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Re: nidan7500 post# 363161

Tuesday, 06/14/2022 10:07:59 AM

Tuesday, June 14, 2022 10:07:59 AM

Post# of 458278
An observation about the current CNS investment-management environment and how it may drive expectations/behavior.

The FDA seriously embarrassed itself recently w/the AD BIIB disaster. They not only showed poor(seriously flawed) technical reasoning skills but even worse management judgement on BP's overall skillset. Face it, 30 years is a long time to beat any horse, never mind the most important (Amyloid Plaque) one of their plate. No one has yet had the stones to come forward and either splain or apologize for decades of clinical incompetence and waste. Thirty years is a long time. Why didn't they GET IT? Billions wasted, millions dead and (worst of all) time is lost which can never be restored.

The FDA management process is now about to be hit between the eyes with an entirely new clinical reality by AVXL. All the required dots and a complete skill based patented process instruction needed to guide how they must be connected is about to be revealed by AVXL. Change is now finally inevitable. Some foot dragging, second guessing along w/political fog is expected. All they can do is manage time, everything else is out of their control. Changes are inevitable and they know it.

IMO, Dr.M. and team are obligated to walk the walk. WGT. AVXL R&D day is step one.
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