3SOF

congrats stockpicker 

what would be now again a good entry price from TA side?

cheers
Oliver

Ok watching again i'm setting an order at pullback

If it helps, the hourly chart gives a suggestion of the kind of support levels I would expect if DNDN pulls back tomorrow.  I think it is unlikely to go below around 5.10 in any case.  Upside is significant, with near term resistance at 5.70 and 5.90 levels.

I think this is what really got juices flowing on DNDN today - there were very positive comments on the conference call, and the analysts seemed quite impressed and upbeat.

Dendreon Announces Preliminary Results From PROTECT (P-11) Study
http://biz.yahoo.com/prnews/061108/sfw066.html?.v=81

After hearing the CC, I am more convinced than ever that Provenge will get approval for late stage prostate cancer, and this additional indication for early-stage prostate cancer presents a significantly larger opportunity.

The momentum may finally be turning for DNDN

Stockpicker,

I am in with you on this one (though my entry is not nearly as safe as I suppose yours is  )  And while yesterday produced a fairly ugly looking red candle, as you said, with DNDN you really have to either trade it VERRRYY fast or give it some room and hold for the medium term.

I had a read of the CC transcript yesterday, and a couple things came to mind that I thought I should highlight.  While the PROTECT preliminary results were encourageing, as they said, the FDA will not grant label expansion on biochemical indicators alone, so at this stage this information will only contribute to the safety profile going into their current BLA.  As you mentioned, DNDN will have to wait until they can assess primary endpoints of time to progression and survival, before they can use this data to support a label expansion.  That could take anything from 9-18 months.  However, it appears from a medical standpoint that the data is very encouraging, but we will just have to wait and see.  Also, this would not be applicabe for very early stage (i.e. when men still have a functioning, although malignant prostate), it would still probably be administered after prostate removal and alongside subsequent therapiies.  (i'm prety sure that is what they were suggesting).

I also really liked the fact that they were very clear that the remainder of the BLA would be submitted this quarter, and they implied that this shoud occur really quite soon (possibly in the next few weeks?)  When this happens, DNDN should get another nice pop.  They clearly have enough cash to get through this period until the FDA decision, and also have manufacturing capacity ready (about 25%, but they said they have the space and it should be relatively easy to ramp this capacity up once they get approval).

Technically, DNDN looks like it is moving into a (somewhat violent) breakout trend and I am going to use the ascending trendline in blue (at least initially) as a guide.  I would also like to see the 20ema (green line) hold on a closing basis, which should track this move.  Support looks to come in at 5.10 and 4.95, so I am going to raise my stop to 4.89.  Next resistance looks to be around 5.46-47, and then 5.70.  I really want to see how this one develops, DNDN has enormous potential, and the next couple of months look to be crucial.  Hopefull, finally, DNDN can begin to realise its true potential.

More STELLAR Clinical News from DNDN:

http://biz.yahoo.com/prnews/061110/sff019.html?.v=72

There is no question that earlier Provenge is better than later Provenge but later Provenge is better than no Provenge.

Also, the difference between Crossovers+Taxotere and Pure Placebo+Taxotere is the final deconstruction of the Aschoff's argument that cross-overs were sicker because they got chemo late. The cross-overs had a 5.5 month median survival advantage over the Pure Placebo.

Provenge+Taxotere           34.5
All Placebo+Taxotere        25.4
Crossovers+Taxotere       25.7
Pure Placebo+Taxotere    20.2


Dr. Daniel Petrylak just said everyone with advancing stages of prostate cancer should take Provenge as first line therapy followed by Taxotere as second line therapy. If you follow this regimen you will see a survival advantage of almost 14 months vs true placebo with all arms well balanced against a Halabi nomogram.

Dr. Petrylak is one of the most respected oncologists researching prostate cancer in the world and one of the lead investigators on the Taxotere study published in the New England Journal of Medicine. Basically, Dr. Petrylak's endorsement of this regimen would be the same as Dr. Eric Small saying some future therapy should be given in front of Provenge and provides a significantly improved survival benefit to Provenge. This data has been presented at the Chemotherapy Symposium for goodness sakes.


--- nothing short of stellar news ---

Its in -

Dendreon Completes Submission of Biologics License Application to FDA for PROVENGE in Hormone Refractory Prostate Cancer
http://biz.yahoo.com/prnews/061113/sfm060.html?.v=67

Should get a nice pop from this -- currently at 5.50-5.68

...still holding.

DNDN got a downgrade with a price target of $3.50 

Hmm... yeah, they really like to downgrade DNDN, it seems to be an ongoing hobby for some oof these analysts.  Whether that relly affects the share price too much in the short-medium term is anyones guess.

My guess is that DNDN should hold above 4.95 support.  Todays action trawled the lows for much of the day, but there was no capitulation and a late rally above 5.15, which looks to be a key short term resistance/support level.  There also apprears to be short term resistance at 5.30.  The last few days look like they ar forming a flag, with the upper trendline coming in at 5.40.  If we break that, then I think DNDN may finally start to have some legs in this move.

Maintaining HOLD and 4.92 stop.  Charts attached.

Nice article (TheStreet.com):
Dendreon's Risks Will Yield Rewards
By Michael Latwis
RealMoney.com Contributor
11/15/2006 7:42 AM EST
URL: http://www.thestreet.com/markets/activetraderupdate/10322188.html

This column was originally published on RealMoney on Nov. 14 at 7:13 a.m. EST. It's being republished as a bonus for TheStreet.com readers.

Dendreon (DNDN) is taking a risk that I believe will pay off, both for the company and for investors who have a high tolerance for the speculative thrills of small-cap biotechs. The latest news out of the company should prompt investors to weigh the risks and the rewards for themselves.

The company made headlines last week with the latest data on Provenge, its controversial first-in-class vaccine, which is in the final stages of development for use in patients with advanced prostate cancer. Dendreon released interim clinical data reported from the PROvenge Treatment and Early Cancer Treatment, or PROTECT, study. The data were constructive in terms of safety, and would mark a much larger potential market opportunity for use in earlier-stage cancer patients as early as 2007.

In the near term, the company continues to move forward with its questionable regulatory strategy in the pursuit of Provenge as an initial indication in androgen-independent prostate cancer (AIPC) patients. This rolling Food and Drug Administration submission is expected to be completed by year-end, and is the key controversy for the stock.

Dendreon has chosen to pursue a high-risk regulatory filing strategy in this AIPC indication: pooling the observed survival data from two separate Phase 3 studies to support the regulatory filing with the FDA. This type of retrospective analysis is considered a high-risk approach to meeting regulatory standards because it's a departure from the objective of the original trial design.

Specifically, the patient-survival data were statistically significant in the first of these trials, with a 23% three-year survival advantage over a placebo. The filing data were then pooled with favorable survival trends observed in a second study. Importantly, survival was not the primary endpoint in either one of these trials.

The near-term opportunity in Dendreon shares is based on the view that the regulators will place the greatest value on observed survival benefits and approve this therapy for prostate cancer patients in whom the disease is poorly controlled. The earliest regulatory ruling is likely to take place by the middle of '07. If the agency requests additional clinical data, then the timing of approval would be pushed out to '09, to await the results of another study.

But that wouldn't be a disaster for Dendreon. The company is already enrolling patients in this additional Phase 3 trial (IMmunotherapy for Prostate AdenoCarcinoma Treatment, or IMPACT), which should be completed by early '08. This trial was designed to provide supplementary safety data to the FDA, but can be used to support approval if the FDA finds the combination clinical data inadequate. I expect that Provenge eventually will gain FDA approval, by 2009 at the latest, based on its demonstrated safety and survival benefits.

The market, however, remains skeptical about the near-term success of this upcoming regulatory decision on Provenge. The majority of sell-side analysts appear to be cautious on the stock, while the bears are visible with ongoing heavy short-interest on the shares -- about 17% of the available float. This has kept the stock confined to the $4-$5 range over the past year.

Based on current market perceptions, I believe Dendreon shares look reasonably valued even if Provenge reaches the market under the more conservative '09 assumption. The number of new patients suffering from the form of prostate cancer Provenge addresses each year has grown to more than 200,000, which should generate about $200 million in revenue for the company in its second-year post-launch. Even if this forecast is pushed out to 2010 and discounted at 30% (a conservative estimate, as the approval/launch is still not guaranteed) for three years, the stock represents good value up to the $7.50 to $8 level.

The greatest risk in this estimation is the negative funding impact that will be felt if this product is pushed out to 2009. Dendreon only has about $93 million in cash, which should cover expenses to late 2007 at the current burn rate. Of course, the company would like to reach a deal with a larger pharmaceutical player to help with ongoing development costs. It's likely that a deal will be reached once the IMPACT study is fully enrolled and once the FDA's position becomes clearer next year.

As for the PROTECT trial, these preliminary results are consistent with the favorable safety trends observed in earlier clinical studies. This trial still needs more time to demonstrate a survival benefit in this larger androgen-dependent prostate cancer (ADPC) setting.

Additional PROTECT results or further data from the ongoing combination trial with Genentech's (DNA) Avastin would go a long way to boosting the longer-term sales potential for Provenge. Once armed with additional clinical data that support expanded market opportunities, Dendreon will be in a much stronger position for partnership discussions.

Once again, the rewards for Dendreon are expected to be great, with the potential to treat about three times more patients in the earlier-stage ADPC setting.

Can you believe it???  Right after their recent CC stating that they had a strong balance sheet with suffiecient funds to get them through this BLA submission, out comes the share selling!!!  Ugh!

DNDN is selling approx 9.9M new shares to instys at an average of $4.54 per share, almost a dollar discount to the recent brekaout price range. That is almost 14% dilution as far as I can tell.

http://biz.yahoo.com/prnews/061116/sfth070.html?.v=71

Needless to say we all know what happens once something like this gets announed - TANK!!!!  And DNDN was looking set to open strong and breakout of its flag formation too!! Grr....

So I got stopped out at 4.90 this morning (at least glad I had a stop in place), for around a 6% loss.  Considering what David has recently been saying about dilution, I am really not sure if I want to jump back in on this one - although the chart pattern was peirced intraday, it is not entirly broken and a reasonable re-entry may exist around 4.60.  Actually, a close above 4.80 would probably look pretty reasonable. This just undoes all the recent hard technical work and suggests the short sellers and nay-sayers were bang on right about this one... again.

It also raises the question of why they need the additional cash now?  This could well add further uncertainty to the uncertainties surrounding their BLA submission and whether they will get first round approval.  for now I think I will leave DNDN alone (at least for the next couple of day and see how the market reaction develops).

DNDN is a great story, but this really seems to be what you (quite consistently) get for pinning your money to hopes and dreams....

Quote from: ScottishTrader on November 16, 2006, 12:22:34 PM
Can you believe it???  Right after their recent CC stating that they had a strong balance sheet with suffiecient funds to get them through this BLA submission, out comes the share selling!!!  Ugh!

DNDN is selling approx 9.9M new shares to instys at an average of $4.54 per share, almost a dollar discount to the recent brekaout price range. That is almost 14% dilution as far as I can tell.

Scotsman,

The bottom of the Symmetrical Triangle came in yesterday at 4.5044.  The low was 4.51, for an exact hit, and the close was right at the 4.54.

The 50/200DMAs finally are properly positioned, so DNDN could bounce here.  I'm staying out of it though, because:

1. I didn't like the 3.7 million share volume reversal on October 20.  The volume on the November 16 black candle was DOUBLE that, at 7.5 million shares, and 4.67 support got violated on an intraday basis.

2. The closes after that candle were 4.69...4.67...4.66 ....then yesterday's 4.54.

3. As long as DNDN closes below 4.67, a Double Top is in place, and 3.64 is IN PLAY, which would take us all the way back to the May low of 3.68.

A few things stood out to me from this November 14 article, prior to DNDN tanking (thanks, Oliver!)

Quote from: la-onda on November 15, 2006, 08:06:24 AM
Nice article (TheStreet.com):
Dendreon's Risks Will Yield Rewards
By Michael Latwis
RealMoney.com Contributor
11/15/2006 7:42 AM EST
URL: http://www.thestreet.com/markets/activetraderupdate/10322188.html

This column was originally published on RealMoney on Nov. 14 at 7:13 a.m. EST. It's being republished as a bonus for TheStreet.com readers.

The company made headlines last week with the latest data on Provenge, its controversial first-in-class vaccine, which is in the final stages of development for use in patients with advanced prostate cancer. Dendreon released interim clinical data reported from the PROvenge Treatment and Early Cancer Treatment, or PROTECT, study. The data were constructive in terms of safety, and would mark a much larger potential market opportunity for use in earlier-stage cancer patients as early as 2007.

That sounded fine.

Quote
In the near term, the company continues to move forward with its questionable regulatory strategy in the pursuit of Provenge as an initial indication in androgen-independent prostate cancer (AIPC) patients. This rolling Food and Drug Administration submission is expected to be completed by year-end, and is the key controversy for the stock.

Those phrases are "red flags" to traders.
 

Quote
Dendreon has chosen to pursue a high-risk regulatory filing strategy in this AIPC indication: pooling the observed survival data from two separate Phase 3 studies to support the regulatory filing with the FDA. This type of retrospective analysis is considered a high-risk approach to meeting regulatory standards because it's a departure from the objective of the original trial design.

Let's go back to when Provenge got Fast Track Appoval status on November 7, 2005, when DNDN traded at $6.22.  Remember how we all thought that we were a lot closer to actual approval?

Now, a year later, we're talking about a 'high risk' regulatory filing strategy?    

Quote
The near-term opportunity in Dendreon shares is based on the view that the regulators will place the greatest value on observed survival benefits and approve this therapy for prostate cancer patients in whom the disease is poorly controlled. The earliest regulatory ruling is likely to take place by the middle of '07. If the agency requests additional clinical data, then the timing of approval would be pushed out to '09, to await the results of another study.

2009?        

I don't think that anyone who paid 6.22 for DNDN on November 7, 2005 was thinking 2009!

Given the fact that the company has opted  to go for a "high risk filing stragegy," I'd say that there's at least a decent chance that they're going to be asked for some additional clinical data, or it wouldn't be called "high risk."

Whether that actually ends up being the case, or not, the current price of the stock is based on the market's perception of this news, along with the $4.54 share sellling.

Quote
But that wouldn't be a disaster for Dendreon . The company is already enrolling patients in this additional Phase 3 trial (IMmunotherapy for Prostate AdenoCarcinoma Treatment, or IMPACT), which should be completed by early '08.

Okay, not a disaster, but early '08?  

Quote
This trial was designed to provide supplementary safety data to the FDA, but can be used to support approval if the FDA finds the combination clinical data inadequate. I expect that Provenge eventually will gain FDA approval, by 2009 at the latest, based on its demonstrated safety and survival benefits.

Again, I don't think that traders were expecting '09.

Quote
The market, however, remains skeptical about the near-term success of this upcoming regulatory decision on Provenge. The majority of sell-side analysts appear to be cautious on the stock, while the bears are visible with ongoing heavy short-interest on the shares -- about 17% of the available float. This has kept the stock confined to the $4-$5 range over the past year.

Maybe that skepticism is because 2009 keeps getting mentioned! 

Quote
Based on current market perceptions, I believe Dendreon shares look reasonably valued even if Provenge reaches the market under the more conservative '09 assumption. The number of new patients suffering from the form of prostate cancer Provenge addresses each year has grown to more than 200,000, which should generate about $200 million in revenue for the company in its second-year post-launch. Even if this forecast is pushed out to 2010 and discounted at 30% (a conservative estimate, as the approval/launch is still not guaranteed) for three years, the stock represents good value up to the $7.50 to $8 level.

Please tell me that 2010 didn't just get mentioned!   

Quote
The greatest risk in this estimation is the negative funding impact that will be felt if this product is pushed out to 2009. Dendreon only has about $93 million in cash, which should cover expenses to late 2007 at the current burn rate. Of course, the company would like to reach a deal with a larger pharmaceutical player to help with ongoing development costs. It's likely that a deal will be reached once the IMPACT study is fully enrolled and once the FDA's position becomes clearer next year.

That sounds like a great idea, and it likely would send the stock price higher.

Quote
the stock represents good value up to the $7.50 to $8 level.

Technically, if DNDN goes back to the 3.68 area and Double Bottoms there, then takes out the recent high of 5.77, a target of 7.86 would be IN PLAY.

Math:

5.77 -3.68 = 2.09 Points + 5.77 = 7.86

DNDN links:
1)
http://professional.cancerconsultants.com/oncology_main_news.aspx?id=38604
(Progress Reported on the Vaccine Provenge® for Treatment of Metastatic Hormone Refractory Prostate Cancer)

2)
Nice summarized DNDN info package from IV:
http://www1.investorvillage.com/smbd.asp?mb=971&mn=16955&pt=msg&mid=885461
(nice reading, lots of information)

thanks for the TA update again MelfElf

Cheers
Oliver

Thanks for those links, Oliver.

Friday was a close below the up trendline off the May, 2006 low of 3.68 (thin red line), as well as a close below our QUADRUPLE nested Bullish Symmetrical Triangle (thick black up trendline).  That looks weak on the chart.

DNDN would need to get back above those trendlines AND get back above 4.67 , in particular, in order to get out of trouble here, technically. 

4.67 is the middle, or "pivot," of the "M."  The highs were 5.77 and 5.70, so it was "pivotal" when 4.67 got taken out to the downside.

Next support is 4.37 (November 16 spike low) and 4.30-4.35 (lows of the Green Falling Wedge).

Quote from: Melf Elf on November 25, 2006, 03:29:29 AM
Friday was a close below the up trendline off the May, 2006 low of 3.68 (thin red line), as well as a close below our QUADRUPLE nested Bullish Symmetrical Triangle (thick black up trendline).  That looks weak on the chart.

DNDN got spanked yesterday, for that break of important support.

Quote
Next support is 4.37 (November 16 spike low) and 4.30-4.35 (lows of the Green Falling Wedge).

No support there, on the technical selling, which further damages the chart.  4.30 - 4.37 now is near-term resistance.