More Videos
SPECIAL REPORT
MOST SHARED
- Future of Marketing
- Obama Sees Strains Unless US, China Balance Growth
- Oil Tomorrow
- Priceline Crushes Profit Forecasts; Shares Jump
- European Commission Objects to Sun Micro-Oracle Deal
- Mad Mail: Buy the Berkshire Hathaway Split?
- Can Apple Top Microsoft as Most Valuable Tech Firm?
- Sprint to Cut Up to 2,500 Jobs, Sees Charge
- A Year on, China's Stimulus Postpones its Problems
- Why Google is Paying $750 Million for Ad Mob
- Warren Buffett to Sell Stakes In Union Pacific & Norfolk Southern
- Nov. 9: Unusual Volume Leaders
- The Battered Businesses Behind Housing
- Modern Warfare 2's Record-Breaking Launch
- Merck’s Mega-Monday Morning
- Why are Traders Bullish on This Food Company?
- Profiting From Natural Gas: Strategists
- S&P Stocks Trading at New 52-Week Highs
- Look Ahead: 'Risk On' Attitude Could Fuel Rally Further
- European Commission Objects to Sun Micro-Oracle Deal
- Obama Sees Strains Unless US, China Balance Growth
- Can Apple Top Microsoft as Most Valuable Tech Firm?
- Buffett to Sell Stakes in Norfolk Southern, Union Pacific
- Cramer: 5 Stocks to Play the Next Bull Run
- Do You Know Your Coca-Cola Myths?
- Electronic Arts Beats Street, Announces 1,500 Job Cuts
- Time Is Here to Look at Overseas Stocks: Bill Gross
RSS FEED
Pharma's Market
Text Size 
 |
CNBC.com |
] was halted for news pending. Then, right after the bell the company issued this press release announcing the Food and Drug Administration has granted "accelerated approval" to Genentech's Avastin for use on breast cancer. The announcement says the FDA will review the results of two more clinical trials before it might grant full approval of the drug and that Genentech will turn in the findings of three other studies.
So, what in the heck is accelerated approval? Here's an explanation from the FDA's web site. I think the most significant part is the last line:
"If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit for patients, FDA has regulatory procedures in place that could lead to removing the drug from the market."
Again, based on what's in the Genentech press release it sounds like the FDA will look at two confirmatory trials.
The stock resumed trading after hours and spiked about nine percent. Mark Schoenebaum at Bear Stearns has already sent out a blitz email to clients saying, "We include only very modest growth for Avastin breast cancer sales in our models. We expect the stock to open up $4+ on Monday. Back to you (the firm's clients) after we speak with the company."
We'll be speaking on Monday with the company in a First On CNBC interview with Dr. Susan Desmond-Hellmann, Genentech's President of Product Development and a former practicing oncologist who specialized in breast cancer. That's Monday at 8:30 am ET on "Squawk Box".
Schoenebaum or someone in his household owns DNA shares. As a reminder, he was on CNBC more than a week ago saying there was about a 55 perecent chance, in his opinion, of DNA winning. That was higher than most analysts placing odds. I guess it was a good call.
Questions? Comments?
Data is a real-time snapshot *Data is delayed at least 15 minutes