, and those "should be" support, but who knows with this incredibly annoying stock! 

The Bottom of the Kumo (Cloud) is at the same level, offering additional support.

Support:

4.552 - 200 DMA

4.525 - 50 DMA

4.520 - Bottom of the Kumo (Cloud)

I "paid up" at the 4.58 RSI Buy Signal to get back in, so a test of that support would put me in the red, even if only temporarily.  And, no guarantee that it will hold, as it "should." 

It also "should have" moved higher out of the QUADRUPLE breakout.

I'm not going to sit for that.  If we print 4.68, a penny below yesterday's low, I'll take another gain (2%), and see what develops as far as a test of 4.52. - 4.55, or a move higher.




STOP THE TORMENT...RALLY, YOU DEVIL 

I jumped in this one.  DNDN printed 4.97 today.  The time to pop is near I believe.   Just needs some volume