Yes, I was somewhat crushed when I read that, it's in the hands of the FDA and it could take even longer than the usual.
I'm hoping that having Fast Track designation will help give it some priority. Also hoping that a sense of duty/obligation to the huge numbers of people suffering from OA, with current treatments being less than ideal, helps give the process some momentum.
Ann: Type D Response Submitted and Received by the US FDA, page-5
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