I don’t fault investors for rewarding Delcath a little for the CE Mark grant, but I'd be much more concerned about the stateside regulatory status of Chemosat. I used to assume Chemosat approval by the U.S. Food and Drug Administration was a given, but now it seems to me that the risk of an FDA rejection is very real.
Delcath disclosed last week that FDA has asked to see hospitalization data from patients in all three Chemosat clinical trials -- phase I, phase II and phase III. Not only is Delcath being forced to compile far more safety data than previously disclosed, but the company also admitted needing to rewrite nearly the entire Chemostat new drug application.
Instead of refiling Chemosat with the FDA in September, as Delcath previously thought possible, the resubmission won't be ready until the end of the year. That means Chemosat's U.S. approval is delayed at least one year. Delcath originally filed for approval last December, which was followed in February by the FDA's refuse-to-file letter.
To allay investor fears, Delcath's Hobbs insists that FDA has not asked the company to conduct additional clinical trials. I believe him, but why would FDA ask for new clinical trials today when the agency hasn't even been provided sufficient safety data from the old clinical trials? Delcath screwed up by submitting a hugely deficient data package in the first place. As a result of its incompetence, Delcath wasted a year just getting to the FDA review starting line. Nothing prevents the FDA from asking for new clinical trials later on, after the agency's reviewers get a look at the data that Delcath should have submitted long ago.It's not like Delcath has a hugely compelling benefit profile to brag about. In the phase III study, Chemosat treatment delayed the progression of tumors in the liver compared to patients treated with best supportive care. However, Chemosat did not help patients live longer than the control patients. On the risk side, five Chemosat patients died because of the Chemosat procedure, according to the investigators of the phase III study.
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 + 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