We are not talking about costs we are asking and commenting on whether the FDA will blow you off if you comply with their rigid process: The proposed preparation doesn't have to do the job it just has theoretically do no harm and have had other processes that allow it to get approved.
If this was a nod of approval why do so many fail after approval. Obviously you know everything there is to know. So then please explain rather than throwing your toys around. After all I thought this was a discussion forum.
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