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Re: GaryJPalys post# 10367

Tuesday, 03/25/2014 8:46:28 AM

Tuesday, March 25, 2014 8:46:28 AM

Post# of 12450
I know they got a light CRL with mainly packaging and manufacturing issues. There was nothing wrong with the dosing and safety of product... Do they still need a new PDUFA date or can the FDA just approve them if they satisfy the other issues?
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