MackTheKnife's Blog on People & Picks

Dendreon's Provenge PDUFA Date: May 1

The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1 of next year to the Dendreon Corp.'s (DNDN's) amended biologics license application (BLA) for Provenge, which the company is seeking to have licensed for men with metastatic castrate-resistant prostate cancer (CRPC) [http://tinyurl.com/y93q38q].

According to Dendreon, the FDA's assignment of the PDUFA date in this case means the agency's goal is to respond to the company's amended B…

Dendreon Files Amended Provenge BLA

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 Dend…

SPX in the Wake of VIX Superspikes

Superspikes in the Chicago Board Options Exchange Market Volatility Index (VIX) comparable with the one of 23.95% recorded Friday are relatively rare phenomena (http://tinyurl.com/yd2t7gw).

Accordingly, I had a host of questions to be answered about them, which were the focus of a historical statistical study conducted here at the home office of the completely fictional Druids Investment Group -- Can You DIG It? -- this weekend.

Based on the VIX data between Jan 2, 1990, and Oct 30, 2009, …

Show Me the Money, Mr. Market . . .

In the first half of the 1980s, I was the editor of a weekly newspaper on a barrier island down the Shore in New Jersey. Timewise, it was a demanding job: writing, editing, writing, copy editing, writing, proofreading, writing, designing the occasional layout, writing. You get the idea.

My motto in those days was "An Ad Rep Works From Sun to Sun, But an Editor's Work Is Never Done." Still, I always managed to find an hour -- or three -- every season to visit the beach and simply watch the cea…

Economists in a Steel-Cage Match

As mentioned on a number of occasions here at P&P over the years, Gretchen Morgenson is my favorite columnist at The New York Times.

However, Paul Krugman also does yeoman work for the local newspaper of record. And I would be completely unsurprised should Krugman eventually be awarded a Pulitzer Prize for commentary to serve as a bookend with the Nobel Prize in economics he won last year.

If I were a member of the Pulitzer Prize Board -- I know: Fat chance! -- then I would give the PULL-I…

September Is the Cruellest Month?

In a commentary today, Mark Hulbert of MarketWatch indicates this month historically has been so bad for the Dow Jones Industrial Average that the cruellest month of the year is not April but September (http://tinyurl.com/nn32ua).

Where have I heard that one before? (http://tinyurl.com/nhekhx)

Alternative U.S. Realty Realities, Redux

"[F]or the slight present advantage the great prospective evil was forgotten . . . "
-- Charles Mackay
Extraordinary Popular Delusions and the Madness of Crowds

In my Alternative U.S. Realty Realities blog-post series in February, I discussed certain aspects of U.S. home-price trends, which are seen here at the home office of the completely fictional Druids Investment Group (Can You DIG It?) as prominent both among the key bases of the past economic contraction and among the key foundations…

OpEx Week and SPX: Aug 2007-Jul 2009

Two years ago this month, the onset of a global credit crisis of historic proportions became clear even to the most obscurant of financial-market observers. For example, the Federal Open Market Committee issued not one but two unscheduled monetary-policy statements during that fateful month: the first on Aug 10 (http://tinyurl.com/l3lwj3) and the second on Aug 17 (http://tinyurl.com/ywvp5w).

With this sea change in credit conditions in mind, we here at the home office of the completely fictio…

SPX and a Confluence of Interest

With Mr. Market currently balanced on the precipice between rationality and irrationality, I have noted a confluence of four interesting figures on this one-year weekly chart of the Standard & Poor's (S&P) 500 (SPX) this afternoon, as follows:

-- 1. I have drawn one horizontal line at 1,009.96, which aligns with a Fibonacci retracement of 38.2% of the 898.36 points the S&P 500 lost when it plummeted from its angelic top of 1,565.15 on Oct 9 of 2007 to its demonic bottom of 666.79 on Mar 6 of …

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