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Biotech / Medical : Elan Corporation, plc (ELN)

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To: Icebrg who wrote (3449)10/28/2002 5:26:33 PM
From: arnie h   of 10345
 
Re: Prialt. An approvable letter for Prialt was received in March 2000. Then in January 2002, we learned, in response to a question in a conference call, they needed to start a new 18 month trial. At no time has the company ever put out a significant PR describing what the issues are and why any trial is needed let alone one taking 18 months. I did read from another source that over 1/3 of of the patients in the Ziconotide trials dropped out due to memory problems and unsteadiness. Apparently, the FDA wasn't happy with the initial safety data and is concerned about any long term use.

Prialt is one of the ones in the Pharma Marketing deal. I wonder if the company would be doing the additional trial if this were not the case. At this point, it seems hard to believe Prialt will amount to anything useful for Elan and its stockholders, of which I'm one.
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