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Re: kevindenver post# 354496

Thursday, 03/17/2022 9:48:38 AM

Thursday, March 17, 2022 9:48:38 AM

Post# of 467072
Kevindenver

How regulatory agencies define the parameters of success for such expression is still to be determined.

2-73 is laying the groundwork for the design of future trials



Exactly correct, IMO a learning process is being lead here by AVXL with the undeniable truths of the MOA science in front of FDA and others. At some point they will abandon the Amyloid Plaque thesis and take up the AVXL MOA. IMO.

The change over must come from w/in the reg .bodies...probably lead by EU or Australia, IMO. FDA is going to be left w/(you know what) on their face as it becomes more and more obvious that the train has left the station. They must move w/urgency to save any kind of face.

Politics as they are will provide a buffer for FDA (being dragged Kicking and Screaming) into reality based science as the ROW builds steam. The sooner they drop their current AD model the better for all. A look back over the past 3 decades of poorly done FDA leadership is warranted, IMO.

Meanwhile, we have work to do.
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