This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Dendreon's Date With Destiny

Are there any other data that help or hurt Provenge's chances?

Yes, on both counts. Dendreon has data from a second, smaller clinical trial that show a similar survival benefit over more than three months for Provenge over placebo. But in this study, the result was not statistically significant. In fact, it wasn't even close.

Dendreon did run another analysis to account for imbalances, just like the first study, and when the numbers were crunched the survival benefit was statistically significant. It remains to be seen how the FDA and the advisory panel handles this data.

C'mon Adam, you're usually an opinionated guy, but in this case, you're sitting on the fence. What gives?

What gives is that I just don't know how the advisory panel shakes out. If the presentations and deliberations lean toward conservative data analysis and adherence to strict biostatistical methods, Provenge is going to be in for trouble.

But if the opposite occurs, if experts on the panel look at the drug through the eyes of a prostate cancer patient and worry less about statistical rigor, Provenge could have a good shot.

I understand your neutral stance, but it's been years since the FDA approved a new prostate cancer drug. In fact, the last prostate cancer drug brought before the FDA, Xinlay from Abbott Labs (ABT - Get Report), was rejected. Also, the new FDA commissioner, Andy Von Eschenbach, is a prostate cancer survivor. I just don't see how Provenge could get dinged.

I understand that point of view, but at the end of the day, the FDA will make its decision based on clinical data. Sentimentality has its place, but I'm not sure I'd make a bet on it. And remember, Dendreon is running another clinical trial with Provenge in prostate cancer. This one is big -- 500 patients -- and is designed specifically to answer the survival question. If the FDA or the advisory panel isn't convinced on this go-round, they'll wait to see the results from this ongoing study. Unfortunately, survival data from that trial aren't likely to be ready until late 2008 or 2009.

3 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
ABT $47.02 -0.16%
CYBX $70.67 0.44%
DNDN $0.06 -6.02%
AAPL $128.76 -0.46%
FB $79.99 0.49%


DOW 18,048.67 -154.70 -0.85%
S&P 500 2,091.66 -16.12 -0.76%
NASDAQ 4,945.8970 -34.0040 -0.68%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs