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DewDiligence

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DewDiligence

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Re: beurskneus post# 6015

Monday, 12/10/2007 11:34:41 AM

Monday, December 10, 2007 11:34:41 AM

Post# of 19309
Re: Orphan designation

Unlike a Fast Track designation, which is all but meaningless, an Orphan Drug designation is consequential.

By granting ATryn an orphan designation even though a plasma-derived antithrombin (Talecris’ Thrombate) is already approved in the US for the HD indication, the FDA is implicitly stating that the benefits of a recombinant drug vs a corresponding plasma-derived drug are substantial.

We already knew this (#msg-23864419), but today’s news is a clear indication that the FDA knows it too.

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

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