All that worrying, mostly for nothing. Mostly.
Monday Delcath Systems
A little over 24 hours later, it's earned back a little confidence announcing that the Chemostat has gained CE Mark approval in Europe.
The Chemostat is a drug device to treat tumors in the liver. The liver is separated from the body and saturated with chemotherapy at higher levels than would be possible if the chemotherapy was run through the entire body.
What's interesting is that the European regulatory authority classifies the Chemostat as a medical device while the U.S. Food and Drug Administration classifies it as a drug. So while it's certainly good news -- the company turned in the right paperwork and secured an approval from a regulatory body -- it's not necessarily a sign that the FDA will approve the Chemostat.
In fact, the European CE Mark is notoriously easy to get with very little data. Medtronic
Even after CE Mark approval, Delcath still has to convince someone to pay for the procedure. In Europe, that's often government single-payer systems that tend to be slow-moving and penny-pinching.
I like Delcath better today than I did earlier in the week, but it's still a risky play. Between getting the Chemostat paid for in Europe and approved stateside, there's still plenty to be worried about.