SubscribeMarketMash: April Fool’s Week
April 6, 2008
A week full of fun and adventure in the stock market. Fun stories, rants and other observations that you may find of interest.
David Gaffen over at the WSJ was somewhat blah about Fitch cutting the rating on MBIA (MBI). DAVE: It could be worse, they could have raised them to a AAA++++! :-) The WSJ MarketBeat Blog also showed us how the markets just do not have a flavor for Bernanke’s Voice..or at least the words that comes with the voice.
Timothy “Tim” Sykes is determined to show us his frustration with most of the financial world and gives a few interesting observations.
The recent Lehman (LEH) preferred offering is, at best, suspect. You gotta love these financials! Mish blogs about the April Fools of the deal.
Motorola (MOT) is cutting jobs, losing money and is just a pathetic excuse for what once was a leading tech company. Will some one put them out of their misery already! (I feel better now).
Then we hear that Microsoft (MSFT) and Yahoo (YHOO) are not playing well together. Now Microsoft is setting a deadline and they are threatening to walk away. I just do not think the Jerry Yang really cares guys!
Want to learn about a Prostate Biopsy? Herb Greenberg takes us behind the scenes of his recent doctors visit. As my son would say: “That is a little more than I need to know.”
You just have to love the Clinton’s; They really know how to make the bacon. $109 million in earnings since 2000. Not bad.
The end of free Wifi is the topic of this year’s April Fool’s prank by John Dvorak. It is a prank right, John?
The money came pouring in from an secret admirer for Dendreon (DNDN). Huckman gives us the skinny.
My book, The Disciplined Investor, is on a special sale at Amazon. 32% off! Get it while you can at this price…
TDI Episode 49: Pharma Huckman’s Market
March 23, 2008
Guest: Mike Huckman, CNBC Pharmaceutical Reporter brings great deal of timely information regarding the Pharma and Biotech sectors. We discuss Merck (MRK), Amgen (AMGN), Genentech (DNA), Dendreon (DNDN), Pfizer (PFE) and others.
Mike’s writes a terrific blog and appears daily on CNBC.
Andrew discusses the current markets and provides a few strategic moves for profit potential. Last week was a see-saw market and if positioned correctly, your portfolio could be holding up well. Even so, it looks as though the economic environment could continue to deteriorate. In this episode, we explore the next looming problem and how to protect yourself.
**AWARENESS and discussion of the Credit Card Crisis has not yet made it to the mainstream headlines, but we see that there is potential for additional economic fallout as Americans continue to build credit in order to pay for their increasingly expensive lifestyles.**
In this edition of The ZachZone, Visa (V) and upcoming IPOs are discussed.
(This edition of The ZachZone is sponsored by Newsflashr – Get a wide angle view of all of the hot topics making news – All on a single page. )
~ Listen and Subscribe in iTunes ~
Other Stocks Mentioned in this and recent episodes: (V) (BSC) (LEH) (SPY) (SAFM) (GS) (MER) (QID) (SKF) (QQQQ) (IBKR)
Podcast: Play in new window | Download
Dendreon’s News – Good Spin, No Spunk
March 12, 2008
Dendreon (DNDN) is one again in the news. At first, it appears that there is a faster track that the FDA is allowing when it comes to the trials for Provenge. If you read the news item it is really nothing significant, yet it is may be a hint that the FDA is softening and may allow for study results to be moved up a year.
None of the informations appears to change any of the results we have seen thus far. It simply allows for the removal of the results within the test-group that show a false-positive return. In other words – the results that are meaningless are being removed from the test group. This should be a common practice, so any excitement created by inferring more from the news should be contained.
Shares are up in pre-market today on this announcement by 15% or so.
This particular topic will be in focus during our upcoming podcast conversation with Mike Huchman, CNBC’s health correspondent.
StreetInsider.com – Dendreon (DNDN) Said FDA Amends SPA on IMPACT clinical trial of PROVENGE
March 12, 2008 7:42 AM EDT Dendreon Corporation (Nasdaq: DNDN) said the FDA has agreed to an amended Special Protocol Assessment for the Phase 3 IMPACT clinical trial of PROVENGE. In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application for licensure of PROVENGE. The amended SPA accelerates the expected timing of the final IMPACT results by approximately one year while maintaining comparable powering of the study’s interim and final results. By increasing the number of events and decreasing the alpha (false positive error) spending function for the interim analysis, the Company is able to reduce the number of events for the final analysis (from 360 to 304) and still maintain a comparable statistical power for both the interim and final analyses. Interim results are still expected in the second half of 2008; however, final results are now expected in the second half of 2009 rather than 2010.
In another spin, there are news reports that read: “U.S. health regulators approved its amended trial design of the late stage study of its Provenge cancer vaccine, accelerating the expected timing of the final study results by about one year.”
The fact that the first few words read : U.S. health regulators approved is a magnificent spin, so don’t get caught in this trap. We need to see a real result and change to the FDA position, which is not contained in this news item. While it may show some level of advancement, it may be a good idea to watch for further results.
Disclosure: Horowitz & Company clients are LONG DNDN as of publish date..
DNDN: Studies are impressive – AGAIN!
February 14, 2008
It is one day after the House Energy and Commerce Committee sent a declination letter to the four Congressmen that had been requesting a further review of the questionable FDA ruling for Dendreon’s (DNDN) Provenge, the company’s groundbreaking Prostate cancer drug. Now, a news release shows another beneficial study result that should have the FDA looking even more ridiculous.
According to the HSE Committee, represented by Chairman John Dingell (D-MI) writes, “An investigative hearing prior to an agency’s final decision runs the risk of interfering with the normal regulatory process.” (CLICK FOR LETTER)
The news looks promising. But realize, so did the last report, and the one before that as well.
SEATTLE and SAN FRANCISCO, Feb 14, 2008 /PRNewswire-FirstCall via COMTEX/ — Researchers from Dendreon Corporation (Nasdaq: DNDN) today presented data demonstrating the correlation of a measure of the cumulative potency of PROVENGE (sipuleucel-T), an investigational active cellular immunotherapy for hormone-refractory prostate cancer, with overall survival. This the first time that an association between higher potency of an active immune therapy and increased patient survival has been reported. The correlation appeared to be independent of other important baseline prognostic factors.
The abstract (#21), “Cell Number and CD54 Expression in Sipuleucel-T correlate with Survival in Metastatic Androgen Independent Prostate Cancer,” is being presented at the American Society of Clinical Oncology’s 2008 Genitourinary Symposium in San Francisco.
In two Phase 3 trials, D9901 and D9902A, researchers evaluated cumulative product release parameters of PROVENGE, including CD54 upregulation (a measure of product potency defined as the increase of CD54 molecules expressed on antigen Presenting Cells [APC] after incubation with the PROVENGE Antigen Delivery Cassette(TM)) and the number of total nucleated cells (TNCs) among patients treated with sipuleucel-T (n=146). CD54 is a costimulatory molecule which serves as a marker for APCs. Its expression is increased when APCs become activated and this upregulation of CD54 serves as a potency release
assay for PROVENGE.Results showed that PROVENGE patients experienced improved survival if they received more cells across the three doses of PROVENGE (higher cumulative TNC count (p=0.019)) or higher cumulative CD54 upregulation values (p=0.009). The effect on survival for TNCs appeared to reflect in part the patients’ baseline prognostic factors. However, the CD54 upregulation ratio appeared to be an independent predictor of survival in patients who received PROVENGE, as the correlation remained strong even after adjusting for baseline prognostic factors (p=0.022).
“We have been able to show a correlation between patient survival and a measure of the cumulative potency of PROVENGE; such a correlation between product potency and clinical outcome has not been previously demonstrated with an active immunotherapy,” said Mark Frohlich, MD, chief medical officer of Dendreon. “These data provide further evidence that sipuleucel-T is actively engaging the immune system in a clinically meaningful way that prolongs
patient survival.”
Disclosure: Horowitz & Company Clients are LONG DNDN
Good News for Dendreon, Bad News for Prostate Cancer
January 15, 2008
These days all eyes are on the state of the economy, not to mention the obsession with the financial sector. Maybe today is the day when we try to think about some of the other pressing matters that are important. Take as an example the good news announced today for Dendreon NASDAQ: (DNDN).
For months, there has been a monstrous backlash over the FDA’s approval letter that was… not approved. That was a big blow to the stock back in May, 2007. Since then, there has been an ongoing battle which was recently taken to the courts for further exploration. The assertion/scuttlebutt is that the FDA did not vote for reasons related to the drug. Rather, it is one of competition and greed. Whatever the outcome will be, today’s news brings those with prostate cancer, one more glint of hope that they will be able to gain access to what has been tagged as a “miracle drug.”
If nothing else, maybe that hope will be only a plane ride away as Europe has granted a patent to their lead product candidate, Provenge.
Dendreon Receives European Patent Covering PROVENGE(R) and Company’s ACI Platform Technology
Dendreon Corporation DNDN today announced that the company has been granted a broad European patent covering the company’s lead product candidate PROVENGE(R) (sipuleucel-T), the Company’s investigational active cellular immunotherapy for the treatment of advanced prostate cancer. European patent No. 0 870 022 B1 covers the composition of matter of PROVENGE as well as the company’s other active cellular immunotherapy (ACI) product candidates, such as NEUVENGE(TM) (lapuleucel-T), which utilize Dendreon’s Antigen Delivery Cassette(TM) technology. The patent also covers methods of activating antigen presenting cells in vitro with certain fusion proteins developed by Dendreon, including the fusion protein that is used in PROVENGE.
The stock has been flat-lined since the FDA postponed their approval in May. Even as the company provides optimistic results and is fighting hard for their cause, it is tough to fight City Hall. Perhaps now the FDA will take notice and Read more
