I don't trust the FDA not to come back with other issues. It reminds me of engineering. We would send drawings to the client to review and provide comments and if not comments then approve. Quite often they would provide a comment which we would address. We would then ask for approval only for further comments to come back from the client on a separate issue and so the loop continues. Will be a relieved man when we come out of TH with approval. Which is likely to be a TH on Friday and a weekend to stew waiting on the outcome.
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