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Replies to #94805 on Biotech Values

DewDiligence

04/27/10 2:11 AM

#94806 RE: genisi #94805

Upon the April, 2008 expiration of the 30-month Hatch-Waxman stay, the prior FDA tentative approval of [Aricept] ANDAs could then be made a final approval.

Correct, but that 30-month stay pertained to a different patent. Why didn’t the FDA require the ANDA filers to make a Paragraph-IV certification on Eisai’s 4895841 patent?