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AngeloFoca

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AngeloFoca

Re: Samsa post# 17705

Friday, 09/16/2016 3:07:10 PM

Friday, September 16, 2016 3:07:10 PM

Post# of 38634

will they file the NDA knowing they cant meet that obligation of naming the manufacturer because they haven't inked a deal?

You seem to be implying that they have a choice.

It's my belief that they are required to demonstrate that they can produce commercial quantities using cGMP before approval is granted and that an FDA inspection is conducted to assure that.

It's an integral part of the approval process, as far as I understand it.

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