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Re: rudygerner post# 75010

Thursday, 09/14/2017 8:23:41 AM

Thursday, September 14, 2017 8:23:41 AM

Post# of 144814
Indeed! ...for good reason.

"...worst-case scenario would be if the FDA found an issue with the Master Cell Bank that could not be resolved and resulted in needing to manufacture the Master Cell Bank, Working Cell Bank and drug product again to the FDA’s satisfaction. This is why it is so important to make sure it is done right the first time.”

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