I missed my appointed rounds by not delivering a Biotech Mailbag last week. But we're up and running again -- as always, send me your questions and comments here.
There was a buzz about
(DCTH - Get Report)
this week, which was the subject of a slew of emails. Among those, Adam H. asks:
"I'm sure you know about the stock, and I'm sure you have read the story, but I think a perfect candidate for your mailbag would be a story highlighting the [National Cancer Institute] vs. the FDA. The NCI has affirmed changes that have been implemented into the trial protocol, but still, the FDA asked for a temporary halt on new enrollments."
Here's some background: Delcath is testing a system that uses catheters and filters to deliver chemotherapy directly to the liver without allowing the toxic chemicals to reach the rest of the body. This Percutaneous Hepatic Perfusion (PHP) system is being tested in phase II and phase III clinical trials, some of which are being sponsored and conducted by the National Cancer Institute.
On Oct. 11, Delcath announced that its phase III trial was highlighted as the "Featured Clinical Trial" in a recent NCI
On Oct. 23, the FDA sent Delcath a letter asking the company to halt enrollment in its clinical trials because of agency concerns over gastrointestinal side effects. Delcath claims that these GI toxicities were previously reported and disclosed to the NCI folks running the trial that changes were made in the study to prevent future events from happening, and that the NCI was OK with the study moving ahead.