Posted on 09/28/2010 12:40:05 PM PDT by facedodge
* Expects to complete FDA submission in Q4
* Expects expedited approval process
* Shares slightly higher (Adds CFO comments, background, stock price)
LOS ANGELES, Sept 28 (Reuters) - Delcath Systems Inc (DCTH.O) expects to finish an application for U.S. review of its cancer drug delivery system in the fourth quarter, which would put it on track for approval by mid-2011, according to the company's chief financial officer.
Delcath in June presented pivotal trial results showing that melanoma patients whose cancer had spread to their liver survived for an average of 398 days before dying or having their cancer get worse after treatment with the company's "Percutaneous Hepatic Perfusion" system.
Patients treated with standard drugs survived for an average of 124 days before they died or their tumor growth restarted.
"We believe we will be granted an expedited review," CFO Dave McDonald said during a Webcast presentation at an investor meeting on Tuesday. "That puts us in mid-2011 for approval."
Delcath's system is designed to deliver high doses of the generic chemotherapy drug melphalan directly to the liver via the hepatic artery.
The system aims to minimize side effects by filtering the highly toxic drug out of the blood stream as it leaves the liver, but some of the drug leaks out.
Two of the 93 patients in the pivotal trial died as a result of the treatment. A third death was attributed to the fact that the patient had such advanced liver metastases that he should not have been enrolled in the trial, McDonald said.
Delcath's pivotal trial, in which patients were allowed to cross over from standard treatment to the Delcath system, was designed in concert with the FDA.
(Excerpt) Read more at reuters.com ...
“Delcath”? Are they serious? What a hideous name for a health care company.
“You can’t spell Delcath without Death!”
typical side effects... toes and ears fall off...
Does the death panel approve of this?
Typical treatments are expected to cost 20K at an avg of 2 to 3 treatments per patient... so 40k to 60k total per patient. This is less than the 90k breast cancer drug and also has better results. Let’s cross our fingers.
what’s an extra year of life worth to the govt experts who will have to approve your getting this drug?
Probably not much if you are over 50.
Has it come to this? Are we really seeing the moderators allow stock pumping on Free Republic now?
I wasn’t going to do it, but after seeing 1000 repeats of the same story like hillary’s demon photo, I figured “what the hell?” If it puts the stock up a couple cents, the board is already trashed with kitty youtube and reposts...
Blue Horseshoe loves Anacot Steel.
DCTH at $9.81, purchased most of my shares in the $8.30 range.
Thanks for the tip, enjoying the ride!!!
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