I think we are looking for clear leadership actions by the FDA(Gottlieb). Many of us recall statements on leadership like..."Lead, follow or get out of the way"...my own favorite is..."Leadership s like pornography, it is hard to describe, but you know it when you see it".
Dr.Gottlieb is not leading. He talks the talk but does not walk the walk. He must show/declare the CNS trials and then he must ensure they actually happen.
I am fed up with Washington and the incompetence of this critical regulatory agency.
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