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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?


To: JOEBT1 who wrote (1329)11/12/2001 5:48:08 PM
From: William Partmann  Respond to of 10345
 
Joe, I'm conflicted about responding to your post because I can't get a grip on what's happening myself. First, ziconotide is not the only drug that has been trapped inside the FDA. There have been numerous published articles about the FDA's failure approve drugs over the last year+. I believe there have only been 8 or 9 to date but I could be wrong on the precise number.

There are a ton of reasons, lack of a FDA chief, lack of funding, greater scrutiny because of previous approvals gone bad. So while zico is delayed, it is not the only drug delayed.

Now my conflicted part is very subjective in other words, I have no knowledge of what is really happening. It does appear that this filing is being slowly and carefully reviewed. I suspect the thoroughness of the review is a result of the novel substance and the method of treatment(intrathecal injection). I have seen no definitive date for its release other than estimates of first or second quarter of 2002. The company is very tight lipped so as not to start down the slippery slope of rising expectations.

The point is this is a very novel drug and with the constrains at the FDA, they will take their sweet time in reviewing the results in the filing. When will it be approved? I wish I knew.

I disagree that it is a dead drug, but it does appear that this one is under a very powerful microscope because of the above mentioned issues.

Bill