This is topic DNDN * $4.40 --FDA approval letter possible next week--more>> in forum Hot Stocks Free for All ! at Allstocks.com's Bulletin Board.


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Posted by Zacktrade on :
 
http://us.rd.yahoo.com/finance/exter...mp;cm_ite=NA

I just got in...should gap on monday and run until approval or denial. Do you own DD--looks exciting though.
 
Posted by Zacktrade on :
 
Up to $4.70 premarket
 
Posted by Zacktrade on :
 
$5.
 
Posted by a surfer on :
 
looking for an entry today Zack.
 
Posted by mindspin311 on :
 
In at 4.55 out at 5.05. Nice little gain. [Smile] Up at 5.15 now.
 
Posted by Livinonklendathu on :
 
In today, tomorrow should be interesting with the meeting.
 
Posted by Stefan on :
 
Yep, the big day is here. The stock should be halted all day tomorrow, and the "verdict" out around 3:30pm EST. The DNDN conference call is at 7:30pm EST. Good luck to all longs!
 
Posted by stocktrader22 on :
 
this is risky as hell here...good luck guys [Smile]
 
Posted by stocktrader22 on :
 
Wow nice jobs boys...was a coinflip here and you all won! Huge news EOD should gap big
 
Posted by Livinonklendathu on :
 
Yep, should be huge tomorrow
 
Posted by Livinonklendathu on :
 
FDA panel votes in favor of Dendreon cancer drug
Marketwatch - March 29, 2007 5:05 PM ET


SAN FRANCISCO (MarketWatch) -- A Food and Drug Administration advisory committee on Thursday found Dendreon Corp.'s experimental prostate-cancer drug, Provenge, to be safe and effective.

Seattle-based Dendreon (DNDN) is asking the FDA to approve Provenge, which acts by stimulating the body's immune system, for the treatment of asymptomatic men with advanced prostate cancer who have stopped responding to hormone treatment.

Though the agency isn't bound by the recommendations of its advisory committees, it typically follows them.

The FDA granted the Provenge application priority-review status in mid-January, taking its review deadline to May 15. Priority review is intended for products that address unmet medical needs.

The advisory committee on Thursday voted 17-0 that Provenge was safe and 13-4 that it was effective.

There was concern that both of the late-stage studies submitted for consideration failed their endpoints, including the first study's primary endpoint of slowing the cancer's progression, noted Celia Witten, director of the FDA's Office of Cellular Tissue and Gene Therapies division. But that study, though small, "...did show a survival difference," she said in a telephone interview after the meeting.

In the study, which evaluated 127 patients, median survival of Provenge-treated patients was found to be 4.5 months longer than those who were given a placebo.
 
Posted by Jo4321 on :
 
What a gamble! Way to go guys. Wonder what it will open at?

I was sitting here watching Survivor, and my local news station station just came on and said "An amazing new vaccine for prostrate cancer, coming up at 11:00".
 
Posted by tompom on :
 
KABOOM
 
Posted by Jo4321 on :
 
Wow! Up over 200% in premarket.

Fidelity won't even let me buy at premarket, says the price is too far away from the closing price. I wonder how many other brokers have this restriction. When the market opens, BOOM!

Jo
 
Posted by Livinonklendathu on :
 
Out 75% of shares 19.08 from 4.80, retirement time. [Wink]
 
Posted by a surfer on :
 
unreal! I missed it. Dumbazz of the week award.
 
Posted by Livinonklendathu on :
 
Total gamble but it did pay off. Could have easily gone the other way.
 
Posted by Jo4321 on :
 
Way to Go, Livinonklendathu!

Not a bad idea to sell some in the premarket at those prices. Who knows what the regular market will do. A bird in the hand....

Congrats!

Jo
(I'm still po'd that Fidelity wouldn't let me put in a $16.50 order this morning. Would have gaind $2.50 a share already..)
 
Posted by urnso77 on :
 
wow this is unreal! Good job guys!
 
Posted by tompom on :
 
quote:
Originally posted by Livinonklendathu:
Out 75% of shares 19.08 from 4.80, retirement time. [Wink]

awesome!
congrats!
 
Posted by creativeflood on :
 
1 billion dollar market here. How long to hold????
 
Posted by a surfer on :
 
down to 17.75

will there be an entry??

looking for 15's. If possible


$170,000,000 traded already.
 
Posted by a surfer on :
 
look for bounce... she's dropping

do I hear 14??
 
Posted by Livinonklendathu on :
 
stopped out the rest 17.50. Should be some nice flips today once profit taking is done.
 
Posted by SherriT on :
 
CONGRATS HERE! Was watching it for days, and thought I was seeing things this morning ;-)
 
Posted by BooDog on :
 
quote:
Originally posted by Zacktrade:
http://us.rd.yahoo.com/finance/exter...mp;cm_ite=NA

I just got in...should gap on monday and run until approval or denial. Do you own DD--looks exciting though.

Excellent Zack!

Congrats to all!
 
Posted by Jo4321 on :
 
There was your $14.00 Surfer.

Now it's time for round two!
 
Posted by a surfer on :
 
going under 12 now
 
Posted by Jo4321 on :
 
Didn't break $12.00, but it did get to $12.00!

That could have been the bottom for now. Back up to $13.40 now.
 
Posted by mindspin311 on :
 
AHHH!!! Kicking myself for taking a quick 12% profit on wednesday. I hate trading javascript:void(0)
Mad LOL
 
Posted by T e x on :
 
nice one, kudos all around...
 
Posted by BooDog on :
 
anyone put this into the cnbc contest?
wowzers
 
Posted by Machiavelli on :
 
this one gapped up too high ... it has nowhere to go now but down for a massive "correction" ... think about taking your profits peeps... you can always buy back in later on... <shrugs> i could be wrong though... just don't get too greedy.. MM's will short it sooner or later...
 
Posted by Jo4321 on :
 
Zacks Bull of the Day for Apr 02, 2007 DNDN

Dendreon Corp. (DNDN) – Up Big on FDA News
The company’s key product candidate, Provenge, received a positive opinion from the FDA expert panel. This will likely lead to the early approval of Provenge in May.

http://www.zacks.com/newsroom/commentary/index_pdf.php?id=4652

Upgraded to Buy from Hold with $20.00 price target

http://www.zacks.com/newsroom/commentary/index_pdf.php?id=4652
 
Posted by Livinonklendathu on :
 
Nice bounce today
 
Posted by Jo4321 on :
 
Monday, April 02, 2007 4:46:59 PM ET
JMP Securities

NEW YORK, April 2 (newratings.com) - Analysts at JMP Securities reiterate their "strong buy" rating on Dendreon Corp (DNR.FSE), while revising their estimates for the company. The target price has been raised from $12 to $20.
In a research note published on March 30, the analysts mention that Center for Biologics Evaluation and Research (CBER) panel has unanimously voted in favour of the safety and efficacy of the company’s Provenge’s BLA for the treatment of late-stage prostate cancer. The analysts believe that the FDA would grant Dendreon an approvable letter for Provenge going forward. The EPS estimate for FY07 has been reduced from -$0.49 to -$1.15. The EPS estimate for FY10 has been raised from $0.84 to $1.27.
 
Posted by Livinonklendathu on :
 
Back to $15, moving nice
 
Posted by birches on :
 
DNDN estimated at $70/share - please read

http://biz.yahoo.com/seekingalpha/070404/31496_id.html?.v=1
 
Posted by netguy81 on :
 
nice article ...
 
Posted by birches on :
 
DNDN closed above 15 today - could see short squeeze tomorrow - I don't see shorts wanting to hold through weekend or into next week when we could get good news in the form of more upgrades, ROW partner announcements for EU and Asia, and long shots like buyouts or fastrack FDA approval.

FDA vote will happen now and 5/15 - no later than 5/15.
 
Posted by Jo4321 on :
 
Mentioned on the Lightning Round tonight:

http://www.thestreet.com/_yahoo/funds/madmoneywrap/10348523_6.html

Lightning Round
Cramer was bullish on Consolidated Edison (ED - Cramer's Take - Stockpickr - Rating), WellPoint (WLP - Cramer's Take - Stockpickr - Rating), Celgene (CELG - Cramer's Take - Stockpickr - Rating), Gilead Sciences (GILD - Cramer's Take - Stockpickr - Rating), Genzyme (GENZ - Cramer's Take - Stockpickr - Rating), Abbott Labs (ABT - Cramer's Take - Stockpickr - Rating), Marshall & Ilsley (MI - Cramer's Take - Stockpickr - Rating), Dendreon (DNDN - Cramer's Take - Stockpickr - Rating) and Starwood Hotels (HOT - Cramer's Take - Stockpickr - Rating).
 
Posted by Stefan on :
 
Jagnotes had a late day rumor of DNDN about to sign with a large pharma partner. This is presumably for international marketing as DNDN plans to handle North America by itself. Roche would be a nice partner!
 
Posted by Jo4321 on :
 
http://www.thestreet.com/_yahoo/newsanalysis/biotech/10348030.html

Forgive if this was posted here before. (from 4/2)
 
Posted by Livinonklendathu on :
 
Trying $16
 
Posted by Livinonklendathu on :
 
16.50 on big volume
 
Posted by Livinonklendathu on :
 
$17.00
 
Posted by Livinonklendathu on :
 
$17.50
 
Posted by Livinonklendathu on :
 
Out 17.95, might try again if it gets through $18.05.
 
Posted by netguy81 on :
 
[Eek!] [Eek!] [Eek!] [Big Grin] [Big Grin] [Big Grin]
 
Posted by lostone on :
 
what an awesome pick.. a shame i'm not in
 
Posted by Jo4321 on :
 
The "Jo effect" helped this one to go up today. I sold 450 out of 500 shares at $16.50. I'm a little frustrated, but at least I got a profit after being down since I bought it.

Jo
 
Posted by TimW on :
 
No shame in any green!
 
Posted by Jo4321 on :
 
Yeah, and now I'll ride my 50 shares to $100.00 [Smile]
 
Posted by Livinonklendathu on :
 
The "Jo effect", lol. When are you selling the other 50 so I can get back in? [Big Grin]

Congrats on the profit, profit good.
 
Posted by Jo4321 on :
 
LOL, Livinonklendathu,

The "Jo effect" does work. I sold JSDA a few weeks ago for $14.70, it's now $25.50!

I'll let you know when I sell that other 50 shares. It might be soon, this makes me nervous:

Dendreon CEO Strikes Gold on Stock Sale
http://www.thestreet.com/newsanalysis/biotech/10348841.html

The reason it makes me nervous is that I've been through FRPT's CEO's stock sale and subsequent drop from 24's to $15's. FRPT is finally working it's way back up.

Even though there are perfectly valid reasons for selling stock, you never know how investors are going to react.

Jo
 
Posted by Livinonklendathu on :
 
That is almost funny, I played JSDA this week a few times. [Eek!]


Saw the CEO sale, no biggie in my book but hey, I rarely hold anything overnight anymore.
 
Posted by BIG * B*U*C*K*S on :
 
http://www.shortsqueeze.com/index.php?symbol=dndn


Massive shorting going on!! 33% of float shorted up 6 million from yesterday.
 
Posted by Jo4321 on :
 
quote:
That is almost funny, I played JSDA this week a few times.
You're welcome for the "Jo effect" Glad you were able to profit from it.

Here's some others I sold recently: Zane at $1.59, NMKT at .407 and DKAM at $1.29. Go for it!

JO [Big Grin]
Oh yeah, I also sold some RNO at $4.00 but you are probably already too late for that one!
 
Posted by Fergy on :
 
Why would a CEO sell stock if they were confident that this would go to $70 like someone had predicted. You would think he would hold on for a higher price if he believe the pps could be sustained and will rise from current levels. Just a thought. I personally think this will retrace some. Good luck though as I don't want anyone to lose their arse.
 
Posted by TimW on :
 
He only sold 20%ish of his shares.. To sell that after a 300% increase.. thats not a bad move.

Id eliminate at least 20% of a position if i gained 300% on it in a week.. wouldnt you?

Never know which way the market will pull your stock prices.

The stock sale was monday too... It increased drastically since the CEO stock sale.

In this case the CEO stock sale is a scare tactic.. its done and over with. If he elimintated a huge percentage of his position, maybe something to worry over..
 
Posted by Livinonklendathu on :
 
Trying $20.00 in pre.
 
Posted by Jo4321 on :
 
Wow, this one isn't quitting! Looks like it is going to hit $21.00 very soon.

Jo
 
Posted by Jo4321 on :
 
$23.67 HOD!

Just amazing!
 
Posted by Jo4321 on :
 
Cramer digs himself out of a hole.

http://tinyurl.com/26nm4r
 
Posted by trade04 on :
 
im baffled
 
Posted by Livinonklendathu on :
 
I'm out, again. Needs a break.
 
Posted by Jo4321 on :
 
CBS news Video

http://www.cbsnews.com/sections/i_video/main500251.shtml?id=2627020n
 
Posted by Jo4321 on :
 
$25 in pre-market!
 
Posted by Jo4321 on :
 
I guess what goes up, must come down. I'm stopped out at $23.50.
 
Posted by TimW on :
 
Just a little dip, no worries [Wink]
 
Posted by Livinonklendathu on :
 
quote:
Originally posted by Jo4321:
I guess what goes up, must come down. I'm stopped out at $23.50.

nice job!
 
Posted by Jo4321 on :
 
Now the hard part: where to get back in?

Jo
 
Posted by netguy81 on :
 
this was kind of expected ... there has to be some market correction ... but how far down this might go ???
 
Posted by Jo4321 on :
 
Back to green. (and back above my stop loss - sigh).

Totally missed that buying op in the 21's.

But I suspect that may come again.

Jo
 
Posted by Jo4321 on :
 
Hmmmm, where's the bottom? I had an order in this morning to buy some more at $18.50, but I cancelled it when I went out to run errands. Not sure this is the end of the slide yet.
 
Posted by TimW on :
 
Im out for now as well, wish i coulda been up earlier to get out in the 20's.. i saw it at 19.80ish and put in a stop limit for 19.50.

I dont plan to buy back in until every place under the sun stops dogging on the company.
 
Posted by Livinonklendathu on :
 
Filled the gap, nice $1+ bounce intraday. Got a downgrade (Market Outperform from Strong buy at JMP) this morning which did not help either.

I'll guess a bounce around the $17 area.
 
Posted by Jo4321 on :
 
hmmmm, $16.90 premarket. Could be the "bounce", but I ain't touching it right now.

Jo
 
Posted by TimW on :
 
back up at $19.00
 
Posted by Jo4321 on :
 
Shoulda "touched it" LOL
 
Posted by TimW on :
 
hehe shoulda woulda coulda..

Im looking for re-entry still myself.
 
Posted by Machiavelli on :
 
quote:
Originally posted by Machiavelli:
this one gapped up too high ... it has nowhere to go now but down for a massive "correction" ... think about taking your profits peeps... you can always buy back in later on... <shrugs> i could be wrong though... just don't get too greedy.. MM's will short it sooner or later...

[Roll Eyes]
 
Posted by Livinonklendathu on :
 
50% fib on the daily is around $14.41, might bounce there like it did at the 38% which was around $17.
 
Posted by Machiavelli on :
 
quote:
Originally posted by Livinonklendathu:
50% fib on the daily is around $14.41, might bounce there like it did at the 38% which was around $17.

Give it up... till if and when it bounces off of RSI 50 and reverses... i predicted this one was overbought and would correct itself.. much like I say the same thing with JSDA... when they are overbought like that .. a "correction" is almost always in the horizon...
 
Posted by Jo4321 on :
 
Weren't you a little early calling the correction on JSDA though? <wink>

Jo
 
Posted by Livinonklendathu on :
 
Upping a bit, $1 bounce so far today.
 
Posted by Livinonklendathu on :
 
$16.60 + 1.50
 
Posted by TimW on :
 
tons of activity today.. moving upward!
 
Posted by Livinonklendathu on :
 
another nice day, $17.17 +1.00 +6.18%
 
Posted by Wildbill on :
 
Probably has something to do with the fact that Medicare is coding and pricing.....
www.cms.hhs.gov/HCPCSReleaseCodeSets/Downloads/2008RequestList.pdf

http://search.cms.hhs.gov/search?q=provenge&btnG.x=0&btnG.y=0&site=default_colle ction&output=xml_no_dtd&client=my_frontend&proxystylesheet=my_frontend&oe=UTF-8

Attachment #07.89
Request to establish a code for sipuleucel-T, trade name: Provenge®. Recommended Language: JXXXX “Sipuleucel-T, 250 mL”
 
Posted by Livinonklendathu on :
 
Saw that earlier, could be helping [Smile]
 
Posted by Livinonklendathu on :
 
Lots of job openings too, hit "view all positions":

http://www.resourcehire.com/clients/Dendreon/publicjobs/controller.cfm
 
Posted by TimW on :
 
Job openings! Existing employees bailed knowing their drug would fail!

Haha just kidding.

glad to see this one rebound.. keeping fingers crossed for approval!
 
Posted by Livinonklendathu on :
 
$18.48 +1.28 +7.44%


I likey
 
Posted by Livinonklendathu on :
 
Big AH volume, hit $19's
 
Posted by Livinonklendathu on :
 
21
 
Posted by TimW on :
 
Up over $3 in an hour and a half... nutty!
 
Posted by Livinonklendathu on :
 
All out for now, was a fun 3 day run.
 
Posted by Livinonklendathu on :
 
Interview with the CEO:

http://feedroom.businessweek.com/?fr_story=4cd35db327da3638eb76f44e386cfddf4f195 234&rf=sitemap
 
Posted by Wildbill on :
 
oops!.......
Wednesday May 9, 7:09 am ET
FDA Requests Additional Clinical Data on Effectiveness of Dendreon's Provenge Cancer Drug

SEATTLE (AP) -- Biotech drug maker Dendreon Corp. said Wednesday the FDA has requested more clinical data on the effectiveness of its prostate cancer treatment, Provenge, delaying the drug's approval.

ADVERTISEMENT
click here
The company received an "approvable" letter on Tuesday from the agency that also sought more information on the chemistry, manufacturing and controls of its application. Dendreon said it is seeking clarification on what kind of efficacy data the FDA needs, but believes it can supply the chemistry and manufacturing data promptly.

In late March, an FDA advisory committee reviewed Dendreon's application and agreed 17 to 0 that the submitted data showed Provenge was reasonably safe and 13 to 4 that the drug was shown to be effective.

"Given our strong belief in the survival benefit and safety profile of Provenge, coupled with the positive outcome of the advisory committee meeting, we are disappointed that this decision will cause a delay in the availability of Provenge for patients who suffer from advanced prostate cancer," said Mitchell H. Gold, president and chief executive of Dendreon.

Prostate cancer is the most common non-skin cancer in the U.S. and the third most common cancer worldwide. More than 1 million men in the U.S. have prostate cancer, with an estimated 218,890 new cases expected to be diagnosed in 2007.

Dendreon has said about 95 percent of prostate cancer cells contain an antigen called prostatic acid phosphatase, or PAP. Provenge is a new kind of cancer treatment designed to help a man's immune cells recognize those cells that carry PAP as foreign and attack them.

Provenge has been studied in a double-blind, placebo-controlled Phase 3 study that showed that a group of men with asymptomatic, metastatic prostate cancer who received Provenge lived an average of 4.5 months longer than those taking placebo. For the men taking Provenge, the study showed a 41 percent overall reduction in the risk of death, and 34 percent of patients were alive 36 months after treatment, compared with just 11 percent of patients receiving placebo.
 
Posted by Livinonklendathu on :
 
The big haircut [Eek!]
 
Posted by TimW on :
 
OUCH!

Down $10 to $7.67
 
Posted by Jo4321 on :
 
I wasn't it DNDN anymore, and I haven't been watching it lately.

I see that this bad news came out in the pre-market. So am I correct that anyone who had a stop-loss order would have been screwed because it went down in pre-market. Is there a good reason for companies to release after or before regular market hours? Seems kind of unfair.

I'm just trying to learn.

Jo
 
Posted by PCola77 on :
 
Jo, someone else can probably answer more definitively, but I think news like this has to be released when the market is closed. I think if news like this is released during the day, they will halt the stock until the info is disseminated (sp) to everyone.
 
Posted by Jo4321 on :
 
That stinks since you can only place limit orders in extended hours. Therefore, you cannot protect yourself with a stop-loss.

This happenned to me with another stock when earnings were released after-hours. Went past my stop loss point by the time the market opened the next day.

I guess with a stock like DNDN, if you were in it, you'd need to constantly monitor it even after hours!

Jo
 
Posted by Machiavelli on :
 
quote:
Originally posted by Machiavelli:
quote:
Originally posted by Machiavelli:
this one gapped up too high ... it has nowhere to go now but down for a massive "correction" ... think about taking your profits peeps... you can always buy back in later on... <shrugs> i could be wrong though... just don't get too greedy.. MM's will short it sooner or later...

[Roll Eyes]
^^^ 6.33 [Roll Eyes] 6.00 in aftermarket [Roll Eyes] ^^^
 
Posted by PCola77 on :
 
Didn't it go up about 50% after you said "It has no where to go but down"?

I know you've been here a long time and respect you and all the advice that you give to everyone, but what was the point of your post there? It seems like you didn't go out on much of a limb by saying a stock that was up 200% was due to pull back. Just seems out of character for someone that I've always thought was very helpful to others to make an "I told you so" post.


quote:
Originally posted by Machiavelli:
quote:
Originally posted by Machiavelli:
quote:
Originally posted by Machiavelli:
this one gapped up too high ... it has nowhere to go now but down for a massive "correction" ... think about taking your profits peeps... you can always buy back in later on... <shrugs> i could be wrong though... just don't get too greedy.. MM's will short it sooner or later...

[Roll Eyes]
^^^ 6.33 [Roll Eyes] 6.00 in aftermarket [Roll Eyes] ^^^

 
Posted by Machiavelli on :
 
I made a warning on this one just like i did with QBID... people like to take my advice on how to get into trading but not so much so when I make a analysis of a stock... this post wasnt so much a "I told you so" post.. but more like a lesson post... Don't fall in love with a stock... learn to let it go if need be... more fish in the sea... but if it bothered you... I won't make any more analysis posts... some people need to learn from experience... I don't mean you in particular... just in general...
 
Posted by T e x on :
 
easy fellas... the point *is* discussion [Cool]
 
Posted by Mysticobra96 on :
 
My guess is $5.25 for bounce.
 
Posted by PCola77 on :
 
Ok, could just be the way intent is often lost on message board postings. I just read it as an "I told you so" given the eye rolling. Entirely possible that I was the only one to interpet it that way.

Tex, it would be only slightly hypocritical if I got upset at someone for pointing out the downside of a stock. That was not my point. Just the way it came across to me seemed more hurtful than helpful.

Anyway, Mach, I'm obviously not suggesting you cease posting your analysis, and am not even suggesting you change the way you word it, was really just asking for clarification0 because of the way that it read to me. As I tried to make clear, it seemed out of character, so I figured it wasn't intended that way.

By the way, I never owned any of this stock, so this was not a case of a holder being overly sensitive to criticism, it was from a neutral observer.

quote:
Originally posted by Machiavelli:
I made a warning on this one just like i did with QBID... people like to take my advice on how to get into trading but not so much so when I make a analysis of a stock... this post wasnt so much a "I told you so" post.. but more like a lesson post... Don't fall in love with a stock... learn to let it go if need be... more fish in the sea... but if it bothered you... I won't make any more analysis posts... some people need to learn from experience... I don't mean you in particular... just in general...


 
Posted by PCola77 on :
 
Double post...
 
Posted by Stock_Pupil on :
 
Don't they still have a chance at approval, they just need to submit more data. I missed the first big gainer, I'm wondering if they eventually do get approval if we'll see a repeat in gains?
 
Posted by Livinonklendathu on :
 
http://seattletimes.nwsource.com/html/businesstechnology/2003701824_webdndn11.ht ml
 
Posted by TimW on :
 
quote:
Originally posted by Stock_Pupil:
Don't they still have a chance at approval, they just need to submit more data. I missed the first big gainer, I'm wondering if they eventually do get approval if we'll see a repeat in gains?

They do have a chance still, but the only thing that took this stock from $4 PPS was the hopes of approval NOW. Without approval, it goes back to its pre-hyped price until it gets close the approval again. So IF there is approval, yes, will see a repeat in gains.
 
Posted by Mysticobra96 on :
 
Up 16% from my guess at $5.25
 
Posted by Machiavelli on :
 
till it gets approval it will stay down unless rumors of it's pending approval starts driving the stock up again... the MM's will go long... but in all fairness I hope it does get approved because I lost someone due to cancer recently so in the case of this company I really don't care about trading but care more about saving lives...
 
Posted by T e x on :
 
sorry to hear that, Mach...my sympathies, pal. That can be a tough road, for sure...
 
Posted by T e x on :
 
a petition to FDA, re Provenge:

http://www.malecare.com/
 
Posted by Machiavelli on :
 
quote:
Originally posted by T e x:
sorry to hear that, Mach...my sympathies, pal. That can be a tough road, for sure...

thanx .. tex...
 
Posted by Livinonklendathu on :
 
http://biz.yahoo.com/prnews/070520/clsu010.html?.v=9
 
Posted by Jo4321 on :
 
Dendreon Slashes 40 Jobs, Or 18% Of Work Force >

DNDN Last update: 5/21/2007 7:11:38 AM

DOW JONES NEWSWIRES

Dendreon Corp.'s (DNDN) board has approved the elimination of 40 jobs, or 18% of the company work force, in connection with the near-term commercialization of prostate cancer drug Provenge, according to a Securities and Exchange Commission filing Monday.

As reported earlier this month, the Seattle biotechnology company lost more than half its market capitalization and most of its stock gains since March after the Food and Drug Administration requested more clinical data supporting the drug's effectiveness.

The FDA made the request in an "approvable letter," meaning the agency is prepared to approve the medicine if certain conditions are met.

Dendreon didn't say how long the request for more data will delay Provenge's arrival on the market. Following the job cuts, the company will have about 200 employees remaining at facilities in Seattle and Morris Plains, N.J.

According to Monday's SEC filing, Dendreon expects to incur non-cash charges of up to $300,000 and cash charges of up to $1.5 million associated with the work force reduction. The company's shares closed Friday at $6.07.

-Chad Clinton, Dow Jones Newswires; 202-862-1349; chad.clinton*dowjones.com (END) Dow Jones Newswires
 
Posted by Livinonklendathu on :
 
nice story on CNBC this morning, back over 7.
 
Posted by stgeorg2 on :
 
Short sellers bet Dendreon's drug won't win FDA approval
By Luke Timmerman

Bloomberg News

Dendreon shares are being sold short at a record pace as some investors bet the company's experimental prostate cancer drug will fail to win approval from U.S. regulators.

About 44 percent of Dendreon shares in mid-April were borrowed stock sold short, in anticipation of being replaced at a lower price, according to Nasdaq Stock Market data compiled by Bloomberg. That's a big bet against a stock that has tripled since March 29, when advisers to the Food and Drug Administration (FDA) recommended the medicine.

The drug, called Provenge, is the first of a new class designed to trigger the body's immune system to attack tumors. While Provenge prolonged lives of patients with advanced prostate cancer in one study presented to the panel, the drug didn't meet the trial's primary goal of slowing the spread of the disease.

"Some people are assuming the FDA won't listen to the panel" because of the discrepancy in the study findings, said David Miller, president of Biotech Stock Research, an independent equity research firm in Seattle.

The short-selling is up 28 percent from mid-March and double the amount in January. It's the second-biggest increase on the Nasdaq this month, after ON Semiconductor, a maker of computer chips in Phoenix.

Shares of Seattle-based Dendreon closed down 30 cents, or 1.9 percent, at $15.15 Friday. The shares have almost quadrupled since Jan. 1, the best performance in the Nasdaq biotechnology index.

Dendreon says it expects to hear May 15 whether Provenge will be released for use in the U.S. The company didn't respond to requests for comment on short-selling of the stock.

The FDA, while usually following the advice of advisory panels of scientists and doctors, isn't required by law to do so. Short sellers say the FDA may counter the advisers' ruling and hold off approving Provenge until results come in from another company-sponsored study. Dendreon has said that trial, measuring survival of 500 men with advanced prostate cancer, could take until 2010 to produce results.

"The short data says to me that people do not believe the panel's decision will be mirrored by the FDA," said Jonathan Aschoff, an analyst with Brean Murray Carret & Co. in New York, in a telephone interview. He has rated Dendreon shares "sell" since November 2004 and doesn't own any.

The stock's price surge reflects the lack of good treatments for advanced forms of the cancer, which is often lethal once it spreads beyond the prostate. The disease kills 27,000 men in the U.S. a year. Doctors say they often try treating terminal patients with Taxotere, a drug from Paris-based Sanofi-Aventis. That medicine has side effects and limited usefulness.




Provenge will be Dendreon's first product and may generate $1 billion a year in sales if approved by the FDA. Dendreon, founded in 1992, is trying to be the first drug maker to market a new class of experimental medicines scientists are developing that stimulate the body's immune system to attack cancer.

The company began its final-stage study in prostate cancer patients in 2000. Its only other product in clinical development is an immune-stimulator against breast cancer. Dendreon had an accumulated deficit of $392 million through the end of 2006, according to its annual report.

Short-sellers may be betting that the FDA won't go along with the panel because of the conflicting clinical trial results. Dendreon's own statistical consultant told the advisory panel on March 29 that the research data is "less than perfect."

Dendreon's first trial of 127 men showed that patients on Provenge lived a median 25.9 months, compared with 21.4 months for those on a placebo. A second trial of 98 men showed a median survival of 19 months, compared with 15.7 months for those taking a placebo. That finding wasn't valid because it didn't reach a statistical threshold, the company said.

Both studies failed to demonstrate the drug slowed the cancer's spread, which was their primary goal. Dendreon says the measurement of whether Provenge was slowing the cancer's progress may have been carried out too early in the studies to detect the drug's ability to generate an attack by the immune system.

Dendreon supporters say the chances of Provenge winning approval are good, given limited treatment options for the disease. The FDA can require additional trials after the drug goes to market if it wants more evidence it works, said Charles Duncan, an analyst with JMP Securities in New York, in a note to clients Tuesday.

The first three of the 17 FDA panelists who were polled voted against recommending approval. The entire panel later voted 13-4 to recommend approval after the definition of the drug's effectiveness was changed by FDA staffers who analyzed the drug studies.

William Ho, an analyst with Bank of America Securities in New York, told clients in a Tuesday that he expects FDA approval. He said the staff's revised definition of the drug's effectiveness was designed to "lower the bar" in evaluating Provenge.
 
Posted by Livinonklendathu on :
 
http://www.earthtimes.org/articles/show/news_press_release,112062.shtml
 
Posted by T e x on :
 
quote:
Originally posted by Livinonklendathu:
http://www.earthtimes.org/articles/show/news_press_release,112062.shtml

this is notice of a class-action suit, kids...

hedzup, if you're affected.
 
Posted by jon clogger on :
 
I should probably stop day-trading this...
 
Posted by TimW on :
 
Some people dont know how to suck up a loss or plan an exit... tsk tsk.
 
Posted by T e x on :
 
lol...

a) hit the sell button... b) before you enter
 
Posted by Livinonklendathu on :
 
flying

http://www.stockhouse.com/news/news.asp?newsid=5541430&tick=DNDN
 
Posted by Jo4321 on :
 
So now it may not be approved until 2008? Or am I misunderstanding?

quote:
We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008.

 
Posted by BIG * B*U*C*K*S on :
 
by far the fastest trading ive ever seen. . . computer cant keep up
 
Posted by Livinonklendathu on :
 
quote:
Originally posted by Jo4321:
So now it may not be approved until 2008? Or am I misunderstanding?

quote:
We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008.

Thats how I read it.
 
Posted by invester on :
 
Man I love stock options!!!!!!!
 
Posted by jon clogger on :
 
Been in and out of this 4 times today. OMG this is too good to be true.

Dodged the three big bombs too! (Only by a hair, though...)
 
Posted by Livinonklendathu on :
 
Good job jon. I caught it in pre, sold at 9:31 and never looked back.
 
Posted by jon clogger on :
 
I was too chicken to buy pre-market prices.

Thats what got me in trouble with CUP...sigh
 
Posted by invester on :
 
June Puts on fire!!!!!
 
Posted by Stock_Pupil on :
 
Hey guys, what's the reason for the recent jump in price on this one, OPTIONS?? I thought it was dead until they improved on some things.
 
Posted by Livinonklendathu on :
 
quote:
Originally posted by Stock_Pupil:
Hey guys, what's the reason for the recent jump in price on this one, OPTIONS?? I thought it was dead until they improved on some things.

posted May 31, 2007 09:09
--------------------------------------------------------------------------------
flying

http://www.stockhouse.com/news/news.asp?newsid=5541430&tick=DNDN
 
Posted by Livinonklendathu on :
 
http://provengenow.org/
 
Posted by Livinonklendathu on :
 
In, news of congressional inquiry into fda non approval
 
Posted by Livinonklendathu on :
 
out 7.70
 


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