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Re: $heff post# 52095

Monday, 02/27/2012 3:21:57 AM

Monday, February 27, 2012 3:21:57 AM

Post# of 97239
TLON..$.93 Accelerated Approval Dust begins to settle. Good article from Nov 2011.
http://www.nature.com/nrd/journal/v10/n11/pdf/nrd3580.pdf


"The higher the unmet need, and the fewer the patient options, the more willing the FDA is going to be to consider an accelerated filing."

The FDA has done this already for TALON. Remember that Ariad & ONXX were never given the accelerated approval "pathway" (subpart H) for their drugs.

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