DNDN - Sector: Healthcare---Industry: Biotechnology & Drugs

[pompano]

I would say around $10 but I'm just pulling that out of the sky.  Long term though, why would you not want to be in this stock.  What man isn't gonna want that vaccine.  I am gonna buy DNDN for my IRA, and just forget about it.

[ScottishTrader]

OK, WOW!!!!!

DNDN is currently trading @$18+ PM, really not sure where it will open at, but up over 250%!!! this is huge!!!

I think this one will be VERY interesting over the next few days.... remeber, while the panel supported Provenge, this was only on the basis of a re-wroding of the efficacy statement to say their was "substantive evidence" that Provenge extends life in men with AIPC.  Several of the panel wanted to see more data to be sure, so this could still get an "approvable" from the FDA next month.  The shorts will be trying to hammer this home as much as possible, so we could se some hefty downside swings too here.  still, I think DNDN will be heading for the $20 range in short order here, will make for e very interesting watching!!!

[la-onda]

Ahead of the Bell: Dendreon Surges
Friday March 30, 8:34 am ET
Dendreon Soars As FDA Panel Endorses Advanced Prostate Cancer Drug Provenge

NEW YORK (AP) -- Shares of drug maker Dendreon Corp. more than tripled in premarket electronic trading Friday after a Food and Drug Administration panel endorsed its prostate cancer vaccine, Provenge.

ADVERTISEMENT
FDA advisers said late Thursday that Provenge is safe, and evidence shows it could be useful in treating advanced prostate cancer. A final FDA decision on Provenge is expected May 15, and while the panel votes are not binding, the group usually follows the advice of its advisory committees.

Provenge did not slow progress of the disease, the studies found, but it could extend patients' lives by 4.5 months by stimulating their immune systems to fight the disease.

JMP Securities analyst Charles Duncan C. reiterated a "Strong Buy" rating on the stock, and raised his price target to $20 per share from $12.

"We believe the panel vote and commentary to clearly signal robust physician interest in this novel treatment," he said. "Therefore, we now anticipate faster and perhaps broader adoption than previously modeled."

Banc of America Securities analyst William Ho said questions remain about Provenge, as the drug was tested on a small population and the trial did not have a clearly defined survival goal. He reiterated a "Neutral" rating on the stock.

Provenge is being tested in a larger trial, with preliminary results expected in 2008.

Because of those concerns, Ho said, the panel decided it could not say Provenge was effective. Instead, it said only there is evidence the drug is effective.

Both analysts said Provenge could bring in more than $1 billion in revenue for Seattle-based Dendreon.

Dendreon shares surged $13.43 to $18.65 in premarket trading, having closed Thursday at $5.22 on the Nasdaq Stock Market, where the stock has traded between $3.57 and $5.77 over the past year.

[ygtrdr]

Took a small speculative position in this one on the hopes Provenge gets approvable letter from FDA. If it does Dendreon should fly IMO. If not, well we all know what happens to biotechs who get FDA rejection.

Sold DNDN at 18.00 

[la-onda]

congrats ygtrdr 

fyi:
/30/2007 - Fidelity / Zack's Report ---

In part , the report says....

KEY POINTS
We upgrade Dendreon shares from Hold to Buy with a price target of $20 per share. Our upgrade is based on the favorable opinion from the FDA advisory committee with respect to the safety and efficacy of Provenge. The FDA advisory committee voted 17 to 0 in favor of the safety of Provenge in response to the question and 13 to 4 in favor of the efficacy question. With the positive opinion from the expert panel, the chance of final approval for Provenge increased greatly although the FDA is not bound to adopt the panel opinion, but it usually does. We estimate full approval of Provenge in May, 2007 by the FDA. Estimated US sales from 2007 to 2010 will be $25, $80, $160 and $300 million respectively. We estimate the company will be profitable in 2009 with an EPS of $ 0.14. With sales potential over $1 billion, Provenge will provide both top line and bottom line growth for Dendreon in the coming years. Our price target is $20.00 based on estimated EPS of $1.07 in 2010.

[stockpicker]

I would say around $10 but I'm just pulling that out of the sky.  Long term though, why would you not want to be in this stock.  What man isn't gonna want that vaccine.  I am gonna buy DNDN for my IRA, and just forget about it.

As I have posted a couple of times before, DNDN is the REAL DEAL.

Not sure why DNDN and CTIC's threads have combined.

DNDN is heading to $50 within a year IF approved (95% chance following yesterday's conference) based on basic fundamentals. Could hit $100 a year later if they increase their manufacturing capacity. The only potential competitor, CEGE, is AT LEAST 3 yrs behind.

DNDN is the real deal!

[cdrankwalter]

been in for 2 months now, congrats to everyone in financially and congrats to the people suffering out there from pc anyway seems like everyone quickly took their profits but im staying in i dont think the fda will wait for the current study, this is needed immediatly which was obvious from the panel comitties meeting, also keep in mind the fda chairman suffered from pc and his family which could have some sway also, this drug has such potential. people tried to make a big deal about dr gold saying they will not partner, why partner it will only hurt margins, we have the best drug out there for pc.

[setravis]

Not sure why DNDN and CTIC's threads have combined.

The threads were never combined.
Saffeysite1 the originator of this thread, that is the way he started this thread. With 2 stock picks on the same thread. I know it is confusing when one tries to post about 2 different picks on the same thread. That is the way I see it !
Should be one thread one stock pick. I don't like the thought of multiple picks on the same thread 
But I do believe the thread is dominated by discussion on DNDN.

[422fwhp]

Yea, this was the most pertinent thread for DNDN that I could find when I searched...

Congrats to those who didn't miss this one....like I did. 

May enter on Monday

[Terliso]

Man, what the heck just happened here? I totally missed this thread.

Congrats to those who ride on it.

[soxguy]

Saw the story on CNBC wed. while i was working out at the fitness center. Went home and bought some with 6 seconds to go in the session. I did not sell any fri.,though my wife said SELL! Still,i'm up 144% and won't this go up into May,when it supposedly gets approved? Wish they were all like this.

[ScottishTrader]

I think it could, but we have to remember that this stock had a huge short position and is first and foremost on everyone's radars.  That means that there will be a lot of hedge funds and the like trying to break it down as much as possible, to cover their shorts and make more money on this stock.

Now the main problem with the approval nod from the FDA panel is that they voted in favour of a revised voting question that Provenge provides "substantial evidence" of efficacy, not that it demonstartes efficacy.  This is a much weaker statement, and shorts will be all over it, using it to instill doubt that Provenge will get approval in May.  They are running a second PIII trial at present, and it is still possible that the FDA will decide that they require results from this trial before they will approve the drug to market.  The problem is that DNDN won't have these results until 2010, and if they go this way, DNDN will get killed.  The difficulty for the FDA is that approval of Provenge when it has failed its primary endpoints may set a dangerous point of precedence that may allow other drugs through that possibly should be approved.  It is also a completely new type of therapy (that is desperately needed), and so while it is compelling, there are still unknowns with regard to its efficacy and operation.

The panel approval definitely improves DNDNs chances, and this should be reflected in the trading price for the stock over the next month, but until the final decision is made there will be a lot of volatility.  If it does get approval, I would expect a second jump inot the $20 range, which will hold.  If it fails, it will get cut to shreds, and you'ld probably be looking at a 50% loss on your original position.  SO my suggestion would be to take some off the table and lock in some gains - ride the free shares, and see how the chart develops.  AT least that means that in the end, if they don't get approval, you won't get taken to the cleaners.  I think there will be many opportunities on both the long and short side over the coming month.

[soxguy]

Scottish,I appreciate your comments and look forward to more posts on dndn. I truly believe this will trend higher as May approaches. AS they say,buying begets buying;maybe $25 is a good sell point. If there is dilution,wouldn't that occur after the FDA approval? Sell the news and all that.

[Jim897]

I think you both need to investigate this stock further.  The FDA really showed their hand at the panel hearing.  The CBER division of the FDA is in charge of the final decision.  The head of that division and the head of a subdivision in charge of the panel were there.  There were 2 votes, one on safety, the other on efficacy.  The safety vote went 17-0.  Then the efficacy vote, the key one, started.  The question they were asked was whether the company had established the efficacy of the product.  The first person asked said no.  At that point the head of the subdivision brought up that maybe the question should be changed to "substantial evidence of efficacy", but nothing was done.  After 4 no votes, the head of the CBER division handed a note to her and she stopped the vote.  She forced the question to be changed because the new wording was in fact the correct wording according to FDA standards.  (You can find it in general documents of the FDA on their website - I've seen it myself.)  The vote was re-started and all (well, I can't remember if it was all, but definitely most) 4 no votes changed to yes votes.  In the end it was 13-4 yes.  I should add that even before the panel met, when the final decision was given to the CBER division, people following the stock closely thought the likelihood of approval went way up.  See an article in early March by David Miller (you can find it via Google) for evidence.  He's been covering the company and this therapy for years.  Everything I'm mentioning can be found on the investorvillage website mb for DNDN.  I did not watch the proceedings myself, but people who were watching were posting a running commentary there as the panel met, and I read that, allowing me to follow in real time.  Some summaries of what happened were published afterwards there.  David Miller also notes the FDA role in the question change in a comment to a WSJ article in the journal published, I think, on Friday.  (It can also be found at the mb.  You might need a subscription to WSJ to find it on their site.)

I think the FDA has already shown their hand.  It's only a matter of no more than 45 days before approval happens.  One way to play it if one is worried is to hedge a long position with puts.  I plan to do that, even though I think the FDA has already shown how they will vote.  Still, I felt I could not say "I know".  I think besides my large amount of stock, I'll also by some calls.  I think there could be a good deal of volatility, so might be good to play with some shares in day trades, but on the other hand, the decision could come early and I would not want to be out of my long position when it happens.

I am fairly new at this, and would appreciate any feedback on whether my plans make sense, and if anyone has any alternative ideas.

[ScottishTrader]

Hi Jim, thanks for your comments.  If you look back at this thread you will see that I've been following this stock for about a year and a half, so I'm not new to it.  I was also trying to follow commentary on IV on Thursday, and it is true that just looking at the simple votes or the articles that came out afterwards does not give a full flavour to what actually went to during the proceedings, so thanks for providing these details.  I also think that the fact that they changed the voting question gives a positive indication of how they will come out next month.

However, my main point is just that, as Friday proved, there is still a lot of uncertainnty in the market as to whether DNDN WILL get approval, and the bears will use everything in their arsenal to try and push that agenda.  So I'm still really not clear as to how price action will develop over the coming month.  Again, my concern is mainly about limiting downside risk (and I already have a significant long position in this stock).  I'm gonna think some more about how the best way to do this would be.  If you are absolutely 100% confdent that they will get approval, then there is nothing to do but ride those shares, however, I don't think anyone can be, and that is wht is causing me to think hard about this.  Right now I think August calls might be a good wy to go, as it will give plenty of time for the price to develop post-decision.  Another thought I had was a ratio call spread (that i described in the understanding options thread).  If setup right, this strongly limits downside risk, while still  providing a decent return on the upside.