Dendreonians, the wait is over. Dendreon had the second-to-last time slot at the BioCentury/Thomson Reuters biotech investment conference this afternoon.
CEO Dr. Mitchell Gold isn't here. CFO Greg Schiffman made the presentation to around 35 people. He kicked things off by proclaiming his company, "One of the more exciting stories in biotech today." Exciting? Controversial might be more accurate.
DNDN is getting closer to a potentially huge milestone. Schiffman reiterated that the company expects to see interim data on its prostate cancer drug next month. He didn't get any more specific about the timing.
If the results look good, Dendreon says the FDA has indicated it would approve the drug at halftime. But if the survival numbers aren't there, Dendreon says it will have to keep at it through next year.
Analysts and the Street remain skeptical the midway results will be strong enough. A lot of investors are still betting the stock will go down by taking short positions. And many of the naysayers may feel emboldened by the failure last week of a similar drug from Cell Genesys.
But Schiffman said the clinical trial is "well powered" to have a "reasonable possibility" of reaching statistical significance on survival by the interim. However, he hedged a little. "We're very excited about the timeframe," he said, "but, I do want to point out that the final (results) always has a higher probability of success." Again, the final results aren't expected until next year sometime.
The Dendreon breakout drew, by far, the fewest people of the ones I've attended today. Nine investors/analysts plus me and a Dow Jones reporter. Read what you will into that.
One of the attendees asked how much the drug, called Provenge, would cost. Schiffman said, "It's not gonna be an inexpensive treatment." When pressed for a dollar figure he only said it would likely be priced in line with other novel biologics. The questioner threw out the figure $20,000. "Probably above that," Schiffman said, adding that novel biologics cost about twice that amount. Presumably that would be for the full three-infusion treatment.
Let the countdown begin.
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