Xconomy: Dendreon Holds Its Breath, Big Provenge Clinical Trial Result Coming In October
Summary
It was started in June 2003, and originally aimed to enroll patients with terminal prostate cancer who have moderate -to-less aggressive tumor types, as measured by a standardized “Gleason” scoring system.The study also was primarily designed to see whether Provenge could slow down the spread of tumors, instead of waiting a longer time for data on whether it helped men live longer—the gold standard for cancer drugs.Since it’s an early peek based on a small set of data, the analysis has to show Provenge patients are living longer than those on placebo, and demonstrate it with a higher degree of statistical certainty than normal to assure regulators that it isn’t a result of chance.The analogy I used in my conversation with Urdal, which he agreed is a good way to think about it, is that an interim analysis is like taking a look at the standings half way through the football season, seeing an undefeated team, and saying it looks like they will win the Super Bowl.Either way, Dendreon bulls and bears are certainly going to rev up their engines between now and October in hopes they can ride the shares up past $20 again, or short them down to something a whole lot lower than its closing price yesterday of $5.69.