"Last Friday (July 16) on a conference call, Exact Sciences said it would release their external validation results for their genetic screening test for colon cancer by Oct. 29. What percent of pre-cancers and what percent of cancers do you believe need to be detected by the validation study for it to be perceived as a positive for Exact Sciences? Also, how big of an event do you believe this is for Exact Sciences?"
These study results are a very big deal for Exact because this will be the first validation data we see that measures the sensitivity of the company's colon cancer test, which is designed to detect small changes in DNA found in stool. These genetic mutations can be a warning sign of early-stage cancer or even of pre-cancerous polyps, in the colon.
Based on previous guidance, Exact is shooting for its test to be sensitive enough to detect about 85% of colon cancers and 50% of pre-cancerous lesions. That would put the company's test ahead of currently used fecal blood tests but less sensitive than colonoscopy -- by design.Exact expects to announce data from the three validation studies on Oct. 29 at the American Association of Cancer Research meeting in Philadelphia. These data are very important, but they don't get Exact to the finish line. None of samples being tested are being tested prospectively, which means Exact will still need data from a large, pivotal phase III study before it can seek FDA approval. Exact plans to run that phase III study starting in the second half of 2011, with the FDA filing set for 2012. I met with Exact's CEO Kevin Conroy at the J.P. Morgan Healthcare Conference in January and walked away impressed. At that time, I called Exact Sciences the "best small-cap story" at the conference during the busy week in San Francisco. The stock was trading just above $4 at that time. Today, shares can be bought for less than $3.50, so my hot stock pick hasn't exactly worked out that well. I'm hoping that changes when the validation data are revealed on Oct. 29.
Mannkind (MNKD) announced Tuesday that the FDA accepted the company's resubmission of the approval application for its Afrezza inhaled insulin device. The agency's new approval decision deadline is Dec. 29. The Afrezza update prompted @RJPeterson123 to tweet, "Hoping for a Christmas miracle for Mannkind."
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV