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Re: cjrick01 post# 7385

Wednesday, 05/14/2014 10:09:09 PM

Wednesday, May 14, 2014 10:09:09 PM

Post# of 140476
They will get approval. But I'm telling you, you cannot count your chickens before theyre hatched. I deal with this regularly - granted on the drug side of the industry - but FDA approval does not come easily. I've worked on FDA audits of sponsor companies and research sites. Auditors are told not to stop an audit until they find a violation. They are regulators... you have to play their "game!"