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DewDiligence

08/14/10 4:38 PM

#101628 RE: zipjet #101626

I do think there is irreparable harm and would find that element met.

An especially creative judge could devise a workaround such as ordering the FDA to grant priority review for a specified number of SNY’s future BLA/NDA filings. This is not as far-fetched as it sounds insofar as the FDA already issues priority-review vouchers to drug companies who conduct clinical studies desired by the FDA that the companies would otherwise not conduct.