A SPA Break For Dendreon
Everyone's favorite small-cap biotech put out a press release this morning, announcing that the Food and Drug Administration has agreed to change the Special Protocol Assessment (SPA) for Dendreon's Provenge.
What's a SPA? It's FDA-speak for the groundrules for a clinical trial -- i.e., here's the stated goal(s) for the study, here are the criteria on which the agency might consider approving the drug, etc. Provenge is an experimental therapeutic vaccine for prostate cancer.
As anyone who follows Dendreon knows, this is a very volatile stock and there's a big short interest -- investors who think Provenge either doesn't work and/or won't get approved and that the stock will go down.
While the press release repeats a previously stated agreement that the agency might approve the drug based on an interim analysis of clinical trial data expected to be available later this year, it does offer at least one piece of news.
The statement has a lot of clinical trial jargon that the layperson probably can't understand.
I love this one: "By increasing the number of events and decreasing the alpha (false positive errors) spending function for the interim analysis, the Company is able to reduce the number of events for the final analysis (from 360 to 304) and still maintain a comparable statistical power for both the interim and final analysis."
The upshot, according to Dendreon CEO Dr. Mitchell Gold, is that the final test results could be available a year earlier than had been expected. So, the numbers could be available in the second half of next year instead of the second half of 2010.
Investors in biotechs -- especially ones that don't have any products on the market yet -- are placing bets on the future and so any potential acceleration of a drug development pipeline is usually warmly greeted.
Dendreon's holding a conference call tomorrow, Thursday March 13, at 11am ET. If they say anything newsworthy, I'll update the blog.
Questions? Comments? Pharma@cnbc.com