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DewDiligence

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DewDiligence

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Re: tinkershaw post# 62566

Tuesday, 05/13/2008 10:26:20 AM

Tuesday, May 13, 2008 10:26:20 AM

Post# of 257257
>VRTX – Would this not be a Reg-E filing?<

Subpart-E accelerated approval applies only to biologics; for small-molecule drugs such as Telaprevir, the corresponding FDA reg is Subpart H. The basic idea is the same, however.

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

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