It may be that the 'inactive' component takes away the time pressure of the regulations, I'm not sure. Cortex certainly seemed to be anticipating something for a while. As I mentioned, I don't think Cortex is worse off for not getting one, they may be better off, because the FDA's case is so flimsy that they'd have to jazz it up just to put it in writing--and that would make it more difficult to back off, if that were ever to come to pass.
I'm not aware of it happening before, but companies would not necessarily bring it up in public. I don't think it is neglect/incompetence per se--though the decision itself was incompetent IMHO. Now, it's more a case of--we aren't sure what to say, and there's no particular need to say anything, so why shouldnt we just move on to the hundreds of other things on our regulatory plate?
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