The Dendreon Corp. (DNDN) announced today it has completed the submission of its amended biologics license application (BLA) for Provenge to the U.S. Food and Drug Administration (FDA) (http://tinyurl.com/yzmx9qo).
Dendreon is seeking to have Provenge licensed for men with metastatic castrate-resistant prostate cancer (CRPC). Should the FDA follow the data this time around, Provenge would be the first product in the new therapeutic class known as active cellular immunotherapies.
Given Dendreon's announcement today, I hereby amend one of the statements in my Probabilities and the Financial Markets blog post: Basically, I now believe there is a high probability the FDA will be compelled to OK Provenge as a treatment for patients with metastatic CRPC by May 2 of next year.
Related Blog Posts
Probabilities and the Financial Markets (http://tinyurl.com/yzv7689)
Dendreon's Provenge: Maximum IMPACT (http://tinyurl.com/yzr2dor)
Congressmen Request Probe of FDA's Provenge Delay (http://tinyurl.com/ygfukge)
Sentiment Analysis: How Do You FEEL About It? (http://tinyurl.com/y93o7jy)
Dendreon CFO Pulls a Rabbit Out of the Hat, Again (http://tinyurl.com/yzrg33c)
Synchronicity! And Three Cheers for Ralph M. Steinman! (http://tinyurl.com/ylzxcm6)
Patient Advocates Plan Protest of Dysfunctional FDA (http://tinyurl.com/yk3qwvv)
Hey, Hey, FDA, How Many Dads Did You Kill Today? (http://tinyurl.com/ykuxrw2)
|
No Stocks are Harder to Find, or More Worth the Effort. They have the greatest potential for quick gains, but they're also the most difficult to find and time correctly. Now Zacks has perfected a system for identifying and profiting from turnaround stocks just as they begin a powerful rebound. Learn more here >>. |
| Find Winning Stocks Quickly with Research Wizard, a powerful desktop software program. Start with easy-to-use pre-loaded strategies, then develop your own. Backtest against years of historical data to see how your approach works in any market. Start a Free Trial Today >> |
| Take advantage of quick short-term moves, and profit from price moves in any direction. Trade options under the direction of an expert guide. Try it now and get a 90-day unconditional money-back guarantee. 50% OFF for a limited time! Zacks Options Trader >> |
| Stock screening and chart patterns expert, Kevin Matras, combs through the best Zacks stock-picking strategies averaging +60% yearly gains to find stocks with charts showing they are ready to skyrocket. Chart Patterns Trader >> |

Read MackTheKnife's blog in RSS


November 2, 2009
Edited: November 2, 2009
Share This

