Wednesday, August 17, 2022 10:33:40 AM
The pasted quote in your response is from you. It would be outrageous to think they are feigning intent to file an MAA before manufacturing cert decision. If your suggestion is they intend to file a vestigial MAA simply to get a manufacturing cert., that too would be outrageous and nearly certainly incorrect. If your point is simply you don’t have to file an MAA before a manufacturing licensing decision is made, wherein the basis of application is a new product, I still say you are incorrect.
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