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Biotech Stock Mailbag: Amarin

One hedge fund investor who's owned Amarin for quite some time told me that his fair value for the stock is in the $18-20 range. Will he sell out completely if the stock gets there? Not likely because he, like everyone else, hopes Amarin finds a buyer willing to overpay. It wouldn't be the first time.

One more Amarin question from KGN32: "Are you concerned about the insider selling this week?"

No. I'm assuming that investors selling Amarin now have owned the stock since it was trading in the low- to mid-single digits. They've made a ton of money so why not book profits? Sounds like a fiscally prudent thing to do.

Simon56 asks, "Lots of news from Delcath Systems (DCTH - Get Report) 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?

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DNDN $0.06 -6.02%
AMRN $2.41 0.00%
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