But the FDA, apparently, isn't satisfied. It wants more information addressing the safety issues. Delcath's stock was essentially cut in half and now trades around $1.54.
Investors in the stock are spitting mad, claiming this as yet more evidence that the FDA is messing with cancer companies, a la Dendreon (DNDN) and Provenge.
If the NCI is a fan of Delcath's PHP system and isn't worried about safety, why is the FDA butting its nose into the picture, they ask?
My simple answer is that the FDA, not the NCI, is the country's final arbiter on drug safety, so if the agency has safety concerns, it's not a trivial matter.Many readers who emailed me about Delcath this week are placing a lot of emphasis on the fact that Delcath's PHP phase III trial was a "Featured Clinical Trial" in the NCI newsletter, as if that's some imprimatur of great import. Well, previous cancer trials featured in NCI newsletters include one study investigating pomegranate juice as a treatment for prostate cancer; another trial is looking at the combination of frankincense and a vegan diet in brain tumor patients. (Apparently, myrrh is not necessary.) I'm not trying to equate Delcath with fruit juice or ancient herbal remedies, but on the other hand, let's all realize that the NCI conducts a lot of cancer research. Some of it is groundbreaking and important, and some of it ends up in the trash heap. So it's best not to equate a newsletter mention with a guarantee of success.