Not only is this a basic error in program management practices but it breaks all the FDA basic GMP requirements for how to manage any process.
Unbelievable incompetence that has gone untested for decades at FDA. They all need to be investigated/fined/fired. Where is the CAPA process...???Corrective and Preventive Action??? All being kept quiet and under the rugs@FDA.
The biggest , undetermined, looser and cost here have to do w/the DECADES NOW GONE-LOST, while the sloppy science folks continued to chase Amyloid Plaques as the people w/dementia/AD just waited in good faith for help.
When the TIME HAS GONE BY, IT IS LOST FOREVER. That is the Big loss here and nothing can be done.