Sunday, April 19, 2009

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.

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