Simon56 asks, "Lots of news from Delcath Systems (DCTH) but no word from you yet. You've been skeptical in the past but wondering if the European approval changes your mind at all? This looks like an exciting opportunity for Delcath to me and the stock is up." I see no reason to be any more optimistic about Delcath. European regulators granted a CE Mark to Delcath for its Chemosat Delivery System, but getting a medical device approved in Europe is a relatively easy task, basically requiring proof that the device is safe for use in patients. Much more difficult is obtaining reimbursement for use of the device, which Delcath hasn't done. Without reimbursement, Delcath will find it difficult to generate significant Chemosat sales. To gain European reimbursement for use of Chemosat and to convince doctors there to try the device on their patients, Delcath needs clinical data demonstrating a significant clinical benefit. Again, Delcath doesn't have that data, especially in Europe, where Chemosat has never been used. Chemosat is a medical device that isolates and bathes the liver with an ultra-high dose of the tumor-killing chemotherapy drug melphalan. Delcath CEO Eamonn Hobbs told investors last week that the CE Mark for Chemosat allows the company to address a potential commercial opportunity of 100,000 liver cancer patients. Really? Based on what data? The only phase III clinical trial of Chemosat conducted by Delcath enrolled melanoma patients with liver metastases. Delcath is running a small phase II study in patients with various tumors of the liver but no data have been presented or published yet. Neither of these studies enrolled any European patients. Hobbs has a credibility problem when it comes to discussing the commercial potential for Chemosat. He consistently overplays his hand, first with the potential for U.S. sales and now in Europe. Why would a doctor, in Europe or the U.S., treat a primary liver cancer patient with Chemosat in the absence of any data to support that use?
Via Twitter, @Detroitblues comments on my dissection of reaZin, the "prescription medical food" that Adeona Pharmaceuticals ( AEN) wants to market to people with Alzheimer's disease. "$AEN what awesome work by @adamfeuerstein on the Alzheimer's test results. Ton of $ could've been made. Tip of the hat Adam and all for free." Thank you. I'm just wondering if Adeona CEO James Kuo has found the time to read the column yet.
More tweets, this one from @aeroforce: "What's your outlook on Dendreon ( DNDN) for the year?" First, think about the first-quarter results. Dendreon reports on May 2, with the current analyst consensus for Provenge sales at $29 million. A more important near-term focus for investors will be second-quarter Provenge sales.
Heather D. writes, "Any word on FDA approval of abiraterone acetate for prostate cancer? Thanks for any info you can share." Johnson & Johnson ( JNJ) has not disclosed a precise FDA approval decision date for abiraterone but the best guess is June 20, based on when the drug was filed. I have heard unconfirmed rumors that the abiraterone approval might come early. Abiraterone's initial approval will be for the treatment of post-chemotherapy prostate cancer patients, so the drug should not compete with Dendreon's Provenge, at least not right away. J&J is conducting clinical studies to move abiraterone treatment before chemotherapy, which could make the drug more directly competitive against Provenge.