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DewDiligence

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DewDiligence

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Re: None

Friday, 06/02/2006 2:45:03 PM

Friday, June 02, 2006 2:45:03 PM

Post# of 252390
GTCB (from SI):

>>
From: DewDiligence_on_SI
6/2/2006 2:30:43 PM
To: Sam Citron who wrote (2517) of 2518

> How do you see this news impacting chance for US approval?<

The U.S. ATryn program figures to be an easier sell to the regulators for two reasons:

1. The U.S. phase-3 trial is larger and contains a control arm.

2. The unmet medical need in the U.S. is greater because (unlike Europe) plasma-derived antithrombin is rarely available in the U.S.

I think the probability of FDA approval for ATryn in 2008 is about 85%. Regards, Dew
<<

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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