A blockbuster FDA deadline looms and Dendreon shares turn red-hot

With the FDA's deadline on a final decision regarding Dendreon's Provenge less than a month away, investors have made the Seattle-based biotech's stock one of this month's hottest plays. Earlier today Dendreon shares broke the $40 barrier, surging more than five percent as various analysts laid their bets on how high shares could climb in the event of an approval by May 1. Its shares are up 12 percent for the last month as Dendreon executives bid to take the company up to a whole new level.

Some of these shareholders have been here before, though. Dendreon (DNDN) was bitterly disappointed when the FDA delayed a final decision on the therapeutic cancer vaccine back in 2007, saying it wanted to see another shot of late-stage data to prove its contentions. That ruling was made despite the support of the agency's expert panel.

But Dendreon has sparked intense passion for years. The regulatory delay three years ago was triggered by two top oncologists who questioned the therapy's effectiveness, and they were subjected to threats from cancer patients who had hoped to get access soon. 

Based on positive confirmatory Phase III data, Dendreon raised more than $600 million to build the infrastructure it needs to deliver Provenge to patients from coast-to-coast. Some obervers note that the higher the stock climbs, the farther it can fall in the event of any new delay or signs of trouble on the regulatory front. And there's no telling how much of an effect hedge funds like SAC Capital can have as they play the market in the lead-up to the FDA's release.

- here's the story from Benzinga