What a long, strange trip it’s been for Dendreon.

Three years ago, positive results from a trial of Provenge, its immune therapy drug for prostate cancer, prompted an FDA advisory panel to recommend that it be approved.

Instead, the FDA ordered another study.

Last fall, the company announced interim results of the second study which showed the treatment group had 22% fewer deaths, but the results were met with skepticism and the company was told to finish out the trial.

Well, final results are in and Dendreon shareholders are celebrating all the way to the bank.

Provenge extended survival in late-stage prostate cancer patients with no major side effects.

The company plans to seek FDA approval for the juice later this year.

Shares of the heavily shorted stock closed at $22.94, up 94% on the day of the announcement.

Just before that, there were 2 “sell” ratings and 5 “hold” ratings among the 7 analysts who follow the biotechnology company. One analyst had set a $1 price target.

Now the chatter is which company in Big Pharmaville will acquire Dendreon and for how much.

After all, the list of pharmaceutical companies facing declining sales, generic competition and withering pipelines is longer than the line outside the toilet in coach on a flight from Boston to San Fran.

“Provenge could be on the market by mid next year, (it) could be instantly accretive to earnings,” said Joe Pantginis, of Merriman Curhan Ford & Co.

And Dendreon maintains full worldwide distribution rights for Provenge, making it even more appealing as an acquisition target.

“There are very few unencumbered assets (like Dendreon) out there,” said a salivating Sven Borho.

He’s a portfolio manager for OrbiMed Advisors which holds a cool 2 million shares of Dendreon.

Nearly 60% of the clinical trials that the FDA reviewed during its approval processes for new drugs between 1998 and 2000 were not published in peer reviewed journals within 5 years after the drugs went to market, according to research published in PLoS Medicine. 

24% of the non-published studies were “pivotal” trials focusing on safety and effectiveness in humans. Within this cohort, the PLoS study revealed publication bias: trials showing significant benefits for a new drug were more likely to be published than those showing no benefit.

Pharmaceutical companies sponsor the studies in question and they get to decide whether to pursue publication of trial results or squelch them.

PLoS study investigators concluded that Big Pharma’s failure to publish the results of all trials amounted to “scientific misconduct” that “harms the public good” because it prevents physicians from making informed decisions on behalf of their patients.

Things may be about to change at least a little however. The 2007 FDA Amendments Act mandated that substantial detail from all trials used in support an FDA approval process must be posted on the NIH clinical trials site. This is a good step, but maybe not enough. Clinicians may or may not recognize the unique value of the newly informed NIH site, much less use it. And it doesn’t address the problem with publication bias at all.