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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