I suspect @Micko22 has been paying close attention and doesn't appreciate being talked down to.
IMO the FDA has a long history of sabotaging pipelines and statistical trials in particular, and in an environment where it appears to me that the FDA is trying to waste our time, 12 months is not an unreasonable estimate but actually optimistic.
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I suspect @Micko22 has been paying close attention and doesn't...
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