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boi568

01/03/23 11:54 PM

#395885 RE: bas2020 #395883

This is not an example that will be followed any time soon. I am sure of that.

Part of FDA culture has been to follow scientific advice and ordinary procedure. The fact that these were ignored in the Aduhelm case tells you their internal value hierarchy. The scandal, though, has elevated those two values. So long as Anavex makes its case on the science -- which Missling already claims -- everything should be aligned for an approval.

The FDA is not going to get hung up on the particulars of an Odds Ratio versus a means test. That is trivial in light of the benefit at stake.

Mikesc

01/04/23 8:48 AM

#395917 RE: bas2020 #395883

Follow the $$$$$$... BP owns the FDA! Was never more obvious than this decision.