Thestreet.com reiterates Sell recommendation--Which is a contrarian signal to Buy

Adam Feuerstein is the biotech analyst at Jim Cramer's Thestreet.com.  He had a Sell recommendation on Dendreon ("DNDN"), before it subsequently soared from $3 to $58 after its prostate cancer drug Provenge was approved by the FDA on April 29, 2010.  (Editor's note:  shares of DNDN have subsequently plummeted back to $5.28 as of today due to commercial uptake issues).

Feuerstein has also had multiple Sell recommendations on another battleground biotech company, Arena Pharmaceuticals ("ARNA").  Shares of arena have also soared from its 52-week low of $1.23 to its 52-week high of $13.50 upon FDA approval of its anti-obesity drug Belviq ("Lorcaserin").  Today, Thestreet.com reiterated a Sell recommendation on ARNA, with the shares trading around $8.72.

http://www.thestreet.com/story/11800338/1/arena-pharmaceuticals-inc-stock-sell-recommendation-reiterated-arna.html

With the benefit of hindsight, any investors listening to Thestreet.com's recommendations would have lost money--or worse, missed out on spectacular returns of more than 1000%.

Meanwhile, Thestreet.com settled Federal civil charges of accounting fraud.  In typical Wall Street fashion,

TheStreet Inc. and the three executives neither admitted nor denied the allegations but agreed to refrain from future violations of the securities laws.

This outcome occurred despite these shenanigans by the company's executives:

The company filed false financial reports throughout 2008 which reported revenue from sham transactions at the subsidiary, which it acquired in 2007, the SEC said. The subsidiary conducts promotions such as sweepstakes on the Internet.

The agency said Alwine and Barnett made the phony transactions and also fabricated and backdated documents to enable the fraud.

Here is a link to the story:  http://finance.yahoo.com/news/thestreet-com-company-3-executives-182033815.html;_ylt=A2KJjb3ILNtQwGgApCSTmYlQ

Meanwhile, shareholder value of Thestreet.com has plummeted over the years.  Here is a price chart of TheStreet ("TST") shares from 1999 to December, 2012:

http://finance.yahoo.com/echarts?s=TST+Interactive#symbol=tst;range=my;compare=;indicator=volume;charttype=area;crosshair=on;ohlcvalues=0;logscale=off;source=undefined;

Shares have plummeted from $45 to $1.61.  How this firm has been accused of and prosecuted for accounting fraud, and has consistently put out wrong directional investing recommendations, and is now trading as a penny stock--but can still stay in the business of stock-picking is beyond me.  But wait--we have our answer:  Jim Cramer, the clownish host on CNBC's Mad Money show is Thestreet.com's co-founder.

In hindsight, TheStreet.com should have put a Sell recommendation on itself 13 years ago.  As for Thestreet.com's reiteration of a Sell recommendation for ARNA, you be the judge.

FDA approves Provenge

Shares of Dendreon (symbol "DNDN") surged today after the FDA approved Provenge for treatment of advanced prostate cancer. Search DNDN in this blog or Google "Deep Capture Dendreon." It's a fascinating story. It includes an analyst who predicted DNDN shares would tank to $1. Jim Cramer and much of Wall Street were negative on the company when it was trading around $3. Today, it hovers above $45, before trading was halted. Laugh out LOUD!

The company has had a tough, arduous, long road, with many opponents--some crooked, including the FDA, short hedge funds, market makers, investment banks, regulators, analysts, and captured journalists--even organized crime syndicates according to conspiracy theorists. But in the end, the white hats won, and many lives will be saved.

This is not a profit-making celebration--this is a confirmation that patience and conviction are sometimes rewarded. Many long investors suffered for years; using luck and some skill (along with courage), I was able to time the trade so I would only be exposed to regulatory risk for one year.

This rollercoaster is not for the faint-hearted.

See disclaimer on side bar.

Disclosure: entry points for DNDN between $4 - $7 in April 14, 2009. Planning to exit a percentage of position at approximately $45 on April 29, 2010.

Edit: after resumption of trading, DNDN is now trading at $52!

Edit 2: Disclosure: another tranche sold at $57.55 on April 30, 2010, purchased at $7.28 on April 14, 2009.

Dendreon revisited

Adam Feuerstein, an analyst on the street.com, who was previously bearish on DNDN, offers the following bullish analysis on Dendreon:


http://www.thestreet.com/story/10503521/1/dendreons-gold-whats-next-for-provenge.html

Interesting tidbit on commercialization prospects:

"Most people are modeling Provenge along the lines of Erbitux now," said Gold, referring to the cancer drug from Eli Lilly(LLY Quote) and Bristol-Myers Squibb(BMY Quote). "I think Erbitux costs around $80,000 a year now. ... I'm not saying that's going to be the Provenge price, but that's what analysts and people on the Street have in their heads when thinking about a Provenge price.

"If you use that assumption and say that the market size is 100,000, men then the total commercial market opportunity for Provenge is $8 billion."

Gold on Provenge in Europe:

"We have only had superficial high-level discussions with the Europeans, so the European regulatory strategy and European commercial plans are things that we're really going to look for a partner to oversee. Dendreon is going to focus on the U.S. market. "

Gold on signing a partnership for Provenge or entertaining acquisition offers for the entire company:

"We are committed to commercializing Provenge ourselves in the U.S. and finding a partner outside the U.S. ... If someone puts an offer on the table for the entire company we have a fiduciary responsibility to consider it, but that's not how we're building the company or how we're planning on building the immunotherapy franchise.

I'm thinking a buyout offer of $300 a share seems reasonable. :-)

Even though myself and several of my friends and family bought DNDN in the single digits, I'm already regretting selling some shares at $25.

This is not a recommendation. Do your own diligence. Investing in equities are inherently risky, especially the volatile biotech sector. Good luck to all.

Next pivotal event for DNDN

Tomorrow (April 28) at 12:20 pm Pacific time, Dendreon will present detailed results of Phase III clinical trials for Provenge, a prostate cancer immunotherapy.

Shares of DNDN tripled April 14, when CEO Mitchell Gold presented "unambiguous" top-line results that Provenge met its 22% primary endpoint survival benefit above the placebo control group.

Mike Huckman of CNBC is preparing several updates and interviews from Dr. Gold at the American Urological Association conference in Chicago. A "clear hit" as quoted by Dr. Gold two weeks ago, could cause shares of DNDN to soar even more. A disappointing result could cause shares to tank. Given his positive, upbeat announcement, while offering no metrics, I would be surprised if the survival benefit guideline was not surpassed by a wide margin, as that would invite shareholder lawsuits.

http://www.cnbc.com/id/30389525

Notice Huckman's comment on shares possibly being halted again. This could potentially be music to those long on the shares, as that occurred April 14 in pre-market trading, when the shorts got squeezed. Look for fireworks tomorrow.

Michael Murphy's take on Dendreon

Murphy is a well-respected investor newsletter writer. His claim to fame was making the right call on biotech behemoths Amgen, Biogen, and Genentech (recently bought out by Roche).


http://seekingalpha.com/instablog/128006-michael-murphy/1133-dendreon-a-360-stock-or-is-that-too-low

He's obviously bullish on DNDN, but a peak into his newsletter reveals he's also bullish on MELA and ARNA.

Do your due diligence and good luck.

Disclosure: I am long DNDN and ARNA.

The FDA drug approval process

Clarity and purpose are very important to me: it is tough to make money in manipulated markets, and I try my best to teach people how money works.

That's why I divorce myself from politics: what the government is doing is more important to me than what our elected officials claim they are doing.

A stock like Dendreon was trading at $3 for a reason--market makers, hedge funds, analysts, and even big pharma companies manipulate the share price down via short selling--one would think they would want a higher price per share. For reasons I've gone to at length, they use the media to rig the markets into suppressing the share price. One analyst--the night before Phase III clinical trial results announcement, reiterated a $1 price target, when it had closed at $7.30 the day before. The next morning, in pre-market trading, it spiked up to $26. The shorts got wiped out and are scrambling to cover in a short squeeze.

A buy out offer just got that much more expensive for any big pharma suitors. In fact, the company is going to go at it alone, manufacturing and marketing the drug themselves in the US, and partnering with another company to penetrate Europe. Valuations from analysts now range between $40 to $300, as this immunotherapy for prostate cancer could potentially extend to cancers of the breast, kidney, colecteral, lung, head and neck, etc. Chemotheraphy companies had a stake in suppressing this technology as well, as they will be wiped out when this treatment gains traction. Couple that with a corrupt FDA with members on the advisory panel with admittedly conflicting interests, and it is no wonder 80% of drugs are rejected by the FDA.

Once in a while, a blockbuster drug comes along. In other words, just because a stock is $3 doesn't mean it stays there, despite darker forces at work. The key is to uncover value when you see it, against a sea of skepticism. Most of the time, the skepticism is warranted. But when it's not, it's a gold mine. I researched DNDN in February, before pulling the trigger just days before their pivotal announcement last week. No textbook or classroom is going to teach me that. The Street (Wall Street and Main Street) is still mulling over an imminent GM bankruptcy, toxic bank assets, bailouts, stimulus bills, yada yada yada. These were discounted into the markets 9 months ago. The funny part is just as the market is getting complacent about real estate foreclosures, a 2nd wave is about to hit more neighborhoods. In order to succeed in investing, look ahead and anticipate what the markets will do. Don't invest based on current events alone--that is looking in the rearview mirror.

Dendreon interview on CNBC

http://www.youtube.com/watch?v=wm4o1fYtCTQ

FDA--Friend or Foe?

From the CaretoLive website. Activism is alive and well.

Provenge went before the FDA for approval over 2 years ago. A panel of experts was convened, who voted it 17-0 safe, and 13-4 substantial evidence of efficacy. Two “doctors”, namely Howard I Scher, and Maha Hussain, from the chemotherapy industry put on the panel by Richard Pazdur aka “the cancer czar”, both had severe conflicts of interest, and had to sign waivers although they conveniently left out many of their conflicts. They were both very vocal at the panel, that they needed more proof. Provenge has already been through over 10 years of Phase I, II and III testing.

The “doctors” lobbied the FDA to delay approval. Letters were leaked to the same inside non peer reviewed source that published the imclone erbitux non approval, sending Sam Waksal, CEO of Imclone, and Martha Stewart to jail. We believe that Richard Pazdur of the FDA was the “leaker”. Richard Pazdur of the Chemotherapy, Radiation side of the FDA, ran roughshod over the approval process, (passing notes to one of the conflicted doctors etc), even though Provenge is a biologic agent and did not reside in his division. Imclone’s Erbitux was subsequently approved for colon cancer, unfortunately not in time to help those who died waiting. A congressional hearing was called over Imclone.

We had several Congressmen call for a hearing over the Provenge debacle, but John Dingell of Michigan refused to hold it. His wife is tied to the cancer industry. Congressman John Dingell (Michigan) and Frank Pallone (New Jersey) decided against a Congressional hearing for all the wrong reasons. You can read their response to those calling for hearings. 2/13/08
micha001.pdf
Three Congressmen, Mike Michaud (D) of Maine, Dan Burton (R) of Indiana, and Tim Ryan (D) of Ohio called for a congressional hearing into the conflicts of interest and what went wrong at the FDA causing the delay of Provenge. (click this link) Read the Congressional Letter calling for a Hearing 12/13/07.

Besides, Congress is too busy holding hearings on steroid usage in baseball players, which nobody has died from. Who cares about 30,000 sick old American men. In reality, men are dying from prostate cancer in their 30’s and 40’s as well.

The really sick people are those running the FDA. They oversee a corrupt, dysfunctional bureacracy, with little care for the lives and health of the citizens of the United States. They are more concerned with power and lining their own pocketbooks.

Billions of dollars paid out to pharmaceutical companies, hospitals, stock holders, and Wall Street titans, will be lost, if the entrenched Oncology treatments are replaced by immunotherapies. This is an uphill battle, but one we need to fight, for all of our sakes.

Dendreon has immunotherapies for breast cancer, colon cancer, etc, on the back burner, due to the delay in Provenge approval, causing a depletion of their research and trial money. This is the way wall street plays the game and influences the FDA decisions. Delay and destroy. If not for Care To Live Provenge would have been long gone, possibly even being bought out by a larger company, whose goal would be to throw it in the trash heap, to ensure nothing interfere with their profits from the current toxic, debilitating treatments and the billions spent managing their horrible side effects.

The common protocols when you are diagnosed with prostate cancer is usually either removing your prostate gland, or some type of radiotherapy such as implanting radioactive seeds in your scrotum, which kill the cancer cells. Unfortunately they kill they healthy parts of your immune system too, and radiate your vital organs. You may also opt for watchful waiting now called active surveillance. Most men are encouraged to be treated. If your cancer progresses, they will give you hormone therapy, which is really female hormones, to try to supress your testosterone. All men who go on hormone therapy, will eventually fail, unless they go on to die from something else.

Provenge has show survival in 20% of the sickest men, those in late stage, who have already had either their prostate gland removed, or been radiated, and also had hormone therapy which is no longer working. These are men whose cancer has already metastacized to their bones and organs. Imagine what it might do, were it given to men earlier in their diagnosis. Once an immunotherapy is approved, it will be a paradigm shift in the way cancer is treated.

Michael Milken, runs the world’s largest prostate cancer charity in the world. He has been silent during this entire fiasco. The Provenge interim results of another Phase III trial were recently released, showing 20% survival. Not a word from him or his Prostate Cancer Foundation. It is apalling but not surprising. Milken, is a convicted felon who sent time in jail for stock manipulation, and has investments in Provenge competitors. His “faster cures” nonsense, rings hollow with us. He helped fund the Proquest Investment fund. He is busy shaking his can everywhere, asking for more funding to begin research 10 years away from approval, but has nothing to say about Provenge, which is ready, willing and able to be used RIGHT NOW! It is an abomination.

DNDN conference call

As I and other investors hoped for, Dendreon CEO Mitch Gold revealed "unambiguous" top-line results that Provenge met the pre-defined primary endpoint for increased survival benefit for late-stage prostate cancer victims in the IMPACT Phase III clinical trial. Shares jumped up over 200% in pre-market open trading. This was a victory for investors and all cancer victims and their families, as other treatments for breast, colorectal, and kidney cancer are also in Dendrean's pipeline. Their cancer immunotherapy platform is a game-changer, and a much better solution than traditional chemotherapy treatments, which carry toxic and adverse side effects.

This paves the way for a New Drug Application (NDA) by the end of 2009, and FDA approval in Q2 2010.

Shares of DNDN halted in after hours trading

Dendreon, a Seattle-based biotech specializing in cancer immunotheraphy, will be announcing top-line results of a phase III clinical trial for Provenge tomorrow. The pivotal metric is whether patients with prostate cancer will have a 22% survival benefit from Provenge vs. the place control group.

An advisory panel gave a recommendation to the FDA of approval in 2007 based on a positive safety profile and promising interim survival benefits. But in a controversial move (especially for life-threatening oncology treatments), the FDA did not approve Provenge, seeking more results for this IMPACT clinical trial.

The results will be announced tomorrow in a conference call at 6 am PT. If Provenge meets its 22% survival benefit benchmark, the share price for DNDN will explode. If they miss their target, the share price could collapse to almost zero. Such is the life of a biotech microcap company.

If IMPACT proves effective, it could open the doors for immunotheraphy of other cancers, and could be a game-changer for oncological treatment. For investors and patients, let's hope this one is a winner.