They always said it was a 12 month process to do the work required.
What I think is new (and the only thing IMO) is that FDA have said they take up to 6 months to make their decision. That pushes the date from 2022 to 2023 potentially. Of course, FDA may not take 6 months.
I don’t believe any fundamentals have changed. I assume that management were not aware of how long the FDA takes.
Ann: Cyclopharm USFDA Update, page-11
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