KIWI IMHO At this time the TDAPA is not something that should concern anyone and it does not affect the acceptance of the OLC NDA by the FDA. The only question left to be answered is: Will they submit the OLC using the originally submitted "third party supplier company or will they use a newly chosen vendor ?. They kept on mentioning before that they have alternative vendors. So which choice will they make and this time ?, and has the supplier been completely vetted to meet the FDA requirements. A second submission refusal would be a total disaster.
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