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Post# of 252412
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Re: A deleted message

Tuesday, 06/05/2007 3:09:55 PM

Tuesday, June 05, 2007 3:09:55 PM

Post# of 252412
drugsdrugsrx,

I am curious as to why you think third time is the charm? I'll admit to being on the fence one day thinking they'll get it another day they won't. The recent draw down on their financing and todays move actually have me thinking (contrary to the price move) that they won't.

If you boil it down the FDA said do another trial. Encysive said no we can show you with existing data. The FDA said no again and oh by the way here is a Class 2 review this time.

I think there is something more we don't know (and Given isn't saying). What has changed between the second approvable (or for that matter the first) and now? No new data just "reformatting" of old data. FDA getting criticized more for safety (OK and from the other side too by DNDN supporters).

I'd be curious as to your perspective like I said I am on the fence and could be convinced with a good argument.


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