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MackTheKnife
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MackTheKnife's Blog : Dendreon Files Amended Provenge BLA

Date November 2, 2009  Edited: November 2, 2009    Comments Comments (22)    Rate this post Recommend This Post (8)   
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The Dendreon Corp. (DNDN) announced today it has completed the submission of its amended biologics license application (BLA) for Provenge to the U.S. Food and Drug Administration (FDA) (http://tinyurl.com/yzmx9qo).

Dendreon is seeking to have Provenge licensed for men with metastatic castrate-resistant prostate cancer (CRPC). Should the FDA follow the data this time around, Provenge would be the first product in the new therapeutic class known as active cellular immunotherapies.

Given Dendreon's announcement today, I hereby amend one of the statements in my Probabilities and the Financial Markets blog post: Basically, I now believe there is a high probability the FDA will be compelled to OK Provenge as a treatment for patients with metastatic CRPC by May 2 of next year.

Related Blog Posts

Probabilities and the Financial Markets (http://tinyurl.com/yzv7689)
Dendreon's Provenge: Maximum IMPACT (http://tinyurl.com/yzr2dor)
Congressmen Request Probe of FDA's Provenge Delay (http://tinyurl.com/ygfukge)
Sentiment Analysis: How Do You FEEL About It? (http://tinyurl.com/y93o7jy)
Dendreon CFO Pulls a Rabbit Out of the Hat, Again (http://tinyurl.com/yzrg33c)
Synchronicity! And Three Cheers for Ralph M. Steinman! (http://tinyurl.com/ylzxcm6)
Patient Advocates Plan Protest of Dysfunctional FDA (http://tinyurl.com/yk3qwvv)
Hey, Hey, FDA, How Many Dads Did You Kill Today? (http://tinyurl.com/ykuxrw2)
Tags : DNDN   BLA   FDA   CRPC   AIPC  

22 Comment(s):

Author JoeJustJoe     Date November 2, 2009 08:31
Yeah butt....what's that gonna do to the price o'the stock, Mack...besides bring it dooooooooown? :-) 3J
Author MackTheKnife     Date November 2, 2009 08:55
Howdy, 3J!

I'm waiting for you, Joe (http://tinyurl.com/2pv5c):

Photobucket

Good luck!

MackTheKnife
Author JoeJustJoe     Date November 2, 2009 09:10
Mack...according to analual returns your wait is o-fish-ally over! WOOHOOOOOOO! :-) The even GOOGer newz for ye is that it twon't take long for your ass-umptions on DNDN to manifest themselves to the opposite of yer ass-umptions....waaaaay befo May. :-) Anxiously waiting for the "proof" that altho yer ramblins about DNDN "appear to be" sumphin the sheeple can use to make $$$... the "reality" says they are the reason yer wait is over. :o 3J
Author ak3583     Date November 2, 2009 09:45
Hi Mack!

Go Dendreon and Go Yankees!! (Since the Cubs aren't playing. Just wait till next year for them..) AK
Author MackTheKnife     Date November 2, 2009 09:55
Howdy, AK!

Go Dendreon and Go Yankees!! (Since the Cubs aren't playing. Just wait till next year for them..)

Personally, I would love for the Bronx Bombers to play the team managed by former New York Yankee Lou Piniella in the 2010 World Series!

Good luck! (To both the Cubbies and you!)

MackTheKnife
Author JoeJustJoe     Date November 2, 2009 10:45
Well...the bad news is that "cheerleading" ainna gonna do a thang to help out this POS that is DNDN. But!...ifn yer gonna cheerlead I would "suggest" you wait until whenst (not if) Fri's low goes bye bye. Taint nuphin werser then a "fair weather fan"...right? :-) On the "flip" side. Try to refrain from WOOHOOin whenst (not if) DNDN turns around whenst (not if) I turn the markets around. Remember sheeple, a rising tide floats all boats and I'm sho yuns herd the story bout the turd floatin in the swimming pool...well,,,,that'd be DNDN :-) 3J
Author MackTheKnife     Date November 2, 2009 10:53
Howdy, 3J!

I'm waiting for you, Joe (http://tinyurl.com/2pv5c):

Photobucket

Good luck!

MackTheKnife
Author JoeJustJoe     Date November 2, 2009 10:57
DNDN now at 25.85...your comin ta get me, Mack! :-) BTW, QCOR was "lucky" enuff to make it to my "almost suitable for rexscue" list this week. You "should" be hapy to hear that I'm wreckin. :o 3J
Author JoeJustJoe     Date November 2, 2009 12:02
DNDN about to go neggy...Mack...AK...get them thur pom poms ready. Rah rah siskoombah....goooooooo dumdum! ....Ooops!... I mean DoNeDoNe! ...sorry fellahs :-) 3J
Author JoeCole     Date November 2, 2009 15:03
Lol, 3J there is hope!

Notice of Deadline for Plaintiff Submissions to Investors Who Purchased or Otherwise Acquired Shares in Direxion Daily Financial Bear 3X Shares (NYSE: FAZ)

http://money.cnn.com/news/newsfeeds/articles/marketwire/0553533.htm
Author JoeJustJoe     Date November 2, 2009 15:41
Sheeeyot...thurs ALWAYS hope. Ya can't rely on "hope" ta make yer trades tho. My "suggestion" to ya would be fergit about "hope" and maybe start all over? But this time I'd do eggZack'sly opposite of what you normally woulda done ifn I wuz you. Just try it for 2 mumphs and then lemme know how it werked out fer ya. And as always...GOOG luck with that thur. *-) 3J
Author InvestmentMAGE     Date November 2, 2009 16:04
MTK,

Good Call.

You are hilarious...

MAGE
Author MightyMo     Date November 2, 2009 20:40
MTK,

DNDN getting approved by the FDA is extremely highly probable. However, DNDN investors are concerned about a buyout. In this case, shareholders DON'T WANT a buyout as the consideration is that DNDN stock price would raise higher without a buyout. DNDN most likely would like a Europeon partner.
Author MackTheKnife     Date November 3, 2009 08:36
Howdy, Mage!

Good Call.

I am unsure about which one you mean, but thanks for the kind words, anyway!

You are hilarious...

Moi? (Heh heh heh.)

Good luck!

MackTheKnife
Author MackTheKnife     Date November 3, 2009 08:37
Howdy, Mo!

DNDN getting approved by the FDA is extremely highly probable.

As indicated in Probabilities and the Financial Markets (http://tinyurl.com/yzv7689), my simple-minded approach to the assessment of probabilities does not encompass the concepts embodied in either 100% or 0%. Because I am mindful of the history of criminality at the highest level of the FDA, I accordingly believe there is a 75% probability, with an upward bias, the agency will be compelled to OK Dendreon's Provenge as a treatment for patients with metastatic CRPC by May 2 of next year. However, I think it is unwise for me to proceed as though the science is the only -- or even the primary -- factor involved with this BLA (i.e., a conflict of interest is not the exception but the rule in many a case at the FDA). Therefore, I plan to continue trading around my core investment in DNDN, which has served me well over the years.

However, DNDN investors are concerned about a buyout. In this case, shareholders DON'T WANT a buyout as the consideration is that DNDN stock price would raise higher without a buyout.

Certainly, the recent appointment of Ian Clark (http://tinyurl.com/yhy2vr5) -- the incoming chief executive officer at the Genentech unit of Roche (RHHBY) -- to the Dendreon board of directors does have me more concerned about the possibility of an acquisition of the company at present than I have been in the past. However, I believe Roche or other would-be acquirers most likely would wait at least until the FDA approval of Provenge is in the bag before launching any potential bids.

DNDN most likely would like a Europeon partner.

Based on my interpretation of Dendreon management's representations on this point, I believe the company would like to manage the U.S. market itself and negotiate with a single potential partner a rest-of-the-world agreement, with coverage including but not limited to Europe.

Good luck!

MackTheKnife
Author JoeJustJoe     Date November 3, 2009 09:40  Edited: November 3, 2009 by JoeJustJoe
Hang in thur, Mack! QCOR within striking distance now. You only need to lose anudder 20% or so from todaze 3.86 low *-) I'll say it >>> You're comin to get me! ....gulp! :o BTW, it's a GOOG thing you are "mostly" long in a raging bull market. Down 78% on yer analual return? You shootin for 100% I take it? :-)3J
Author MightyMo     Date November 3, 2009 22:41
MTF

Thanks for the response to the comments........I'll take 75% probability with an upward bias. I continue to hold DNDN.
Author MackTheKnife     Date November 4, 2009 03:28
Howdy, Mo!

Thanks for the response to the comments

My pleasure.

I'll take 75% probability with an upward bias.

Me, too.

I continue to hold DNDN.

Me, too. Of course, I also plan to continue trading around my core investment in DNDN, as I buy the dips and sell the rips.

Good luck!

MackTheKnife
Author JoeJustJoe     Date November 4, 2009 09:18
Just "so ya know" ...the only high that needs to go bye bye fo sho as of right now is the "rah rah" induced high from the open on Mon. I "guess" that was like 26.88 er sumphin like that thur. Every udder high on the chart has been confirmed with a higher high. I'm wreckin that once this POS trades thru 26.90 (now at 26.93) it can begin werkin its way down to the news release that you will all get taken down by. Again, the day DoNeDoNe sees 18.50 is the day it see $11 dollahs. Nuff said bout DNDN. I'll still try and rexscue QCOR for ya, Mack. *-) 3J
Author JoeJustJoe     Date November 5, 2009 10:55
Even with the indicies taking out yestermadaze highs and DNDN following suit thur wasn't enuff "oomphage" on the move to 27.35 to assure this POS needs to trade back up heeeya again. Now that the markets are getting ready to stage a substantial selloff I sssuspect DNDN will move on to an even lower low....now that it made a lower high. Simply watch the chart from left to right thur, sheeple. Lower highs n lows mean >>>>Downtrend. *-) I know for a fackt that many o'you DoNeDoNe "wishful thinkers" have trouble with "reality"....I figgerd I'd sssplain what a downtrend is..."hopefully" you will come to yer senses befo I take this POS to 18.50 *-) Today "might be" the day fer QCOR tho, Mack...ifn not today...then I would "hope" whenst I'm finished with this selloff I am gonna bring to the markets it twill be. No need to wish me "luck" ...luck is fer azzholes. *-) 3J
Author JoeJustJoe     Date November 6, 2009 10:35
Well those sneaky bastages...."they" took DoNeDoNe up to 28.57 (a high that needs to go bye bye) whilst I was off taking care of FAS n URE. DNDN now at 27.97...thurs still time to get in before the coming salamie...but ya better hurry! :-) 3J
Author JoeJustJoe     Date November 9, 2009 10:20
Now 29.21 needs to go bye bye...now at 29.20 but thaaas "OK" ...DoNeDoNe will close down on the day "if" 29.21 goes bye bye. Don't do it, Mack! :o 3J
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